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Sterilization manual for health centers

1. Hydrogen 2 heavdsdeseetssssearesvenss Formaldehyde aSa irsana iira General 5 3 Waste Manageme mt iios siise a eaa aaa Classifications aa Disposal and final treat Ment eeseceeseceeeeseeeeseeneeteseeteseeneeteneeteateneaees 5 6 510 r Recommended standards and practices for infectious WASTE Terms related to 2 Bibliography Se oe ee eer vill Introduction rior to World War Il the sterilization plant was the right hand of the operating room the dressing room where primarily female hospital auxiliaries met to fold gauze and prepare bandages During the postwar period the need for a medical and surgical sterilization plant emerged in all hospitals The plant s primary responsibility was the sterilization of instruments and devices but with time other functions were added Wenzel R 1993 Toward the end of the 1970s the following goal was proposed the objective of the sterilization plant is to provide a service to improve patient care and maintain high standards of medical practice It would also collaborate with hospital admini
2. Validating the sterilization Validation of the sterilization PrOCOSS ee seseseeseseseseseeesetesneeeestesseeneeeeeetees Validation of loads Components of sterilization validation Validation of the sterilization process by dry 127 Validation of the sterilization process by steam Validation of sterilization by ethylene Oxide cscs eee Validation of hydrogen peroxide Validation of low temperature steam formaldehyde LTSF Management areas and critical Summary of validation activities When should sterilization validation be Carried 133 Quality indicators for the sterilization 135 Criteria for verifying the effectiveness of the sterilization process 135 Criteria for sterilization Expiration time ccsseseceeseeteseeeeteseetesteneeeeeetenenenees 136 Criteria for adequate packaging of material to be sterilized sss 136 Criteria for safety the sterilization 1 Criterion for
3. 3 50 Opening techniques 51 Basic guidelines for disinfection and 2 53 Guideline criteria for disinfection or sterilization sssrin 53 55 6 0 16 55 Factors that affect the effectiveness of the disinfection 55 Disinfection methods csssrsussssnssnen niio EENEN Sann 56 Actions of different disinfectants ss sssssssssrrssssrrissrrersnrreenrninssrnensnreranrrensnrnnas 58 Recommendations for the use of disinfection 63 SteriliZatiOn issia E i 73 Nature of what is sterile 73 Factors that impact the effectiveness of sterilization 74 Resistance of MICrOOrQaNiSMS sssseesessssssesesureesesvnuuroeusnuunteoununereesvssueroessner eorne 75 Sterilization methodS 76 irisaren ireid 76 Dry NG abe 76 Moist heat or steam 51 79 Chem
4. Cytoplasmic antiseptic Glutaraldehyde 2 Chemical Alkylation of thermolabile sterilizer DNA RNA instruments Legend ppm parts per million B bacteria LV lipophilic virus HV hydrophilic virus M mycobacterium F fungus spore El enzymatic inactivation PD protein denaturation INA inactivation of nucleic acids Orthophthaldehyde This chemical agent is new and is used for high level disinfection HLD It cor responds to the group of inorganic aldehydes and contains benzenecarboxalde hyde 1 2 Mechanism of action it causes the alkylation of cellular components and acts directly on nucleic acids Spectrum Studies have demonstrated its excellent microbicidal activity and higher activity than glutaraldehyde for mycobacteria It is a mycobactericide and viricide Advantages and disadvantages The principal advantage is that it has excel lent stability in a broad range of pH 3 9 and as a result does not require activa tion It also has excellent compatibility with any type of material or article and has chemical indicators It is not carcinogenic but it is recommendable to use this compound in ventilated areas since it still has not been determined if it can pro 58 Desinfection duce irritation in the eyes and nostrils At this time its high cost seems to be the principal disadvantage for its use Instructions for use The time required for high level disinfection varies
5. 39 40 Bibliography dispersion of resistant microorganisms in the hospital JAMA January 17 1996 275 N 3 234 240 Gottardi W Yodo and composed of iodine In Block Disinfection sterilization and preservation Pennsylvania USA 4 ed 1991 152 66 Greene JJ Sterility Assurance Concepts Methods and Problems Oxford Black Well 1992 605 30 National Institute of Epidemiology Society Argentina of Infectious Diseases Association Argentina of Nurses in Control of Infections Society Argentina of Pediatrics II Ontrol National meeting of Standards for the C of the Hospital nfecciones December 1995 IFIC International Federation of Infection Control Education program for infection control Basic concepts and training hands washing and decontamination England 1995 12 15 Larson E y col Alcohol for surgical scrubbing Inf Control Hosp Epidem 1990 11 130 38 Low Temperature Sterilization alternatives in the 1990s Philip M Schneider Tappi Journal Vol 77 N 1 January 1994 Malchesky Paul S Use of Paracetic Acid as a Sterilant D Eng Steris Corporation 5960 Heisley Road Orlando Florida 1999 Martin MA Reichalderfer M APIC Guideline for Infection Prevention and Control in Flexible Endoscopy Am J Infect Control 1994 22 19 38 Ministry of health of the Nation Argentine Republic Guide of Procedures and Methods of Sterilization and Disinfection for Health Facilities Buenos Aires Argentina May
6. 113 Sterilization manual for health centers Integrating indicator Class V These are indicators designated to react to all of the critical parameters of the autoclave sterilization process temperature time quality of the steam within a specific interval of the sterilization cycle These indicators are much more precise than those in Class IV They should be used inside each package as an internal indicator Simulation indicators for cycle verification Class VI These are also known as simulation indicators since they are designated to react to all critical parameters within a specific interval of specific steriliza tion cycles They function when 95 of the specific cycle has concluded Their performance and reading is similar to Class V integrating indicators Specific indicator Bowie Dick Test Class 11 This is a method for evaluating the effectiveness of the vacuum system in the pre vacuum autoclave Its purpose is to demonstrate the absence of air or other uncondensed gases in the sterilization chamber that can impede the rapid uniform penetration of steam within the load The test package will be formed by pure cotton cloths or towels folded so that they reach the measure of 30 x 22 x 25 cm and an approximate weight of 6 5 kg A Bowie Dick test sheet will be placed in the center of the package and everything will have its corresponding packaging This package will be placed in the lower part of the chamber near
7. Sterilization manual for health centers Criteria for selecting a packaging system Since the market offers many products it is necessary to first evaluate and select the product that fulfills the majority of needs The principal purpose of any packaging material is to hold the objects maintain the sterility of the content and provide an aseptic presentation At the same time it should be economically effective and cost saving for the institution The following criteria can be helpful when choosing a suitable efficient packaging material Porosity permeability The packaging material should make it possible for the sterilizing agent to penetrate and leave the package while also providing a highly effective bacterial barrier The flow of air or permeability is expressed in liters per minute every 100 cm Air flow is necessary for ensuring the sterility of the contents the package A lower measure is equivalent to lower air flow and a higher measure means that the result will be better more sterile Good penetration of steam and ethylene oxide for example allows the achievement of improved sterility conditions in the materials On the other hand kraft crepe parchment and other similar types of paper are closely woven and do not allow adequate flow of the steam or gas used A very simple test is to exhale cigarette smoke through an unwoven cloth and repeat the experience with a piece of paper This will make it possible to obs
8. can certain disinfectants contrast media drugs etc be aggressive and incapacitate reprocessing As a result the requirements that should be met in order to reuse single use medical devices are Cleaning The design and manufacture of a device should permit the cleaning of all surfaces Cleaning is defined as the total removal of all visible dirt from the surfaces crevices joints and lumens of the device For the cleaning procedu re enzymatic cleaners brushes and or automatic cleaning equipment should be used in order to remove the dirt from all contaminated surfaces without leaving toxic residues or causing damage to the device Inspection Following cleaning tests of functionality and physical integrity should be carried out in order to confirm that the device is safe to be reused The level of inspection will depend on the complexity of the device and its later use The inspection process can be by a simple visual check in order to ensure that all visible dirt has been eliminated and or by a complex process that requires adequate equipment Packaging The same quality of packaging that was used for the original product should be used at this stage taking into account that the device will ex perience a subsequent sterilization process Sterilization The sterilization process should demonstrate a sterility safety coefficient CSE of 10 the coefficient that is accepted for devices that will have contact with tissue Ethylene oxi
9. Sterilization manual for health centers Authors Silvia I Acosta Gnass Valeska de Andrade Stempliuk USAID 07 FROM THE AMERICAN PEOPLE oe PAHO HQ Library Cataloguing in Publication Pan American Health Organization Sterilization Manual for Health Centers Washington D C PAHO 2009 ISBN 978 92 75 12926 5 I Title 1 STERILIZATION instrumentation 2 DESINFECTION methods 3 CROSS INFECTION prevention amp control 4 MEDICAL WASTE DISPOSAL standards 5 HEALTH EDUCATION standards 6 GENERAL CLEANING PRODUCTS 7 HANDWASHING NLM WC 195 Copyright 2009 Pan American Health Organization Publications of the Pan American Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention All rights are reserved The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the Pan American Health Organization concerning the status of any country territory city or area or of its authorities or concerning the delimination of its frontiers or boundaries Material in this publication may be freely quoted reprinted or translated totally or in part provided proper credit is given and it is not used for commercial purposes The opinions expressed in this document are the authors and they do not necessaril
10. b Technique In a 5 000 ml flask add one part of 70 alcohol propylene glycol and glycerin and shake well until it is totally uniform Complete the volume with 70 alcohol Finally add the stain and mix well until the color is uniform Then divide up Formulation for alcohol solution IV a Ingredients 70 Alcohol 250 ml 1000 ml Glycerin 8 32 ml Patent blue stain 1 drop 1 drops b Technique In a 250 ml or 1 000 ml flask add one part of 70 alcohol Dissolve the glycerin in the alcohol Complete the respective volume with 70 alcohol Add the stain Mix softly until the color is uniform Then divide up 15 Sterilization manual for health centers Utilization of hand washing products If the soap is in bar form cut it into small pieces and discard after each use If the soap is in dispensers these should preferably be disposable If the container is not disposable it should be emptied every 24 hours and washed rinsed and dried before filling it again with new soap This practice is difficult to control and epidemics due to contamination of soaps in filled containers have been documented even when the soaps are antimicrobial Some common soaps have an added chemical agent that conserves the soap but does not have any type of antiseptic action Sinks for hand washing should be deep and wide with smooth non po rous surfaces that are made of stainless steel insofar as it is possible since this is a high qualit
11. Denton G W Clorhexidina In Disinfection sterilization and preservation 1991 274 89 4 ed Pensylvania USA Disinfection Sterilization and Waste Disposal Cap 27 pag 563 564 en Wenzel R Prevention and Control of Nosocomial Infection Williams and Wilkins 1997 Sterilization of Health Products European Society for Hospital Sterile Suply Heart Consultancy 1999 10 8 183 Ethylene Oxide use in Hospital A Manual of Health Care Personnel National Occupational Health and Safety Commission Work safe Australia 1992 European Standard EN 866 Biological Systems for testing sterilizers and sterilization processes Part 2 Particular systems for use in ethylene oxide sterilizers European Committee for Standardization 1997 Favero M S and Bond WW Chemical Disinfection of Medical and Surgical Materials In S S Block Ed Sterilization and Preservation 4 Ed Philadelphia Lea y Febiger 1991 Pag 617 641 Favero M Disinfection practices for endoscopes and other semicritical items Infect Control Hosp Epidemiol 1991 12 N 5 Food and Drug Administration FDA Guidance on Premarket Notification 510 K Submissions for Sterilizers Intended for Use in Health Care Facilities Infection Control Devices Branch Division of General and Restorative Devices Rockville MD March 1993 Goldman D et al Strategies to prevent and control the emergency and 164 26 27 28 29 30 31 32 33 34 35 36 37 38
12. Do not use an oily substance for lubrication Do not allow a worker with any type of dermatological lesion to carry out this activity General principles of packaging This refers to objects that are sterilized and later stored such as instruments drapes accessories or devices The purpose of any type of packaging system is to hold these objects and protect them from contamination by dirt dust and microorganisms The package should preserve the sterility of its content until the time it is opened which is when it will be used in a sterile area Some materials undergo high level disinfection and are stored for later use such as laryngoscopes and anesthesia masks After the disinfection process these materials should be kept in a simple plastic bag in order to avoid their recontamination The packaging material selected and used should maintain the sterility of the package contents after sterilization The preparation and conditioning of packages should be carried out in such a way that the sterilization process is effective e g the sterilizer ethylene oxide steam or dry heat should have the capacity to penetrate the package and make contact with the object to be sterilized The objects should be packaged in such a way that the wrapping can be opened and the object removed without contamination and while maximizing the convenience of the user The preparation and content of a package should respond to the need for use ease of
13. For sterilization by dry heat Metal boxes should not contain more than 30 articles It is not recommendable to use boxes made from common aluminum since they can release aluminum particles into the instruments at high temperatures Techniques or procedures for preparing packages Envelope type e Position the material diagonally in the center of the packaging e Place the internal chemical indicator or integrator in the center of the package e Fold the end facing the person who is preparing the package in such a way that it reaches the center of the package and covers the article e Then make a fold with the point facing outward e Fold the sides into the center of the package in the form of an envelope always making a fold at the point Carry out the same procedure on the other side so that they both cover the article e Complete the package by lifting the fourth and final point toward the center of the package and seal the entire package with process indicator tape e The control tape should not measure less than 5 cm 47 Sterilization manual for health centers Rectangular type of surgical clothing e For quality implementation of surgical activities it is important that the surgical textile material be prepared in packages that contain the quantity of articles that are necessary for the type of intervention to be performed e Taking into account that the sheets compresses and scrubs are dense enough to serve as a barrier to pe
14. The reading instrument should be exact which is why it is necessary to calibrate it periodically The sterilization process is complex We can discuss a degree of reliability in the processed material only when strictly respecting the conditions involved in each stage Sterility cannot be ensured only through tests It is obtained through a system of total control throughout the process A good infection control program involves the continuous validation of the conditions of the process Validation can be defined as a systematic documented study that provides a high degree of certainty that a procedure piece of equipment process material activity or system will actually behave within certain predefined limits The validation and observation of good manufacturing practices are the fundamental pillars of quality assurance In order to obtain sufficient safety the program should include adequate training of personnel and adequate preparation of the location the equipment and the system for circulating materials Equipment should also be adequately monitored The air filters the water for washing the measures of biosafety the physical plant the clothing of the personnel the quality of the steam etc also integrate quality control The Bowie Dick specific indicator test is carried out before the first sterilization cycle each day and for each steam autoclave with a standard package according to predetermined standards
15. related to the events that it experiences 103 Sterilization manual for health centers In 1993 AAMI established Shelf life The shelf life of a sterile material will depend on the events the quality of the packaging the storage conditions the transport conditions and the number of times handled Expiration date The items that should be used when sterile should be labeled with a lot number a control date for rotation of stock and the following message This product is not sterile if the package is opened damaged or moist Please review before using Furthermore different studies have demonstrated that correctly packaged materials can remain sterile indefinitely Regarding storage we should also take into account that closed shelves are for storing articles or packages that have low rotation and that open shelves are for articles or packages with high turnover Calculation of the shelf life of a package For general guidance we have reproduced a table for the estimated calculation of the shelf life of a package including an explanatory example First package 20 40 40 80 100 100 with filter Second package 60 80 80 100 120 250 If the material has protective wrapping in addition to the packaging then add the following points Sealed polyethylene bag 400 Protective container or wrapping 60 104 Handling transporting and storing materials According t
16. the effectiveness is E n m After sterilization the average number R of microorganisms per object is equal to R CoxV orS x10E Where R also represents the probability that an article is non sterile or the risk of non sterility of the article R should be as small as possible R is never null The European and American pharmacopeia have set 10 as the maximum limit for the risk R of non sterility Sterility of a lot of medical articles is a relative notion According to analytical techniques this is the level of quality that should be analyzed for 1 million sterilized articles Factors that impact the effectiveness of sterilization processes Factors that affect the effectiveness of sterilization processes are e number of microorganisms e organic matter e time e temperature e relative humidity e standardization of the load Keene 1996 and Rutala 1993 described these factors which should be taken into account in order to carry out an adequate sterilization process Number of microorganisms Co This is a fundamental factor since it is one of the two factors that measure the effectiveness of different sterilization processes The R or D value refers to the time needed for the sterilization method 74 Sterilization to achieve elimination of 90 of the microorganisms It is used to evaluate the different methods Organic matter S The presence of organic matter hinders the elimination of microorganisms but is
17. urinals and bedclothes and disinfection standards which are always available for their review thermometers Non critical Phonendoscopes Intermediate level and low Concurrent disinfection They only come into contact sphygmomanometers and level disinfection Personnel daily and terminal with healthy skin sleeves as well as objects are informed about cleaning disinfection at discharge of patient Separation of clean objects and materials from dirty ones 54 Disinfection isinfection is the physical or chemical process that eliminates vegetative microorganisms from inanimate objects without ensuring the elimination of bacterial spores Every semi critical article that cannot be sterilized should be disinfected according to the guideline criteria and the validated protocol Levels of disinfection These levels are based on the microbicidal effect of the chemical agents on the microorganisms and can be High level disinfection HLD This is carried out with liquid chemical agents that eliminate all of the microorganisms Examples are orthophthaldehyde glutaraldehyde peracetic acid chlorine dioxide hydrogen peroxide and formaldehyde among others Intermediate level disinfection ILD This is carried out using chemical agents that eliminate vegetative bacteria and some bacterial spores This includes the phenol group sodium hypochlorite cetrimide and benzalkonium chloride Low level disinfe
18. If they are small packages they should be placed in drawers or baskets It is recommend ed that the storage containers not be wooden e They should be located at a minimum distance of 30 cm from the floor 45 cm from the ceiling and 5 cm from the wall e The material should be far from sources of moisture or heat e Air exchange should be carried out in such a way that it meets 10 changes per hour e The presence of steam plumbing potable water or wastewater should not be permitted in this area e There should be an adequate level of illumination e The material should be placed in a position that makes it simple to label and visualize the expiration date indicated on the container e Materials should be grouped homogeneously well differentiated and whenever possible placed vertically e Other materials should not be touched when removing the one that is needed e They should be identified 102 Handling transporting and storing materials Every container when being stored and prior to being released should be inspected in order to verify that it meets the requirements of a sterile product Shelving and cabinets for storing sterile products should always be in op timal conditions in terms of order and cleanliness Requirements that the storage location should fulfill It should be large enough for the amount of material that needs to be stored there The walls should be smooth and easy to clean It should have adeq
19. In a previously published study Reichert 1985 industrial practices were emulated and thirty devices in three samples of ten were tested For example if the MD will be reused twice a sample of thirty MD should be tested after each level of use for a total of sixty tests This test is focused on cleaning and the sterilization process Analysis of the sterilization process The effectiveness of the cleaning procedure can be demonstrated with MD after they are used in clinical procedures These stained devices should be cleaned using the procedure developed 141 Sterilization manual for health centers The first phase of analysis at each level of re use is a visual inspection of the device after cleaning it This inspection is carried out to verify that all visible dirt has been removed Small lumen devices like catheters should be cut and opened in order to examine the internal lumen If the device is not visibly clean the cleaning procedure should be repeated until acceptable results are obtained The second phase of analysis once the effectiveness of the cleaning procedure has been verified is the test of the sterilization process At each level of re use the devices are cleaned prepared and sterilized After sterilization the MD is sent to the microbiology laboratory where bacterial sterility is confirmed by culture The sterile culture medium should be placed in contact with all of the surfaces of the MD Devices that are lumens
20. SP should have easily accessible emergency exits water shower or bath should be available in the case of a spill with eth ylene oxide or other chemical substances Chemical hazards With regard to the prevention and treatment of the chemical risks detailed above it is recommendable to take into account e When glutaraldehyde EtO FO and hydrogen peroxide are used we should consider well ventilated environments personal protection according to possible contact gloves goggles mask the use of chambers designed to prevent exposure and automated equipment e Inthe case of sodium hypochlorite it should never be mixed with ammonia 151 Sterilization manual for health centers substance that is used to clean toilets e Inthe case of an EtO leak some people are able to detect the leak if there is a sweet odor it can cause signs of eczema and pruritus In this case the area should be evacuated and ventilated immediately and an expert should be contacted In addition the gas should be eliminated with pulver ized water and the water jets should not be allowed to drip e When FO and glutaraldehyde are used environmental control is im portant Biological hazards Biological hazards occur when there is contact with contaminated materials and when both infectious and noninfectious waste of human origin from isolation areas is handled such as tissues and bodily fluids including blood and plasma Other hazards derive
21. achieve good antiseptic action Below are four formulations of alcohol solutions that can be selected according to their convenience and availability at the health center Formulation for alcohol solution a Ingredients 96 Ethanol 833 33 ml Glycerol 98 14 5 ml Hydrogen peroxide 3 41 7 ml Distilled or boiled water that has been cooled q s 1 000 ml Technique In a 1 000 ml flask add the ethanol glycerol and hydrogen peroxide Fill up to 1 000 ml with distilled or boiled water that has been cooled Shake the flask softly in order to mix the content Divide up This formulation leads to the following final concentrations ethanol 80 v v glycerol 1 45 v v and hydrogen peroxide 0 125 v v 14 Hand washing Formulation for alcohol solution II a Ingredients Isopropyl alcohol 99 8 751 5 ml Glycerol 98 14 5 ml Hydrogen peroxide 3 41 7 ml Distilled or boiled water that has been cooled q s 1 000 ml b Technique In a 1 000 ml calibrated flask add the isopropyl alcohol glycerol hydrogen peroxide and distilled or boiled water that has been cooled Shake the flask softly in order to mix the content Divide up This formulation leads to the following final concentrations isopropyl alcohol 75 v v glycerol 1 45 v v and hydrogen peroxide 0 125 v v Formulation for alcohol solution III a Ingredients Propylene glycol 161 3 ml Glycerin 250 ml Patent blue stain 1 V drops 70 Alcohol q s 5 000 ml
22. and multiple germicidal agents exist in liquid form This method requires many controls during execution Since it is a method that is carried out for the most part manually all stages of the protocol recommended by the manufacturer and validated should be followed closely Deficiencies in the disinfection process can result in serious infectious or inflammatory complications in patients who come into contact with these articles The principal disinfectants used in the hospital area are orthophthaldehyde glutaraldehyde chlorine and chlorinated compounds formaldehyde hydrogen peroxide peracetic acid phenols and quaternary ammoniums It is important to mention that not all disinfectants are available in all countries 57 Sterilization manual for health centers Actions of different disinfectants Chlorine 2 1000 Intermediate PD INA floors 100 ppm low lodine 30 50 ppm Intermediate RP hemoculture bottles medical devices Hydrogen 3 25 Intermediate he ROH contact lenses peroxide Alcohols 60 95 Intermediate PD thermometers endoscopes external surfaces Phenols 0 4 5 Intermediate El low Quarternary 0 4 1 6 Low EI PD floors furniture ammoniums Peracetic 0 001 0 2 High Oxidant dialysis acid equipment Chlorhexidine 0 05 Low
23. associated with installation by the service provider and includes the calibration of measurement and control elements documentation plans and work instructions Operational qualification OQ This is the crucial phase of fine tuning the process during which its robustness and reliability when facing the worst cases should be demonstrated Provisional or functional qualification PQ This final phase examines the replicability of the process including the precise formation and qualifications for its operations and work instructions that are definitive and put into action 125 Sterilization manual for health centers Validation of the sterilization process Installation qualification Qualification of the 3 Operational qualification equipment Provisional or functional qualification Parameter tests Qualification of the load Microbiological tests Others The validation process consists of verifying in a certified and sufficiently documented manner that a process meets the requirements for which it was designed In the case of sterilization labeling a health product with the word sterile is only permissible when a validated sterilization process has been used As a result validation should consist of the following points e Installation qualification e Operational qualification e Process qualification e Documentation e Case fatality calculation e Validation report and certific
24. be processed by moist heat Disadvantages requires long exposure periods is a difficult process to certify or validate and accelerates the process of destruction of the instru ment Basic principles to prevent errors Validate the equipment and ensure the efficient calibration of the instru ments Sterilization will be efficient when the coldest point registers 170 C after two hours of exposure As a result the user should have precise informa tion The selection of the packaging material should be made based on its ther mal conductivity Textiles or paper should not be sterilized or used Burden sharing Make sure that the packages do not touch the walls and that there is sufficient space between each package in order to obtain good circulation Adequate packaging materials such as metal boxes and refractory glass jars should be used Carry out chemical and biological controls in order to guarantee the effec tiveness of the process Moist heat or steam sterilization Steam sterilization is the most common sterilization procedure except for materials that cannot resist heat and moisture The equipment used is called an autoclave The action mechanism for moist heat is the denaturation of proteins This method should be considered as the top choice whenever the materials permit it It has the advantages of rapidly producing elevated temperatures having short sterilization times and not leaving toxic waste in
25. contained in the waste receptacles should be closed with a safety seal to prevent accidents They should then be placed in other receptacles identified as pathological or common waste for their transportation and circulation through the institution All waste receptacles should be washed once a day and whenever they are visibly dirty This should be done in the sector designed for that purpose The waste receptacles located at the nursing stations should be used for large quantities of pathological waste for example major treatments No waste receptacle should exceed its content Waste storage This is the place where waste will be placed temporarily This location should be adequate for this function and should guarantee its temporary isolation personal protection and environmental safety This sequence has three stages e Primary storage This is carried out in baskets equipped with plastic bags e Intermediate storage This is carried out in larger size containers where the bags will be placed after removing them from primary storage and until being transported for their final storage and treatment These are restricted access areas in order to avoid contact with the general public e Final storage This is the physical space where the waste generated in the establishment s different services is deposited until the time it is removed for final treatment and disposal 156 Waste management Recommended standards and practices for
26. delays deterioration or losses received by the SP per month x 100 No of sterilization loads carried out during the month Quality standard less than 1 138 Re use of a single use medical device e used is currently understood as the repeated use of any medical device including those that are reusable or labeled as single use with the corresponding reprocessing between uses Reprocessing is understood as all the operations necessary for reusing con taminated single use or reusable materials The steps include cleaning func tional testing packaging labeling and sterilization The reuse of single use medical devices MD should be authorited by specific national regulation Despite this the practice of re use in many health centers is indiscriminate and disobeys regulations in the majority of cases due to ignorance The situation that countries experience suggests the need to implement a re use program that is sustainable over time When intending to re use a single use MD one should first demonstrate that there will be savings This should be done while also evaluating operational issues such as the functionality and integrity of the MD the risk of infections the risk of endotoxic reactions personnel safety and legal and ethical responsibility Manufacturers of MD that are labeled as single use maintain the position TO NOT RE USE alleging that the products have not been designed or validated by clinical
27. infectious waste management All infectious waste should be discarded separately from other waste Infectious waste should be discarded as close as possible to the site where it was generated Infectious waste should be contained in red plastic bags common waste in black plastic bags and sharps in rigid containers The micronage of the bags should be 40 to 60 microns for small bags 60 to 80 microns for medium bags and 100 to 120 microns for large bags The sizes should be analyzed and adapted to the quantity of waste that is generated by the sector or service These bags should be closed tied firmly and collected by housekeeping personnel when they full The use of a double red bag is not routinely required Prior to contact with excretions blood and bodily fluids personnel should put on gloves as stipulated in the standard precautions Hands should be washed completely after removing the gloves Sharp elements should be discarded in rigid containers provided in the nursing units Needles should not be recapped bent or broken Patients should be encouraged to discard dirty paper tissues in bags or receptacles located next to the bed Dressing changes should be carried out using aseptic techniques and dirty dressings should be discarded in a red plastic bag that is closed prior to discarding The infectious waste generated during the treatment of patients who re quire isolation precautions should be placed in receptacle
28. levels of waste for EtO and by products Implant Small 10 g 250 ppm 100 ppm 25 ppm Environment 10 g to 100 g 250 ppm 100 ppm 25 ppm Large gt 100 g 5 000 ppm 2 000 ppm 500 ppm Intrauterine device 5 ppm 10 ppm 10 ppm Intraocular glasses 25 ppm 25 ppm 500 ppm Devices in contact with mucous membrane 250 ppm 250 ppm 5 000 ppm Devices in contact with blood and tissues 25 ppm 25 ppm 250 ppm Devices in contact with skin 250 ppm 250 ppm 5 000 ppm Sponges for surgical washing 25 ppm 250 ppm 500 ppm Source Federal Registry 43 no 122 23 June 1978 United States Integrity and functionality of MD As a final step in the design of the protocol it should be demonstrated that the reprocessed MD is functionally similar to the original MD The test should aim to confirm the specific characteristics of the MD For example if a MD needs to have flexion during regular use a demonstration that it can be folded would be important 143 Environmental cleaning and disinfection of the sterilization plant he environmental cleaning and disinfection of the sterilization plant should be carried out daily Floors and horizontal work surfaces should be cleaned at least once a day Other surfaces shelves ceilings windows walls should be cleaned periodically according to the regular program created by the supervisor During the cleaning procedure personnel should be very careful to not alter the i
29. n order for the sterilization procedure to be correct the following points should be taken into account The chamber should be in a perfect state of cleanliness Burden sharing should permit the free circulation of the sterilizing agent in the chamber Each package should be separated from its neighbors and it should not be in contact with the walls floor and ceiling of the sterilizer The load of the sterilizer should be constituted preferably by similar materi als and should not surpass 80 of the total capacity of the chamber Daily care of the sterilizer Remove lint and sediments on the meshes with a brush It is through the meshes that air and condensation are removed e All accessible surfaces of the cart should be washed with a damp cloth using a smooth detergent moving from the top down The baskets should be cleaned last All objects that are sterilized by steam should be adequately wrapped or packaged with the corresponding indicator When the cart is loaded unloaded use the following instructions Place all of the packages on their side and arrange the load in the chamber so that resistance to the passage of steam through the load is minimal Place the instrument trays on the side with the longer side on the shelf In mixed loads where there are textiles place large equipment on the lower shelves This prevents cloths from getting damp if condensation drips from the equipment Do not overload the shelves or com
30. of the process even when they operate at 80 Sterilization the same temperature as gravity displacement sterilizers 121 C or 132 C It represents a much more efficient system than other systems The advantage of this system is that the penetration of the steam is practically instantaneous even in porous materials Furthermore with this method sterilization periods are shorter due to the rapid removal of air both from the chamber and from the load and due to the higher temperature to which it is possible to expose the materials Autoclaves with a vacuum pump function at temperatures of 121 C 132 C in periods that last 4 to 18 minutes Instantaneous flash autoclaves These are special high speed sterilizers that are usually located in the operating room in order to process unwrapped instruments and instruments for extremely urgent use These sterilizers operate at 134 C for 3 to 4 minutes This sterilization method should be avoided since the material is sterilized without packaging and the cycle eliminates drying As a result the possibility of recontamination of the material increases Components of a basic autoclave A steam sterilizer has the following principal components High pressure vessel with attached cover The solid container or vessel where water will be heated using pressurized steam is called an autoclave The space where the objects to be sterilized are placed is called a sterilizing chamber In order t
31. one of the most easily modified factors These two factors Co and S justify the importance of CLEANING prior to sterilization in order to always guarantee a reduction in the risks that affect the sterilization process Time This is another factor that is used to evaluate the performance of sterilization methods Value F is the time needed for a suspension with a temperature of 121 C to eliminate all bacterial spores It is also used as a reference value in the evaluation of sterilization methods Temperature An increase in temperature during a specific sterilization process increases its effectiveness when the level is higher than the optimal temperature needed for the growth of a microorganism This usually induces microorganism death Relative humidity RH RH is defined as the fraction of water vapor pressure a system with respect to another system at maximum pressure 100 saturated and at the same temperature Higher relative humidity is associated with higher water content in the cells or spores and a better faster end sterilization result Standardization of the load Packages should meet the international standards for measurements 28 x 28 x 47 cm and types of packaging The load to be sterilized is very variable It can change with regard to the number and size of instruments the volume of the load and the content of the packages It is important to standardize the sterilization processes according to the different article
32. only strict adherence to disinfection and sterilization guidelines can guarantee the safe use of invasive and non invasive medical surgical instruments Therefore the purpose of this publication is to facilitate the uniform application of practices that ensure the correct sterilization of these materials and equipment The publication is targeted at the technical personnel who are responsible for these processes and in turn for guaranteeing the prevention of hospital acquired infections From within these pages PAHO would like to extend an invitation for the critical reading of this manual so that its implementation can be adapted to the different realities of health establishments Each establishment should have written procedures that detail the processes that are used locally and that meet national regulations Thanks to the collaboration of the authors Silvia Acosta Gnass and Valeska de Andrade Stempliuk this manual is available to bring about a positive impact on patient safety and on the safety of health professionals V Jarbas Barbosa da Silva Jr Area Supervisor 5 Health Surveillance and Disease Prevention and Control FROM THE AMERICAN PEOPLE This publication was possible thanks to funding and support from the Office of Sustainable Regional Development Office for Latin America and the Caribbe an United States Agency for International Development according to what was agreed upon in the subsidy L
33. organic and inorganic dirt or any other foreign material 159 Sterilization manual for health centers e Contaminated this refers to every surface moving or unmoving that it is known to house microorganisms e Decontamination this is the process for the removal of pathogenic mi croorganisms from objects and equipment in order to make them safe for handling e Disinfection this is the process by which the majority of pathogenic mi croorganisms with the exception of bacterial spores are killed or destro yed Disinfectants are used on inanimate objects e High level disinfection disinfection process that kills vegetative bacteria tubercle bacilli fungi and viruses but not necessarily a high number of bacterial spores e Intermediate level disinfection disinfection process that kills vegetative bacteria the majority of fungi tubercle bacilli and the majority of viruses but does not kill resistant bacterial spores e Low level disinfection process that kills the majority of vegetative bacte ria some fungi and some viruses but does not kill Mycobacteria or bacte rial spores e Terminal disinfection process through which an area or object is disin fected after some type of contamination has occurred e Ethylene oxide gas highly inflammable toxic gas capable of sterilizing an object e Fungicide chemical agent capable of killing fungi e Germicide chemical agent that destroys microorganisms It may destroy pathogen
34. possibilities of recontamination This can only be used for heat resistant devices because thermosensitive material does not tolerate temperatures of 93 C Water quality is important for guaranteeing the effectiveness of the process Considerations for the washer disinfector Surgical instruments or critical devices emerge ready for packaging and sterilization Semi critical devices e g respiratory assistance are ready for use at the conclusion of the process This type of cleaning replaces manual cleaning The water used in the disinfection stage should undergo microbiological controls and should be free from Pseudomonas aeruginosa Legionella and atypical mycobacteria 24 Cleaning of materials Technique Place the instruments in the equipment making sure that all parts are in contact with the stream of water The instruments should be open and the operator should make sure that larger sized instruments do not impede the smaller instruments contact with the water The water should circulate freely throughout the machine Cycle Cold rinse water at 25 C 3 minutes 2 times Wash with detergent see table below Alkaline 60 C 5 minutes Enzymatic 40 C 10 minutes Neutral 50 6 7 minutes Adapted from http www wfhss com index_en htm Hot rinse water at wash temperature 3 minutes 2 times Disinfection water at 93 C 10 minutes 1 time Drying follow manufacturer recommendations for the e
35. presence of organic matter or dirt on the materials This applies for example to oil or fat for cases in which the microorganisms are protected from heat based action Dry heat penetrates slowly in materials which means that long exposure periods are required Hot air is not corrosive but the process is slow It is usually used at 170 C for 60 minutes or 150 C for 150 minutes This system eliminates microorganisms through coagulation of the proteins in the microorganisms Its effectiveness depends e the diffusion of the heat e the quantity of heat available and e the levels of heat loss 76 Sterilization Types of stoves or Poupinell There are two types of stoves that are commonly used the gravity convection stove and the mechanical convection stove forced air circulation Gravity convection stove This stove consists of a covered chamber with electric resistance on its interior wall and a channel or orifice for air drainage on its upper wall Circulation depends on the currents produced by the rise in temperature and shock due to differences in temperature For these reasons its process is slower and less uniform Mechanical convection stove This stove has a device that produces the rapid movement of a large volume of hot air facilitating the transmission of heat directly to the load or package Less time is used and it offers thermal balance Instructions for use e only be applied when materials do not s
36. should be sterilized by dry heat Sterilization with gaseous chemical methods should be carried out in chambers with automated cycles that provide safety for the user and guarantee the processes Sterilization by immersion in liquid chemical methods which are carried out manually will always be the last method of choice These processes are difficult to control have major possibilities of recontamination during rinsing or drying and do not allow for storage The sterility of a medical instrument cannot be guaranteed if the instrument does not enter the sterilization process following prior cleaning Our objective is to obtain sterile inputs that can be used safely with the patient Nature of what is sterile Risk of non sterility the sterile or non sterile state of an object cannot be shown through conventional analytical techniques This condition can be estimated by calculating the number of residual microorganisms that exist in an article subject to a given sterilization method The residual number depends on Initial contamination Co concentration volume or mass of the articles that will be sterilized Volume V or Surface S of the articles that will be sterilized Effectiveness E of the sterilization expressed in the number of decimal 73 Sterilization manual for health centers reductions For example if sterilization has permitted the reduction of the initial population of 10 microorganisms to a population of 10
37. such as catheters have to be cut and opened to make sure that the culture medium is in contact with all surfaces Results f there is no growth the test confirms that the cleaning procedure was sufficiently effective for reduce the microbial charge to a level that can be destroyed during the sterilization process If there is growth the procedure should be repeated and the MD reexamined Frequency of the analysis The test should be carried out initially when the product changes e g another manufacturer when the process equipment is modified or changed or when the cleaning agents are changed Analysis of pyrogens The test of pyrogens should be used for any product that comes into contact with blood and bodily fluids and as a result could contain bacterial endotoxins that cause a pyrogenic response Products like catheters can be visibly clean and sterile and still be hazardous to the patient due to high pyrogen levels Limulus amebocyte lysate LAL analysis is used to determine the endotoxin level and is available in a commercial kit Sample size A sample size of 10 MD for each level of re use should be carried out in order to test for the presence of pyrogens when developing the preliminary protocol Waste analysis Although there are no standards for waste levels the standards published by the FDA have been used as acceptable standard levels for the industry 142 Re use of a single use medical device Recognized acceptable
38. that the machine is equipped with the adequate technical doc umentation installation plans technical operational user manual etc e OQ Operational quality This consists of verifying that the sterilizer s diffe rent measure and control elements function correctly and within the ranges specified by the manufacturer Furthermore it aims to verify that the tem perature distribution in the chamber is uniform and within the parameters designated by the standards To achieve this the following steps should be taken Calibration of the regulation and control elements Carry out a cycle with the Vacuum test Carry out a cycle with the Bowie Dick test Implement three thermometric tests in an empty chamber in order to obtain the temperature profile at all points of the chamber e PQ Process quality This procedure documents that the parameters of temperature pressure and case fatality reached within the load throughout the sterilization process and in repeated cases are within the criteria defi ned by the country s standards The quality of the process is demonstrated by carrying out three thermo metric tests for each type of load and obtaining the temperature profile at all points for each one This verification ensures that the parameters of temperature pressure and case fatality are within the parameters de signated by the country s standards Technique and material This validation should be carried out by conf
39. the introduction of filtered air The complete process lasts approximately 75 minutes e Currently a smaller chamber has been designed which means that the processing time would be shorter e At these concentrations and conditions of use hydrogen peroxide is not corrosive for metals and is compatible with a large number of materials 96 Sterilization e The diffusion of hydrogen peroxide in lumens less than 1 millimeter in diam eter and more than 1 meter long is difficult e It is recommendable to not include any material that contains cellulose as is the case with cotton paper and wood Equipment e Sterilizers for hydrogen peroxide gas plasma that meet the standards for the organization and operation of plants for the sterilization and processing of medical use products in health facilities should be used Implementation of the method e Over the course of the cycle the vacuum injection and diffusion of the sterilizing agent take place prior to the plasma stage during which the reactive chemical radicals are formed from the vaporized solution Advantages and disadvantages of the method e Advantages Absence of toxic waste easy installation speed of the pro cess Compatible with moisture sensitive materials e Disadvantages lt has low penetration power Materials derived from cel lulose cannot be sterilized It requires special non cellulose packaging for the composition 97 Correctly loading the sterilizer
40. the market In general hydrogen peroxide at a concentration of 6 is sporicidal but very corrosive when used for delicate instruments and opti cal fiber endoscopes Formaldehyde e The use of formaldehyde is indicated for all materials that are used for hemo dialysis Sterilization is achieved at 8 concentration and 24 hours of immer sion Formaldehyde has been questioned recently due to its high toxicity Peracetic acid e This agent which can be considered as a derivative of hydrogen peroxide has microbial activity that was identified at the beginning of the century In this regard it is necessary to mention the existence of recommended formulations of peracetic acid with hydrogen peroxide that in high con centrations 40 are inflammable This element should be handled with extreme precaution since it constitutes a very corrosive and unstable solu tion It can be used alternatively for sterilization of hemodialysis equip ment A new technology approved in 1999 by the FDA is the combination of peracetic acid 35 hydrogen peroxide and neutralizing solutions that eliminate their corrosive effect It is usually indicated for submersible heat sensitive material at temperatures that fluctuate between 50 C and 56 C at a neutral pH of 6 4 and at a final concentration of 0 2 It is ideal for materials and parts that require rapid re use since the cycle lasts from 25 to 30 minutes Moreover it has a system of chemical and biologica
41. the material 79 Sterilization manual for health centers The efficiency of steam as a sterilizing agent depends on e moisture e heat e penetration e the mixture of steam and pure air and other impurities it could contain Types of steam sterilizers Gravity displacement or gravitational autoclaves In this type of machine the air is removed by gravity since cold air is denser The air tends to leave when the steam is admitted exiting through a channel placed in the lower part of the chamber This process is very slow and favors the residual permanence of air These machines vary in size from small models that are placed on the table and used in clinics and physician s offices to large units capable of handling carts for transporting materials Penetration time becomes prolonged when there is incomplete exit of air and accordingly sterilization times are longer This type of equipment is obsolete There is currently much more sophisticated equipment available Although they operate using the same principle the newer equipment facilitates functioning and increases security through automatic controls vacuum pumps and microprocessors Pre vacuum sterilizers This equipment has a vacuum pump or Venturi system to remove air from the chamber rapidly in the form of pulses so that the steam enters the chamber at greater speed This improves the efficiency of the autoclave since it eliminates air bubbles and increases the speed
42. the more inaccessible parts with different sized brushes Surfaces should never be rubbed with household cleaning powders abrasives steel wool metal sponges wire brushes etc since these scratch and damage metals and increase possibilities of corrosion Do not spatter the physical environment or other people while carrying out the washing process Rinsing should be carried out only when the operator is certain that all of the dirt has been removed Rinse the medical device vigorously with potable running water passing the water through all of the channels in order to remove possible traces of the enzymatic detergent Carry out the final rinse of the material with soft water in order to guarantee that all of the salt residues are removed and thus avoid damage to the material Mechanical cleaning Some centers may have the assistance of machines for mechanical cleaning These could include e Ultrasonic washer e Washer disinfector e Lavador desinfectador 21 Sterilization manual for health centers Manual washing and rinsing of the material Washing machines should be in a perfect state of hygiene for their use to be determined by the cleaning standards of the institution for each type of equipment This is important since these machines often act as contamination vectors biofilm for the elements being washed Both the ultrasonic washer and the washer disinfector carry out the complete process wash rinse and dry within the
43. the satisfaction of the internal client vii Sterilization manual for health centers Re use of a Single use medical Validation of the processes to reuse Evaluation of the Cleaning issccocecsssssscsscsscsscecseteasessssstanaperatssraustapeieraes oesaznanaieas Analysis of the sterilization 5 5 Analysis amp ees Waste analysis minna Ee Integrity and functionality Of MD siisii Environmental cleaning and disinfection of the sterilization A Sica oud Gasastatdecnusscuiada POG CCUG S E Hygienic Occupational Adverse effects of some chemical 5 ISOPrOpyl alcohol cis cesesccscesescesesncsesncecenesncecsncucecesnducsntscereantapancacesescdtesvesceneact Sodium MY POCHIOF IC PUSS a AAE Gllutaralde hy de Ethyl me OXI G
44. to controlled permeability resistance or porosity given that it was not designed specifically as sterilization packaging Therefore it may not constitute an adequate barrier This refers to materials made of natural woven fibers such as cellulose cotton linen or a mixture of cotton and polyester Woven cloths Appropriate cloths are those made of cotton and cotton with polyester with a count of 55 threads cm distributed in the following way warp 28 threads cm weave 27 threads cm total 140 threads inch in double wrapping These are used for heavy packages that need resistant packaging The cloth should be washed after each process and discarded in the case of any holes Instructions for use Cotton or cotton polyester cloth packaging 140 threads inch should be using with double wrapping This is the least effective bacterial barrier It can be used for ethylene oxide steam lt should be washed free from lint and inspected prior to use Yean type cloth packaging 160 threads inch should be used with double wrapping It can be used for ethylene oxide steam It should be washed free from lint and inspected prior to use Cloth barrier 272 to 288 threads inch is resistant to liquids and has good penetration by steam and ethylene oxide Since they can retain moisture the drying time should be increased It should be washed free from lint and inspected prior to use Woven cloths should be washed between each use in order to r
45. 2004 Newman J L Steiz J Intermittent use of an antimicrobial hand gel for reducing soap Induced irritation of health care personnel Am J Infect Control 1990 18 194 200 Standard DIN 58948 1998 on sterilization by formaldehyde And N 866 5 1998 European Standard on indicators to prove effectiveness of sterilizers of Formaldehyde Norma ISO 11140 1 Indicadores Quimicos Perkins J J Principles amd Methods of Sterilization in Health Sciences Charles C Thomas 1983 pag 56 74 Principles and Practice Infection Control and Applied Epidemiology APIC Caps XV y XVI 1996 Ritche A y col Hand washing why when how and with what Asepsis 1993 15 7 11 165 Sterilization manual for health centers 41 42 43 44 45 46 47 48 49 50 51 52 53 54 Rotter M Hand Washing and Hand disinfection In Mayhall Hospital Epidemiology and Infection Control Cap 79 1052 1065 1996 Williams Wilkins Baltimore Maryland Rubino J O Connor D Phenolic compound In Block Disinfection sterilization and preservation 1991 4 ed Pensylvania USA Rutala W A Gergen M F Jones J F Weber D J Levels of microbial contamination on surgical instruments Am J Infect Control 1997 25 185 Rutala W A APIC guideline for selection and use of disinfectantes Am J Infect Control 1990 18 99 Rutala W A Gergen M F Weber D J Sporicidal activity of chemical sterilants used in hospitals nfect Con
46. 25 e Concentrated 10 e Pools 12 Concentrations for use in the hospital area 10 000 ppm 1 Concentration for disinfection of spills following cleaning 5 000 ppm 0 5 Disinfection of materials following cleaning 1 000 ppm 0 1 Disinfection of critical areas following cleaning 100 to 500 ppm 0 01 to 0 05 Disinfection of non critical areas Formaldehyde Formaldehyde is an aqueous solution with a penetrating odor that is polymerized forming a white deposit inside containers when found in high concentrations and on the articles themselves after prolonged immersion even in lower concentrations like 37 to 40 formalin Mechanism of action produces the inactivation of microorganisms through the alkylation of the amino and sulfhydryl groups of proteins and of the nitrogenous ring of puric bases This causes alterations in the synthesis of nucleic acids Spectrum It is a bactericide mycobactericide fungicide viricide and spori cide Disadvantages presents a disagreeable odor in addition to irritating the mucous membranes It is considered potentially carcinogenic Occupational ex posure precautions should be taken when this element is used Indications lts use is limited to hemodialysis filters and the conservation of pathological anatomy parts Due to its toxic and irritant effects formalin under any presentation has been excluded from the list of disinfectants in the United States of North Ameri
47. 6 Methods for controlling the sterilization process Basic procedure for using biological indicators Place a biological indicator in the center of a package surgical clothing labeling its position the lot number of the load the date and number of the autoclave with a full load in a normal work cycle Afterwards place the package in the central part of the chamber and begin the cycle The frequency of use can be daily AAMI 1994 AORN 1999 or weekly CDC 1985 After the cycle is complete it should be taken to an incubator at 56 C for indicators used in an autoclave G stearothermophilus and an incubator at 37 C for indicators used in ethylene oxide Bacillus atrophaeus The internal vial will break before placing it in the incubator so that the culture medium remains in contact with the spores At 48 hours register the results Negative result When the indicator does NOT change color according to the protocol EO green and autoclave violet it means that the sterilization process was correct or adequate Positive result lf the sterilization process was inadequate the indicator will change to a yellow color which indicates that the bacilli are still alive and deve loped in the culture In this case report and immediately follow up on all of the packages sterilized in that lot in order to reprocess them All sterilization processes should be controlled by means of physical monitors and chemical and biologica
48. AAMI CEN European Committee for Standardization single use commercial package adjusted to the characteristics of the cycle or independently prepared package that adjusts to the requirements of the test Physical indicators Mechanical operation Sterilization controls Chemical indicators steam exposure time Microbiological indicators Destruction of microorganisms and spores 110 Methods for controlling the sterilization process Physical monitors e These are measurement elements that are incorporated into the sterilizer such as thermometers pressure manometers barometers chronometers load censors parameter registry valves and systems among others e They allow visualization if the equipment reaches the parameters required for processing Many types of equipment currently have a microprocessor that prints the characteristics of the process at all stages These monitors however can present errors or not reflect what really occurs with the pro cess e This is particularly certain due to the existence of other factors that affect sterilization such as the size of the load and the presence of organic mat ter which cannot be detected by physical monitors e Physical monitors are very useful but they are not sufficient as sterilization indicators Additionally they should be calibrated periodically in order to guarantee the information they provide Periodici
49. AC G 00 07 00001 Contents INtrOCUCTION sns 1 Physical areas and personnel of the sterilization 3 Advantages of CentraliZation 0 3 Infrastructure requirements eceesesesecseetsseeessteseeteseesesteneeeseesssteneeeaeeesneneeeeaes 3 Technical E 5 ACiMINIStatiVesarGa sci saris naan 7 OUPPOM areas sain ai 7 Flow of material and 22 7 Human resources and 1 9 Personal protective 11 Hand 13 washing With 13 Hand hygiene with alcohol 5 14 Utilization of hand washing 16 CUS AMG neas 17 General principles Of 17 Factors involved in cleaning 1 17 Steps in t
50. CJD agent The CJD vi rus requires special recommendations It has been transmitted iatrogenically through cerebral electrodes that were disinfected with 70 alcohol and form aldehyde after their use with patients known to have CJD The contagion was also observed in corneal and human hormone receptors The need for special recommendations is based on the high resistance of the virus when it is protected by tissues or skin Washing followed by steam sterilization at 132 C for one hour is the preferred method for the contaminated material Disinfectants such as sodium hydroxide 1 N for one hour and at room tem perature kill the virus but are caustic Items unrelated to the patient such as floors or autopsy tables do not require special recommendations since they are not considered potential transmission agents A chlorate can be used dilution 1 10 on these surfaces In order to inactivate the virus in patient tissue samples formalin formic acid is required Sterilizing agent e Saturated steam at a pressure that is higher than the normal level Mechanism of action e lt acts by microbial death due to the denaturation of proteins which is produced by the action of the temperature and saturated steam e Saturated steam is a surface sterilizing agent which is the reason why ma terials should be placed in a way that ensures close contact of all of their components with the steam e g open tweezers adequately conditioned textile C
51. ac cording to the following standards and manufacturers American standard Food and Drug Administration FDA 10 to 12 minutes at 20 C Standard in Canada 10 minutes Standard in Europe 5 minutes In our environment the recommendation is 10 to 12 minutes Concentrations for use A concentration of 0 55 is recommended The solution can be reused for 14 days and has a shelf life of two years Glutaraldehyde This is an aldehyde compound that is presented as aqueous acidic and alkaline solutions The acidic solutions are not sporicidal but when an alkalinizing agent is used as activator this product becomes sporicidal Once activated it has an alkaline pH which is drastically reduced starting 14 days post activation There are also formulations that allow a longer shelf life of 28 days Mechanism of action its action is the result of the alkylation of cellular com ponents that alters the protein synthesis of DNA and RNA acids Spectrum It is bactericide fungicide viricide mycobactericide and spori cide Advantages and disadvantages It is not corrosive For HLD 45 minutes at room temperature it has germicidal activity in the presence of organic matter The great disadvantage of glutaraldehyde is its toxicity once activated it tends to produce vapors that irritate the mucous membranes respiratory system and skin Therefore it should be used in highly ventilated environments and with personal protective equipmen
52. age conditions It has a rough side exterior and a glossy side interior which means that it does not release lint The term kraft paper only applies to the material that brings together the aforementioned characteristics as certified by a regulatory agency Instructions for use Double wrapping is recommended It can be used for steam and ethylene oxide It is a better barrier than muslin It wrinkles easily It should not be reused Surgical grade or medical grade paper This is the ideal paper for the sterilization process lts porosity of 0 1 micras is controlled It should have no less than 55 long fibers the rest are short fibers made of pure cellulose British Standards 6255 1989 Optical bleaches are not added during the preparation of this paper The grammage is 60 to 65 g m its pH is neutral and it is highly resistant to tearing This paper does not release lint but it does release fibers if the paper is broken by the hand during opening A grammage of 60 to 80 g m guarantees mechanical resistance Thicker paper guarantees protection against the entry of bacteria During sterilization especially by steam the structure of the paper fibers undergoes strong pressures This paper is safe and blocks bacteria following one sterilization but its capacity for protection decreases in successive sterilization processes Instructions for use It can be used for steam and ethylene oxide It should not be reused Surgical
53. alth Authority Advantages and disadvantages of the method e Advantages Speed absence of toxic waste easy installation Disadvantages Incompatible with moisture sensitive materials FO is con sidered to be a potentially carcinogenic and mutagenic toxic product Toxicity Contact of the product with the conjunctiva can cause permanent injury to the cornea In very low environmental concentrations between 0 1 5 it can cause irritation of the eyes and respiratory tract In concentrations over 10 to 20 ppm it can cause coughing precordial oppression tachycardia and headache Exposures between 50 and 100 ppm can cause pulmonary edema pneu monia and death Measurement and control of FO Residual levels of FO are variable depending on the materials Papers and woven cloths are not compatible with this sterilization method It has a wide biocidal spectrum viruses fungi TB bacilli etc Its sporicidal action is low at room temperature which is why it should be combined with heat at temperatures of 50 C 75 C This method also requires work with an automated system to avoid and prevent occupational exposure The permissible exposure limit PEL is 0 75 ppm in 8 work hours General recommendations Recommendations are the same as for ethylene oxide In many countries sterilization with FO is prohibited in the absence of ad equate equipment and installations At present paraformaldehyde f
54. anics and engineering controls will also improve worker safety Each type of activity requires a certain type of protection for implementation In the material cleaning and decontamination area it is necessary to use the following PPE eye or face protector cap mask exclusive clothing plastic apron thick long latex gloves and rubber boots or waterproof footwear protectors In the material conditioning packaging preparation and sterilization area the PPE will be divided by activity e For review of the cleaning and conditioning of medical instruments and devices the following is necessary simple latex gloves cap and exclusive clothes e For professionals who work with autoclaves or stoves the following is nec essary thermal protective gloves cap and exclusive clothes e Other activities require cap and exclusive clothes In the area for storage of sterile material the following is required exclusive clothes and a cap In the disinfection or chemical sterilization area the PPE used will depend on the method used See the specific PPE in the description of each method 11 Hand washing measure that is important to diminishing environmental microbial contamination is that personnel meet adequate hygienic requirements for the functions they carry out Hand washing is the simplest most effective method for stopping the spread of the infections Always remove rings and bracelets nails should be short and without
55. asy and rapid in order to confirm the presence or absence of viable microorganisms after the sterilization process These indicators should be introduced into the interior and at the midpoint of the largest heaviest packages of the load Different controls should be used in the different cycles of each piece of equipment In 1996 Rutala classified biological indicators into first second and third generation according to the order of growth speed and rapidity of results First generation These appeared in the seventies in very simple form as paper strips with spores They had to be transported to the laboratory in order to incubate them which took 2 to 7 days Second generation These are vials with the dry content of spores in which the final reading is taken after 48 hours They have a portable incubator These indicators are not available for dry heat Third generation These are quick read biological indicators At present a new biological indicator has been designed based on the detection of an enzyme associated with microorganic spores The method allows for results to be attained in three hours autoclave compared to the 48 hours needed for the traditional biological control Evaluations of the method have concluded that the method is even more sensitive than the biological indicators used to date The latest generation incubator has an ultraviolet light lamp fluorescence in order to accelerate the reading process 11
56. at are processed in the hospital should return to the SP In the SP the boxes should be opened the cotton towels replaced and a new chemical indicator placed in their interior Prior to re sterilization the ob jects should be packaged in new packaging Objects wrapped in plastic or paper should be removed from the previous package and replaced with new packages New chemical indicators should be placed in each pack age in order to re sterilize it All sterilization parameters that are appropriate for the reprocessing of medical equipment should be followed e Products sterilized by the manufacturer should not be re sterilized unless the trade name provides written instructions for their re sterilization There are standards for the re sterilization of medical use materials In the event that a sterilizer fails revealed by a change in color in the bi ological indicator it should be taken out of service immediately and the maintenance service should be notified in order to repair it All objects that have not been used in this load should be collected and re sterilized Pa tients exposed to sterile objects from the deficient lot should be monitored Infection Control personnel should be notified about the deficiency of the sterilizer in order to follow up with the patients Responsibility e The SP technician is responsible for the results obtained from the biologi cal indicators in each load both in autoclaves by steam and by ethylene oxi
57. ates In this way the SP can demonstrate in a sufficiently documented manner that the parameters of temperature and pressure reached throughout the sterilization process of a load were within the criteria defined by the standards and for repeated loads The validation of a process is the documented procedure of evidence with regard to the equipment and its operation Validation of loads It is important to validate the process at all points washing loading unloading of the material and the sterilization process itself In the case of loading unloading of the material the validation of this procedure consists of meeting the minimum stages and evaluation criteria that the user should handle 126 Validating the sterilization process Technique and material Documented evidence contributes a high degree of safety to this process during which the following aspects should be taken into account e Position of the articles within the load e Packaging of the load e Cycle selected e How to unload e Repeat three times Components of sterilization validation Audit This process demonstrates documents and confirms that the equipment meets the performance specifications as they were designed following their installation in the place of use Certification to operate This process demonstrates that the equipment following review will produce acceptable products when it is operated according to the specifications of the proces
58. atest percentage of dirt is removed in the first 15 seconds Washer disinfector Action Ten minutes of a combination of detergent and water at 93 C and vigorous cleaning through streams of water guarantee the cleaning and disinfection of articles The cycle is divided into three stages cleaning disinfection and drying Disinfection at 93 C maintained for at least 10 minutes is carried out after repeated washings with detergent and water It guarantees action that is bactericidal fungicidal and tuberculocidal inactivating viruses including Hepatitis B virus 23 Sterilization manual for health centers 1 Cycle of the thermodisinfection process ot a CHEMICAL THERMAL F 50 C _ P lt S Fig 1 VARIO or Variable Pragramme Fig 2 Chemical thermal programme for hoatssensitive instruments Adapted from http www wfhss com index_en htm Advantages This equipment facilitates the work routine and diminishes the contact of professionals with infective agents once the material is placed within the equipment and at the conclusion of the cycle since the material will be clean and disinfected at that point Disadvantages The equipment requires preventive maintenance and care during operation If the machine does not have a dry cycle the instruments and devices should be dried with compressed air The latter increases instrument handling and
59. be false negative reactions Do not read the strip after 8 minutes since the color vanishes making interpretation difficult The strip should remain completely yellow in order to indicate that the solution is effective Any tone of yellow is acceptable the intensity varies according to varia tions in concentration If white residue remains on the strip the Cidex solu tion is ineffective and should be discarded Refer to the original bottle to facilitate the visual interpretation of results by comparison Write down the results obtained in the file provided Keep a record of each test that is carried out Quality control Prepare a control solution of positive and negative Cidex in order to con firm the quality of the strips Activate the Cidex solution This activated solution as of that point will be used as a positive control Dilute one part of the activated solution with one part of water This will be the negative control Following the previous steps for use submerge three strips in each solu tion The strips submerged in the positive control should be completely yellow within 5 to 8 minutes The strips submerged in the negative control should be completely white or present an incomplete yellow color when they are read at 5 to 8 minutes If the results obtained are not satisfactory discard the remaining strips and do not use them in the test 118 Methods for controlling the sterilization process Summary of quality contr
60. ble exposure limit PEL is 0 8 ppm or 1 4 mg m in 8 work hours Hydrogen peroxide This is a colorless liquid that is water miscible and can be decomposed by numerous organic solvents It can produce acute toxicity and irritates the skin and mucous membranes at high concentrations Contact with so lutions over 35 can produce phlyctenas on the skin The inhalation of hydrogen peroxide vapors or mist can induce severe inflammation of the upper respiratory tract If over exposure continues it could result in pulmonary edema Formaldehyde gas The principal means of occupational exposure is through the ocular mucous membrane upper respiratory tract and cutaneous contact After being inhaled it is absorbed in the upper part of the respiratory tract due to its hydrosolubility It is soluble in blood distributed rapidly in the body and more commonly in highly vascularized organs has rapid cellular renewal and has high protein synthesis Its elimination is very variable It can produce acute and sub acute toxicity Its principal effect is to produce primary irritation in eyes nose and throat Irritation increases when the environmental concentration surpasses 50 ppm It can produce severe bronchiospasm With regard to chronic exposure studies have demonstrated that exposed people present subjective signs of irrita tion of the ocular mucous membrane and respiratory tract that can cause chronic respiratory pathology Since its carcinogenic mutag
61. ca since 1996 Hydrogen peroxide Hydrogen peroxide is an oxidant agent used for HLD Mechanism of action lts antimicrobial action is performed through the pro duction of hydroxyl free radicals that damage the lipid membranes DNA and other 61 Sterilization manual for health centers cellular components Spectrum It is a bactericide mycobactericide fungicide viricide and spori cide in concentrations from 6 to 7 Advantages and disadvantages does not damage glass or plastic ar ticles It is an oxidant for metal articles It presents ocular toxicity and can also produce pseudomembranous colitis due to poor rinsing during HLD Instructions for use It is indicated in the use of HLD for endoscopes given its compatibility with this material Concentrations for use lts presentation ranges between 3 and 7 5 In order to carry out high level disinfection the indication is for 6 to 7 5 for 30 minutes The solution can be reused for 21 days Peracetic acid Also known as peroxiacetic acid this is an oxidant agent that acts similarly to hydrogen peroxide Mechanism of action It produces the denaturation of proteins altering the permeability of the cell wall Spectrum lt is a bactericide fungicide viricide and sporicide Advantages and disadvantages The greatest advantage of this element is that it does not produce toxic waste and does not require activation It can cor rode copper bronze or galvanized iron This corr
62. case of tubular shaped material use a 60 cc syringe with a cone point to fill the entire lumen with the solution Remove and rinse with abundant water If possible use high pressure water guns or specialized cone shaped pressurized water pipes to pressure in different sizes or diameters to wash the lumen of catheters extension tubes connector tubes corrugated tubes etc Carry out the final rinse of the material with water Let it drain into the environment and then dry If it is possible use compressed air less expensive or drying chambers for corrugated materials that contain filtered air It is important to note that there are currently washing machines that are specially designed for washing material or devices with lumens such as endoscopes bronchoscopes etc The cleaning process for latex gloves is not recommended or mentioned since in recent years various cost effectiveness studies have demonstrated a high reprocessing cost Moreover mechanical reprocessing is difficult and this material is not made to be reused Washing of glass material jars and syringes Manual washing Submerge the material in a solution with enzymatic detergent 27 Sterilization manual for health centers It should be taken into account that when cleaning the interior of the jar the type of brush that is used with feeding bottles or swabs should be used according to the required size Rinse repeatedly under a stream of running water Dry the o
63. ccording to the need for the services Waste transport should not be carried out when meals medical visits pub lic visits or patient transfer are scheduled The closed bags should be placed in primary containers located in each sector These will be removed by designated personnel if necessary twice per shift All waste should be transported to the designated storage areas in closed carts Personnel that handle and collect waste should use adequate clothing and elements They should use gloves made of a resistant material a plastic apron washable and adequate footwear rubber boots or similar At the conclusion of the task personnel should wash the carts used with water and detergent rinse with running water and then disinfect with so dium hypochlorite 0 05 dil 1 100 of commercial bleach Finally personnel should take off the protective elements wash and disin fect them Then they should take off their gloves and wash their hands and forearms Terms related to sterilization Antisepsis process that destroys the majority of pathogens located on moving surfaces Antiseptic chemical agent that inhibits the development of microorga nisms or destroys them and that is used on live tissue Area for preparation and packaging where clean dry elements are ins pected arranged in sets or boxes and adequately wrapped or packaged for the selected sterilization process Area for raw material deposit an environment to store in
64. ccording to the standards established by interna tional agencies For example in gravitational and pre vacuum autoclaves where the material is protected with simple packaging we will use Porous or non 121 30 Gravitational porous surface 134 25 Liquid 134 30 Porous or non 121 15 Pre vacuum porous surface 134 4 Liquid 134 30 Adapted from Rutala and Weber 2002 and the MAC Manual July 2002 Instructions for use Textiles This includes cotton thread synthetic fibers etc The porosity stiffness of the weave can hinder the passage of steam and the suction of air through the vacuum pump Therefore in the case of new clothes carrying out a prior washing to diminish this risk is recommended e Metals This includes instruments sinks kidney trays drum trays etc Metal material requires washing and drying prior to sterilization 82 Sterilization e Glass or crystal On some occasions sterilization by dry heat is prefer able but it is also feasible to use saturated steam e Liquids This refers to distilled water and pharmacological solutions when ever they do not change their composition As a guideline it should be taken into account that the container should not be filled to more than 2 3 of its total capacity e Heat resistant rubbers and plastics These materials should be clean and dry in order to ensure the elimination of organic matter e Inactivation of the Creutzfeldt Jakob disease
65. ces that enter for later processing are reduced This area is separated by a physical barrier from the other areas of the SP preparation processing deposit and is easily accessible from an exterior corridor The importance of physical separation is based on the need to avoid the transport of aerosols droplets and dust particles from the dirty to the clean area through air currents This is key given that this sector generates a large quantity of aerosols due to the type of work performed brushing ultrasound The floors walls ceilings and work surfaces should be constructed with non porous materials that can tolerate frequent cleaning daily as a minimum and humidity conditions All air from this sector should be expelled to the exterior without recirculation thus preventing the introduction of contaminants that endanger the patient and personnel into clean areas The circulation of people is restricted and controlled and only adequately dressed personnel can enter This area should also have a compressed air terminal for drying elements with a lumen catheter mount trocars Air should arrive clean and dry to the sector which means that it should be treated appropriately with a silica gel air dryer or oil filtrate Oxygen is also used for drying and is superior to other options since it does not present the moisture problems derived from compressed air It is more expensive however in the form of cylinder containers This area sho
66. chamber of the machine or in successive modules This process can be considered safer since it avoids cuts and scrapes to personnel water splatters in the washing area etc When using washing machines disinfector or ultrasonic manufacturer instructions for installation and use should be followed strictly Ultrasonic washer Action Electric power is transformed into a high frequency sound wave and transmitted to the liquid by transducers located under the sink The high frequency sound waves are converted into mechanical vibrations Two types of waves are generated high pressure and low pressure The low pressure waves flow through the solution causing the formation of millions of 0 001 mm microscopic bubbles on the surface and cavities of the instrument The high pressure waves cause the bubbles to expand until they become unstable and collapse The implosion produces localized vacuum areas that are responsible for cleaning the surfaces of the objects This process is called cavitation Soluble particles are dissolved in the solution inside the tank which includes a detergent that facilitates the process Insoluble dirt is deposited on the bottom of the tank Advantages This process can clean dirt from areas that are inaccessible to manual cleaning due to the design of the equipment Disadvantages The equipment requires preventive maintenance and attention to the operational procedure If the ultrasonic cleaner does not have a r
67. ction LLD This is carried out by chemical agents that eliminate vegetative bacteria fungi and some viruses within a short period of time less than 10 minutes One example is the group of quaternary ammoniums Factors that affect the effectiveness of the disinfection process e Quantity and location of the microorganisms As the bioburden in creases the amount of time that a disinfectant needs to act also increases Therefore it is fundamental to carry out a scrupulous cleaning of the instru ments surfaces This holds particularly true for instruments with multiple components which should be disassembled and cleaned part by part e Resistance of microorganisms to the chemical agent This refers primarily to the spectrum of action of the method or agent used 55 Sterilization manual for health centers e Concentration of the agents This refers to each agent s potential strength to produce the expected action Concentrations vary with respect to disinfecting agents and can be related in some cases to a deleterious effect on the material corrosion Physical and chemical factors Some disinfectants specify the temper ature at which they need to be used in order to be effective The pH level favors the action of disinfectants e Organic matter The presence of organic matters such as serum blood pus stool or other organic substances can inactivate the action of some disinfectants and compromise their effectiveness e Dura
68. ction of non critical articles and on smooth surfaces Its use is not indicated in semi critical articles due to the absence of data on its germicidal effectiveness Furthermore its utilization is contraindicated when cleaning incubators and other surfaces in areas for neonates since it generates hyperbilirubinemia Currently due to its low effectiveness and to the risks described it is not recommended for use in the hospital environment Concentrations for use The concentrations vary with the presentation of the product Quaternary ammoniums The compounds most commonly used in hospital establishments alkyl dimethyl benzyl ammonium chloride alkyl didecyl dimethyl ammonium chloride and dialkyl dimethyl ammonium chloride Mechanism of action They produce the inactivation of energy producing enzymes denaturation of cellular proteins and rupture of the cellular membrane Spectrum They are fungicides bactericides and viricides against only lipo philic viruses They are not sporicides or mycobactericides and cannot act against hydrophilic viruses Advantages and disadvantages These elements are good cleaning agents due to their low toxicity Gauze and cotton remnants can affect their action Instructions for use Due to their low toxicity they can be used to disinfect surfaces and furniture Concentrations for use The concentrations for use vary according to the com bination of quaternary ammonium compounds in each commercial for
69. d be in a perfect state of hygiene according to the institutional cleaning standards that will be applied for each type of equipment The recommendations for the cleaning and disinfection of endoscopes are summarized in the following table Disinfection process for endoscopes Immediately after the procedure submerge and review the external surfaces and internal Lemi channels with brushes a water solution and enzymatic soap 9 Rinse Rinse the exterior and all channels with abundant water and with adequate syringes Subsequently drain the water 3 Dry After rinsing and before disinfection treat the internal channels with forced air and the exterior with a clean compress Submerge the endoscope in a high level disinfectant making sure that it penetrates 4 Disinfect through the channels of air water suction and biopsy Leave it for at least 20 minutes Rinse the endoscope and channels with sterile water If this is not possible use faucet ave water followed by an alcohol rinse 6 Dry After disinfection and prior to storage treat the internal channels with forced air and the exterior with a clean compress 7 Store The endoscope should be stored in a place that prevents recontamination 67 Sterilization manual for health centers If the endoscope cannot be sterilized a high level disinfection HLD pro cess should be carried out immediately prior to its use with the patient e One time u
70. d between every use Handheld instruments that do not tolerate high temperatures should be replaced by others that can be exposed to heat Disinfection processes should not be used in critical or semi critical dental elements Implantable objects Implantable objects for articulations should come sterile from their procurement from the manufacturer Implantable objects such as bones screws plates and meshes which are 70 Desinfection not sterile should be sterilized in an autoclave and maintained in the service until the biological indicator is negative HLD cannot be carried out on implantable objects Anesthesia masks Anesthesia masks and intranasal airways should be cleaned and disinfected after each use Wash the internal and external parts of anesthesia masks with a brush soft detergent and water In order to clean the interior of intranasal airways a round flexible brush should be used Inspect the masks in order to confirm their integrity If the rubber is broken or cracked parts of the mask are missing or the rubber around the edge is missing the mask should be discarded Clean by sonication for 10 minutes Rinse with water Dry Submerge the masks and intranasal airways in glutaraldehyde for 10 minutes Remove the objects rinse with clean water and allow them to air dry Adequate reprocessing of reusable anesthesia materials is the responsibility of the Sterilization Plant Disinfection of elements contam
71. d it is prepared with a dilution of 1 10 or 1 20 as a preservative or sterilizer Mechanism of action e Its mechanism of action is similar to by the alkylation of hydrogen atoms from functional groups of structural proteins enzymes and nitrog enous bases of nucleic acids in synergism with the lethal action of steam at low temperature Conditions of the process e The parameters of the process are Temperature 50 C 65 C Relative humidity 100 Exposure time 2 to 6 hours Pressure Sub atmospheric throughout the cycle e Sterilization occurs through the action of FO in the presence of saturated steam e This is obtained by making a formalin solution pass through a vaporizer and has four stages air elimination injection of FO humid stage washing of the chamber The gas is removed from the chamber through repeated vacuum pulses and steam in order to then carry out a drying phase and an aeration phase Equipment e Sterilizers for formaldehyde with steam that meet the standards for the organization and operation of plants for the sterilization and processing of medical use products in health facilities should be used Standards are produced by the National Program for Quality Assurance in Medical Care 94 Sterilization Implementation of the method Procedure and quality manuals should contain the guidelines that will be fol lowed by each institution and that are approved by the He
72. d training Despite technological innovations in the arena of disinfection and sterilization with automated equipment this equipment requires trained operators that should be informed about the sterilization processes they are performing APEICH 2003 The centralization of cleaning and sterilization services from the entire hospital in the SP guarantees the quality of the processes in addition to optimizing and economizing human resources and materials The number of SP employees will depend on the volume of the work carried out but there should always be a minimum of stable employees The area for the cleaning and decontamination of material dirty area should have one exclusive professional Each remaining area should have one or more professionals that can perform activities in the different cleaning areas There should be an ongoing training program for all SP staff that includes notions of microbiology operation of equipment principles of cleaning disinfection and sterilization selection and packaging of instruments preparation of textile material loading of autoclaves control of processes storage of sterile material collection and distribution of material and use of personal protective equipment PPE Personal protective equipment ersonnel should work protected by PPE in order to critically prevent percutaneous and permucosal exposure to blood and other potentially hazardous materials Safe work practices appropriate mech
73. data that support multiple re uses They consider that re use goes against the recommendation of the label and implies risks to the parties involved primarily the patient The first devices to be analyzed are usually costly MD which in general turn out to be critical or high risk The evaluation of low cost high consumption MD which are usually medium or low risk is often overlooked According to the FDA single use MD are classified as e CLASS or low risk These devices are considered to pose a low risk for patients These require general controls CLASS 1 or medium risk These devices can have some risk for patients which means that they need special controls CLASS III or high risk These products are considered to pose a high risk for patients These require rigorous controls 139 Sterilization manual for health centers Although the washing packaging and sterilization of reusable medical devices are normal functions of the SP the reprocessing of devices labeled as single use is not Therefore the methodology or protocol that should be used to DEVELOP AND MAINTAIN A PROGRAM FOR RE USE should simulate the practices of the industry It should establish the procedures step by step through quantifiable documented and replicable results It is therefore important to initiate contact with the manufacturer in order to ask for example what polymers does the device contain does it have lubricants
74. de If the biological indicator suggests a deficiency in the sterilizer the technician should report this immediately to the department supervisor and 123 Sterilization manual for health centers take the sterilizer out of service The department supervisor should notify the maintenance service about the repair of the sterilizer This cannot be placed in service again until the verification procedures are carried out All hospital staff should review the sterile packages routinely and organize them on the shelves according to their expiration date Objects with an earlier expiration date should be placed up front If the expiration date has passed the package should be removed from the service and sent to the SP for reprocessing This is the responsibility of each department Summary If there is a potential sterilization failure the following steps should be undertaken The SP technician should notify the supervisor at the first sign that a bio logical indicator is positive this normally takes 48 hours but positive re sults could potentially be obtained in 24 hours The sterilizer that fails should immediately be taken out of service The lot number of the batch affected should be reviewed and all objects listed under the lot should be removed from patient care areas and sent to the SP for reprocessing It should be assumed that objects that have not been located have been used with patients All possible efforts to identify which
75. de is the most commonly used sterilizer for thermosensitive products although all possible alternatives should be evaluated s de todas formas deberian evaluarse todas las alternativas que se poseen 140 Reuso de dispositivos m dicos de un solo uso Validation of the processes to reuse materials The validation of the processes for reusing MD should be carried out through e Verification of the effectiveness of the cleaning e Verification of the effectiveness of the sterilization processes e Verification of the absence of toxic waste Verification of the absence of toxic waste is not simple to carry out in health centers More complex centers should carry out the primary development work and then give this information to centers of lower complexity The development costs of the protocols can be reduced if hospitals collaborate on the creation of each section The results can then be applied to devices from the same manufacturer duplicating the procedures and using the same sterilizer equipment as long as they operate according to manufacturer specifications Evaluation of the cleaning The initial analysis for the development of the protocol should include a test for each level of re use since waste and biofilms can go unnoticed and accumulate in a device with each subsequent use Sample size The sample size or number of MD that need to be tested should be sufficiently large to ensure that the process can be duplicated successfully
76. ded after the required temperature is reached and not from the time that the sterilizer is charged since a prolonged time could be required to reach the steriliza tion temperature Relationship between time temperature for sterilization by dry heat Temperature C Exposure time 180 C 30 minutes 170 C 1 hour 160 C 2 hours 150 C 2 hours and 30 minutes 140 C 3 hours 121 C 12 hours Adapted from Block 5 edition Equipment Sterilizing stoves that meet the standards for the organization and opera tion of plants for the sterilization and processing of medical use products in health facilities should be used Standards are produced by the National Program for Quality Assurance in Medical Care Implementation of the method The preparation and arrangement of the load should be carried out taking into account that dry heat is a mass sterilizing agent Procedure and quality manuals should contain the guidelines that will be followed by each institution and that are approved by the Health Author ity During the sterilization cycle the door of the sterilizer should not be opened 78 Sterilization When the material to sterilize is a poor heat conductor talcum it should be used in a thin layer in the quantity necessary for a single use Advantages and disadvantages of the method Advantages It permits the sterilization of vaselines fats and heat resistant powders which cannot
77. device in a container with a 2 glutaraldehyde solution without surfactant being particularly careful when filling the working channels for 20 minutes In the case of non submersible endoscopes a rigid tube can be used making it possible for the entire moveable part to be submerged The device should be aspirated through the channel using a syringe while maintaining the syringe attached to the aspiration channel This ensures that the channel it is in contact with the glutaraldehyde during the entire disinfection period The activity of the glutaraldehyde solution should be controlled and the containers should be adequately labeled in order to confirm the activation date Rinsing should be carried out with abundant common water or preferably 68 Desinfection distilled sterile water a physiological solution should not be used on the exterior cover and the working channels The final drying is carried out with oxygen or filtered compressed air At the end of the day the bronchoscope should be kept preferably hung in a dry dust free location Biopsy forceps or foreign body forceps should be washed with enzymatic detergent and subsequently sterilized in an autoclave The brushes for cytological and bacteriological studies should be discarded During the study the light source should be covered with a disposable sheet of plastic in order to avoid contact with the biological materials Afterward it should be cleaned with a piece of ga
78. e Mechanical energy friction Water Water that contains dissolved minerals such as calcium chlorine magnesium and phosphates is called hard water When boiling this type of water the aforementioned minerals will be deposited inside the washing or sterilizing container forming a layer known as plaque or caliche This layer which is composed of a type of calcareous stone is not a good heat conductor and reduces the effectiveness of the washer or sterilizer since more heat will be needed to overcome this difficulty and therefore more energy 17 Sterilization manual for health centers either gas or electric will be consumed This process also produces mineral deposits on the valves or filters which will stop functioning correctly as a consequence of this action Water that does not contain minerals or only has a small number is called soft water Soft water and especially demineralized or distilled water does not cause calcium deposits and is recommended for cleaning materials Identification of the quality of softened water can be carried out by measuring the pH which should be neutral and conducting a chemical study to measure the level of salts minerals and phosphates Selection of the type of water is very important for determining the type of washing Given the high cost of maintaining water treatment soft water should be used in the cleaning process only in the final rinse of the material in order to guarantee that all
79. e of instruments sohygmomanometers bedclothes incubators mattresses and furniture 53 Sterilization manual for health centers Classification of medical instruments for their correct processing and use in p atient care Critical They penetrate sterile tissues including the vascular system and normally sterile cavities Surgical and treatment instruments Vascular skeletal and other prostheses IV and angiography catheters Urinary catheters syringes needles forceps implants Autoclave or poupinel sterilization ethylene oxide with sterilization and aeration equipment Use before the expiration time Chemical and biological controls according to standards Continuous maintenance and review of equipment Sterile technique Sterile drape gloves and cloths Sterile instruments and materials in individual packages Hand washing before and after the procedure Semi critical They come into contact with mucous membranes and non intact skin They should be free from vegetative bacteria Respiratory assistance devices Anesthesia devices Endoscopes laparoscopes bronchoscopes endotracheal cannulas probes aspiration tubes tongue depressor rectal Sterilize if possible or high level disinfection Aseptic technique Hand washing before and after the procedure Separation of aseptic area and contaminated area for patient use glasses plates silverware bedpans
80. e use of longer boiling times is recommended for locations at high altitude above sea level Objects should be air dried or dried with a sterilized towel before reusing or storing them This method is not used in the hospital environment Water and water jet disinfectors This equipment is used to clean and disinfect objects that are used for patient care in the hospital room Water jet disinfectors are used to empty clean and disinfect objects such as bedpans and urinals through a process that eliminates manual washing and in some cases uses a minimum quantity of chemical germicides It uses temperatures over 90 C Ultraviolet radiation UV This method inactivates microorganisms in the range of 240 280 nm It acts through the denaturation of nucleic acids but its effectiveness is influenced by factors such as the potency of UV tubes presence of organic matter wavelength temperature type of microorganisms and the intensity of the UV which is affected by the distance and dirtiness of the tubes UV radiation does not disinfect or sterilize water The use of UV radiation as a disinfectant in the operating room en vironment is currently under debate due to lack of clinical evidence that it reduces infection rates Furthermore it is necessary to take into account that it induces keratoconjunctivitis in patients and professionals exposed to radiation Liquid chemical methods This is the most frequently utilized method in our hospital system
81. ectants Am J Infect Control 1996 24 313 Saurina G y col Activity of disinfectants against Vancomycin Resistant Enterococcus faecium Inf Cont Hosp Epid Vol 18 5 345 347 1997 Seymour S Block Disinfection Sterilization and Preservation Fifth Edition Williams amp Wilkins 2000 Spaulding E H Chemical sterilization of medical and surgical materials In A Block S S Eds Disinfection Sterilization and Preservation Philadelphia Lea y Febiger 1968 517 531 The Medical Devices Act and European Standards for Sterilization DIN en 285 554 y 556 Tratamiento de Instrumentos M todo Correcto Grupo de Trabajo Dr H G Sonntag Instituto Higiene de la Universidad Heidelberg Alemania 6 Ed 1997 Wade J y col Higienic hand disinfection for the removal of epidemic vancomicin resistant Enterococus faecium and gentamycin resistant Enterobacter cloacae J Hosp Inf 1991 18 211 218 Wade J y col Higienic hand disinfection for the removal of epidemic vancomicin resistant Enterococus faecium and gentamycin resistant Enterobacter cloacae J Hosp Inf 1991 18 211 218 167
82. enic and teratogenic effects have been demonstrated in in vitro cells it has been recognized as a type C2 agent According to OSHA its permissible exposure limit PEL is 0 8 ppm or 0 9 mg m in 8 work hours 150 Ocupational hazards General recommendations Physical hazards In the case of physical hazards that can usually be modified and solved it is recommendable to take into account e Internal training communication and regulation as the main strategies to prevent physical hazards e Close monitoring of adequate temperature control and ventilation in envi ronments such as machine rooms and adequate use of personal protection in high risk areas contaminated areas e Train human resources in what to do in accidents such as burns cuts and injuries e Have an emergency kit adequately set up for emergencies e These should all be adapted to health and safety policies in the workplace and current electric safety e Transport carts should have rubber wheels e Personnel should use footwear with rubber or anti slip soles e Fire distinguishers should be in a perfect state of use e Personnel that work with steam sterilizers or stoves should use antithermic gloves or mitts Asbestos gloves should never be used e Equipment to cut off electric currents should be available e Gauze cutting machines should have a frontal safety switch e Personnel that work with textile cutting machines should use protective metal gloves e The
83. erve the differences Strength The factors that should be considered for measuring the strength of a certain type of packaging for sterilization are three resistance to bursting tearing and abrasion Burst resistance refers to possible punctures or pricks produced by the corners of instrument trays or packaged instruments Burst resistance is measured through the Mullen Burst Test This test uses an apparatus with an expansive 1 1 4 rubber diaphragm that pushes the material upward progressively until it literally bursts The pressure required is measured in pounds per square inch PSI Higher values correspond to better resistance by the material Tear resistance is not as important as burst resistance since the tests of tear resistance Elmendorf Test only measure the strength that is necessary to apply 36 Preparing and packaging materials in order to propagate the tear but once the tear has already occurred Abrasion resistance on the other hand is very important in two aspects the resistance that the material offers to abrasion and lower release of lint or microparticles If the sterilization packaging wears away with friction the material weakens and is more vulnerable to holes and tears Lint or particles A product or material that does not release lint should be selected Lint microparticles should be minimized in areas where patients undergo surgical procedures Sterilization packaging made from materials with hig
84. es the operation of the equipment Performance A microprocessor should be used to evaluate the physical parameters Additionally there are specific chemical indicators and a biolo gical indicator test package that consists of a plastic tray with a restricted 131 Sterilization manual for health centers dissemination opening that ends in a closed compartment that contains a chemical indicator and a biological indicator The chemical indicator indica tes that hydrogen peroxide an essential part of the sterilization cycle has been introduced into the sterilization chamber The biological indicator con sists of a paper strip containing 10 spores of Bacillus subtilis var Niger in a Tyvek bag The physical parameters should be confirmed with a test package followed by three complete cycles with chemical and biological controls during three consecutive days and with loads Validation of low temperature steam formaldehyde LTSF Technique and material This validation should be carried out by confirming the quality of the following elements e Environment The installations should be verified The physical area in cludes the structure itself climate control dimensions and the need for an installation for extraction toward the exterior Furthermore the electric installations voltage and protective devices should be observed e Equipment The structure for the installation of the autoclave should be confirmed including its phys
85. estore the moisture content and ensure the filtration capacity of the fibers Continuous washing of textiles reduces their efficiency as a barrier which means that their storage time may be reduced Given that this type of material is susceptible to deterioration and experiences changes when used it should be rigorously examined prior to each use In the case of holes or tears adhesive patches should be used Mending is not appropriate since it may alter the weave and allow the passage of particles It should be taken into account that textile material is not water repellent which means that precautions to avoid moisture should be maximized by securing and protecting the packaging with a plastic cover if it is going to be stored for a 39 Sterilization manual for health centers long time The cover also constitutes protection from penetration by dust Unwoven cloths These cloths are a combination of cellulose and synthetic fibers or 100 synthetic fibers joined by methods other than traditional weaving They are joined by the fusion of fibers and resins that are later dried They are disposable compared to reusable cloths eliminating the need for washing and inspection Instructions for use Unwoven cloths are resistant to liquids and have good penetration by steam and ethylene oxide Since they can retain moisture the drying time should be increased Paper It is important to discuss all existing types of paper and which ones are ap
86. f ethylene oxide and eliminates it very slowly For example the time needed to eliminate the substance at room temperature is 1 to 2 weeks It is not recommended as packaging for sterilization Polypropylene and polycarbonates These are both heat resistant materials that are formed by 3 layers that are thermally joined SMS e Spunbond formed by long fibers that provide strength e Meltblown formed by short disordered fibers that provide a barrier They are accommodative non toxic and water repellent Instructions for use They can be used in steam sterilization resistant up to approximately 140 C 150 C Since they can retain moisture the drying time should be increased Polypropylene is the packaging of choice for sterilization with hydrogen peroxide plasma Nylon poliamide This material is temperature stable and permeable to steam but does not tolerate vacuum gaps Therefore it breaks when used in steam autoclaves It is not appropriate for sterilization by ionizing radiation It has low permeability to ethylene oxide There is a poliamide that tolerates up to 180 C and can be used with dry heat Tyvek This material is a synthetic polymer and a spunbonded olefin that is made essentially of polyethylene fibers in a sheet that is similar to paper It has excellent shielding characteristics Its mechanical stability is high and it does not release fibers when opened Its porosity is controlled for permeability to ai
87. fferent sterilization methods They should be used according to manufacturer instructions They can be made from aluminum stainless steel plastic or plastic metal combinations Some contain bacterial filters and others have valves that provide a biobarrier They are very effective since they do not break do not release fibers do not become contaminated and are easily transported Rigid containers without filters These include closed stainless steel boxes that transmit heat through conduction Instructions for use These are used exclusively for dry heat Rigid containers with filters Rigid containers in order to be compatible with other sterilization methods should be perforated Some of these perforated containers have an incorporated filter that 42 Preparing and packaging materials permits their use without exterior packaging These filters should be examined and replaced periodically according to manufacturer instructions in order to ensure their effectiveness Perforated containers without an incorporated filter should be packaged externally with packaging that is compatible with the selected sterilization method Instructions for use These are used for steam Polymers Polymers are an absolute barrier against microorganisms and dust Therefore storage using these materials as a barrier can be very prolonged Since they are transparent they are also useful for visualizing the contents There are various types Pol
88. from handling the contents of contaminated sharp pointed instruments used in operating rooms laboratories etc The recommended measure is the application of the biosafety principles detailed below e Universality means that every material that has organic matter is handled as highly infectious material A label that says that the material is contami nated should not be necessary The aforementioned clean up and decon tamination protocols should be applied The use of physical barriers for personal protection is very important when contaminated materials and instruments are handled and when disinfec tion is carried out with chemical agents e The use of a mask for the preparation of textiles in the blue area is compul sory e For proper waste management especially in the case of sharp pointed instruments it is important to segregate the waste material This process should be carried out by the external user It is important to take into account the classification of waste according to the standards of the General Environmental Sanitation Bureau 152 Ocupational hazards Ergonomic hazards With regard to ergonomic risks it is recommendable to take into account e Maintain a direct relationship with the work team in order to rapidly identify environmental factors moisture steam heat that affect the normal limits of comfort e Train personnel on adequate positions for working and on the natural movements that should be
89. gas plasma one in each load e Dry heat per week or according to the periodicity of its use Furthermore e Each time the equipment is repaired e Whenever the equipment is used to sterilize prostheses or implants Each biological indicator should specify e quantity of spores e lot number e expiration date e D value Biological controls should meet current national or international standards Placement of the controls e For control of the chamber Place them in locations that are as inaccessi ble as possible to the sterilizing agent inside of a syringe and with double wrapping e For control of packages Place the control in the center of a package that will be placed in a location that is as inaccessible as possible to the sterilizing agent 115 Sterilization manual for health centers Biological references e Moist heat Geobacillus stearothermophilus e Dry heat Bacillus atrophaeus e Ethylene oxide Bacillus atrophaeus e Steam formaldehyde Geobacillus stearothermophilus e Hydrogen peroxide gas plasma Geobacillus stearothermophilus Biological indicators are prepared to contain a sufficient charge of microorganisms that are highly resistant Geobacillus stearothermophilus Bacillus atrophaeus and others to sterilization and whose destruction when exposed to a given cycle indicates that it has been satisfactorily implemented They are designed in such a way that their reading and interpretation is very e
90. grade crepe paper This paper is made with cellulose paste and has a porosity of 0 1 micras a grammage of 60 to 65 g m and neutral pH It is used instead of cloths to prepare high volume packaging Its characteristics of flexibility and resistance make it adequate for this use lts characteristics have been defined in British Standards SW 6254 1989 It is accommodative liquid repellent does not release lint 41 Sterilization manual for health centers does not irritate the skin is resistant and does not have memory Instructions for use It can be used for steam and ethylene oxide It wrinkles easily It should not be reused It is used most commonly as the inner wrapping of packages Mixed paper This paper is a combination of medical grade paper and a transparent polymer It represents the most common packaging in sterilization services It consists of a transparent sheet that allows the article to be seen and an opaque sheet medical grade paper It is resistant to tension bursting and tearing heat sealable easy to open and has incorporated chemical indicators The presentation of this material is in the form of sleeves that are adaptable to materials of different sizes and envelopes Instructions for use It is compatible with sterilization by autoclave with steam ethylene oxide and formaldehyde steam Rigid containers There are a wide range of containers on the market with different characteristics and compatible with di
91. h lint release is a potential risk for patients since lint serves as a vehicle for transmitting microorganisms If lint penetrates a patient s critical tissues it will cause a foreign body reaction If it penetrates the bloodstream it can cause an embolism As mentioned earlier abrasion is an important source of lint Another source is the mechanical extraction of fibrous elements For example removing the tape that seals the package produces lint release The ideal is a material that has a zero coefficient for microparticle or lint release Repellency Sterilization packaging should be repellent to liquids such as water or saline solution This is in order to prevent its penetration by liquids and to maintain the sterility of the contents The normal test to measure the degree of repellency is the Mason jar test which simulates critical use The capacity of penetration by liquids into the material is tested by placing saline solution in a glass jar mason jar and covering the mouth of the jar with the material being examined The bottle is then inverted over a glass base and the time required by the liquid to penetrate the material is measured A longer amount of time measured in minutes and seconds is equivalent to a more efficient protective barrier At least 30 minutes are required in order to be considered acceptable In addition to water repellency the packaging should demonstrate resistance and repellency to a cohols This aspect sh
92. h the water from which it is formed It is completely dry and cannot be used in autoclaves Its temperature rises rapidly Saturated steam can also overheat when there is a rapid reduction in pressure abruptly by more than 50 causing higher pressure and temperature in the jacket than in the chamber Another reason is over drying produced by the passage of steam through materials that have lower than 50 relative humidity as is the case of some textiles that are stored at high temperatures Inadequate preparation of the material The preparation of the material with regard to the type of articles packaging or wrapping size and loca tion within the chamber are also important factors in sterilization They can affect the elimination of air the diffusion of heat and steam and the pre heating of the chamber 85 Sterilization manual for health centers Diagram for the preventive maintenance of autoclaves Daily Cleaning of the internal chamber Operator Monthly Cleaning of drainage filters Operator Discharge of the generator Engineer or technician Quarterly Verification of the cleaning of electrodes Engineer or technician Lubrication of the heating system Engineer or technician Confirmation of pitfalls Engineer or technician Biyearly Verification of the operating and safety systems Engineer or technician Confirmation of the water inlet filters Engineer or technician Yearly Cleaning of the stea
93. hand the majority of disinfectants become inactivated in the presence of organic matter and if some of their concentrations are increased they can be caustic or toxic Alternatively it would be advisable to use chlorine based products to carry out cleaning of equipment and the environment resulting in early elimination of blood and visible dirt This practice also eliminates viruses and reduces the time corrosion and toxicity of the disinfection process Blood and dirt can also be eliminated by first cleaning and later using alcohol 70 for disinfection The adequate selection of the disinfectant will depend on the type of element the corrosion factors and the possibilities of submerging the element In general the recommendations are regulated in the following manner Eliminate or minimize the risk of occupational exposure to pathogenic microbes that are transmitted through the blood by first cleaning and then decontaminating with an appropriate disinfectant 72 Sterilization terilization refers to the set of operations that are developed to eliminate or kill all forms of living beings that are contained in an object or substance Every critical article should undergo some type of sterilization method according to its compatibility Every heat resistant material that is compatible with moisture should be autoclaved This is the principal method used in a SP Every heat resistant material that is incompatible with moisture
94. hand washing and hand antisepsis in health care settings Am J Infect Control 1995 23 251 69 USA Association for the Advancement of Medical Instrumentation AAMI Technical Information Report Designing Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities A Guide for Device Manufacturers AAMI TIR N 12 Arlington VA AAMI1994 Association for the Advancement of Medical Instrumentation AAMI Good Hospital Practice Handling and Biological Decontamination of Reusable Medical Devices 163 Sterilization manual for health centers 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Association for the Advancement of Medical Instrumentation AAMI Recommended Practice Good Hospital Practice ETO gas Ventilation Recommendations and Safe Use American National Standard AAMI ST 43 1993 Arlington VA AAMI 1993 Association of Operating Room Nurses AORN 1996 Standards Recommended Practices Instruments Scopes and Powered Surgical Instruments 197 204 Ayliffe G Nosocomial infections associated with endoscopy Cap 47 en Mayhall G Hospital Epidemiology and Infection Control Williams amp Wilkins 1995 Ayliffe G y col Hand disinfection A comparison of various agents in laboratory and ward studies J H Inf 1988 11 226 246 Bred Alvarez JJ Pelayez Ros B Fereres Castiel J Esterilizaci n in Health Centers DD FISCAM Madrid Spain 2006
95. he process for cleaning 5 19 Validation of the Cleaning 29 Validation Of TUNCTIONAI IY 30 Preparing and packaging 33 Preparation of materials packaging and 5 33 Inspection and verification Of ArtiCleS csesssecseseeeeseeseeeeseeeeseeseeteseetesteneeeeaes 33 General principles Of packaging 34 Packagingimate rials risiini an 35 Criteria for selecting a packaging 1 36 Types of materials used and instructions fOr USE sesser 38 Packaging Selection and evaluation ss essssssessssssrueossrneurevsnuneeeeevssnreorssunereerss 45 Sterilization manual for health centers Type of packaging recommended for each type of sterilization DIOCOSS N 45 Packaging teChn iQue 46 SOE AMV E festa 48 Identification or labeling of the 49 Evaluation of the packaging
96. ic microorganisms but not necessarily resistant bacterial spores It be used on live tissues antiseptics or inanimate objects disinfec tants e Glutaraldehyde chemical agent capable of sterilizing objects e Inanimate non living e Peracetic acid chemical agent capable of sterilizing objects e Sanitation process that results a reduction in the microbial population on an inanimate surface at a safe or relatively safe level e Shelf life time period that a packaged object will remain sterile after un dergoing a sterilization process e Sporicide chemical agent capable of killing spores especially bacterial spores e Sterilization process by which all types of microorganisms are destro yed 160 Terms related to sterilization High vacuum sterilizer type of steam sterilizer that mobilizes the air in the vacuum chamber Steam sterilizer sterilizer that exposes the objects to steam at high pres sure Gravitational displacement sterilizer type of sterilizer that mobilizes air using gravity Sterilization control verifier method that determines whether a process has been completed It does not indicate if the objects subject to this me thod are sterile Tuberculocide chemical agent capable of killing Mycobacterium tubercu losis Ultrasonic cleaner equipment for cleaning instruments using cavitation Virucide chemical agent capable of killing viruses Washer disinfector equipment that washes and ste
97. ical Methods 86 chemie alsia as naear 86 Gaseous 88 Physical Chemical 1 5 93 Correctly loading the SteriliZer 2 cscsecseeseseeseeetesesnenseseenenneneneneneens 99 Daily Care of the 99 Handling transporting and storing 101 FRAN d a 101 tain ae 101 vi Contents 500 12 0 Distribution Methods for controlling the sterilization 109 Physical Chemical indicators Biological indicators 115 generalo snusa anonn Sanno 116 Second generalo A 116 Third generatio M 116 Reactive strips for determining the minimum effective concentration of 117 Failures in the sterilization process Responsibility cesses sacseestesessts aespereesncsstareanessstnedrtectecrssnant aeaaaee SUMMA
98. ical adaptation harmony ventilation and mi nimum distances in order to facilitate maintenance e Operation The existence of an Operational Manual should be confirmed as should the registry of the most commonly replaced parts the informa tion registered by the technical service and a voucher that certifies the operation of the equipment e Performance A microprocessor should be used to evaluate the physical parameters There are also specific chemical indicators the strips should be introduced within the test package The parameters that these chemical indicators measure in different sterilization methods are presence of formal dehyde concentration of formaldehyde temperature and climate The bio logical indicator consists of a vial with a paper strip containing 10 spores of Geobacillus stearothermophilus which should be placed within the test package The physical parameters should be confirmed with a test package followed 132 Validating the sterilization process by three complete cycles with chemical and biological controls during three consecutive days and with loads Management areas and critical points Direct observation can be used to determine the type of mistakes made and the critical points risk areas A multidisciplinary team with knowledge about the field of sterilization should be created to implement this There are eight critical points work areas which can be divided into five areas Criado Al
99. iciencies in the sterilization process Packaging materials that do not provide an adequate barrier Technical documentation regarding the barrier s quality permeability resistance to tearing porosity etc should be reviewed Handling It is recommendable to not handle packages more than 3 or 4 times from when it leaves the sterilizing equipment until it arrives at the patient Transport Transfer standards that minimize or eliminate accidental contamination should be established Storage conditions Environmental factors such as microbial pollution air movements temperature and humidity should be reviewed continually Crushing the packages when they are being stored should be avoided Whether the materials will be stored on open or closed shelves should be established The AAMI also establishes that storage on open shelves requires greater care that the area should be ventilated and that the transit of people and speaking should be avoided Application of an event related policy An event related policy is a method for improving the efficiency and reducing the costs of reprocessing Communication strategies should be developed to provide training and discussions to strengthen this policy Ultimately the application of an event related policy is based on eliminating the entities that compromise sterility e Events that require reprocessing should be specified for example tears moisture 106 Handling transporting and stori
100. inated with HBV HIV or Mycobacterium tuberculosis Semi critical biomedical elements contaminated with the blood of patients with HBV or HIV or with the respiratory secretions of patients with tuberculosis should receive high level disinfection since experimental studies have demonstrated the inactivation of these germs with disinfectants of this type It is necessary to mention that many patients are asymptomatic carriers of these germs and that it is not possible to separate biomedical elements in order to give them additional treatment Therefore it is very important to always respect the steps of disinfection processes Inactivation of Clostridium difficile Endoscopes such as colonoscopes can serve as vehicles of transmission It is therefore important to reemphasize that the patient can be endangered if all steps of the disinfection process are not fulfilled 71 Sterilization manual for health centers Inactivation of pathogenic agents from blood on equipment and in the environment The emergence of HIV raised awareness concerning all of the pathogenic microorganisms that are transmitted through blood However national and international recommendations related to the elimination of these germs on the surfaces of the environment do not seem to be very useful Studies conducted on disinfectants point out that an immersion time of 10 minutes is required However items such as equipment floors and beds cannot be submerged On the other
101. ing recommended for each type of sterilization process Metal boxes WITHOUT NR R NR NR NR perforations with hermetic cover Metal organizer boxes WITH perforations R NR R R R Metal organizer boxes with filter R NR R NR Plastic boxes WITH perforations and heat resistant R NR R g Plastic boxes with filter and R NR R NR R heat resistant Glass jars with hermetic cover NR R NR NR NR Glass jars and tubes with gauze and paper R NR NR NR NR stopper Medical grade paper R R R R NR Double sided bags pouches with medical R NR R R NR grade polyethylene paper Muslin 140 threads inch or double cotton R NR NR R NR Polypropylene and polycarbonates R NR R R R Poliamide NR R NR NR NR Crepe paper R NR R R NR Tyvek NR NR R R R Adapted from APECIH 2003 2 Ed and http www wfhss com html educ educ php R recommended NR not recommended Boxes with filter lacking cellulose or cotton 45 Sterilization manual for health centers Packaging techniques An adequate packaging technique provides adequate protection identification and maintenance of sterility in addition to facilitating transport management by the user and opening and transfer of the sterile material with aseptic techniques All of these enable safe utilization Conditioning materials for sterilization Clothing Nat compressed In equipment for clothing what will be u
102. ings and can cause local re actions on skin and mucous membranes and systemic toxic effects with clinical manifestations such as dyspnea cyanosis gastrointestinal disor ders hemolysis necrosis mutagenesis and carcinogenesis Due to these adverse effects it is considered a highly dangerous substance and its use should be restricted to adequately trained personnel It is a slow process that requires environmental and residual controls of the materials There are no chemical indicators that can monitor the concentration of EtO dur ing the sterilization cycle It requires packaging materials that are perme able to EtO It is a high cost method Stages of sterilization by EtO Conditioning and humidification Entrance of the gas Exposure to the gas Evacuation Aeration Sterilization temperatures range from 35 C 55 and exposure times range from 1 hour 20 minutes and 4 hours The aeration process that should be implemented is carried out at 40 C 60 C for 6 to 12 hours times suggested by the AORN Association of periOperative Registered Nurses and the AAMI This results in a total duration for the entire process of 8 to 16 hours It is worth pointing out that implementation is carried out under the prem ise that ower temperatures require longer aeration times Sterilization by EtO is recommendable provided that it is automated Aeration The aeration of objects sterilized by EtO permits the desorption of the ga
103. inse cycle loose particles can remain in the devices These should be rinsed by hand 22 Cleaning of materials Delicate objects can be damaged Considerations during ultrasonic cleaning Ultrasonic cleaning cannot be used for optical instruments because it removes glue from glass rubber PVC wood different types of metals at the same time or metals and plastics at the same time This cleaning does not remove encrusted dirt It is a supplement to manual cleaning The wave frequency utilized does not produce microbial death and if the cover of the tank is not closed it can produce polluting aerosols Devices that go through ultrasonic cleaning should be aired out prior to cleaning in order to eliminate all gases Otherwise the process of cavitation will decrease since gases will be introduced into the steam bubble diminishing the energy of the implosion Technique Elevate the instrument relative to the base of the tank by placing a rack on the floor of the tank The instrument should be open and the operator should make sure that larger sized instruments do not produce shade areas over smaller instruments The water temperature should not be higher than 55 C since this would cause large instead of micro steam bubbles The established times are 5 minutes for 20 25 KHz transducers and 3 minutes for 35 KHz transducers Increasing the amount of time is not favorable since the dirt tends to get re deposited The gre
104. interpret and familiar to the users It can be e Manual e Mechanic 49 Sterilization manual for health centers Mechanical labeling is carried out by machines or templates that are produced for this use Manual labeling should be done on self adhesive labels or on the fold or flap of the package making sure not to perforate the package and that the writing ink does not stain the medical use device The medical use product should be identified with the following information e Name of the material e Destination in the event that it is needed e Preparation and or sterilization date e Code of the person responsible e Lot number Any other clarification that is considered necessary expiration date Every package should have an exposure control as well as identification or labeling of the content service lot expiration date and initials of the operator Adequate labeling of the package allows for identification of the contents storage and expiration period It also enables the tracking of sterilized packages in the event of technical problems with the device or an infectious event that is attributed to deficiencies in the sterilization process Adhesive labels or adhesive tape masking tape a bar code or a manual label maker can be used A registration system for the storage and distribution of articles should be developed and all users should be knowledgeable about the system Evaluation of the packaging process Packages sh
105. ir flows from the clean to the dirty areas and is then released into the exterior or into a filtered recirculation system There should be no less than 70 air changes per hour Fans should not be allowed in the SP since they generate high turbulence of dust in the air and microorganisms that are projected from the floor to the work tables Temperature and moisture The ideal environment will maintain a stable temperature from 18 C 25 C and a relative humidity of 35 50 Higher temperature and moisture favor microbial growth and lower levels can affect given sterilization parameters such as the penetration of the sterilizing agent Sinks for washing instruments The sinks should be deep in order to avoid splatters during the task and permit the correct immersion of the elements a key factor for the correct cleaning of instruments Physical areas and personnel of the sterilization plant Fire extinguishing systems The service should have at least two fire extinguishers based on CO or ABC chemical powder in a visible accessible location The physical areas of the SP are divided into technical area which has several spaces administrative area and support area Each area is physically divided and each one should maintain its integrity Technical area Area for cleaning and decontamination of material dirty area In the cleaning and decontamination area the microbial load and organic matter of instruments and medical devi
106. irming the quality of the following elements e Environment The installations should be verified The physical area in cludes the structure itself climate control dimensions and installed net works of steam and compressed air With regard to the hydraulic installa tion the water hardness should be observed With regard to the electric installations the voltage protective devices installation to the source it 129 Sterilization manual for health centers self and quality of the steam should be observed e Equipment The structure for the installation of the autoclave should be confirmed including its physical adaptation harmony ventilation near the doors of the autoclave and minimum distances between walls and the equipment in order to facilitate maintenance e Operation The existence of an Operational Manual should be confirmed as should the registry of the most commonly replaced parts the informa tion registered by the technical service and a voucher that certifies the operation of the equipment e Performance Performance should be evaluated by assessing effective ness and efficiency Established physical parameters types of packaging types of loads and their registries types of materials quantity and volume the arrangement of the materials within the chamber and its capacity and the adequate use of registries for chemical and biological indicators should all be confirmed In pre vacuum autoclaves three cycle
107. l controls or monitors Its principal disadvantage is that it cannot sterilize in struments that are not submersible for example older flexible endoscopes with heads or video chambers that are not submersible 87 Sterilization manual for health centers Gaseous chemicals Chemical sterilization by ethylene oxide Indication In general any thermolabile article can be sterilized by ethylene oxide EtO The only recommendation is that the aeration process should be controlled if the article is porous Sterilizing agent e Ethylene oxide or ether 1 2 epoxy ethane is an alkylating agent The pro cess by which ethylene oxide destroys microorganisms is by alkylation replacing the hydrogen atom in a molecule of the organism with an alkyl group and thus preventing the cell from metabolizing or reproducing Its presentation is liquid and it volatizes to form a gaseous compound Pure EtO is inflammable and explosive EtO gas is colorless is heavier than air has an ethereal odor is detectable between 230 to 700 ppm and is soluble in water and in the majority of solvents The characteristics of EtO make the sterilization of materials in special controlled conditions pos sible It is only considered effective if the equipment used guarantees the parameters necessary for sterilization such as temperature moisture ex posure time pressure and concentration of the agent Physical properties Solubility in organic solve
108. l indicators The disadvantage of these indicators is the waiting period for results since the reading is taken after the first 12 hours and at a maximum of 72 hours Reactive strips for determining the minimum effective concentration of glutaraldehyde Use of the strips e The strips are a semi quantitative method for determining if the glutaralde hyde concentration is above or below the minimum effective concentration MEC e They should NOT be used to validate the sterilization or disinfection pro cess 117 Sterilization manual for health centers Instructions for use Submerge the end of the reactive strip in a container with Cidex solution for one second and remove it Do not leave the strip in the solution for more than one second or stir the strip in the solution If it is submerged for more than one second or moves vigorously in the solution it will wash the reagents off the strip This can cause a deficiency in the formation of a yellow color error when the solution would normally pass the test Remove the excess solution from the strip by touching the longer edge with a paper towel Do not shake the strip after removing it or dry it ona towel paper facing downward because it would remove the reagents and the same effect described in item 1 would occur Read the results of the color reaction between 5 and 8 minutes after the strip has been removed from the solution If it is read prior to 5 minutes there can
109. lements exposed to high temperatures or destroyed due to processing by dry heat or modification of the safety parameters of the process such as an increase in the temperature of the process by using dry heat to empirically increase the safety of the process Infrastructure requirements The SP has certain general requirements for all physical areas which we will describe briefly Sterilization manual for health centers Space requirements These vary significantly according to the processes that the SP will carry out and are always calculated during planning The general recommendation is one square meter per hospital bed Mechanical systems In addition to mechanical energy water and steam requirements sterilization processes habitually require pressurized systems such as compressed air nitrogen and vacuum systems A system for water distillation or demineralization which will be used both for cleaning and for filling the steam autoclaves is recommended Floors and walls Floors and walls should be constructed with washable materials that do not release fibers or particles and that are not affected by the chemical agents that are habitually used for cleaning Ceilings Ceilings should be constructed so that there are no exposed angles and only one surface sanitary angles in order to avoid condensation by moisture dust or other possible causes of contamination Ventilation Ventilation systems should be designed so that the a
110. lied vertically at the closure Boxes metal or plastic should not be sealed with any type of adhesive tape The sealing should permit later opening that is aseptic and allows the use of an easy technique that prevents dropping or breakage of the material 48 Preparing and packaging materials Sealing can be carried out according to the following techniques e With adhesive tapes e Bundled with strings or cotton thread e Manual folding e Heat sealed Do not use the following for sealing e Clasps e Pins e Other sharp elements All of these elements could break the package Materials and machines used in heat sealing e Mixed or simple packaging with polyethylene e Adhesive tape with an external chemical control e Internal chemical indicator or integrator e Machine sealer Practical recommendations e Observe the integrity of the package by looking for wrinkles and burned areas e The sealer should be regulated at an adequate temperature level for effec tive sealing e When carrying out the sealing process allow a minimum margin of 3 cm from the edges of the package in order to permit later aseptic opening of the package Sealing of paper and folios film made of plastic or polyethylene should guarantee the hermetic seal of the packaging e There are two types of machines for sealing materials for sterilization man ual and automatic Identification or labeling of the package The labeling should be clear easy to
111. ll be classified according to type of material which can be e metal ideally stainless steel e polyethylene e rubber e plastic e glass Prewashing soaking or decontamination of the material Classification is followed by prewashing or decontamination This is known as a physical process or method designed to reduce the number of microorganisms bioburden of an inanimate object in order to make it safe for handling It is important to mention that prewashing or decontamination is one of the principal tasks within the cleaning of articles and precedes any other related task This process is carried out by submerging the material in a tray or container that is perforated with an enzymatic detergent according to the time recommended by the manufacturer and then passing the material under a stream of running water Prior to every cleaning materials should be completely disassembled The next step is the manual prewashing of the instrument or device through submersion in a solution of enzymatic detergent 0 8 see manufacturer recommendations in running water whose temperature is not higher than 45 C Then soak the device until all of the organic matter is dissolved and has been eliminated At least 1 minute of soaking is recommended and the soaking time should be extended for devices with adhered organic matter Materials that are non stainless steel or carbon steel and chromium plated materials that have lost their integrity eve
112. ls like a balloon and can break It is for this reason that it is advisable to use only paper containers since they are completely perme able to air In the case of the pouch only the paper face which makes up 50 of the package is permeable Issues to take into account e Never use metal clasps since they perforate the packaging that protects the material e When paper paper entirely paper bags or paper plastic pouch or win dow package are sealed fibers can be released during opening and pro duce adverse reactions if they make contact with human tissue As a result a great deal of attention should be paid when opening these packages e The ideal situation is to leave a flap to make opening more practical e The seal of the package should always be inspected prior to sterilization and immediately prior to opening in order to evaluate its integrity 51 Basic guidelines for disinfection and sterilization ll instruments that are used during a specific procedure in a patient need to be sterilized or disinfected Therefore it is advisable to identify different types of instruments according to their use and determine the steps for managing the different groups Guideline criteria for disinfection or sterilization In 1968 Earl Spaulding established the first criterion for disinfection with the objective of rationalizing guidelines for processing materials and instruments Spaulding considered the level of infection risk tha
113. ly after finalizing the cycle Open the door of the sterilizer by 5 to 10 cm and leave the area immediately for at least 15 minutes This may not be necessary in sterilizers with purge sys tems Storage of cylinders should be a vertical position including during transport Symptoms associated with exposure to ethylene oxide Initially irritation of the eyes respiratory tract nose and throat with a pe culiar taste Late headache nausea vomiting dyspnea cyanosis pulmonary edema weakness EKG abnormalities urinary excretion of biliary pigments Skin irritation and burns through direct contact Elevated absolute white blood cell count and decline in hemoglobin values following intermittent exposures over several years In the case of exposure to high concentrations of EtO for a short period of time a high number of chromosomal abnormalities were observed The union of EtO and water produces a toxic compound called ethylene glycol which depresses the central nervous system and has renal toxicity Protective measures for personnel Personnel should have a biyearly medical exam The employer has the obligation to inform the worker about the risks of us 92 Sterilization ing EtO The employer should document the corresponding instructions the list of exposed workers annual consumption of the gas and the result of the biyearly measurements of environmental EtO Such documentation should be in additio
114. ly penetrate and as a result microorganisms are not destroyed There are lubricants that contain an oxide inhibitor that is useful for preventing the electrolysis of the ends and edges The use of lubricant is the first step in the preventive maintenance of instruments Validation of the cleaning process The process to validate the cleaning carried out can be done through e verification of compliance with procedural guidelines protocols e visual inspection after the process and e the presence of implemented water irrigation systems The validation of the cleaning process is subjective given that it is not possible to visualize the bioburden defined as the number and type of viable microorganisms that an article contains after cleaning of each article and for each cleaning procedure 29 Sterilization manual for health centers Thus it is important to adopt cleaning protocols that seek to standardize the validation of this process When validating the procedural guidelines protocols data on the following should be clearly indicated dilution of the products used length of immersion time mode of rinsing and the technique that should be used to disassemble the articles and instruments Furthermore an important part of validating the cleaning process is visual inspection after washing when the operator should carefully observe whether there are any signs of dirt particularly in toothed bars If there is any doubt in this
115. m generator Engineer or technician After 3 years the operation of the control instruments will be evaluated All heat resistant material that is compatible with moisture should be autoclaved Chemical methods These methods are used only in the case of materials that do not tolerate heat but do tolerate chemicals Liquid chemicals Sterilization by manual immersion in chemical agents will always be the ast method of choice These processes are difficult to control have a high probability of recontamination during rinsing or drying and do not allow later storage Automated equipment increases the safety of the sterilization process However this equipment requires controls and operators who are well trained in their use and management Some hospital infection outbreaks have been related to the use of automated equipment without the appropriate supervision Glutaraldehyde e This disinfectant which can be acidic or alkaline is used as a high level disinfectant and can be used at a concentration of 2 for sterilization purposes The duration of the contact time necessary for sterilization is approximately 10 hours It has a wide spectrum of antimicrobial activity is 86 Sterilization active in the presence of organic matter and rapidly inactivates microor ganisms except spores It is easy to used and relatively non corrosive Hydrogen peroxide e This disinfectant is used very little since it does not exist commercially on
116. made of washable material It cannot be wooden Chairs Magnifying glasses for confirmation of the cleaning Sink for personnel Exit for compressed air Cabinets with doors to store non sterile material and supplies Area for storage of material sterile area The area for storing sterile material should admit only wrapped sterile devices or instruments which should be placed on open shelves or in closed cabinets This area should be ventilated with at least 2 air changes per hour with a temperature from 18 C 25 C and environmental relative humidity between 35 50 All sterile packages should be stored at a minimum distance of 30 centimeters from the floor Physical areas and personnel of the sterilization plant The transit of people is prohibited and only authorized adequately dressed personnel should enter the area Minimum necessary physical structure Washable floors and walls Cabinets to store material after the sterilization process Prior to entry a sink for personnel Administrative area The SP should have an administrative area for carrying out administrative activities related to personnel and supplies that is adjacent to but separated from the technical area Furthermore all documentation generated by the SP should be kept in this area such as controls of sterilization cycles controls of the number of materials devices and supplies personnel functions and all other administrative processes
117. mical indicator or integrator e Gauze or protectors for sharp pointed instruments e Sealer in the case of mixed or polyethylene packaging Packaging models The manual preparation of the following models is recognized worldwide for the packaging of medical use products in the SP 46 Preparing and packaging materials e Envelope type This type is for small rounded and light elements The opening is made on the operator s hand e Rectangular type This type is for large and heavy elements boxes of instruments and packages of clothing The opening is made on the table e Paper bags There is a considerable range of sizes all of which need to be folded and sealed with tape or heat sealed by machines They should be made of medical grade paper with bellows that facilitate aseptic open ing have a glossy interior side If it has a printed chemical witness it should be indelible to steam The adhesive part of the bags should be resistant to sterilization processes Pouch or window package paper film consists of a transparent folio or film front side that is sealed to the paper using heat The folios can be made from polyester and polyethylene or polyester and polypropylene Size of the package For sterilization by steam autoclave The size of the packages should not be larger than 28 x 28 x 47 cm If packages of 25 x 25 x 20 cm are used exposure and drying times can be reduced The weight should not exceed 4 to 5 kg
118. mulation Recommendations for the use of disinfection processes Since high level disinfection is commonly used outside the SP endoscopy and dentistry services and surgical areas it is essential for the professional responsible for the SP to participate jointly with the institution s Infection Control Service in the implementation of high level disinfection processes and to take responsibility for their supervision 63 Sterilization manual for health centers This assertion justifies that the efficacy and safety of disinfection processes requires strict monitoring of written parameters and procedures that detail work operations Additionally the chemical controls control of the concentration with chemical reaction strips and physical controls temperature and exposure time performed on the disinfectant solution should also be registered These controls should have the same degree of rigor that applies to the sterilization processes carried out within the plant General guidelines for performing high level disinfection The disinfectants used for high level disinfection should have ANMAT National Administration of Medicines Food and Technology Argentina authorization for commercialization Provision 4324 00 or other provisions that are currently in effect The disinfectants that are currently used for medical use products are glutar aldehyde ortoftalaldehyde formaldehyde and peracetic acid Independent of the product used adeq
119. n if they have minimal erosion should not be exposed to the enzymatic detergent for more than 5 minutes in order to prevent corrosion Thus the removal and reduction of the bioburden are achieved through entraining without any type of handling so that the operator can carry out the 20 Cleaning of materials manual cleaning safely An issue that warrants mention is that in reality and in almost all cases the material used in a procedure or during surgery is not taken immediately to the SP This results in a bioburden blood organic matter or others that dries and further hinders washing particularly when it is carried out without adequate prewashing or soaking Once they are classified and prewashed soaking or decontamination articles will then be washed taking into account their characteristics and uses Pour diluted enzymatic detergent solution according to manufacturer recommendations through all of the channels With a soft non metal bristle brush or a soft cloth and water at a temperature from 40 C 50 C mechanically clean all of the surfaces of medical devices Brushing should be carried out underwater If it is carried out outside of the water it will create aerosols that contain microorganisms and are dangerous for the operator After the thick dirt is removed an ultrasonic cleaner can be used to clean the difficult to reach parts of an instrument If an ultrasonic cleaner is not available try to reach
120. n to the Inspection Book for Oc cupational Health and Safety and should be overseen and reported to the oversight body by a specialized engineer Work with EtO is prohibited for any individual who has blood dyscrasia or is pregnant Personnel should have a mask with a specific filter for EtO gas or organic vapors a gown and protective gloves neoprene nitrile rubber or similar material whenever participating in the sterilization process with ethylene oxide The work environment should be controlled periodically and whenever there is suspicion of a gas leak The use of glass vials containing pure EtO should be ruled out completely Containers with EtO should be kept in deposits far from the processing area and in environments that meet the conditions for the deposit of inflam mable material Physical Chemical Methods Gas with formaldehyde steam FO or Low temperature steam form aldehyde LTSF Indications Formaldehyde gas methanol or formic aldehyde is an alternative to ster lization by for the sterilization of equipment and materials that do not resist high temperatures Sterilizing agent Formaldehyde 2 with steam at low temperature Formaldehyde gas FO is a colorless gas with a spicy odor that is highly soluble in water and reacts with water to produce formalin Formalin is used in variable concentrations The common preparation of formaldehyde 93 Sterilization manual for health centers is 40 an
121. nail polish clothing or uniforms should have short sleeves Hands should be washed with common soap or an alcohol solution if they are not visibly dirty on the following occasions When entering and leaving work Following contact with contaminated material even if gloves or mitts have been used Before and after preparing instruments Before and after eating or drinking Before and after using the bathroom After removing gloves When passing from one area to another the SP Hand washing with soap Technique 1 If liquid soap is used wet hands with running water 2 If bar soap is used pick it up with dry hands 3 Apply soap and distribute it across the entire surface of hands and fingers 4 Rub for at least 15 seconds away from running water 13 Sterilization manual for health centers Rinse thoroughly Dry completely with disposable paper towel Close the faucet with the paper towel Avoid the use of hot water since it increases the risk of dermatitis Hand hygiene with alcohol solution Technique Vi w Apply dose of alcohol solution 60 70 isopropyl or ethyl with emollients Distribute it across the entire surface of hands and fingers Rub until the skin on hands is dry The skin on hands should not remain wet with alcohol if so the asepsis was not effective In places where there is no water source or supply alcohol solutions are indicated and
122. netration by steam it is advisable to wrap these elements in packages that do not exceed 30 x 30 x 50 cm Otherwise they should be wrapped separately packages are larger they run the risk of blocking the flow of the sterilizing agent inside the autoclave preventing elimination of air and sterilization of the packages Pouch or window package e These packages should only be filled to 3 of their capacity Otherwise effec tive sealing cannot be carried out and the container will be at risk of bursting e Regardless of the sterilization method used recall that when adjusting the pouches or packages in the sterilization chamber each polymer side should be placed against another polymer side since the exchange of air steam or gases happens only through the paper e One precaution related to sealing is that in the case of a very high resistance by the sealing cord there can be problems opening the bag and possible bursting of the package Do not forget to always confirm the sealing cord and reduce its resistance by lowering the temperature of the seal Sealing The purpose of hermetic sealing is to maintain the sterility of the content of the packages after the preparation sterilization storage and distribution processes both prior to and at the moment of use The sealing of the package should be very secure and avoid any type of open ing Paper bags will be folded twice and then sealed with adhesive tape which will be app
123. ng materials Items that need expiration dates should be determined and rotation poli cies should be established Both should then be monitored The packaging form and technique of every article should guarantee and maintain the sterile content during storage and transport Practical recommendations e Sterile articles should be handled carefully and the least number of times possible e Register the movement of articles at entry and exit e Carry out periodic inventories of the articles stored in reserve to ensure sufficient quantity e After sterilization packages should remain at room temperature before be ing stored in order to avoid the formation of any steam condensation within the cabinets e Establish the frequency of cleaning needed for this area e Store and distribute the packages according to the chronological order of their sterilization lot number trying to arrange for old lots to be distributed prior to new lots e In this case a basic rule should be used F E F L which means The first one to enter is the first one to leave Summary The implementation of events related to shelf life is synthesized here e This practice recognizes that the product should be kept sterile until cer tain events contaminate it such as breakages moisture falls to dirty sur faces like the floor etc In other cases the expiration date of 6 months can be used to ensure avail able inventory and conserve sto
124. ns is from 3 to 6 hours Note The parameters depend on the type of equipment used and manufacturer recommendations for the use of the equipment e The pressure of the chamber should be sub atmospheric throughout the cycle when pure EtO is used In the case of authorized mixtures the pres sure will be at higher than normal values e The aeration stage should be included in the validation of the process in order to guarantee that the sterilized materials do not contain residual ethylene oxide in concentrations higher than the recommended levels e For materials that have higher fixation of PVC latex the recommend ed estimated aeration times are between 12 and 16 hours depending on the work temperature Equipment e tO sterilizers that meet the standards for the organization and operation of sterilization plants in health facilities should be used Standards are pro duced by the National Program for Quality Assurance in Medical Care Implementation of the method e Procedure and quality manuals should contain the guidelines that will be fol lowed by each institution and that are approved by the Health Authority 89 Sterilization manual for health centers Advantages and disadvantages of the method Advantages EtO is a substance with a high level of diffusion and pen etration which permits high versatility for the sterilization of heat sensitive materials Disadvantages It is highly toxic to living th
125. nsing sink Make an abundant amount of potable quality running water circulate through the channels of the endoscope Proceed with the rinse of the instrument s exterior Carry out successive rinses of the instrument in order to eliminate all of the toxic remains from the chemical agent used Discard the wastewater after each rinse Drying Carry out a final rinse of the channels and external surfaces of the endo scope with 70 alcohol 66 Desinfection e Carry out drying by runoff or with filtered compressed air which should be free from oils and water and at low pressure less than 12 pounds per square inch e Store the endoscope in a sealed plastic bag or pouch within 40 minutes and until its later use If more than 40 minutes passes it should be disin fected again prior to use e Inthe case of a sealed pouch for storage of the instrument label the pouch DISINFECTED in order to indicate the validity of the process Automatic disinfection The use of automated equipment for washing and high level disinfection decreases procedural variability and errors There is currently equipment that is appropriate for many of the available commercial products In spite of being automated processes written internal institutional protocols for their use should be developed in order to facilitate training and guide the technical personnel in charge of operating each type of equipment Equipment used in automatic disinfection shoul
126. nstitution is always the responsibility of the institution itself The quality of the material sterilized in another health institution can only be assured if the packaging is intact and with no stains or wrinkles In general it is recommended that all material sterilized in another health institution be washed packaged and sterilized again unless there is knowledge and guarantee of the process controls carried out in the other institution Some health institutions outsource sterilization of their medical devices However it is the responsibility of the health institution to evaluate the quality of the sterilization processes by accessing the process controls carried out by the company in charge of sterilization Control and registration of the material from the sterilization plant All medical equipment and instruments should be registered in order to control the process of reserves maintenance and preventive substitution Furthermore certain characteristics of the material that enters or leaves the SP should be registered type quantity conditions of conservation if they are stained oxidized or have operational deficiencies etc Boxes with surgical instruments should contain a description of the content in order to facilitate the work of organizing the boxes in the SP They should be counted or reviewed in the operating room before and after each procedure Physical areas and personnel of the sterilization plant Human resources an
127. ntegrity of the containers and materials that have already been processed Cleaning should always be carried out from clean areas to dirty areas in order to avoid contaminant transfer lt is ideal to have cleaning utensils rags cloths sponges that are differentiated by areas dirty and clean Personnel should be trained to fulfill the standardized protocol taking into account the following aspects Carry out the cleaning procedures exhaustively placing greater emphasis on floors and surfaces where the amount of dirt and microorganisms is more concentrated e Walls should be free from stains and splatters and should be cleaned com pletely when dirt or fungi are present e The utilization of water aspirators is recommended for improved disinfec tion of floors although this equipment is not available in the majority of health institutions e Cleaning materials should be placed in mobile carts in the corridors e Dry sweeping with a broom should never be done since this induces the movement of microorganisms from the floor into the air There they will remain suspended for several minutes until being deposited once again on the horizontal surfaces in the area The use of air aspirators is not recommended for the same reason e Rags with dust should not be shaken out and surfaces should not be cleaned with dry rags 145 Sterilization manual for health centers Procedure Cleaning and disinfection will be carried o
128. nts Soluble in almost all solvents Boiling point 10 4 C at 760 mmHg Odor of the gas Perceptible above 700 ppm Chemical properties EtO is a highly reactive substance e Reacts with water to form ethylene glycol e Reacts with chloride ions to form ethylene chlorohydrin e Has alkylating properties and can be combined with different chemical groups such as sulfhydryl amino carbonyl etc 88 Sterilization Mechanism of action e It acts as an alkylating agent for functional groups of structural proteins and enzymes and for nitrogenous bases of nucleic acids Conditions of the process e The values of gas concentration temperature humidity exposure time and aeration should be the same as those that result from the corresponding vali dation of the cycle The following table is presented as general guidance Concentration of the gas 300 600 mg l There are ranges of up to 450 to 1500 mg l of gas mixture depending on the requirements of the sterilizer Temperature 37 55 C Increases in temperature shorten the sterilization process Relative humidity Optimal moisture 50 range of 40 to 60 relative humidity This is necessary for the penetration of EtO into the microbial cell There is no way to measure the level of relative humidity inside the majority of sterilizers Sterilization time The time is affected by the gas concentration temperature and moisture Cycle timing from when the door closes to when it ope
129. o avoid leaks between the container and the cover the sterilizer has a seal joint between the two Furthermore it has a lock mechanism with screws or a bayonet type system composed of small portable autoclaves Pressure control valve The pressure control valve is located on the base in order to maintain the level of desired steam If necessary it will allow the escape of a certain quantity of steam In modern units this instrument has a pressure sensor for steam and a temperature sensor for heat 81 Sterilization manual for health centers Safety valve This is useful in the event that the control valve does not work well If this occurs the escape of the steam will not take place and the pressure of the autoclave could rise and eventually burst In that situation the safety valve would permit the escape of steam In some countries this safety valve is compulsory by law Mechanism for air expulsion This is also called a drip trap Modern autoclaves are equipped with an air expulsion system that operates through a piece or bellows that is filled with a mixture of water and alcohol General control parameters for autoclaves The control parameters are steam pressure time and temperature Steam pressure Saturated steam with a degree of 0 95 95 steam and 5 condensated and free of impurities using soft or treated water Time and temperature These will have a direct relationship with the thickness or type of packaging defined a
130. o the storage environment it should have the following points Drawers 0 Open cabinets 0 Closed cabinets 100 According to the storage location then add the following points Patient room 0 Nursing office 50 Material deposit 15 Sterile material deposit 250 Deposit in operating room or fee 300 sterilization plant Scoring or scale list 1 25 24 hours 26 50 1 week 51 100 1 month 101 200 2 months 201 300 3 months 301 400 6 months 401 600 1 year 601 750 2 years 751 or higher 5 years Example Conditions ProduetA ProduetB Double paper polypropylene pouch 80 100 80 100 Protective wrapping Storage in open cabinet 0 Storage in closed cabinet 100 Storage in operating room 300 300 Total score 480 580 Expiration date 1 year 1 year 105 Sterilization manual for health centers Distribution e The sterilized medical use product should be distributed while preventing dropping and unnecessary manipulation The discharge of the product should be documented in the discharge regis try e Clean bags or containers should be used to distribute the sterilized medical use product to different sectors of the institution e Once distribution is complete the necessary mechanisms for the rapid replen ishment of stock should be implemented What causes contamination Sterility can be compromised by Def
131. oducts change if a key element is fulfilled for example temperature and not necessarily the three elements mentioned at the same time These controls can be internal and external e Internal controls are placed inside of the packages Their principal advan tage is that they provide immediate information on the results although they do not present definite proof of sterility e External controls indicate that the process has undergone sterilization con trol but do not show whether or not it was effective These controls are presented as adhesive tapes e Chemical indicators differ according to the process used dry heat moist heat or gas and should be selected according to the parameters that need to be measured Simple parametric indicator Class III e This is an indicator for only one parameter In this case it only indicates that the package was exposed to a given temperature according to the AAMI 1994 e This is carried out to verify the temperature during the sterilization pro cess e It is important to mention that new indicators currently exist These indica tors are no longer being used in our arena Multi parametric indicator Class IV e This is a type of indicator for multiple minimum parameters time and tem perature of the sterilization process e This consists of a strip of paper impregnated with termochromic ink which changes color when it has been exposed to the necessary minimum condi tions of the method
132. of an SP Support area The support area should be made up of at a minimum A dressing area for changing out of street clothes and storing both clothes and personal objects A deposit area for chemical products detergents and cleaning products This area should have an additional sink to wash the accessories used to clean the environment Flow of material and personnel Responsibility All employees are responsible for maintaining and protecting each area for the function that was assigned to it and for respecting the established circulation Control of circulation Access to the technical areas of the SP should be strictly for personnel that work in each area Visits technical personnel from other areas and suppliers should be received in the administrative area of the SP Sterilization manual for health centers In order to have access to the processing area every visitor or supplier should be dressed appropriately according to standards including use of a gown boots and cap and accompanied by the person responsible for the SP Hospital personnel Only authorized personnel should have access to the area for processing and sterilizing materials No individuals from outside of the service can enter the clean and sterile areas unless the person has authorization from the Head of the SP and is appropriately dressed according to standards Material sterilized in another institution The quality of the product used within a health i
133. of the salt residues are gone and thus avoid damage to the material Cleaning products There is no single cleaning agent that removes all types of dirt Dirt includes a variety of ingredients soluble in water insoluble in water organic and inorganic A cleaning product should carry out the following tasks e Emulsification of fats This is the process in which fats are suspended in water e Saponification of fats This is the process in which fats are made solu ble in water e Surfactation This is the process in which the superficial tension of water is reduced in order to permit greater penetration into dirt e Dispersion defloculation This is the breakage of dirt aggregates into small particles e Suspension This is the process for maintaining insoluble particles sus pended in water e Peptization This is the rupture of proteins e Water softening This is the removal of calcium and magnesium ions while maintaining their insolubility Inorganic agents sequestration or organic agents chelation are used These agents should sometimes be added to the product Detergent 18 Cleaning of materials This is a cleaner composed of an agent that diminishes superficial tension a cleaning agent that is the active ingredient or a chelating or sequestering agent Considerations when selecting a detergent e Follow manufacturer recommendations for the type of dirt against which the detergent is effective Follow manufact
134. ol of the sterilization process Physical controls Temperature Verify for every cycle Time Steam pressure Concentration External chemical Indicate whether it has passed the physical Verify for every package upon exiting identifiers conditions chamber and prior to use Internal chemical Indicate whether the interiors of the In the interiors of packages or containers gt indicators containers and packages have achieved the 30 liters conditions of the process Verify before using Biological indicators Document the effectiveness of the At least 1 per week in steam and 1 per cycle sterilization process in Verify before using External chemical controls Adhesive tape or ink Verify in all packages Internal chemical controls In packages without external chemical control or in which the volume or composition make it difficult for the sterilizing agent to pass container Verify one or all parameters integrator These exist for all systems Verify before using Biological controls Spores Bacillus atrophaeus for and Geobacillus stearothermophilus for steam Types Fast reading hours and slow reading days Examples of controls for the interiors of boxes 1 Non sterile o 2 543 CAMBIA A VERDE 2 Sterilized EO 02543 CAMBIA A VERDE STER ee TURNS TO GREEN CONFORM TO EN 867 CLASS D STERIGUT TURNS TO GREEN CONFORM TO EN 867 CLASS D 119 Sterili
135. onditions of the process e The conditions to take into account are temperature and exposure time which will be established during the validation of the equipment and pro cesses 83 Sterilization manual for health centers e For saturated steam there is equivalence between temperature and pres sure AAMI 96 The following table is presented as general guidance 121 123 15 to 30 minutes ravitational gt 132 135 10 to 25 minutes 121 123 15 to 30 minutes Pre vacuum 132 135 3 to 4 minutes e The application of the procedure known as Flash is accepted under the following conditions in accordance with AAMI 96 1 Only metal non porous articles 3 minutes 7 without lumens Gravitational 2 Metal articles with lumens and metal p 10 minutes porous articles sterilized together 1 Only metal non porous articles 3 minutes without lumens Pre vacuum 2 Metal articles with lumens and metal 4 minutes porous articles sterilized together e It should be ensured that the later transfer of the material to the place of use is carried out in aseptic conditions Prostheses should never be sterilized using the flash procedure Equipment e Steam autoclaves that meet the standards for the organization and opera tion of plants for the sterilization and processing of medical use products in health facilities should be used Standards a
136. ormalin tablets are no longer used since they represent a procedure that does not guarantee disinfection or steril ization 95 Sterilization manual for health centers Hydrogen peroxide plasma e This method uses hydrogen peroxide as a plasma precursor Plasma which is considered to be a fourth state of matter that is different from liquid solid and gas is composed of reactive ions electrons and neutral atomic par ticles Indications e Hydrogen peroxide in its plasma phase has sterilizing properties at low temperatures It is useful for the sterilization of equipment and materials that do not resist high temperatures Sterilizing agent e The sterilizing agent is hydrogen peroxide vaporized in aqueous solution at 58 of the plasma state Mechanism of action e There is synergism between the oxidant action of hydrogen peroxide in the vapor state and the alkylating activity of free radicals Conditions of the process The parameters of the process are Temperature lt 50 C Total cycle time 45 to 75 minutes Pressure Sub atmospheric throughout the cycle The sterilizing equipment operates through the injection of hydrogen per oxide 58 By means of the emission of radiofrequency energy it creates an electromagnetic field in the chamber which generates plasma It is in this state that sterilization takes place e Subsequently the radiofrequency is cut and the atmospheric pressure re turns through
137. osion can be controlled with pH additives It produces ocular toxicity and irritation of the mucous membranes Instructions for use There are formulations associated with hydrogen perox ide that are indicated for the capillary reprocessing of hemodialyzers Concentrations for use In low concentrations of 0 1 to 0 2 and in 10 to 15 minutes it takes fast action against microorganisms including spores The solution lasts for 14 days Phenols Phenol derivatives that are commonly found as the active ingredient of formulations are ortho phenyl phenol and ortho benzil para chlorophenol Phenol compounds are produced through the substitution of one or two atoms of aromatic hydrogen from phenol with a functional group alkyl phenyl benzyl halogen Mechanism of action high concentrations they break the cell wall pene trating the cell and precipitating cytoplasmic proteins In low concentrations they cause the death of microorganisms by inactivating the enzymes in the cell wall Spectrum It is a bactericide mycobactericide fungicide and viricide It has 62 Desinfection little action in small viruses such as echovirus poliovirus and coxsackievirus Phe nols are inactivated when organic matter is present Disadvantages Phenols can be absorbed by porous materials such as plas tic leaving waste that produces irritation in the mucous membranes Instructions for use Phenolic derivatives are indicated mainly in the disin fe
138. ould be considered since the most commonly used solutions in hospitals contain alcohol A very common procedure consists of placing three drops of an alcohol solution on the material After five minutes the material is observed to see if there 37 Sterilization manual for health centers has been penetration The initial solution should not contain alcohol then it should increase by 10 alcohol for every five minutes of exposure Alcohol repellency is measured in the solution with the highest percentage of alcohol that does not penetrate the cloth within a period of five minutes A solution with 70 alcohol range 7 for five minutes is considered acceptable Memory Once the package has been processed and is ready to be opened in the sterile area the opening process should be both easy and maintain the asepsis of its contents All packaging has memory or the ability to remain where it is placed During its opening the extremes of the packaging should remain where they are placed without the edges caving in onto the content of the package bad memory Ease of handling Unwoven packaging materials should be easy to handle during all of the processes related to their use The material should be soft ductile and permit packaging without resistance Softness is important for preventing irritation of the skin of the professional who handles many packages per day Materials that are hard and have low ductility have sharp edges that can cause
139. ould undergo continuous evaluation in order to confirm the following e Integrity of the external layer of the material e Integrity of the seals e Correct identification e Gauge of the chemical indicator e Reading of the expiration date The timing and human resources external auditors for evaluation of the packaging process should be established 50 Preparing and packaging materials Opening techniques Double fold of paper or cloth When removing the product we should avoid the contamination of the external face of the interior container This position has consequences for the extraction technique in the operating room The instruments should not rub the external face of the container The exterior container or second packaging should be opened by the assistants of the instrument handler who will touch only the sterile material One of the most common ways to contaminate the interior container when opening the exterior one is by dragging the powder from the flaps of the external container What causes pouch holders to break A container that is too small for the dimensions of the material can cause breakage since this exerts pressure on the sealing cord and opens the pouch very profound vacuum gap during sterilization can cause the holder to burst e Packaging of textiles in pouches tends to break these holders because textiles retain air for longer in the pouch When the vacuum gap is broken the container swel
140. packaging types of loads and their registries types of ma terials quantity and volume the arrangement of the materials within the chamber and its capacity and the adequate use of registries for chemical indicators Validation of the sterilization process by steam Sterilization by moist heat should be validated in order to guarantee the safety adaptation and effectiveness of the process The validation process to demonstrate evidence of sterilization by moist heat will guarantee that this is always carried out in the same way and with the same quality The purpose is to guarantee the pre established parameters for sterilization by means of moist heat All of these verifications can be defined with the terms IQ installation qual ity OQ operational quality and finally PQ process quality 1Q Installation quality This consists of verifying that the equipment has been adequately installed and is safe to operate following manufacturer specifications and the standards applied in each country Following steps should be taken 128 Validating the sterilization process Verify the correct installation of connections water steam electricity compressed air ventilation etc This process verifies that the different parameters meet manufacturer specifications as well as the regulations that apply Verify the correct operation of the equipment s different security func tions according to standards Confirm
141. patients were af fected should be made The head of the SP should be the one in charge of reporting the possible failure of the sterilizer immediately to Infection Control personnel 124 Validating the sterilization process uality is a basic tool for improving processes and services The ISO 9001 general quality and EN ISO 13485 quality of the installation and maintenance of health products standards make it possible for us to evaluate our system and guide the steps to improve the system In the case of sterilization an adequate level of sterilization SAL Sterilization assurance level should be ensured so that the specific process generates a product or service according to its predetermined specification and in keeping with established quality characteristics The European Standard 1994 defines that a medical device that is determined to be sterile should reach a SAL of 10 when it undergoes a validation process A common requirement of ISO 13485 Correct Manufacturing Standards CMS from Europe Good Manufacturing Practice GMP and the FDA is the use of validated processes Validating a process consists of systematically carrying out the process a specific manner in order to improve it using the following phases Planning Establish temporary programs and checklists validation protocols with criteria for acceptance rejection needs for resources risk analysis Installation qualification IQ This phase is
142. press the packages Do not allow wrapped packages to come into contact with the sterilization chamber Leave at least 7 5 cm between the upper part of the sterilizer and the highest part of the load Never place packages on the floor of the chamber 99 Sterilization manual for health centers e Place pouch plastic paper type packages in a metal mesh basket The packages should be placed on their side with the plastic side of one pouch facing the paper side of the other pouch All the packages should be tilted slightly with the paper side facing downward in order to prevent the mois ture from becoming trapped e Sterilize liquids separately from other materials e When the sterilization cycle is complete do not place the load near air conditioning or a cold air fan e Visually control the exterior part of the packages in order to verify whether they are dry An instrument tray that has drops of water or visible moisture on the ex terior part of the package or on the adhesive tape used to wrap it is not considered sterile e Sterilized objects should remain in the cart and should not be handled until the content has reached room temperature Depending on the objects and the environment this can take approximately 1 to 3 hours e When all of the objects have cooled remove them from the cart carefully making sure not to damage the packaging e Storage of sterile articles should be arranged in a location that avoids risk
143. propriate for the sterilization process Wrapping paper This material is used for sterilization by steam autoclave It is not considered to be an efficient barrier since it has memory is not waterproof generates lint and does not have standardized porosity Furthermore given that in some cases its manufacture is not standardized it can contain toxic waste as part of it composition Newspaper Newspaper is of very poor quality The ink resins mask spores and contain toxic salts Pb and Hg Furthermore newspaper has very little resistance to tears and stains Recycled papers This includes sulphite and wood paper which are both of similar quality Preparations are made of paper that is recycled and bleached with sodium sulphite Na SO During preparation the pH moisture starch concentration microbial food resistance to tearing and porosity are all uncontrolled Kraft paper White monolucid kraft paper is made from cellulose The difference with wrapping paper is that kraft paper has controlled porosity and its manufacture 40 Preparing and packaging materials is standardized with regard to additives water repellency and resistance It is a paper with high mechanical resistance obtained from the chemical paste made of bleached wood The accepted grammage is 60 to 80 g m with a moisture of 8 It has porosity of less than 0 3 micras which means that it represents a good antimicrobial barrier under adequate stor
144. puts such as textiles packaging material and other clean products Area for reception and cleaning where reusable elements instruments equipment etc are received registered and undergo a cleaning process Area for support bath showers office and other facilities for personnel Area for sterilization where steam autoclaves ethylene oxide EtO auto claves dry heat stoves and any other sterilizing equipment such as formal dehyde or hydrogen peroxide plasma are located This includes the space for loading and unloading the carts Area for storage of sterilized material where the already sterilized mate rials are placed prior to their distribution Area for textile preparation where clean reusable textiles surgical linen and different hydrophilous materials gauzes bandages etc are inspec ted arranged and packed in their process packaging Bactericide chemical method or agent that is capable of killing or des troying bacteria Bacteriostatic chemical method or agent that is capable of inhibiting bac terial growth but not necessarily killing bacteria Biological control method that determines the presence of pathogenic bacteria in objects subject to a sterilization process Broad spectrum disinfectant disinfectant that has activity against a wide range of microorganisms Cavitation process by which air bubbles implode break inwards libera ting dirt particles or tissue remains Cleaning process that eliminates
145. quently the smaller activity depends on the pH Its efficiency diminishes with an increase in pH It has corrosive activity becomes inactive in the presence of organic mat ter produces irritation of the mucous membranes is polymerized by sun rays and needs to be protected in opaque containers Chlorine solutions should not be conserved in uncovered containers for more than 12 hours due to the evaporation of the active product Evaporation causes the concentrations of available chlorine to decline from 40 to 50 Concentrations for use The minimum concentration to eliminate mycobac teria is 1 000 ppm 0 1 for 10 minutes Objects should not be submerged for than minutes due to the element s corrosive activity Abundant rinsing is also recommended to prevent chemical irritation from possible waste It is im portant to point out that there are many factors that affect the stability of chlorine such as the presence of heavy ions the pH of the solution the temperature of the solution the presence of biofilms the presence of organic matter and ultraviolet radiation Formula to prepare a hypochlorite solution cc Liters of water x ppm Purchase concentration 60 Desinfection Where cc cubic centimeters of sodium hypochlorite to add to the preparation Liters of water quantity of final solution to prepare ppm parts per million final concentration to prepare Purchase concentration e Household 5
146. quipment or validate the drying process Cleaning of special articles Instruments have significant material value within a hospital s total investments Thus a series of recommendations should be taken into account depending on the material used Washing of metal materials Cuvettes drum trays kidney trays sinks etc 25 Sterilization manual for health centers Manual washing Any remnants of adhesive tape should be removed The materials should be placed in the sink with enzymatic detergent for the amount of time and at the dilution specified on the product s instructions They should be rinsed with abundant water eliminating all residues from the detergent solution A final rinse should be carried out The corresponding brushing should be carried out if necessary The materials should be dried with a clean cloth Mechanical washing The instructions for the washing machine should be followed The operator should be sure not to overload the chamber with instruments in order to avoid problems when closing the doors Washing of surgical instruments Tweezers scissors etc Before proceeding to wash the instruments it is necessary to thoroughly check the instrument received according to its description number of parts and state of conservation of each part It is sometimes necessary to open and disassemble tweezers The instruments should be placed in order at the bottom of the container made of metal or perforated plastic s
147. r ethylene oxide or any other sterilizing gas It is moisture resistant It is durable and flexible at 73 C It shrinks at 118 C and melts at 135 C In general it should not be used above 65 C This material is optimal for gas sterilization it leaves 100 times less EtO and formaldehyde after sterilization which reduces the desorption time It is a material with a never ending amount of polyethylene fibers It is impermeable to water and alcohol can be heat sealed and has an incorporated chemical indicator The heat seal temperature is lower than 120 C Correct sealing will be opaque and non transparent 44 Preparing and packaging materials Instructions for use This is the packaging of choice for sterilization with hydrogen peroxide plasma It is also compatible with sterilization by ethylene oxide Packaging selection and evaluation The procedures for packaging selection should be in accordance with the sterilization methods available in the establishment Before incorporating new packaging there should be an evaluation and validation with regard to compatibility ease of use and cost benefit of the material at the local level A program for continuous supervision should exist in order to evaluate packaging options The supervision should confirm the integrity of the external layer the integrity of the seals compatibility with the sterilization method the chemical indicator gauge and the expiration date Type of packag
148. rage space In order to change the labeling of the expiration date the following should be carried out e First carry out an inventory of all articles that are not used for 6 months 107 Sterilization manual for health centers For articles sterilized in January the expiration date should be July For articles sterilized in February the expiration date should be August The same pattern should be followed for other dates If this system is used different storage locations can be supervised 12 instead of 365 times a year Storage processes should be reevaluated if Storage is not being carried out well This could happen if recently steril ized packages are stored on top and as a result are the first to be used The quantity of a single article requested is exaggerated There are some articles that are probably never used There are sterilized articles whose use is unknown to all personnel Once these steps have been analyzed and overcome analyze Which conditions can be used to store the articles required for each ser vice while trying to meet the storage standards mentioned above Analysis of any changes should be carried out together with the Infection Control Committee The costs associated with the change in packaging including no repro cessing and the time used by personnel for reprocessing should be ana lyzed 108 Methods for controlling the sterilization process ontrol is carried out by verifying that
149. re capable of inducing work related alterations or patholo gies Sterilization services are not an exception to the occurrence of occupational risks On the contrary the SP constitutes a work area with high occupational risk The risks can be of a different nature or etiology of which these are the most common Physical hazards These are hazards caused by equipment whose use in volves risks such as noise and vibrations that can induce sound trauma and high temperatures that can induce burns Chemical hazards These are hazards caused by aerosols gases vapors and organic dusts that can be natural or synthetic and inorganic The chemical sterilizing agents with the highest risk are ethylene oxide glutaraldehyde perace tic acid hydrogen peroxide and formaldehyde Biohazards These hazards are induced by the presence of microorganisms fungi viruses bacteria etc Ergonomic hazards These hazards are directly related to the design of the equipment stress workload fatigue repetitive tasks monotony etc Adverse effects of some chemical compounds Isopropyl alcohol This is used to dry rubber and latex materials and material with lumens Isopropyl alcohol can irritate the eyes and mucous membranes Its permissible limit is 400 ppm Sodium hypochlorite This is used to disinfect environments The sodium hypochlorite solution can irritate the eyes nose and respiratory tract Its permissi ble exposure limit is 0 5 ppm Phenol
150. re produced by the National Program for Quality Assurance in Medical Care Implementation of the method 84 Sterilization The type of load should be taken into account when programming the ster lization cycle For each type of load the corresponding validation should be carried out in order to achieve and be able to document valid results using process indicators Procedure and quality manuals should contain the guidelines that will be followed by each institution and that are approved by the Health Authority Advantages and disadvantages of the method Advantages This method is considered the most economical and most rapid It has no adverse effects since it does not leave residues from the sterilizing agent Disadvantages is not suitable to apply in materials that do not support the conditions of the process Factors that affect sterilization by autoclave Factors that affect sterilization by autoclave are Incomplete elimination of the air in the sterilizer This produces a re duction in temperature which affects sterilization The air bubbles trapped in packages act by impeding the diffusion and expansion of the steam This occurs because of deficiencies in the vacuum pumps or in gravity displace ment autoclaves due to the incomplete elimination of air Overheated steam This can affect the microbicidal power since it loses moisture and acts only as hot air This can occur when the steam is not in contact wit
151. red by the technical service and a voucher that certifies the operation of the equipment Performance Performance should be evaluated by assessing effective ness and efficiency Established physical parameters types of packaging types of loads and their registries types of materials quantity and volume the arrangement of the materials within the chamber and its capacity and the adequate use of registries for chemical and biological indicators should all be confirmed Three complete cycles should be confirmed with chemical and biological controls during three consecutive days and with loads Validation of hydrogen peroxide plasma Technique and material This validation should be carried out by confirming the quality of the following elements Environment The installations should be verified The physical area in cludes the structure itself climate control dimensions and the need for an installation for extraction toward the exterior Furthermore the electric installations voltage and protective devices should be observed Equipment The structure for the installation of the autoclave should be confirmed including its physical adaptation harmony ventilation and mini mum distances in order to facilitate maintenance Operation The existence of an Operational Manual should be confirmed as should the registry of the most commonly replaced parts the informa tion registered by the technical service and a voucher that certifi
152. regard a magnifying glass is useful Another indispensable requirement for validating the cleaning process is that the red area be equipped with water irrigation systems with pressurized devices for articles with lumens Without these devices optimal and safe cleaning cannot be achieved In addition there are chemical controls to validate the effectiveness of mechanical cleaning the visible dirt test and the disinfection test The visible dirt test uses a powder reagent that simulates blood when mixed with water This reagent is applied to the instrument in order to visualize possible organic matter residues In the clean area blue area area for material preparation it is important to have a magnifying glass for visual inspection Validation of functionality Both the hygiene and functionality of the device or instrument should be controlled Once dry do a thorough inspection of the material by e Cleaning e Drying e Functionality of closures e Absence of cracks or tears for glass material clothing and instruments e Absence of lint or fibers e Correspondence of parts arm piston body cover The medical device is now ready for high level disinfection or sterilization 30 Cleaning of materials Important Discard the solutions when used or when visibly dirty Rinse the solution into the drain with abundant water Do not use to store devices Take into account that the enzymatic detergent should be used together wi
153. rilizes surgical instru ments after an operation 161 Bibliography Association Argentina of Nurses in Control of Infections Multidisciplinary Workshop of Referents Reuse of Medical Material July 2002 Buenos Aires Argentina AAMI Proposed Recommend Practices for Sterilization in the Practice Setting 1994 Alfa M De Cagne RT N Olson BSc T Puchalski BA Comparison of lon Plasma Vaporized Hidrogen Peroxide and 100 Ethilenne Oxide Sterilizars to the 12 88 Ethilene oxide gas Sterilizer Infect Control and Hospital Epidemiol 1996 17 92 100 Altemeier W Surgical antiseptics In Disinfections sterilization and preservation 1991 4 ed Cap 12 204 221 Pensylvania USA American Society for Testing and Materials ASTM Standard Practice for Cleaning and Disinfection of Flexible Fobroptic annd Video ENDOSCOPES Used in the Examination of the Halluw Viscera ASTM F1518 94 Philadelphia Pa ASTM 1994 AORN Association of Operating Room Nurses Inc Standards recommend ed practices and guidelines hand scrub surgical 1997 197 203 USA AORN Association of Operating Room Nurses Inc Recommended Practices for Sterilization inthe Practice Setting Standards recommended practices and guidelines 1999 323 34 USA APECIH Association of Sao Paulo of Studies and Control of Hospital Infections Sterilization of Articles Hospitalarios 1998 I 5 APIC Guidelines for Infection Control Practice Guidelines for
154. s Metal objects do not require aeration However the packaging used does The proposed aeration time for all materials is 90 Sterilization Temperature Time Temperature Time 20 C 1 days 49 C 50 C 12 hours 60 C 62 C 8 hours Measurement and control of EtO For better monitoring and control of exposure to EtO OSHA Occupa tional Safety and Health Administration and NIOSH National Institute for Occupational Safety and Health recommend environmental monitoring engineering controls and certain ventilation strategies Environmental monitoring This can be carried out with passive moni tors with brand names as Dupont Proteck Amsco ETO Self Scan 3M 3551 Ken Medical ETO Track available for periods of 8 hours 15 minutes Eight hour controls should be carried out twice a year Fifteen minute controls should be carried out 4 times a year This instrument or monitor which looks like a dosimeter should be placed as close as possible to the operator s face as if it were an identification Subsequent to exposure the monitor should be sent for the corresponding reading of the limit value of exposure Other materials that exist but that are not available in all countries include infrared analyzers photoionization equipment electromechanical equipment Gas Technologies Inc Etox Catalyst Research Intercom Gas Track gas chromatographs HNO Sys
155. s ISO 11140 1 Class Process indicators They distinguish between processed and unprocessed units Class 11 Indicators for use in specific tests Bowie Dick Test Class III Simple parametric indicators They respond to one parameter For example temperature Class IV Multi parametric indicators They respond to more than one critical parameter such as temperature and climate Class V Integrating indicators They respond to all of the critical parameters and are adjusted to the response of biological indicators Class VI Emulating indicators They respond to all of the critical parameters and are adjusted to those of a known cycle Process indicators Adhesive tape Class e These are adhesive tapes that are impregnated with thermochemical ink that changes color when it is exposed to a given temperature e Their purpose is to demonstrate that the article was exposed to the steril ization process and to distinguish between processed and unprocessed articles e These devices are based on chemical reactions and are sensitive to the 112 Methods for controlling the sterilization process parameters of different sterilization methods by saturated steam tempera ture and time e They are presented in the form of paper strips printed with ink and other non toxic reagents that change color when the established requirements for the process are fulfilled e It is important to emphasize that these pr
156. s The following will have to be demonstrated e Certification of the equipment Test of the effectiveness of the equipment e Monitoring of the equipment s operational routine e Validation if an alteration in the routine is identified Validation of the sterilization process by dry heat Ensure that sterilization by dry heat is adequate safe and effective The validation process to demonstrate evidence of sterilization by dry heat 127 Sterilization manual for health centers will guarantee that this is always carried out in the same way and with the same quality The purpose is to guarantee the pre established parameters for sterilization by means of dry heat Technique and material The validation of this process consists of meeting the minimum stages and evaluation criteria that the user should handle Furthermore documented evidence contributes a high degree of safety to this process during which the following aspects should be taken into account e Equipment quality The electric installations voltage structure dimen sions and ventilation should be confirmed e Operational quality This should confirm that all of the components of the equipment function according to the Operation Manual and maintenance instructions Similarly a report of the most common parts replaced and the technical service carried out will be generated e Performance quality This should verify the established physical param eters types of
157. s This is used as a surface disinfectant It can irritate the eyes mu cous membranes and skin It can also affect pigmentation and generate skin ne crosis Its permissible limit is 5 ppm Glutaraldehyde This is a disinfecting agent that produces toxicity by inha 149 Sterilization manual for health centers lation causing cough headache difficult breathing and nausea In the case of cutaneous exposure it can produce reddening and irritation Ethylene oxide The routes of entry into the body are through breathing more frequent the skin and digestion less frequent It is rapidly absorbed through the respiratory tract and highly soluble in blood It is distributed rapidly in the body and of it is eliminated through urine within 48 hours It can produce acute and sub acute toxicity by inhalation of high concentrations in a short time greater than 100 ppm It produces irritation of the eyes and respiratory tract with dyspnea cyano sis and even pulmonary edema digestive symptoms nausea vomiting diarrhea and neurological symptoms headache somnolence lack of coordination and in exceptional cases convulsions In a liquid state and in solutions its irritant effect is greater and can trigger allergic dermatitis Cases of carcinogenesis mutagenesis and teratogenesis have been demonstrated in animals in experimental studies It is for this reason that EtO is classified as a type C2 substance According to OSHA the permissi
158. s of contamination and favors rapid easy movement and identification of the articles e Adequate storage of the material will be reflected in how well their sterility is maintained The effectiveness of this stage of the sterilization process will generate an impact of cost related savings for the institution reflected in expendi tures on packaging time used by personnel and duration of the usage cycles for sterilization equipment Re sterilization without reason will be prevented resulting in a reduced workload better inventory management and evidence of recently sterilized elements 100 Handling transporting and storing materials terile material should be stored in conditions that ensure their sterility The shelf life of a sterile product is the time that elapses from when it is processed until it is used or reaches the expiration date At that point it should be removed in order to be re sterilized if it is reusable or discarded if it is a single use product The shelf life of a sterile product depends directly on the following fundamental aspects manipulation transport storage and correct use independent of the sterilization method used Handling Product handling begins from the time that the material comes out of the sterilizer Handling should always be kept at the minimum amount necessary Before touching containers that contain sterile products it is important to take the following into account Allow
159. s or protuberances capable of cutting including needles scalpels and broken glass Patient elements with communicable diseases Waste from dialysis including arterial tubes and dialysis membranes Waste with blood and or bodily fluids and everything that is used with the patient e Household waste This type of waste does not carry organic matter from patient treatment It includes primarily Food scraps Kitchen elements Paper Boxes Cardboard Packaging Every disposable element that does not contain blood or biological liquids Administrative waste e Chemical waste This includes chemical products and anti neoplastic drugs which should be discarded according to national laws e Radioactive waste This includes radioactive products which should meet the federal regulations for their disposal 155 Sterilization manual for health centers Disposal and final treatment e Sharps They should be placed in disposal containers that have been approved by infection control at the time of their use When these contai ners reach their maximum capacity 3 4 full they should be closed and placed in red bags with other pathological waste The final treatment is incineration e Contaminated liquids These should be discarded in toilets which drain into the sewage system e Household type waste Its final disposal is in containers for household waste companies and will follow the same path as household waste The waste bags
160. s being sterilized since the effectiveness of the method can vary in relation to the articles Resistance of microorganisms The susceptibility of different microorganisms to inactivation processes relates to the aforementioned factors However microorganisms have an intrinsic or innate resistance to sterilization processes The nature of this resistance resides primarily in the composition of the cell wall which regulates the penetrability of disinfecting and sterilizing agents 75 Sterilization manual for health centers Diagram of the susceptibility of microorganisms to sterilization processes Maillard 2004 1 Prions 2 Bacterial spores 3 Mycobacteria tuberculosis avium chelonae 4 Protozoans Cysts Giardia Cryptosporidium 5 Small viruses without sheath Picornavirus Poliovirus A Parvovirus and some Rotavirus Hepatitis A and E Norovirus 2 6 Large viruses without sheath Adenovirus gt 7 Fungal spores Aspergillus Absidia 8 Bacterial and fungal vegetative forms 9 Large viruses with lipid sheath HIV HCV HBV Herpes Chickenpox Rubella Sterilization methods Physical methods dry heat and moist heat Chemical methods liquids and gases ethylene oxide Physical chemical methods low temperature steam formaldehyde and gas plasma hydrogen peroxide Physical methods Dry heat It is important to always take into account that the microbicidal action of heat is conditioned by the
161. s should be checked with the Bowie Dick test followed by three complete cycles with chemical and biological controls during three consecutive days and with loads In gravitational autoclaves the test should be carried out with an empty chamber A frequent problem is that preventive maintenance is not carried out on machines since what is most common is to wait until the machine fails Validation of sterilization by ethylene oxide Validation should be determined and provided by the manufacturer of EtO autoclaves Technique and material This validation should be carried out by confirming the quality of the following elements e Environment The installations should be verified The physical area in cludes the structure itself climate control dimensions and the need for an installation to extract environmental gas toward the exterior Further more the electric installations voltage and protective devices should be observed Equipment The structure for the installation of the autoclave should be 130 Validating the sterilization process confirmed including its physical adaptation harmony ventilation and mini mum distances in order to facilitate maintenance The existence of a device to measure the quantity of residual EtO in the environment should also be confirmed Operation The existence of an Operational Manual should be confirmed as should the registry of the most commonly replaced parts the informa tion registe
162. s with red plastic bags Precautions not to mix other dangerous waste e g cytotoxic drugs mer cury etc with infectious waste should be maximized Liquid waste can normally be thrown in the toilet or similar object This can be used to eliminate blood stools vomit urine sputum secretions and other body fluids Personnel should wear resistant gloves or mitts in order to handle liquid residue avoid spattering their clothes and wash their hands They should be particularly careful when pouring liquids not to stain the walls toilets furniture floor etc Disposable containers should be closed hermetically in order to avoid spill age 157 Do not place explosive material alcohol solvent aerosols or glass in bags being sent for incineration They should be treated as special waste placed in rigid boxes and labeled Human pathological waste breasts uterus placenta amputations etc should be placed in well closed bags and if necessary a double bag in order to avoid spillage They should be placed in closed rigid boxes and labeled BIOHAZARD In the case of long lower limbs they should be placed in a double bag closed and labeled BIOHAZARD Pay attention when discarding pathological waste to not mix it with the rest of the waste even when everything is headed to the incinerator Label and discard it without delay The circulation and transport of waste should be programmed The fre quency of the collection should be a
163. se elements Also called disposable elements the manufac turer provides these elements sterile Opening of the sterile package im plies its immediate use Once used they should be discarded and should not be reused under any circumstance e The process for the cleaning and disinfection of arthroscopes and lap aroscopes is the same as the process for endoscopes with the exception that the rinse should be carried out with sterile water without any excep tions The area and timing for carrying out this procedure is the operating room prior to the surgical procedure Drying should be carried out with sterile compresses Bronchoscopes Endoscopes light sources and tweezers should be inspected before commencing the procedure in order to confirm their correct functioning or state of conservation The bronchoscope should receive high level disinfection HLD prior to the first study of the day and immediately following each study All of the removable parts should be disassembled for mechanical cleaning The inside and outside of the bronchoscope should be cleaned vigorously with enzymatic detergent The channels should be brushed The parts that have been removed should be submerged in a neutral enzymatic detergent during a period of time that will depend on the detergent used The head of the non submersible bronchoscope should be cleaned with gauze soaked in detergent Disinfection should be carried out through the complete immersion of the
164. sed first will be placed on top Prepare with surgical fold Do not overload Maximum size 30x30x50 cm Maximum weight 3 kg Sizes over 45 cm place in spiral form Rubber tubes Sizes over 45 cm place in spiral form but first moisten the lumen with distilled water Separate arm and Optional assembled if sterilized with dry heat but monitor the heating times for the material Talcum In small envelopes of 1 or 2 grams Vaseline In glass jars with hermetic cover Maximum quantity 30 grams Oils In neutral glass jars with hermetic cover Maximum quantity 30 grams Test tuhes When sterilized with moist heat use gauze stopper and paper cap When sterilized with dry heat use with corresponding cover that is hermetic and heat resistant For surgery the fold should be made maintaining the edges inwards without leaving loose threads and lint Design the necessary measures Prepare them with hydrophilous gauze Dressings Prepare them with hydrophilous gauze and cotton Aqueous contents Load to only 70 of the capacity of the container With semi open hermetic cover and paper cap Boxes of instruments Do not overload Maximum weight 3 kg Arrange internally for surgical use Elements used for packaging Packaging material to use e Adhesive tape with external chemical control according to the sterilization method to be used Adhesive tape for identification of the package masking tape Internal che
165. ses HIV adenovirus and herpes However these disinfectants were not tested for all of these viruses Currently disinfection with isopropyl 70 or ethyl alcohol is used for 15 minutes after an exhaustive cleaning with enzymatic detergents rinsing and drying The effectiveness of this practice however has not been verified HLD also needs to be used for cryosurgery instruments Vaginal sonography probe In gynecology one or two condoms are used to cover the vaginal explorer in sonographic scanning studies Nevertheless this small object can fail and as a result HLD is required between patients HLD should be carried out with glutaraldehyde 2 that is allowed to act for 20 minutes Dental instruments Increased scientific articles and publicity about the potential transmission of infectious agents in the dental practice focused the attention of professionals in this discipline on dental instruments as possible agents of disease transmission The ADA American Dental Association issues the reminder that every surgical element or elements that normally penetrate soft tissue or bone forceps scalpels surgical aspiration elements bone chisels etc are classified as critical The ADA recommends that they be sterilized between uses or discarded Instruments that do not penetrate tissues or bone amalgam condenser air water syringe etc but are in contact with the oral cavity are considered semi critical They should also be sterilize
166. small cuts which constitute a source of contamination both for the professional and for the patient Types of materials used and instructions for use The type of packaging should be selected according to the required sterilization method At the global level there is no doubt that in order to package biomedical articles only products manufactured for this purpose should be used This refers to products that meet the conditions for being considered medical grade As mentioned earlier it is very important to eliminate the use of drum trays newspaper and recycled paper made from mixtures that are uncontrolled and of very low quality Sterilization packaging is classified according to its origin or manufacturing as medical grade non medical grade and rigid container materials Within these differ ent types there are materials that are disposable and others that are reusable The term medical grade is used by the sterilization packaging industry to designate materials that are specially designed for packaging and whose preparation is standardized This type of packaging has a controlled porosity no higher than 0 5 microns and water repellency 38 Preparing and packaging materials For packaging that is not medical grade its preparation is not standardized and it may not fulfill the principal characteristics required for ensuring the sterile conditions of articles Usually this type of packaging does not have quality assurance with respect
167. stration to protect personnel from infections or accidents thus providing a safe environment for employees Wenzel R 1993 The sterilization plant plays a very important role in the prevention of hospital acquired infections which have been associated with the inappropriate disinfection of reusable objects including endoscopic devices respiratory care devices transducers and reusable hemodialysis devices There was a recent controversy concerning the reprocessing of expensive medical devices for example probes without lumen for cardiac electrophysiology labeled by the manufacturer as single use If decision is made to re use a disposable device the responsible institution should demonstrate that the safety effectiveness and integrity of the product have not been compromised in the process Sterilization plant services are also responsible for collecting and receiving the objects and devices used during patient care and for processing storing and distributing them throughout the hospital This manual has been published by the Headquarters of the Pan American Health Organization in order to inform health workers about the simple protocols and procedures that have been developed to prevent hospital acquired infections inside and outside the sterilization plant Sterilization manual for health centers The guidelines included in this manual show the steps to follow in cleaning preparing sterilizing storing and transporting hospi
168. t There are currently workspaces for HLD that protect the operator Instructions for use is indicated for the HLD of endoscopes when steril ization is not possible It is also indicated for the use of metal articles or materials such as speculums ear nose and throat and dental instruments and the slides for laryngoscopes Concentrations for use In our environment we have a 2 solution A time of 45 minutes is required to carry out HLD at a temperature of 20 C There are other formulations of glutaraldehyde in concentrations that range from 2 4 to 3 4 59 Sterilization manual for health centers In Europe there are concentrations of 1 5 with longer immersion times The threshold limit value TLV exposure value of glutaraldehyde is 0 02 ppm parts per million to 0 05 ppm in 8 work hours Chlorine and chlorated compounds Chlorine based disinfectants are usually available in liquid form as sodium hypochlorite bleach or in solid form as calcium hypochlorite sodium dichloroisocyanurate Mechanism of action t produces the inhibition of enzymatic reactions de naturation of proteins and inactivation of nucleic acids Spectrum It is a viricide fungicide and bactericide mycobactericide Advantages and disadvantages lts action is fast low cost and easy to man It has deodorizing properties and microbicidal activity attributable to the un dissociated hypochlorous acid The dissociation of this acid and conse
169. t the degree of moisture of the articles since it could interfere in the disinfection or sterilization process Drying can be manual and automatic Manual drying should be carried out with a cloth or compressed air Dry the devices well by hand with soft cloths made from very absorbent 28 Cleaning of materials material or cellulose fiber Make sure that lint or fibers do not remain on the surface or interior of the materials Automatic drying should have a specific tube for each lumen The principal advantage of automatic drying is the speed of the process which reduces work time and costs At present special chambers for drying tubular and corrugated materials are available The cycle lasts approximately 25 minutes to 2 hours depending on the type and amount of materials to dry The specific connection should be taken into account for different lumens Different lumen materials can be placed in the drying chamber always ensuring that that they have the same characteristics Lubrication Following cleaning instruments can become rigid and difficult to manage and present stains or other imperfections This is why lubrication after cleaning and before sterilization is important This is only carried out for surgical instruments The lubricant solution utilized should be water soluble and made specifically for sterilization Mineral silicone or machine oils should not be used since they do not allow the sterilizing agents to ful
170. t the utilization of these articles would represent and classified them in the following way Critical articles Critical articles are instruments that come into contact with cavities or sterile tissues including the vascular system These articles pose a high risk of infection if they are contaminated with any microorganism which means that they should always be sterile This includes for example surgical instruments cardiac probes catheters and prostheses Semi critical articles Semi critical articles are instruments that come into contact with the mucous membrane of the respiratory genital and urinary tracts and with skin that is not intact Although mucous membranes are usually resistant to infections by bacterial spores they can present infection when they are contaminated with other microbial forms For this reason they should be sterile or at the least they should be submitted to high level disinfection HLD This includes for example respiratory assistance devices anesthesia and endoscopic devices Non critical articles Non critical articles refer to all instruments that only come into contact with intact skin In this case healthy skin acts as an effective barrier to keep out the majority of microorganisms As a result the level of disinfection needed is lower In general only adequate cleaning and drying are required with the need for intermediate or low level level disinfection on some occasions Some examples of this typ
171. table water in the washing tray respecting the proportion and temperature of water indicated by the product manufacturer Submerge the endoscope fully in the solution for non submersible mod els the head is not immersed Make the solution of diluted enzymatic detergent circulate through the channels of the endoscope until the organic remains are completely elimi nated Leave the instrument submerged and the channels full of solution for the time indicated by the manufacturer of the cleaning product In non submersible models the head should be cleaned with a cloth im pregnated with an enzymatic detergent solution Discard the enzymatic detergent solution Rinse the washing tray used with potable water Place the washing tray in the washing sink Make an abundant amount of water circulate through the channels of the endoscope Proceed with the rinse of the instrument s exterior Confirm that both the exterior and interior rinses have completely elimi nated the remains from the cleaning agent Discard the water in the sink after each rinse Drying Carry out a final rinse of the channels and external surfaces of the endo scope with 70 alcohol Carry out drying by runoff with a clean disposable cloth and or with com pressed air at low pressure less than 12 pounds per square inch 65 Sterilization manual for health centers Disinfection itself The disinfecting agent should be contained in a disinfection tray wi
172. tal equipment so as to obtain sterile material It is very important to be aware of this information in order to provide patients with safe health care Physical areas and personnel of the sterilization plant he sterilization plant SP by definition is the service that receives prepares processes controls and distributes textiles clothing gauzes dressings biomedical devices and instruments to all sectors of the hospital with the goal of providing a safe input to be used with the patient Advantages of centralization The centralized sterilization system has the following advantages Efficiency When duly organized this system provides efficiency through supervi sion of the cleaning maintenance and sterilization tasks This system facilitates the standardization uniformity and coordination of procedures since it requires the constant supervision of a person devoted to supervision Economy A centralized service proves to be economical since it avoids the du plication of expensive equipment steam autoclaves dry heat stoves pouch seal ers etc The life of the instruments is prolonged thanks to efficient manipulation cleaning preparation sterilization overseen by specialized personnel Safety In the old decentralized sterilization systems with unsupervised personnel there was an increased probability of failures within processes Examples include materials exposed to improper sterilization methods non resistant e
173. tant which can be sodium hypochlorite 1 100 should be used to clean the surfaces A clean rag should be used for each area Alternatively surfaces can be sprayed with a sodium hypochlorite solution diluted at 1 100 and then rubbed vigorously with a clean rag saturated in the solution 146 Environmental cleaning and disinfection of the sterilization plant Hygienic and biosecure In order for a SP to be a hygienic and biosecure place the following recommenda tions should be followed Corresponding measures to avoid or minimize the generation of drops or aerosols should be taken The use of liquid soaps is recommended in order to prevent contamination and clogged plumbing Wash hands before and after each procedure Deposit the materials in completely dry places Avoid air currents or movements within the areas of the SP Fulfill the requirements of the institution s de infestation program Avoid all types of construction or un programmed renovations in the area Personnel should use the complete uniform provided by the institution suit cap etc according to the standards of the SP The use of nail polish cosmetics and jewelry is prohibited The use of feather dusters and brooms is prohibited Eat or drink only in designated areas Avoid the unnecessary handling of processed medical use products 147 Ocupational hazards he health team that works in a hospital establishment is exposed to count less risks that a
174. tarting with the heaviest one Manual washing To carry out decontamination place the instruments in a perforated tray and submerge them in a container with enzymatic detergent This container should be located in the wash sink Then put the container under the stream of water to eliminate the maximum amount possible of bioburden Proceed with brushing placing special emphasis on the toothed bars and internal spaces of the tweezers Rinse with abundant water eliminating all residues from the detergent solution Carry out a final rinse Dry the materials with a clean cloth 26 Cleaning of materials Mechanical washing Place the perforated trays in the washer disinfector of instruments and turn it onto the automatic cycle which varies according to the brand Once the manual or mechanical washing period is complete place the instruments on the drying table Then take the instruments through the pass thru window toward the clean or blue area for their preparation conditioning and packaging Washing polyethylene rubber plastic and latex material When washing polyethylene rubber plastic and latex material we should follow the following steps During washing it is important to have cuvettes trays or perforated containers Remove any remnants of adhesive tape that are stuck to the surfaces for example adhesive tape using cotton impregnated with white benzine Then submerge the material in an enzymatic detergent In the
175. tems Foxboro Envirogard III and detector tubes General recommendations Place the equipment in ventilated areas and far from the circulation of per sonnel and the public Use protective barriers Carry out periodic controls environmental monitoring If anyone presents hypersensitivity to EtO the person should avoid expo sure Guaranteed removal of EtO in work environments and materials is achieved with the adequate functioning of ventilation and extraction equipment in rooms where this equipment operates and with the fulfillment of all recom 91 Sterilization manual for health centers mended technical specifications Such removal is necessary in order to avoid exposures that can carry serious consequences for the health of personnel or patients The ventilation system should expel air directly toward the exterior The extraction channel should be at or below the level of the door and the equipment s drainage area The room should have 10 air changes per hour be at 21 C and have a relative humidity of 50 MAXIMUM ENVIRONMENTAL LEVEL ALLOWED 1 part of EtO per 1 million parts of air 1 ppm for an 8 hour work day according to Resolution 444 91 Ministry of Labor MAXIMUM LEVEL PERMITTED FOR MEDICAL DEVICES 5 ppm ac cording to Resolution 255 94 Ministry of Health and Social Action It is necessary to monitor the levels of EtO gas in the room Discharge the sterilizer immediate
176. th PPE because it irritates the eyes and skin It is also toxic when inhaled therefore an exhaust fan should be used continuously and harmful if in gested Store the enzymatic detergent at a controlled temperature 15 30 Avoid excessive heat more than 40 C Rinse the container well before discarding Use it prior to the expiration date see the lower part of the container Cleaning brushes once used should be disinfected at the end the day Disinfection can be carried out using a sodium hypochlorite solution 1 10 for 15 minutes Personnel who work specifically in cleaning are fundamental to its suc cess They should be neat and meticulous Personnel should be vaccinated against Hepatitis B 31 Preparing and packaging materials very article to be sterilized stored and transported should be packaged in packaging that is selected to guarantee the sterile conditions of the material processed Packaging should be selected according to the sterilization method and the article to be prepared Every package should have an exposure control and an identification or label of the content service lot number expiration date and initials of the operator Preparation of materials packaging and methods Once articles are processed in the red contaminated or dirty area they will be taken through the pass thru window to the blue clean area according to the condition and use for their preparation This stage includes
177. th a cover on which the preparation date and validity of the solution should be clearly and legibly indicated In the case that the product requires it the disinfecting agent should be previously activated by the addition of the activating solution during the preparation of the solution The tray should be opaque in the case that the product used is photosensi tive Confirm the concentration of the disinfecting agent with reactive strips that are specific to the product used at the beginning of the day or after every 10 immersions or procedures Confirm that the temperature of the solution is the minimum recommended for the disinfection time utilized Confirm the expiration or validity date of the solution If the product validity date has passed or the product was diluted or in activated shown in that the reactive strips did not reach the final point discard the solution If the product is apt submerge the endoscope completely except for the head in the non submersible model and make the disinfectant solution circulate through the channels of the endoscope repeatedly Cover and leave the instrument and channels in contact with the solution for the minimum amount of time specified for disinfection in the institution s internal procedures Remove the endoscope from the solution Cover the disinfection tray for later use without discarding the disinfectant solution Rinse of the disinfecting agent Place the tray in the ri
178. the door and in a horizontal position the sheet should be parallel to the base of the sterilizer A cycle should be carried out at 134 C with an exposure time of 3 5 to 4 minutes Rutala 1996 AORN 1994 Scali 1997 At the end of the cycle the package will be removed and the results will be interpreted Correct test The indicator will have turned toward the other tonality uni formly across its entire length Incorrect test This is expressed through a color that is fainter than the one indicated by the manufacturer or through the appearance of spots or areas of different color or color density There are currently factory packages that replace the ones just discussed 114 Methods for controlling the sterilization process e Critical aspects lf the test indicates incorrect sterilization it is positive it should be repeated If incorrect sterilization is confirmed the operation of the equipment should be interrupted and maintenance assistance should be requested review of drip traps solenoids and the vacuum pump After the review perform the test again in order to corroborate its functioning Biological indicators Biological controls are currently the only means available to confirm the sterilization of an article or to determine the effectiveness of the sterilization process Periodicity of use e Moist heat one per week e Ethylene oxide one in each load e Steam formaldehyde one in each load e Hydrogen peroxide
179. the inspection and verification of the articles selection of the packaging packaging of the article sealing and labeling of the package and evaluation of the package Inspection and verification of articles The inspection and verification of articles should precede the preparation stage in order to detect deficiencies in the cleaning process as well as the conditions of integrity and functionality of the articles In order to complete this activity and avoid the contamination of the materials thus guaranteeing that they are in perfect conditions for use personnel should use a cap and latex gloves and have a well illuminated environment lubricants and a magnifying glass The visual inspection of each article should be carried out by observing deficiencies in the cleaning process corrosion and other damage like cracks The functional inspection of each article should also be carried out confirming that scissors are able to cut confirming the fit of the teeth in dissecting forceps and confirming the catch system for the toothed bars of hemostatic forceps Their 33 Sterilization manual for health centers lubrication conditions should also be verified Articles that are not ready for use will be withdrawn and replaced in the shortest amount of time possible Recommended practices Use the hand washing technique before carrying out this activity Maintain the work table in good conditions both in terms of hygiene and organization
180. them to cool prior to removing them from the sterilizer in order to avoid condensation Hands should be clean and dry If the operator carried out another activity prior to the current one carry out exhaustive hand washing Take off gloves used for the other activity and wash hands Transport materials in carts if the volume requires it and never resting against work clothes Work clothes should be clean Transport Materials should never be taken directly by hand to the shelves For their transport carts that are easily cleaned have smooth surfaces and are preferably made of heat resistant plastic polymers should be used This type of cart produces less temperature difference in materials than stainless steel carts 101 Sterilization manual for health centers and the possibility of condensation is also lower Depending on the route that the cart would need to follow the following can be used e Open carts e Protected carts with protective cover e Closed carts In any of these cases carts should be taken directly from the SP to the destination area Storage Although the storage of sterile products is carried out in different areas of the health center the conditions should always be the same General considerations e The storage area should be separated from other materials primarily dirty clothes and waste e Access to the area should be restricted e Packages should be placed on shelves or in cabinets
181. tion of exposure Each disinfection method and agent is associ ated with a specific amount of time that is necessary for achieving the desired result e Presence of extracellular material or biofilms Many microorganisms produce thick masses of cells and extracellular material or biofilms which generate a barrier against the disinfection process For this reason disin fectants should first saturate the biofilms in order to eliminate the microor ganisms they contain Disinfection methods Disinfection is one of the oldest procedures in the hospital environment It was originally used to eliminate microorganisms from the environment and to sanitize hands There are two disinfection methods physical and chemical Physical methods Pasteurization This method was originally used by the French Louis Pasteur This process is used to carry out HLD by bringing water to 77 C for approximately 30 minutes This destroys all microorganisms except bacterial spores Boiling This method uses boiling water at very high temperatures to achieve disinfection For example during HLD instruments are boiled in a covered container for 15 to 20 minutes measured from the time the water starts to boil The objects should be covered completely by the boiling water and no other objects should be added while it is boiling The heat should be low since high heat causes 56 Desinfection objects to bounce decreases the water level and consumes more gas Th
182. tion time x 100 Total No of sterilized products Quality standard less than 1 Criteria for adequate packaging of material to be sterilized Indicator No of errors or defects in the packaging of materials to be sterilized per week x 100 No of sterilization loads during the week Quality standard 0 136 Quality indicators for the sterilization plant Criteria for safety in the sterilization plant The sterilization plant needs to work with standardized safe procedures in order to guarantee a minimum frequency of work related accidents Accident indicator No of accidents that take place in the sterilization plant in a month x 100 No People day working during the month Quality standard 0 Incident indicators No of incidents that take place with the autoclave in a month x 100 No of loads by autoclave carried out during the month Quality standard less than 1 No of accidents that take place with ethylene oxide in a month x 100 No of loads by ethylene oxide carried out during the month Quality standard 0 No of accidents that take place with gas plasma in a month x 100 No of loads by gas plasma carried out during the month Quality standard less than 2 137 Sterilization manual for health centers Criterion for the satisfaction of the internal client Indicator N of claims or complaints due to
183. trol Hosp Epidemiol 1993 15 36 39 Rutala W A Weber D J FDA labeling requeriments for disinfection of endoscopes a counter point Infect Control Hospital Epidemiol 1995 16 231 235 Rutala W Weber D Disinfection of endoscopes review of new chemical sterilants used for high level disinfection Infect Control Hosp Epidemiol 1999 20 69 76 Rutala W Antisepsis Desinfection and Sterilization in Hospital and Related Institutions En Murray PR eds Manual of Clinical Microbiology Washington ASM Press 1995 227 45 Rutala W Changing practices in disinfection and sterilization Lecture in APIC Conference Baltimore 1999 Rutala W Desinfection Sterilization Waste Disposal En Wenzel R Prevention and Control of Nosocomial Infection Williams and Wilkins Baltimore MD Third Edition 1997 Cap 21 460 495 Rutala W Disinfection and sterilization of patient care items nfect Control Hosp Epidemiol 1996 17 377 384 Rutala W Selection and Use of Desinfectants in Health Care En Mayhall Glenn Hospital Epidemiology and Infection Control Williams and Wilkins Baltimore Maryland 1996 Cap 10 913 936 Rutala WA Weber DJ CJD Recommendations for disinfection and sterilization Clin Inf Dis 2001 32 1348 Rutala WA Weber DJ New disinfection and sterilization methods Emerg Inf Dis 2001 7 348 166 55 56 57 58 59 60 61 62 Bibliography Rutala WA APIC Guideline For Selection And Use Of Disinf
184. ty of use e During every sterilization cycle Temperature e The temperature of the chamber and of the interior of the packages are recorded through temperature sensors that are made specifically for the apparatus and through other external sensors thermocouples etc Pressure e Through manometers manovacuometers or pressure sensors that should be calibrated periodically Time e According to the clock that is part of the equipment which should be cali brated periodically Maximum thermometer e This indicates the highest temperature that has been reached but not its duration e For sterilization by moist heat it is necessary to take the precaution of wrapping the thermometer in surgical clothing in a way that does not form channels that hinder the arrival of the sterilizing agent 111 Sterilization manual for health centers At the end of the cycle confirm fulfillment of the parameters with the values required for the total sterilization cycle The printed registries that can be issued by the equipment should be used These registries should be filed with the rest of the documentation of the process Chemical indicators Periodicity of use e In every cycle and or package e The chemical indicators used for each process should meet the following conditions printed on non toxic tapes stable over time easy to read and interpret permit the replicability of the process Classification of chemical indicator
185. uate environmental conditions in terms of both tem perature and moisture 15 C 28 and 30 50 Shelving or cabinets should be selected based on the rotation of the ma terials and of personnel access to the area Open shelving should be made of racks in order to avoid condensation of moisture and concentration of dust Closed cabinets should be used when the material will have infrequent rotation or when personnel access is not restricted Accessory baskets that are used should be placed on shelving or cabinets whenever the material is unstable or the basket could slide or fall It is advisable for furniture to have wheels in order to be able to move them away from the walls for cleaning Rigid containers should be stored in a way that their expiration date can be identified and controlled without having to moving them When the content is heavy or has protruding edges cardboard containers or a plastic interior protection with a double bag is suggested Shelf life It is accepted universally that the validity of the sterilization process is conditioned on the events to which the medical use product is exposed For this reason it is important to have a reliable control of the product in the SP and in the sectors where it is used Expiration of sterilized articles shelf life Shelf life is the maximum time that a sterile package can be stored The AORN and the AAMI established that the shelf life of a sterile material is
186. uate monitoring of the critical parameters of the process should be carried out e concentration of the disinfectant agent e temperature e exposure time The validity date of the solution should also be controlled It is fundamental to confirm the physical and functional compatibility of the instrument with the disinfectant product as stated in manufacturer instructions The ventilation conditions required in the work area should be respected in order to avoid the exposure of personnel to vapors in concentrations higher than the limits established by occupational health agencies The disinfection area should have forced ventilation broad work benches and two sinks for the washing and elimination of the disinfectant from the instruments through rinsing Standards of the AAMI Association for the Advancement of Medical Instrumentation or other standards that are currently in effect As was previously mentioned the international tendency is to consider high level disinfection as part of a set of operations designed to guarantee the adequate reprocessing of medical products As a result the full treatment for complete high level disinfection including the stages prior to and following disinfection itself should be understood as the following 64 Desinfection These stages are Washing Rinsing Drying Disinfection itself Rinsing of the disinfecting agent Drying Washing Prepare a solution of enzymatic detergent in po
187. uld have negative air pressure relative to adjacent areas and should have an air extractor that functions continuously while working in the area at a rate of 10 air changes per hour with the air exit of air toward the exterior Fans of any type should not be used within the area and windows should be closed permanently If it is not possible to close the windows due to the heat produced by Sterilization manual for health centers the washing machines ultrasound devices and hot water used to wash materials windows should have a metal screen to avoid the entry of insects The environmental relative humidity should be between 35 and 50 Minimum necessary physical structure Washable floors and walls Two deep sinks Bench made of washable material It cannot be wooden Lavatory or toilet to discard large amounts of organic matter Area for conditioning packaging preparation and sterilization of material clean area The area for conditioning packaging preparation and sterilization of material should admit completely clean dry objects Here instruments and devices are checked in order to safeguard their cleaning integrity and functionality Transit of people should be strictly controlled and only adequately dressed personnel should enter the area Here medical devices boxes of instruments clothing etc are prepared for the sterilization process Minimum necessary physical structure Washable floors and walls Bench
188. upport the action of moist heat e Its recommended use for the sterilization of certain materials derives from its facility to penetrate solids non aqueous liquids and closed cavities e Its behavior with metal is less corrosive but more oxidant e lt does not erode glass as is the case with steam e Although its use is limited for petrolates and liquids the following instru ments materials and substances can be sterilized in dry heat e Sharp stainless steel instruments scissors and tweezers e Needles crystal syringes tubes glass pipettes heat stable powders e Liquids and substances that are liposoluble and water resistant such as oils silicone paraffin vaseline creams and talcum powders Sterilizing agent e Hot air Mechanism of action e Microbial death occurs as a consequence of energy transfer and oxidation mechanisms Conditions of the process e Institutional procedure manuals should establish working conditions ac 77 Sterilization manual for health centers cording to the load volume weight and thermal resistance of the material It is indispensable to respect the parameters obtained during the validation of the procedure Temperature the temperature of sterilization by dry heat should stay be tween 160 C 170 Times the total exposure time of the material is determined through the corresponding validation of the cycle It is important to point out that the exposure time should be recor
189. urer recommendations about the device or instrument to be cleaned e mechanical cleaner such as an ultrasonic cleaner is used follow the recommendations for using the device e Take into account the degree of water hardness Lubricants A lubricant is a solution used to protect instruments t should not be oily sticky toxic but it should be soluble in water Steps in the process for cleaning materials e Reception e Classification e Prewashing or soaking e Manual washing e Mechanical cleaning if there is access e Rinse with water e Rinse with alcohol e Drying e Lubrication Reception This is carried out in the dirty decontamination area or red area Using a pass thru window the materials and instruments should be confirmed in terms of number state in which received and point of origin and recorded in the respective registry Their entry will be recorded manually in notebooks or forms or through computerized systems During reception personnel should use PPE thick gloves plastic apron etc and use great caution to avoid dropping or spills 19 Sterilization manual for health centers Transfer of material between different services or areas should be carried out taking into account the necessary biosafety standards It is important to consider that the transport cart should be used only to transport dirty or contaminated material Classification After carrying out the reception of the material it wi
190. use and safety of the procedure A package should contain the necessary amount of material for a single procedure or visit 34 Preparing and packaging materials A package should be designed to permit the easy use of its content in terms of its size internal arrangement aseptic opening etc Packaging materials Factors to take into account when selecting the packaging material It should meet national and or international standards or another regulation that is in effect It should be adequate for the method of sterilization used and should per mit the penetration of the sterilizing agent It should be a reliable biological barrier and should not be a vehicle for bacteria It should be durable It should be efficient when used It should have integrity It should be resistant to abrasion breakage and moisture It should be water repellent It should be liquid resistant It should be easy to open It should be flexible It should be free of even the smallest perforations It should be free from toxins or stains and should not release lint or fibers It should not react with the sterilizing agent It should be permeable to the sterilizing agent It should not react with the material that will be packaged It should not release any type of odor It should be inexpensive and readily available The use of the following should be prohibited Metal drum trays Newspaper Packages made from recycled material 35
191. used when transferring loads lifting weight etc The use of aids such as transfer carts or adequate mechanical equip ment should be employed in order to prevent fatigue and musculoskeletal disorders e Work furniture chairs tables footstools and others should be equipped in such a way that they permit postural ergonomics e Establish a rotation of activities between personnel in order to avoid mo notony at work e Human resources should determine their own pace for producing activi ties This should not be subject to a total dependency on machines or other people e When the organization of teamwork participation the pace of work and automation are maintained problems of stress or psychosocial ergonom ics will be avoided e The personnel in charge of waste collection should wear waterproof re sistant gloves and wash their hands whenever they take off the gloves In addition they should be vaccinated against Hepatitis B and tetanus 153 Waste management Classification In a health institution waste is classified as pathological or infectious and household chemical and radioactive types e Infectious waste This type of waste can transmit infectious diseases and is also referred to as pathological waste It includes primarily Laboratory materials cultures blood and derivatives Pathological anatomy material and material from operating rooms Sharp pointed elements all devices that have sharp rigid corners edge
192. ut from the green area cleanest or most sterile to the blue area in order to finish in the red area Floors Dry method or static sweeping This consists of passing a synthetic barrier that is lightly impregnated with an electrically polarized substance magnetic effect across the floor so that it retains all types of particles that are possible carriers of microbe particles It represents a hygienic adapta tion of the broom that it replaces and is ideal for avoiding the dispersion of dust in the environment It will eliminate dirt that is not stuck to the floor in order to subsequently apply the moist method Moist method This includes two techniques the use of a double buc ket or the use of a single bucket Double bucket procedure This is the most common method and the method of choice It is carried out using a two bucket system one for the disinfectant or detergent solution and the other with clean water for rinsing This method minimizes the recontamination of areas Single bucket procedure When this method is used the solution should be changed 1 when it is dirty even if the cleaning of the area is not complete and 2 before moving to another area Surfaces All shelves should be cleaned weekly with a clean cloth and alcohol 70 in order to remove dust At that time the expiration date and the integrity of the packaging for sterile medical equipment should be reviewed A cloth or rag treated with disinfec
193. utside with a cloth but never dry the inside with a cloth in order to avoid the introduction of foreign bodies like lint Recommendations for the deep cleaning of material with accumulated dirt organic matter and others Instruments that have a lumen hinges articulations and grooves run a greater risk of accumulating dirt or organic matter Therefore the immersion of these instruments in enzymatic detergent for a longer period of time than usual is recommended If surgical steel instruments accumulate carbonized organic matter through heat based sterilization varnish minerals or oxide stains the use of an oxide and corrosion removal solution that is specifically for surgical steel is recommended The active ingredients in this solution are phosphoric acid ether propyl glycol It is also recommended that this activity be programmed regularly according to the specific needs of each material Rinse with 96 alcohol After exhaustive rinsing with water rinsing the material with pure alcohol 96 is recommended especially hollow tubular corrugated etc devices The purpose of this rinse is to increase the drying speed Drying the material Drying instruments devices and other hospital use articles constitutes a fundamental part of the cleaning process It is very important to dry the instruments immediately after rinsing in order to prevent later contamination When drying materials it is necessary to take into accoun
194. uze soaked in detergent Advice The immersion of the endoscope in glutaraldehyde for 60 minutes is advised when the study will be conducted in a patient with a compromised immune system Frequent monitoring of the pH of the glutaraldehyde is advised given that the time needed for the activity is variable depending on the quantity of studies carried out Its estimated duration time is 14 days Routine bacteriological control of the endoscope is not advisable except in the case of a suspected cross infection In these cases the best method of bacteriological isolation is the brushing of the channel In the case that persistent contamination of the endoscope channel is confirmed it should be sterilized with ethylene oxide following exhaustive washing Non compliance with these standards makes both the operator and the institution where the procedure was carried out jointly responsible for ensuing accidents due to the transmission of pathogens to patients or intervening personnel Tonometers diaphragm rings and cryosurgery instruments The disinfection strategies for these elements are highly varied and few studies have demonstrated their effectiveness Although these are semi critical elements many of the studies conducted used 69 Sterilization manual for health centers alcohols and chlorated compounds which are intermediate level disinfectants The microorganisms that we are interested in inactivating are primarily Hepatitis viru
195. varez 2006 Preparation Prepare protocols and work procedures Provide training for personnel Management of the process Ensure correct selection and allocation of resources Ensure adequate working conditions Safeguard the safety of the user and the environment Supervision system Guarantee correct execution and control and continuous surveillance Organization of resources Carry out operational efficient planning Verification of the process Ensure documented validation and accreditation Summary of validation activities Create a multifunctional validation team Plan the approach and define the requirements Identify and describe the processes Specify the parameters of the process and the desired outcome Create a master validation plan Select the validation methods and tools Create validation protocols Carry out IQ OQ and PQ and document the results Determine continuous process controls Prepare the final report and ensure administrative approval Provide continuous control of the process When should sterilization validation be carried out Sterilization validation should be initial and periodic Once the equipment is installed a test should be carried out jointly by the 133 Sterilization manual for health centers center s personnel and the manufacturing company s technical service e This test confirms that the apparatus works correctly in that environment This test should be repeated whene
196. ver e Damages are repaired e Maintenance operations are carried out e The packaging material is modified e The composition of the load is modified substantially 134 Quality indicators for the sterilization plant Criteria for verifying the effectiveness of the sterilization process The sterilization process should be effective and neutralize any life form that is present It has to be confirmed through a correct result on the physical chemical or biological indicators Indicators No of loads per autoclave with a verification sheet with the correct sterilization indicators per week x 100 Total No of loads per autoclave during the week Quality standard 99 No of loads with EtO with a verification sheet with the correct sterilization indicators per week x 100 Total No of loads with ethylene oxide during the week Quality standard 100 135 Sterilization manual for health centers No of loads with gas plasma with a verification sheet with the correct sterilization indicators per week x 100 Total No of loads with gas plasma during the week Quality standard 99 Criteria for sterilization expiration time Every sterilized product needs a printed label that shows the expiration time of the sterilization Material that needs to be re sterilized due to an expired time should be kept to a minimum Indicator No of re sterilized products that passed the expira
197. what is planned according to the standards of the service is fulfilled The process should be controlled at every stage and this control should be recorded In order to adequately control sterilization processes it is necessary to have in depth knowledge of e the way the equipment works e its current state e deficiencies that it can have e ways to control it and e its tolerance to materials In order to approach a control method we should first ask ourselves Was it processed Was it processed correctly A control system should meet the following objectives e Identify each material e Confirm that the process was carried out using a chemical control e Establish an acceptable operating point e Detect deficiencies in the equipment beforehand Control of the process includes the control of inputs used at each stage the raw material gauze paper cotton ethylene oxide capsules etc biological monitors chemical indicators etc When the result of the control is satisfactory it will pass to the following stage Sterilizing equipment is validated both in a chamber that is empty in loaded chamber at least once a year and whenever it is repaired Such repairs should be carried out by trained personnel A plan for corrective and preventive maintenance is recommended User manuals in the appropriate language for each type of equipment should be on hand in the SP 109 Sterilization manual for health centers
198. y material whose finish does not chip or split It should also have rounded edges Faucets should provide lukewarm water If the temperature regulator is not centralized they should have mixing valves since very cold or very hot water facilitates skin irritation Towels should be made of disposable resistant paper and placed in ad equate dispensers that permit extraction or cutting without the need to handle the towels 16 Cleaning of materials leaning of every material that is used in the hospital should be carried out prior to the disinfection or sterilization process Cleaning is an essential component in the reprocessing of medical devices and sterilization can never be achieved without a complete cleaning General principles of cleaning Dirt acts by protecting microorganisms from contact with lethal agents disinfectants sterilizers reacting to and inactivating cleaning agents Physical cleaning eliminates large quantities of organisms that are associated with dirt Safe cleaning practices are important to reducing the microbial load on the surfaces of medical devices Manufacturer recommendations always need to be taken into account when devices are cleaned Handling of contaminated objects should be kept to a minimum A necessary requirement for cleaning is that each object be completely disassembled prior to beginning Factors involved in cleaning activities e Chemical energy detergent e Thermal energy temperature
199. y reflect the policies or criteria of the Pan American Health Organization or the Member Governments Published by Pan American Health Organization Pan American Sanitary Bureau Regional Office of the World Health Organization 525 Twenty third Street N W Washington D C 20037 Preface At the end of the XIX century Joseph Lister made key contributions to solving one of the most significant problems that still faced surgery infection In those days 30 to 50 of patients that underwent surgery died because of hospital gangrene pyemia erysipela and other infectious complications The use of phenic acid for cleaning surgi cal material and the operating room environment made it possible for this proportion to decrease to 15 today In the century the general public and health professionals are concerned about emerging pathogens such as Helicobacter pylori Escherichia coli 0157 H7 human immunodeficiency virus HIV Hepatitis virus the coronavirus responsible for severe acute respiratory syndrome SARS and multi drug resistant Mycobacterium tuberculosis Fortunately it can be assured that the standard disinfec tion and sterilization processes described in this publication are adequate for steril izing or disinfecting instruments or materials that are contaminated with blood or other fluids from people infected with these pathogens The preparation of this manual responds to a need expressed by countries who are aware that
200. yethylene Since this is a thermolabile material it can only be used at low temperatures It is useful for ethylene oxide or ionizing radiation The most adequate is low density polyethylene 0 076 mm A problem arises during its use since it is a material that is waterproof which impedes the humectation of the material when sterilized by ethylene oxide moisture is an essential factor in this process The entrance of water in the form of steam into the package being sterilized by ethylene oxide would be solved through the use of a Pouch also called a peelable bag or window package The Pouch consists of one folio film side and one paper side The folios are made using a pure petroleum base as raw material non chlorinated as is the case with PVC which means that they can be burned or stored since they do not produce dioxanes or furans The folio behaves neutrally in groundwater in rubbish dumps and does not release toxic substances during thermal elimination The folio is waterproof to liquids air and gases and therefore blocks bacteria Film bags of medical grade polyethylene These are temperature stable and permeable to steam but they do not tolerate vacuum gaps PVC Polyvinyl Chloride This material is not recommended since it is labile to temperature and to ionizing radiation forming ethylene chlorohydrin a non volatile fixed substance as a response 43 Sterilization manual for health centers PVC absorbs large amounts o
201. zation manual for health centers 3 If sterilization is correct the bar should be blue Comply SteriGage EO Chemical In A REJECT gt 1244 Blue bar must entor ACCEPT area Examples of controls for the interiors of boxes _ ere Seg 20 828 0 feorway ONG 487 msa EELA Logra 9985917915 Adwo we 1 a 1 O gt m U A Non sterile B Sterile C Back side Adapted from Enfermera de Quir fano Spain 2006 Examples of controls for the exteriors of boxes or bags 1 In the controls for the exteriors of boxes and on tapes we should also put the date that that the box was sterilized 2 We should also take advantage of the tape in order to note whether a cer tain part clamp etc is missing 120 Methods for controlling the sterilization process 3 Tape once sterile the lines should turn black 4 The yellow point should turn brown once sterilized Adapted from Enfermera de Quir fano Spain 2006 121 Failures in the sterilization process n the event that the sterilization process fails and for the management of sterile equipment that have an expiration date the following recommendations should be used All sterile materials whose expiration date has passed are not considered safe for use with patients and should be removed from the service e Objects th

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