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Foot Care Devices Infection Prevention and Control (IPC)

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1. Alberta Health Mm Services GUIDELINE in July 17 2013 DOCUMENT TITLE INFECTION PREVENTION AND CONTROL SOURCE IPC Standards and Projects IPC BEST PRACTICE GUIDELINE FOR FOOT CARE DEVICES RELATED DOCUMENTS ALBERTA HEALTH SERVICES ROUTINE PRACTICES HTTP WWW ALBERTAHEALTHSERVICES CA IPC HI IPC ROUTINE PRACTICES INFO PDF ALBERTA HEALTH SERVICES HAND HYGIENE POLICY HTTP WWW ALBERTAHEALTHSERVICES CA HP IF HP PHYS HAND HYGIENE POLICY PDF ALBERTA HEALTH SERVICES SINGLE USE MEDICAL DEVICES POLICY HTTP WWW ALBERTAHEALTHSERVICES CA POLICIES IF HP IPC CLP SINGLE USE MEDICAL DEVICES POLICY PDF APPROVING AUTHORITY PRACTICE SUPPORT DOCUMENT SPONSOR Infection Prevention and Control Operations Infection Prevention and Control If you have any questions or comments regarding the information in this guideline please contact Infection Prevention amp Control at infectionoreventioncontrol albertahealthservices ca OBJECTIVES This infection prevention and control IPC best practice guideline BPG for foot care devices FCD was developed to e minimize the risk of exposure or injury and to prevent transmission of micro organisms to clients and personnel e describe best practice for e single use FCD e client owned FCD often used for routine clipping and filing e multi client reusable FCD often used for routine difficult such as on deformed feet or nails or invasive foot care such as paring corns and callouses e
2. Non critical means a medical device that touches only intact skin but not mucous membranes or does not directly touch the client For the purpose of this document client owned FCD are classified as non critical Reprocessing means the steps performed to prepare a used medical device for reuse Reusable FCD means a FCD intended by the manufacturer for multiple uses Single Use FCD means a critical or semi critical medical device designated by the manufacturer for single use only and may be indicated by but not limited to the following terms used for labelling by the manufacturer Disposable Consumable Not for re use or do not re use Discard after single use Do not use twice Or a symbol such as 9 Sterilization Sterilize Sterilized means the validated process used render product free from viable organisms REFERENCES 1 ALBERTA HEALTH 2012 STANDARDS FOR CLEANING DISINFECTION AND STERILIZATION OF REUSABLE MEDICAL DEVICES FOR HEALTH CARE FACILITIES AND SETTINGS CLEANING STANDARDS HTTP WWW HEALTH ALBERTA CA DOCUMENTS IPC MEDICAL DEVICE CLEANING 2012 PDF 2 CANADIAN STANDARDS ASSOCIATION 2008 Z314 8 DECONTAMINATION OF REUSABLE MEDICAL DEVICES 3 ALBERTA HEALTH AND WELLNESS 2011 SINGLE USE MEDICAL DEVICES AS APPLIED TO CRITICAL AND SEMI CRITICAL MEDICAL DEVICES SINGLE USE STANDARDS HTTP WWW HEALTH ALBERTA CA DOCUMENTS IPC MEDICAL DEVICE SINGLE USE 201 1 PDF 4 ALBERTA HEALTH SERVICES SINGLE USE M
3. eee If considering purchasing a sterilizer 1 Is it possible to send reusable medical devices requiring sterilization to Central Service Sterile Processing Department 2 he sterilizer has a printer data logger to document a permanent record of time temperature pressure sterilizer identification date time and load or cycle number The sterilizer uses a dynamic air removal cycle this may be stated as a steam flush pressure pulse or a pre vacuum system Note this method of air removal is important if reprocessing complex instrumentation lumened or wrapped items 4 The sterilizer has a Health Canada medical device license License number The sterilizer manufacturer supplies the following information in writing 5 Statement of sterilizer s ability to sterilize the proposed medical devices e g lumened instruments power tools wrapped sets of instruments oummary of documentation is supplied to support validation claim 6 Any unique requirements for installation and maintenance of the sterilizer These may include operational constraints specific to altitude e g Calgary is at approximately 3500 feet elevation Ft McMurray is at approximately 1213 feet elevation and water supply e g reservoir potable treated water 7 Recommended sterility assurance monitoring a Appropriate biological and chemical monitors b Appropriate Class II Bowie Dick chemical indicator for pre vacuum sterilizers 8 R
4. ultrasonic cycle rinse FCD to ensure removal of debris Test the ultrasonic cleaner weekly using a foil test or method recommended by the manufacturer and document the results including the name of the responsible person O O O O EN Alberta Health B Services GUIDELINE July 17 2013 DOCUMENT TITLE INFECTION PREVENTION AND CONTROL IPC BEST PRACTICE GUIDELINE FOR FOOT CARE DEVICES 3 Packaging e Use tip protectors validated for sterilization to protect sharp tips and prevent perforation of peel pouches Wrap FCD in approved packaging material prior to steam sterilization Individual self sealing peel pouches are recommended for individual devices or small sets oeal peel pouches according to manufacturer s instructions Do not over fill peel pouches Devices must not place stress on the seams of the peel pouch Each package to be sterilized must have an external process chemical indicator Cl and an internal Cl If using non woven wrap apply wrap according to established CSA standards See Appendix B AHS IPC MDR Audit Wrapping Techniques e Label each package with contents date load number sterilizer used if more than one and responsible person e Label peel pouches on the plastic side and wrapped packages on the autoclave tape using a soft tipped approved marker or label applier validated for use in steam sterilization e Keep a log of each load devices within the load and person responsible for releasin
5. AND SAFETY ACT OHS REGULATIONS 13 CANADIAN STANDARDS ASSOCIATION CSA 2314 15 WAREHOUSING STORAGE AND TRANSPORTATION OF CLEAN AND STERILE MEDICAL DEVICES 14 CANADIAN STANDARDS ASSOCIATION CSA Z314 10 1 SELECTION AND USE OF GOWNS DRAPES AND WRAPPERS IN HEALTH CARE FACILITIES 15 CANADIAN STANDARDS ASSOCIATION CSA PLUS 1112 INFECTION PREVENTION AND CONTROL IN OFFICE BASED HEALTH CARE AND ALLIED SERVICES EN Alberta Health B Services GUIDELINE July 17 2013 DOCUMENT TITLE INFECTION PREVENTION AND CONTROL IPC BEST PRACTICE GUIDELINE FOR FOOT CARE DEVICES 10 of 15 This document was developed by the Infection Prevention and Control IPC Committee for Best Practice Guidelines for Foot Care Devices with representation from AHS Environmental Public Health Services AHS IPC from each Zone including community continuing care rural urban and acute care sectors as well as IPC representation from the Health Protection Branch of Alberta Health Covenant Health and the Good Samaritan Society AHS experts from the medical device reprocessing area and workplace health and safety also reviewed and provided feedback on the draft BPG for FCD In addition this draft was reviewed by external stakeholder groups Respondents included Alberta Health Health Protection and Health Benefits and Compliance Branches First Nations and Inuit Health Branch Capital Care and Health Professional Regulatory Bodies including the College and Associa
6. EDICAL DEVICES POLICY AHS SINGLE USE STANDARD HTTP WWW ALBERTAHEALTHSERVICES CA POLICIES IF HP IPC CLP SINGLE USE MEDICAL DEVICES POLICY PDF 5 PUBLIC HEALTH AGENCY OF CANADA FOOT CARE BY HEALTH CARE PROVIDERS CANADA COMMUNICABLE DISEASE REPORT DECEMBER 1997 VOLUME 2358 HTTP ORIGIN PHAC ASPC GC CA NOIS SINP GUIDE PUBS ENG PHP 6 CANADIAN STANDARDS ASSOCIATION 2011 CSA Z314 3 EFFECTIVE STERILIZATION IN HEALTH CARE FACILITIES BY THE STEAM PROCESS 7 BRITISH COLUMBIA 2011 BEST PRACTICE GUIDELINE FOR CLEANING DISINFECTION AND STERILIZATION IN HEALTH AUTHORITIES APPENDIX B DECISION CHART HTTP WWW HEALTH GOV BC CA LIBRARY PUBLICATIONS YEAR 201 1 BEST PRACTICE GUIDELINES CLEANING PDF 8 ALBERTA HEALTH 2008 STANDARDS FOR CLEANING DISINFECTION AND STERILIZATION OF REUSABLE MEDICAL DEVICES FOR ALL HEALTH CARE FACILITIES AND SETTINGS 9 COLLEGE OF PHYSICIANS AND SURGEONS OF ALBERTA CPSA PHYSICIAN TOOLKIT 2010 HTTP WWW CPSA AB CA SERVICES IPAC PHYSICIANTOOLKIT ASPX Alberta Health B Services GUIDELINE July 17 2013 DOCUMENT TITLE INFECTION PREVENTION AND CONTROL IPC BEST PRACTICE GUIDELINE FOR FOOT CARE DEVICES ADDITIONAL RESOURCES 10 ALBERTA HEALTH SERVICES MEDICAL DEVICE REPROCESSING 2010 HTTP WWW ALBERTAHEALTHSERVICES CA 6853 ASP 11 ALBERTA CONTINUING CARE HEALTH SERVICES STANDARDS CC STANDARDS HTTP WWW HEALTH ALBERTA CA DOCUMENTS CONTINUING CARE STANDARDS 2008 PDF 12 ALBERTA OCCUPATIONAL HEALTH
7. PhysicianT oolkit asox December 6 2012 A Flooring Is easy to clean and is not slippery when wet B Personal Protective Equipment Storage A dedicated space for storage of personal protective equipment C Space for receiving contaminated equipment D Disposal of Waste Bins must be available for disposal of waste E Alcohol Dispenser An alcohol dispenser for hand hygiene F Sharps Disposal A secure biohazard sharps disposable container is required G Dedicated sinks for cleaning rinsing equipment In the absence of two sinks dedicated for equipment cleaning and rinsing a basin for rinsing equipment post decontamination is an acceptable alternative H Drying Area An area for drying equipment post rinsing I Packing Area A clean separate area for packing equipment for sterilization J Instruments awaiting sterilization A labeled container for instruments awaiting sterilization is recommended K Sterilizer It is important that a daily sterilizer log book be kept by each autoclave in use L Cooling Area A clean area for allowing sterilized packs to cool before storage M Storage Area There needs to be adequate storage areas for cleaned packaged and sterilized instruments E Alberta Health HM Services GUIDELINE July 17 2013 DOCUMENT TITLE INFECTION PREVENTION AND CONTROL IPC BEST PRACTICE GUIDELINE FOR FOOT CARE DEVICES APPENDIX B Alberta Health Services IPC MDR Audit Wrapp
8. acturer s instructions and stored in a manner to protect from contamination 2 24 Single Use FCD is used once and then discarded gt 2 2 1 1 FCD must be treated as single use when a Itis labelled as a single use medical device by the manufacturer b The labelling is unclear as to whether or not it is a single use medical device or c There are no manufacturer s reprocessing instructions for it 2 2 2 Client owned FCD 2 2 2 1 A client s own dedicated FCDs must e never be used for another individual e be cleaned at a minimum between uses according to manufacturer s instructions e be inspected regularly and replaced if damaged corroded or no longer functional EN Alberta Health B Services GUIDELINE July 17 2013 DOCUMENT TITLE INFECTION PREVENTION AND CONTROL IPC BEST PRACTICE GUIDELINE FOR FOOT CARE DEVICES e be labelled and stored in a manner that prevents use by other individuals i e in a clean designated container that is labelled with personal identifiers such as the clients name and room number 2 2 3 Multi Client Reusable FCD 2 2 3 1 Multi client reusable FCD must be cleaned and steam sterilized according to the manufacturer s instructions prior to reuse on another client Sterility must be maintained until use on the next client 4 2 2 3 2 Foot care providers staff or contracted providers must have the right number of sterile FCDs to provide foot care for every client 2 2 3 3 Multi client re
9. describe requirements for reprocessing multi client reusable FCD APPLICABILITY This guideline applies to all Alberta Health Services AHS staff medical staff volunteers students and other persons acting on behalf of AHS IPC Principles Routine Practices are a standard of care used for all clients at all times to reduce the risk of infection transmission More information about AHS Routine Practices is available at http www albertahealthservices ca ipc hi ipc routine practices info pdf 2 0 Foot Care Devices FCD 2 1 All devices used for foot care including devices used for electronic nail filing must be intended by the manufacturer for use on human beings see Medical Device definition page 7 Client refers to patients residents or individuals receiving care EN Alberta Health B Services GUIDELINE July 17 2013 DOCUMENT TITLE INFECTION PREVENTION AND CONTROL IPC BEST PRACTICE GUIDELINE FOR FOOT CARE DEVICES 2 2 Management of Single Use Client Owned and Multi Client Reusable FCD See Figure 1 Figure 1 Management of Single Use Client Owned and Multi Client Reusable Foot Care Devices Foot Care Device FCD used by person providing foot care services on behalf of AHS Single use FCD Client owned FCD Multi client Reusable FCD FCD is used once FCD is cleaned and steam and then discarded sterilized between uses according to current accepted standards FCD is cleaned between uses according to manuf
10. ecommended maintenance procedures and schedules and qualifications of technical support providers References Canadian Standards Association CSA Z314 3 09 Effective sterilization in health care facilities by the steam process Mississauga ON March 2009 E Alberta Health B Services GUIDELINE July 17 2013 DOCUMENT TITLE INFECTION PREVENTION AND CONTROL IPC BEST PRACTICE GUIDELINE FOR FOOT CARE DEVICES 14 of 15 APPENDIX D Sample Sterilization Log Sheet Sterilization Log Sheet Load Time Cycle Load contents External Cl BI Result Air Initials Cycle Parameters Results removal Started test Ege mmm mI min C F M gt am a Ga 655 PE a a _ Lo Low o pL _ Alberta Health HM Services GUIDELINE July 17 2013 DOCUMENT TITLE INFECTION PREVENTION AND CONTROL IPC BEST PRACTICE GUIDELINE FOR FOOT CARE DEVICES APPENDIX E CPSA Recall Procedure for Positive Biological Indicator College of Physicians amp Surgeons i Alberta Check processed BI results following appropriate incubation If positive Tor growth failed test Y Notify responsible person in If negative for growth aad P E successful test Stop using sterilizer last negative Review cycle mechanical and chemical indicator Cl results If failed mechanical and Cl results investigate and correct potential cause of load failure Notify appropriate p
11. ersonnel If 299 Retest sterilizer with new Bl for growth successful mj g test and all mechanical Review BI retest results and chemical Indicators and cycle mechanical and Cl results meet pass parameters If the retest Bl is positive for growth second failed test Recall all loads instruments and packages sterilized in affected sterilizer since last negative Remove stenlizer from service and notify appropriate personnel Repair sterilizer If any Bl Rechallenge sterilizer three positive for times with Bl in empty sterilizer chamber growth If all 3 Bls are negative for growth successful tests Return sterilizer to service Reprocess repackage and re sterilize recalled items failed test o Release sterilized goods Document all results and actions taken in response to positive Appropriate personnel includes extemal facilities if your facility is a provider of reprocessing services and your sterilizer maintenance service provider Adapted from CSA 23143 09 Local Medical Officer of Health must be Effective Steam Sterilization in Health contacted if patients were exposed to instruments Care Facilities by the Steam Process processed in failed loads April 16 2010 Copied with permission from the College of Physicians and Surgeons IPAC Physician Toolkit http www cpsa ab ca services IPAC PhysicianToolkit aspx December 6 2012
12. g the load 4 Sterilization e Follow manufacturer s instructions for installation loading operation routine and preventative maintenance and quality assurance monitoring of sterilization equipment e Load the sterilizer so that steam is able to circulate freely around each package and enter and exit from each package Packages should never contact the inside walls of the sterilizer chamber e Load peel pouches on edge paper to plastic If peel pouches must lie flat consult the manufacturer s instructions to determine if the package should be placed paper side up or plastic side up e Do not stack packages e Use steam sterilization for FCD that are compatible with heat and moisture e Use a sterilizer suitable for sterilizing FCD e g validated for packaged devices and hollow devices if any are used which can be monitored that produces dry packages at the end of the cycle and can accommodate required turn around time Check with sterilizer manufacturer s written claims See Appendix C Alberta Health Services Criteria to Consider if Purchasing a Sterilizer 5 Quality Monitoring e There are three types of indicators to monitor sterility physical or mechanical chemical and biological e Results of monitoring must be documented and recorded See Appendix D Best Practice Guidelines for Foot Care Devices Sample Sterilization Log Sheet e If any of these indicators fail devices should not be used Physical or Mecha
13. grity is compromised e Store sterile packaged FCD in a clean area protected from excess humidity temperature extremes contamination vermin or excessive handling and crushing e Do store sterile packages beneath the sink or in the soiled holding or cleaning areas e At the point of use upon opening the packaged FCD inspect the packaging for integrity and review the results of the internal and external Cl e Clean and disinfect contaminated transport containers before using the container to transport clean or sterile medical devices EN Alberta Health B Services GUIDELINE July 17 2013 DOCUMENT TITLE INFECTION PREVENTION AND CONTROL IPC BEST PRACTICE GUIDELINE FOR FOOT CARE DEVICES DEFINITIONS Bowie Dick Test means an indicator used to determine whether a dynamic air removal type pre vacuum sterilizer has properly evacuated the air from the load The air removal or Bowie Dick test is not a test for sterilization Biological Indicator means a test system containing viable micro organisms providing a defined resistance to a specified sterilization process Centralized Medical Device Reprocessing Area means an area within a health care setting for cleaning disinfection or sterilization of medical devices In community settings and offices the area can be any segregated area where reprocessing of devices takes place away from clients and clean areas Chemical Indicator means a test system that reveals change
14. in one or more pre defined process variables based on a chemical or physical change resulting from exposure to a process Cleaning means the removal of contamination from an item to the extent necessary for its further reprocessing and its subsequent use Client means any person receiving health care within any health care setting For readability this BPG uses the term client to represent client patient resident Critical means the device presents a high risk of infection if the device is contaminated with any micro organisms including bacterial spores because of their potential to cut skin and enter sterile tissues For the purpose of this document FCD with the exception of client owned FCD are considered critical medical devices Event related sterility means that if items have undergone proper sterile processing i e they have been correctly decontaminated wrapped sterilized stored and handled sterility can be maintained almost indefinitely unless the integrity of the package is compromised Foot care means health care services performed on a client s feet which may include clipping cutting filing of nails and callous removal Foot care device FCD means device used to perform care on client s feet including but not limited to nail nippers files rasps scalpel handles and nail probes Manufacturer means a person who sells a medical device under their own name or under a trade mark design trade name or other na
15. ing Techniques 12 of 15 IFC MOR Audit ELE Alberta Health Wrapping Techniques BD Services pr ng el Underside of wrapper ia shaded pra Doubla Vvrapping Envelope Feld X A e 10 Simultaneous Dauble Wrapping Envelope Fold DO d M 1 4a 4 d Ser Went ial ay leg Square P E g le sm E Simultaneous Double Mrapping Square Fold wrappers oF Dna handed ear iT fo per ABS IEC VDR SLI Pose 1 of 1 Techy glee EN Alberta Health B Services GUIDELINE July 17 2013 DOCUMENT TITLE INFECTION PREVENTION AND CONTROL IPC BEST PRACTICE GUIDELINE FOR FOOT CARE DEVICES 13 of 15 un Alberta Health E Services Appendix C Checklist for Table Top Steam Sterilizers Infection Prevention and Control Best Practice Guideline Related to Foot Care Devices All sterilization processes should follow the manufacturer s instructions for installation operation preventative maintenance and quality assurance of the equipment Sterilizers also should be subjected to rigorous testing and monitoring on installation and following disruptions to their normal activity Sterilizer records should include results of time temperature and pressure to ensure that effective sterilization has been achieved In order to meet these requirements table top sterilizers should meet the following criteria Criteria Criteria Comments Met ee
16. me or mark owned or controlled by the person and who is responsible for designing manufacturing assembling processing labelling packaging refurbishing or modifying the device or for assigning to it a purpose whether those tasks are performed by that person or on their behalf Manufacturer s Instructions means the validated written directions provided by the manufacturer or distributor of a medical device or product that contain the necessary information for the safe and effective use of the medical device or product EN Alberta Health B Services GUIDELINE July 17 2013 DOCUMENT TITLE INFECTION PREVENTION AND CONTROL IPC BEST PRACTICE GUIDELINE FOR FOOT CARE DEVICES Medical device means any instrument apparatus appliance material or other article whether used alone or in combination including the software necessary for its proper application intended by the manufacturer to be used for a human being for any of the following purposes Diagnosis prevention monitoring treatment or alleviation of disease Diagnosis monitoring treatment or alleviation of or compensation for an injury or handicap Investigation replacement or modification of the anatomy or of a physiologic process or Control of conception and that does not achieve its principal intended action Intended Purpose in or on the human body by pharmacological immunological or metabolic means but that can be assisted in its function by such means
17. nical Indicators e Monitor and document the physical parameters of each sterilization cycle time temperature and pressure e The sterilizer should be equipped with an electronic data log or paper printout documenting the physical parameter of each sterilization cycle EN Alberta Health B Services GUIDELINE July 17 2013 DOCUMENT TITLE INFECTION PREVENTION AND CONTROL IPC BEST PRACTICE GUIDELINE FOR FOOT CARE DEVICES e Inthe absence of a printout or data logging system observe the gauges on the outside of the sterilizer to ensure that the correct sterilization time temperature and pressure have been achieved e Document the results including the person responsible for releasing the load Chemical Indicators e Chemical indicators measure predetermined values such as time temperature or steam quality e Monitor and document results of external chemical indicators Cls before releasing devices for use Look for a color change in the external chemical indicator e Perform a Bowie Dick air removal test each day a pre vacuum dynamic air removal sterilizer is used and document the result Biological Indicators e Monitor the sterilization cycle with a biological indicator BI each day the sterilizer is used o Note Bls are contained in a BI challenge test pack A BI test pack can be commercially prepared or can be constructed in house by placing a BI inside a pack that is the most difficult to sterilize among those most freque
18. ntly processed Place the Bl test pack in the area of the sterilizer considered least favourable to sterilization The cold point in table top sterilizers varies with sterilizer design but is normally located in an area near the drain Run the BI in a cycle with normally fully loaded chamber check your sterilizer s user manual for details e Maintain a log of BI results e Follow a written recall procedure in the event of a failed biological indicator See Appendix E Best Practice Guideline for Foot Care Devices Sample Recall Procedure for Positive Indicator Bl 6 Cool Down e Sterile packages shall not be touched or otherwise handled until the load is cooled to room temperature e Ensure packages are dry following sterilization Inadequate drying or dampness compromises package Sterility because the seal the integrity or the barrier protection ability of the package is compromised e Packages or peel pouches that are wet or have internal condensate after cool down are contaminated and must be reprocessed 7 Storage Maintain sterility of FCD until point of use oterility of packages or peel pouches is event related otock rotation first in and first out must be in place as an element of inventory management Ensure sterile devices are stored in a manner to protect devices from contamination and preserve package integrity Damaged torn wet or dropped packages are considered contaminated Reprocess FCD if the package inte
19. red sorting and soaking physical removal of soil rinsing drying physical inspection corrosion reduction lubrication if required and packaging e Clean package and sterilize all hinged FCD in the open position e Follow manufacturer s instructions if disassembly is required for sterilization e Follow manufacturer s instructions for detergents and or enzymatic cleaning agents household products are not suitable Use recommended dilutions and soak times and change the solution according to the manufacturer s instructions e Perform manual cleaning below the surface of the water to minimize splashing and generation of aerosols e After cleaning rinse items thoroughly to remove residue by submerging the items in water not by holding them under running water Inspect to ensure the FCD are clean and in good working condition Dry using a clean lint free soft absorbent towel Use of paper towel or air drying is not acceptable Discard disposable cleaning accessories e g brushes and sponges Clean and sterilize reusable cleaning accessories between uses and store in a clean dry location Ultrasonic cleaners e Follow the manufacturer s instructions for installation maintenance loading and use including o Remove visible soil from FCD prior to placement in the ultrasonic cleaner Change the cleaning solution when visibly soiled and at least daily Always keep the lid of the ultrasonic closed when the cycle is on Following the
20. roviders must use personal protective equipment PPE appropriate for the task e g chemical and puncture resistant gloves eye protection procedure mask protective gown when reprocessing devices EN Alberta Health B Services July 17 2013 DOCUMENT TITLE INFECTION PREVENTION AND CONTROL IPC BEST PRACTICE GUIDELINE FOR FOOT CARE DEVICES 2 3 5 Reprocessing Requirements 1 Handling and Transport e Remove visible soil from FCD at the point of care prior to transport to the reprocessing area Gross visible debris should be removed with cloth or gauze moistened with water or detergent e FCD if not cleaned immediately must be kept moist by using a wet towel moistened with water a holding solution or foam or a spray or gel product specifically intended for this use not saline Follow manufacturer s instructions e Transport contaminated FCD in a labelled closed and leak proof container e Procedures should be in place to 1 identify contaminated FCD which have not undergone reprocessing and 2 differentiate multi client FCD to be reprocessed from similar looking single use FCD to be discarded 2 Cleaning e Follow the manufacturer s instructions for the FCD including specifications for detergent type water temperature and cleaning methods e Whether or not FCD appear soiled clean FCD before sterilization The cleaning step is essential before sterilization The cleaning process includes disassembly if requi
21. tion of Registered Nurses of Alberta CARNA College of Licensed Practical Nurses of Alberta CLPNA College of Physicians and Surgeons of Alberta CPSA and the College of Podiatric Physicians of Alberta CPPA Revisions Month DD YYYY APPENDIX A Suggested Reprocessing Area Design and Layout APPENDIX B Alberta Health Services IPC MDR Audit Wrapping Techniques APPENDIX C Alberta Health Services Criteria to Consider if Purchasing a Sterilizer APPENDIX D Sample Sterilization Log Sheet APPENDIX E CPSA Recall Procedure for Positive Biological Indicator EN Alberta Health HM Services GUIDELINE July 17 2013 PAGE DOCUMENT TITLE INFECTION PREVENTION AND CONTROL IPC BEST PRACTICE GUIDELINE FOR FOOT CARE DEVICES APPENDIX A Suggested Reprocessing Area Design and Layout 11 of 15 SAN NG Suggested Reprocessing Area Design amp Layout G Dedicated sinks for cleaning rinsing equipment F Sharps Disposal H Drying Area E Alcohol based sanitizer for staff hand hygiene hahd hygjene B Personal Protective Equipment Storage C Space for receiving contaminated equipment A Flooring D Disposal of Waste J Instruments awaiting K Sterilizer sterilization L Cooling Area Packing Area M Storage Area work flow Copied with permission from the College of Physicians and Surgeons of Alberta IPAC Physician Toolkit htto www cpsa ab ca services IPAC
22. usable FCD should be reprocessed in a centralized medical device reprocessing area see Centralized Medical Device Reprocessing Area definition page 7 2 2 3 4 Reprocessing of multi client reusable FCDs must meet Alberta Health IPC Standards Providers unable to meet Alberta Health Standards may choose to reprocess multi client reusable FCD through a designated medical device reprocessing area or use single use FCD available in kits and discard after use 2 2 3 5 Foot care providers who clean and sterilize multi client reusable FCD must be aware of and follow relevant Alberta Health Standards AHS policies and guidelines and Canadian Standards Association CSA Standards see References page 8 2 2 4 Key requirements for reprocessing multi client reusable FCD 2 2 4 1 Foot care providers responsible for reprocessing of FCD must be educated and competent in reprocessing practices and follow infection prevention and control principles for handling and transport cleaning packaging sterilization quality monitoring cool down and storage 2 2 4 2 A designated reprocessing area is dedicated to reprocessing set up with a clear one way workflow where reprocessing moves in one direction from the dirtiest task to the cleanest task in order to prevent cross contamination See Appendix A Suggested Reprocessing Area Design and Layout cleaned regularly and e kept free of excess and unrelated devices and supplies 2 2 4 3 Foot care p

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