Supporting Document - Maryland Patient Safety Center
Contents
1. Fazel R Krumholz HM Wang Y et al Exposure to low dose ionizing radiation from medical imaging procedures N Eng J Med 2009 Aug 27 361 9 849 57 Food and Drug Administration U S Letter to the Medical Imaging Technology Alliance regarding CT recommendations online 2010 Nov 8 cited 2011 Oct 10 Available from Inter net www fda gov Radiation EmittingProducts RadiationSafety RadiationDoseReduction ucm232551 htm Lauer M Elements of danger the case of medical imaging N Eng J Med 2009 Aug 27 361 9 841 3 Mertens M Cedars Sinai apologizes for ra diation errors NPR Health Blog 2009 Oct 16 includes link to 2009 Oct 15 statement from Thomas M Priselac president and CEO of Cedars Sinai Medical Center cited 2010 Oct 11 Available from Internet www npr org blogs health 2009 10 cedarssinai_says_sorry html The National Academies Health risks from ex posure to low levels of ionizing radiation BEIR VII phase 2 Washington DC National Academies Press 2006 Smith Bindman R Lipson J Marcus R et al Ra diation dose associated with common computed tomography examinations and the associated lifetime attributable risk of cancer Arch Intern Med 2009 Dec 14 169 22 2078 86 3 Medication Adminis tration Errors Using Infusion Pumps Patients can be highly sensitive to the amount of medication or fluid they receive from infusion pumps what s more some medications are life sustaining There fore i2. 4 Cross Contamination from Flexible Endoscopes Patient cross contamination from improp erly reprocessed flexible endoscopes has affected large groups of patients at hospitals large and small At minimum endoscope reprocessing problems when discovered can be detrimental to a facil ity s reputation and can create anxiety when patients are told they may have been exposed to a contaminated endoscope At worst they can lead to life threatening infections Such incidents are almost always associated either with failure to fol low established cleaning and disinfection sterilization guidelines and instructions or with the use of damaged or malfunction ing equipment Flexible endoscope reprocessing requires consistent adherence to a multistep procedure Failure to properly perform any step including some necessary manual www ecri org gt HEALTH DEVICES NOVEMBER 2011 369 guidance ARTICLE tasks could compromise the integrity of the process On a more general note in October 2011 FDA and AAMI held a Medical Device Reprocessing Summit to identify discuss and formulate strategic initiatives and priorities to improve reprocessing of reusable devices The discussion top ics included the definition of clean design issues personnel competency and instructions for use There was discussion of the general lack of understanding of reprocessing needs for example clini cians may prefer a given model of device
3. Coverage Model 1 Assemble a multidisciplinary team om sport Nurse managers Patient safety risk II stoff e g CNO VP Quality Front line nurses manager Consult with others as Key medical staff Clinical engineering staff appropriate Monitor technicians A EE E E E Root causes Aggregate of alarm types Review remediation results l Frequency of alarm types per care area shitt Trends 3 Observe alarm coverage processes and ask Routine rounding Map processes for alarm Identity obvious problems Delayed alarm response notification and response Excessive alarms nurses and other staff about their concerns Listen to staff concerns Pagers not being worn problems Difficulty in hearing alarms 4 Review entire alarm coverage system Culture Infrastructure Practices Technology 5 Identify patient safety vulnerabilities FAILURES Delayed alarm response CAUSES Diffuse responsibility for alarm response and potential failures Transport Communication Breakdown Competing priorities Leads off Apathy Assumptions that someone else will respond Alarm Fatigue Excessive nuisance alarms 6 Develop realistic implementable Proper skin prep THINGS Delineate responsibility for alarm response strategies to address underlying causes Proper electrode placement TO Develop a back up plan with tiers of coverage Routine change of electrodes CONSIDER Delineate responsibil
4. ECRI Institute s Patient Safety Blog Keller J Making Clinical Alarm Management a Patient Safety Priority 2010 Jul 29 www ecti otg blog Lists Posts Post aspx ID 52 ECRI Institute web conference Don t Kill the Alarm The Time to Improve Alarm Management Is Now 2011 May 18 Recording available for purchase www ecti otg Conferences AudioConferences Pages Improve_Clinical_Alarm_Management aspx Additional resources Association for the Advancement of Medical Instrumentation Horizons 2011 Spring focus on improving medical alarm systems Also available www aami org alarms Materials Horizons_Alarm_060111_small pdf Kowalczyk L MGH death spurs review of patient monitors Boston Globe 2010 Feb 21 Also available www boston com news health atticles 2010 02 21 mgh_death_spurs_ review_of_patient_monitors No easy solutions for alarm fatigue Boston Globe 2011 Feb 14 Also available http articles boston com 2011 02 14 news 29342842_1_false alarms patient safety hospitals Patient alarms often unheard unheeded Boston Globe 2011 Feb 13 Also available http articles boston com 2011 02 13 news 29347393_1_alarms monitors nutses 2 Exposure Hazards from Radiation Therapy and CT Ionizing radiation is a vital tool for both therapy and diagnosis But it can cause serious patient harm instances of which have received national attention over the past few years see for example t
5. Hazard Report 2011 May No Flow Alarm Disabled in Respironics EverFlo Oxygen Concentrators Equipped with Optional Low Flow Flowmeter Hazard Report 2011 Apr Unfamiliarity with Differences in the Way Ventilators Set Pressure Control Values May Lead to Lung Injuries Hazard Report 2010 Jun Additional resources Food and Drug Administration U S Home use devices how to prepare for and handle power outages online 2011 cited 2011 Oct 10 Available from Internet www fda gov downloads MedicalDevices ProductsandMedicalProcedures HomeHealthandConsumer UCM252812 pdf Medical device home use initiative online 2010 Apr cited 2011 Oct 10 Available from Internet www fda gov downloads MedicalDevices ProductsandMedicalProcedures HomeHealthandConsumer HomeUseDevices UCM209056 pdf p www ecri org gt HEALTH DEVICES NOVEMBER 2011 373
6. adapters and connectors ANSI AAMI 1D54 1996 1996 reaffirmed 2005 Bankhead R Boullata J Brantley S et al A S PE N enteral nutrition practice recommendations J Parenter Enteral Nutr 2009 Mar Apr 33 2 122 67 Food and Drug Administration U S 2011 ECRI Institute Member hospitals may reproduce this page for internal distribution only Letter to manufacturers healthcare profes sionals and purchasing departments regard ing preventing misconnections online 2010 Jul 9 cited 2011 Oct 18 Available from Internet http www fda gov downloads MedicalDevices ResoutcesforYou Industry UCM218631 pdf Medical device safety calendar 2009 on line 2009 cited 2009 Jun 18 Available from Internet www fda gov downloads MedicalDevices Safety AlertsandNotices UCM134869 pdf Guenter P Hicks RW Simmons D Enteral feed ing misconnections an update Nutr Clin Pract 2009 Jun Jul 24 3 325 34 Guenter P Hicks RW Simmons D et al Enteral feeding misconnections a consortium position statement USP Medication Safety Forum Jz Comm J Qual Patient Saf 2008 May 34 5 285 92 Joint Commission Tubing misconnections a persistent and potentially deadly occurrence Sentinel Event Alert 2006 Apr 3 36 1 3 Simmons D Symes L Guenter P et al Tubing misconnections normalization of deviance Nutr Clin Pract 2011 Jun 26 3 286 93 7 Surgical Fires ECRI Institute continues to receive reports of surgical fires
7. but not appreciate that reprocessing that model could take more than the 15 or 30 minutes available between cases mean ing that reprocessing could be rushed and ineffective Other key points included the desire for more standardized reprocessing protocols for similar equipment and the need for education and training for central processing personnel One other help ful idea was reviewing device instructions before purchase This would allow facilities to identify and possibly avoid devices that are extremely complicated or that call for equipment or supplies not currently in use thereby eliminating the need to find or pur chase additional materials when the device arrives in central processing the first time Recommendations gt Ensure that a specific reprocessing pro tocol exists for each flexible endoscope 366 HEALTH DEVICES NOVEMBER 2011 gt wwwa ecri org model in your facility s inventory Refer to the device s user manual and consult the endoscope manufacturer to iden tify unique requirements e g cleaning procedures channel adapters that need to be addressed within each protocol document Remember to repeat this review for each newly purchased endo scope model endoscope reprocessor ot related equipment and accessories Periodically review protocols to ensure that they are clear and comprehensive and that they reflect the current envi ronment For example verify that they don t include obsolete workflo
8. feeding tubes in a July 9 2010 letter to manufacturers healthcare professionals and purchasing departments FDA 2010 FDA urged manufacturers to implement safeguards such as color coding and to build designed incompatibility into their products to help reduce or prevent misconnections At this time the International Organi zation for Standardization ISO is working on a standardized enteral connector The eroup has a few design proposals on the table However after a design is selected it will need to go through bench testing and clinical testing It will therefore not be available for some time Recommendations Given the limited non Luer design solu tions currently available for enteral feeding hospitals need to implement special pre cautions to minimize misconnection risks Below we list recommendations specific to addressing these risks In developing them we made particular use of Bankhead et al 2009 and Guenter et al 2008 We have divided the list into 1 work practice solutions directed toward clinical users and 2 policy level solutions directed toward patient safety officers clinical engineers risk management staff and pur chasing materials management personnel Some of the items are quoted directly from their sources while others are paraphrased Work Practice Solutions for Clinical Staff gt Whenever possible use enteral pumps for enteral feeding gt Trace lines from end
9. must be aware of a possible domino effect wherein changes to one component of the system affect the operation of another 2011 ECRI Institute Member hospitals may reproduce this page for internal distribution only ECRI Institute is aware of an increasing number of problems related to change management including issues involving wireless networks cybersecurity planned maintenance or software upgrades In one case involving software upgrades a facility had an integrated physi ologic monitoring system with features that allowed clinicians to access EMR flow sheets use bar codes for medication administration and view PACS images on a patient monitoring display as opposed to bringing a workstation on wheels into the patient room Unfortunately when this facility performed a software upgrade to its physiologic monitoring system the bar code medication administration sys tem that was integrated with the patient monitors went down Since that incident the facility performs extensive testing on every software upgrade before distribu tion They test it in a test lab first then in a staged room where devices are configured and operate as they would in a hospital room but with no patient and then dis tribute it to the hospital In subsequent software upgrade testing they have found that with every software update there are at least one to three issues that must be resolved before the software upgrade can be distribut
10. 2011 ECRI Institute Member hospitals may reproduce this page for internal distribution only concentrations consult with other orga nizations and seek out best practices gt When implementing a new infusion system take advantage of vendor con sulting programs Consider requesting that a representative help the facility troubleshoot problems gt Before and during purchasing be sure to get buy in from staff members who will be using the system and emphasize to clinicians the importance of infusion pump technology safeguards Be aware that there may be resistance to new workflows introduced with new infu sion pump technology Safety system noncompliance must be identified and rectified as soon as possible gt Determine how and when infusion pump data will be captured analyzed and disseminated gt Read the Infusion Device Safety Council report AAMI 2010 and con sider how your facility is addressing the 13 clarion themes Resources Health Devices General Purpose Infusion Pumps Evaluation 2007 Oct Large Volume Infusion Pumps The Evolution Continues Evaluation 2009 Dec gt Patient Controlled Analgesic Infusion Pumps Evaluation 2006 Jan Syringe Infusion Pumps with Dose Error Re duction Systems Evaluation 2008 Feb Health Devices Resource Center Infusion Pumps https members2 ecri org Components HDJournal Pages ResourceCenter_LV P0706 2471 aspx Add
11. C virus HCV and human immunodeficiency virus HIV from needlesticks and other sharp instruments used in the healthcare environment continues to be a serious problem According to a report from the Massachusetts Sharps Injury Surveillance System the year 2009 saw a sharps injury rate among hospital workers of 28 injuries per year per 100 occupied beds Massachu setts Department of Public Health 2010 Sharps injuries include those sustained and inflicted on others by clinicians trying to activate needlestick prevention devices A recent article published in Infection Con trol amp Hospital Epidemiology concluded that passive safety engineered devices were significantly more effective than those that were manually activated During this study mote than one fourth of all the needlestick injuries were from nonactivation or incom plete activation of the device and could have been avoided Tosini et al 2010 What s more clinicians and custodial staff continue to get stuck while using or han dling sharps disposal containers Most hospitals have ongoing programs to address sharps safety But these pro grams may have been established some time ago and may no longer be receiv ing adequate attention or achieving their expected level of effectiveness Continuing injuries are a signal that additional atten tion is needed it could be that clinicians are using poor technique that the safety devices being used should be replac
12. at a rate of about one or two per week Our research indicates that there are approximately 600 surgical fires in the United States each year Not all sur gical fires result in patient injury but when they do the consequences can be severe including potentially fatal airway burns and horrible facial disfigurement Virtually all surgical fires can be avoided But doing so requires that each member of the surgical team clearly understands the role played by oxidizers ignition sources and fuels in the operating room Each team member should also make a point of com municating information on the risks to other team members intraoperatively or in seminars for example In 2009 new clinical practice recom mendations for delivering oxygen during surgery were developed by ECRI Institute in conjunction with the Anesthesia Patient Safety Foundation APSF These recom mendations which focus on surgeries to the head face neck and upper chest www ecri org gt HEALTH DEVICES NOVEMBER 2011 during which oxygen accumulation creates an enriched atmosphere are discussed in detail in our October 2009 Guidance Article New Clinical Guide to Surgical Fire Prevention and summarized in our second recommendation below Some healthcare facilities take active steps to educate staff on the dangers of surgical fires One healthcare system for example has heightened its clinicians awareness of the risks of surgical fires by add
13. before it is to be used on a patient There are also many reports in FDA s Manufacturer and User Facility Device Experience MAUDE database describing problems that were discovered while the device was in use on a patient These reports cover misconnected breathing circuits ventila www ecri org gt HEALTH DEVICES NOVEMBER 2011 371 guidance ARTICLE tor leaks empty gas cylinders and many other problems that if unnoticed may lead to patient injury In a February 2009 Hazard Report we discussed a severe patient injury that resulted from the mis connection of the breathing circuit in an anesthesia unit Thorough pre use inspection of anesthesia units has long been accepted as a standard procedure However in actual practice such inspections can be inconsistent and incomplete Hospital staff sometimes conduct pre use checks using obsolete procedures or procedures designed for anesthesia units other than the one being used Additionally staff may skip a portion of the inspection simply because they do not understand its impor tance or because they mistakenly believe that the step is performed by the unit s semiautomated self check a common fea ture in currently marketed anesthesia units ot by another person Regardless of the reason missing or skipping any portion of the inspection leaves the safety of the anesthesia unit in question and increases the risk of patient injury Recommendations To help ensure
14. diagnostic tool However both inappropriate use and inappropriate dose levels can lead to unnecessary radia tion exposure to patients controlling both is essential One contributing factor is that image quality improves as dose levels are increased so there is a natural tendency to use higher doses a tendency facilitated by the lack of a legal maximum dose for CT Moreover most healthcare facilities do not routinely audit CT doses so there is a wide variation in dose for the same types of studies Consequently many patients are likely to have been exposed to unnecessarily high radiation levels Smith Bindman et al 2009 There is a clear need for hospitals to implement robust measures to control these complicated risks Increasing the focus on this topic is the Joint Com mission s Sentinel Event Alert titled Radiation Risks of Diagnostic Imaging which was issued in August 2011 see the Radiation Therapy Resources Recommendations There is no simple fix to ensure that radiation for therapy and diagnosis is used safely and effectively A comprehensive review of all aspects of operations and quality assurance is needed ECRI Institute recommends the following General gt Ensure that staffing levels are adequate gt Commit to a nationally recognized accreditation certification gt Verify that appropriate quality assur ance and quality control procedures are in place and documented Oversight and peer
15. gt guidance ARTICLE 958 HEALTH DEVICES NOVEMBER 2011 gt www ecri org TOP 10 TECHNOLOGY HAZARDS FOR 2012 HEALTH TECHNOLOGY OFFERS COUNTLESS BENEFITS IT ALSO PRESENTS NUMEROUS RISKS MOST OF THESE CAN BE AVOIDED WITH WORK BUT IN A CONSTANTLY CHANGING ENVIRONMENT IT S NOT ALWAYS EASY TO KNOW WHERE BEST TO CONCENTRATE YOUR EFFORTS OUR ANNUAL LIST WILL HELP YOU MAKE SMART DECISIONS ABOUT YOUR SAFETY INITIATIVES DURING 2012 Deciding how to prioritize your efforts when tack ling the risks associated with healthcare technology is a continual challenge Device planning selection implementation use and support all these and more figure into the choice of which risks to give the greatest attention Not only are there a lot of areas to consider but also the technology safety landscape changes all the time a new safety technology is introduced or a new regulation is issued or a well recognized haz ard makes national headlines and suddenly you re forced to reexamine your priorities That s why our list of the top 10 health technol ogy hazards is updated each year to help you focus on the most pressing safety issues over the next 12 months To develop the list we ve weighed a num ber of factors particularly those listed below You can examine the same factors when judging the criti cality of each of these hazards for your own facility gt How harmful is it Can it kill someone or cause serious in
16. may provide only a partial solution and may also introduce new opportunities for fail ure While some of our recommendations are specific to individual care areas and are 360 HEALTH DEVICES NOVEMBER 2011 gt www ecri org Exposure hazards from radiation therapy and CT Medication administration errors using infusion pumps Cross contamination trom flexible endoscopes Inattention to change management for medical device connectivity Anesthesia hazards due to incomplete pre use inspection Poor usability of home use medical devices important to consider don t let them keep you from looking at the bigger picture gt Examine the entire alarm environ ment when setting up your facility s alarm management program for each cate unit Your review should take into account items such as The full complement and configuration of equipment in use e g physiologic monitoring system including telemetry ventilators infusion pumps bed exit alarms nurse call and how it s configured as well as any associated ancillary alarm notification technologies Staffing levels staffing patterns and care model The physical layout of the care unit gt Establish protocols for alarm system settings These should include defin ing the default alarm settings for the specific care unit that is which alarms are active and what their limits are Additionally establish protocols to guide caregivers in tailoring ala
17. of problems and there are times when alarms actually contribute to the occurrence of adverse events Alarm related adverse incidents may result from a variety of factors 1 Alarm fatigue in which staff become ovet whelmed by the sheer number of alarms This can result in alarm desensitization which in turn can lead to missed alarms or delayed alarm response Consequently staff may take inap propriate steps such as a Improperly adjusting alarm limits outside the safe and appropriate range for a pat ticular patient in an attempt to reduce the number of alarms If such modifications are made without careful consideration of the patient s condition and the alarm s 2011 ECRI Institute Member hospitals may reproduce this page for internal distribution only www ecri org gt HEALTH DEVICES NOVEMBER 2011 function the alarm may be set in such a way that it effectively becomes disabled b Turning down the volume of alarms to an inaudible level in an attempt to reduce alarm fatigue and reduce stress on the patient and family Staff being unable to distinguish the urgency level of alarms or tell which device an alarm is coming from Alarms not being restored to the active set ting after being put on standby e g while the patient has left the floor for testing Alarms not being properly relayed to ancillary notification systems e g paging system wire less phones potentially leading to a failu
18. reprocessing Pa Patient Saf Advis 2010 Dec 7 4 135 40 Also available http patientsafetyauthority org ADVISORIES AdvisoryLibrary 2010 dec7 4 Pages 135 aspx Vockley M Probing the challenges of en doscopes Biomed Instrum Technol 2011 May Jun 45 3 174 84 2011 ECRI Institute Member hospitals may reproduce this page for internal distribution only 5 Inattention to Change Management for Medi cal Device Connectivity The growing interrelationship between medical technology and IT a situation referred to as convergence offers signifi cant benefits but it also raises significant concerns about potential risks to patients if the device IT interface is poorly imple mented For example new hazards can be introduced through unexpected problems with device performance problems that occur because of inherent limitations within or interactions among any of the networked devices interfaces or IT based systems Hazards can arise from software anomalies problems with interoperability between systems and degraded network performance A key reason problems arise is the failure to implement adequate change management policies and procedures that accommodate both IT and medical technology needs Change management is a structured approach for ensuring that modifications to an existing system are performed in a controlled manner Because medical devices and health IT are becom ing so interconnected healthcare facilities
19. to end when making an initial connection e g upon the patient s arrival in a new setting or service and any time you are making a reconnection gt Never use a standard Luer syringe for otal medications or enteral feedings gt Do not modify or adapt IV or feeding devices doing so may compromise the safety features incorporated into their design gt Label or color code feeding tubes and connectors and since there is no stan dard in color coding educate staff about the labeling or color coding system gt Examine any identification label before administering a solution to be sure that it is administered via the intended route Do not rely on the solution s appearance for identification enteral formula may look like some IV solu tions e g lipid containing solutions three in one admixtures which have a milky appearance thus creating the risk that an enteral container will be mistak enly spiked with an IV administration set Label the bags with large bold statements such as WARNING For Enteral Use Only Not For IV Use Polcy Level Solutions for Nonchnical Staff gt Purchase enough enteral pumps that IV pumps don t have to be used for enteral delivery If syringe pumps are used in 2011 ECRI Institute Member hospitals may reproduce this page for internal distribution only neonatal intensive care units for human milk or other feedings they should be clearly distinct from syringe pumps us
20. 2010 Apr Radiation Dose in Computed Tomography Why It s a Concern and What You Can Do about It Guidance Article 2007 Feb Health Devices Resource Center Computed Tomography https members2 ecriorg Components HDJournal Pages Computed Tomography Resource Center aspx Health Devices PowerPoint presentation CT Radiation Dose Safety ECRI Institute s Patient Safety Blog Keller J CT Radiation Safety Now It s Personal 2010 Aug 5 wwwecti org blog Lists Posts Post aspx ID 53 364 HEALTH DEVICES NOVEMBER 2011 gt www ecri org Additional resources American College of Radiology ACR appropriateness criteria online www act org secondarymainmenucategories quality_safety app_criteria aspx Berrington de Gonzalez A Mahesh M Kim KP et al Projected cancer risks from computed tomographic scans performed in the United States in 2007 Arch Intern Med 2009 Dec 169 22 2071 7 Bogdanich W After stroke scans patients face serious health risks N Y T7zmes 2010 Jul 31 Also available www nytimes com 2010 08 01 health O1radiation html _r 1 West Virginia hospital overradiated brain scan patients records show N Y Times 2011 Mar 6 Also available www nytimes com 2011 03 06 health 06radiation html Bogdanich W McGinty JC Medicare claims show overuse for CT scanning N Y Times 2011 Jun 17 Also available www nytimes com 2011 06 18 health 18radiation html pagewanted all
21. CRI Institute web conferences Avoid Risk with Health Information Technology 2011 Mar 16 Recording and CD ROM toolkit available for purchase www ecti org Conferences AudioConferences Pages Health_Information_Technology aspx Avoiding the Pitfalls of Medical Device Connectivity 2011 Oct 12 Archive recording available for purchase www ecti org Conferences AudioConferences Pages Medical Device Connectivity aspx PSO Navigator published by ECRI Institute s patient safety organization ECRI Institute PSO Patient Safety at Intersection of Medical and Information Technology 2011 Aug Additional resources American National Standards Institute Association for the Advancement of Medical Instrumentation International Electrotechnical Commission ANSI AAMI IEC Application of risk management for IT networks incorporating medical devices part 1 roles responsibilities and activities ANSI AAMI TEC 80001 1 2010 Oct Food and Drug Administration U S Testimony of Jeffrey Shuren Director of FDA s Center of Devices and Radiological Health online 2010 Feb 25 cited 2010 Oct 11 A PDF of the tes timony can be downloaded from the February 25 2010 HIT Safety Hearing section available at http healthit hhs gov portal server pt ope n 512 amp objID 1473 amp amp PageID 17117 amp mode 2 amp in_hi_userid 11673 amp cached true Joint Commission Safely implementing health information and
22. converging technologies Senti nel Event Alert 2008 Dec 11 issue 42 Also avail able www jointcommission org SentinelEvents SentinelEventAlert sea_42 htm 6 Enteral Feeding Misconnections Enteral feeding is the delivery of nutrients via a tube into the gastrointestinal GI tract of individuals who cannot receive food and nutrients by normal means because of a health condition Misconnection incidents 968 HEALTH DEVICES NOVEMBER 2011 gt www ecri org during enteral feeding usually take one of two forms 1 Nutrients intended for the GI tract are inadvertently delivered elsewhere e g the vasculature 2 Inappropriate fluids e g IV solu tions are inadvertently delivered to the GI tract By far the first hazard is the more critical one It can easily result in death usually by embolus or sepsis Bankhead et al 2009 In 2005 a voluntary standard Ameri can National Standard ANSI AAMI 1D54 1996 R 2005 Enteral Feeding Set Adapters and Connectors was introduced to reduce the risk of misconnecting enteral administration sets to unintended medical lines that employ a female Luer connec tion Unfortunately this standard has not had a major impact in preventing miscon nections One reason is that as a voluntary standard it cannot actually prohibit the use of adapters which can allow two lines to be connected that should not be FDA highlighted the dangers associ ated with misconnections of enteral
23. e to ensure that the patient can use the technology appropriately Reassess the patient regularly and any time the patient experiences a clinical event gt Ensure that patient education matert als are provided to patients and their caregivers so that they can be easily referenced over time gt When patients leave the hospital be sure that they have appropriate contact information for the hospital or the home health agency in case they have ques tions on the use of the medical device gt Educate patients and their family mem bers or caregivers on the appropriate use of the technology and ensure that they understand the relative risks and benefits involved gt When purchasing devices be sure to consider the home healthcare market Look for devices that are designed for the lay user Do not consider using older hospital medical equipment for home use purposes unless it has been expressly designed for that application gt Ensure that you are receiving recalls and alerts on all devices that are prescribed to patients Ensure that procedures are in place to disclose information about adverse events and recalls to the patient and that the procedures clearly define who is responsible for the disclosure and what is required of the patient Resources Health Devices Incorrect Key Presses May Cause Nutricia Plocare Infinity Series Enteral Feeding Pumps to Appear to Be Infusing Even Though an Occlusion Exists
24. ed Recommendations gt Take steps to ensure that changes are assessed approved and implemented in a controlled manner Change man agement applies to a variety of actions including hardware uperades soft ware upgrades security changes new applications new work processes and planned maintenance gt Evaluate your facility s policies and procedures regarding change manage ment to ensure that situations involv ing convergence and health IT are properly addressed Care should be taken to determine how technology decisions involving medical devices and IT networks can affect current operations patient care and clinician work processes gt Develop contract wording that is specific to change management For example contracts with vendors e g information system vendors device suppliers should require the necessary documents e g revised specifications software upgrade documentation test scenarios to be provided to the appropriately designated hospital staff member s to facilitate change management gt Consider applying risk management principles to change management as discussed in the IEC 80001 1 stan dard Application of Risk Management for IT Networks Incorporating Medical Devices Part 1 Roles Responsibilities and Activities Refer to our May 2010 Guidance Article 10 Questions about IEC 80001 1 for answers to some common questions about the standard gt Ensure good working relat
25. ed for IV or other medical purposes Consider using non Luer tubing tech nologies to prevent mix ups Limit the leneth of contracts for purchasing administration sets to one year to allow for the switch to a standardized con nector once available gt Ensure that hospital purchasing policies mandate buying only enteral feeding sets that are compliant with the ANSI AAMI ID54 standard which excludes any sets that are compatible with female Luer connectors and excludes adapters that would allow such connections gt When purchasing prefilled enteral feed ing containers purchase only those that are non V compatible gt Ensure that enteral administration sets are packaged with the enteral feeding bag or container before it is sent to the patient care unit The set should be secured to the bag perhaps with a rub ber band or preattached sets should be requested from the manufacturer gt Obtain enteral pumps that feature an automatic flush mode This will keep clinicians from having to manually flush lines and therefore will make them less likely to use an adapter or Luer device between the enteral administration set and the feeding tube Resources Health Devices Fixing Bad Links Preventing Misconnections in Your Hospital Guidance Article 2009 Jul Additional resources American National Standards Institute ANSI Association for the Advancement of Medical Instrumentation AAMI Enteral feeding set
26. ed with more effective models or that gaps exist in the facility s sharps safety program An effective sharps safety program will include input from a variety of stake holders Thus a typical sharps safety 2011 ECRI Institute Member hospitals may reproduce this page for internal distribution only committee will include personnel from risk management materials management nursing clinical laboratory and pharmacy as well as the patient safety committee frontline healthcare workers in the United States the Occupational Safety and Health Administration OSHA requires that they be involved and housekeeping staff A new campaien called Stop Sticks launched in 2011 by the National Insti tute for Occupational Safety and Health NIOSH is designed to raise awareness about sharps safety and to prepare and motivate healthcare workers mainly oper ating room and emergency department staff to make the changes necessary to reduce sharps injuries More information is available online see CDC NIOSH Stop Sticks Campaign in the Resources Recommendations To achieve consistent success in preventing needlesticks and other sharps injuries facil ities should annually review and refine all aspects of their sharps safety efforts We recommend that the sharps safety commit tee perform the following activities gt Assess injuries and current prac tices Analyzing information about needlesticks and ot
27. f risk for each of the hazards from low to high This will help you to focus your mitigation strategies on the hazards that are most relevant to your institution The self assessment tool will be updated annually in conjunction with the release of each new Top 10 Hazards list In addition the Top 10 Hazards Resource Center is being updated with the hazards for 2012 The site also includes links to the archive of previous years hazards and a video about the list trom James P Keller Jr vice president for health technology evaluation and safety who directs the Health Devices Group You can access the Top 10 Resource Center from your membership home page exposure of the population of the United States Report no 160 Bethesda MD NCRP 2009 Pennsylvania Patient Safety Authority Errors in radiation therapy Pa Patient Saf Advis 2009 Sep 6 3 87 92 Also available http patientsafetyauthority org ADVISORIES AdvisoryLibrary 2009 Sep6 3 Pages Home aspx Terezakis SA Pronovost P Harris K et al Safety strategies in an academic oncology department and recommendations for action J4 Comm J Qual Patient Saf 2011 Jul37 7 291 9 World Health Organization WHO Radio therapy risk profile Geneva WHO 2008 Also available www who int patientsafety activities technical radiotherapy_tisk_profile pdf CT Resources Health Devices CT Radiation Dose Understanding and Con trolling the Risks Guidance Article
28. he Bog danich articles listed in both sections of the Resoutces In radiation therapy very high levels of radiation are used to deliberately kill tumors Unfortunately errors during radiation therapy can have devastating consequences including ineffective tumor control as well as critical damage to normal tissue and organs that can lead to severe morbidity and death It isn t clear how many patients are affected by radiation therapy errors for one thing there isn t an unambiguous defi nition of a reportable event and there is a good chance that incidents are being signifi cantly underreported In the diagnostic setting much lower radiation levels are used and only in extreme cases do noticeable short term effects such as hair loss occur But far more patients undergo diagnostic radiography and any cancers resulting from these procedures may only become apparent many years later CT is a particular concern because it s being used more and more often and because it has a relatively high dose It alone contributes about 50 of the entire 2011 ECRI Institute Member hospitals may reproduce this page for internal distribution only radiation dose from artificial sources NCRP 2009 and one person in 1 000 would be expected to develop cancer in his or her lifetime from a typical CT study which delivers a dose of approximately 10 mSv National Academies 2006 When used appropriately CT is an indispensable
29. her sharps injuries that have occurred in your facility 1s essential for designing or assessing a program Such an analysis can help you identify where and when e g during which procedures or applications such injuries typically occur For instance if yout hospital already has sharps safety devices in place historical and current data is helpful for deciding whether a particular safety device should be replaced with a new one gt Define specific objectives The data collected on injuries devices and cur rent practices will help you define or refine the objectives of your program and prioritize your efforts gt Establish an action plan Within each action plan each identified category of injury should have some plan for 2011 ECRI Institute Member hospitals may reproduce this page for internal distribution only remediation or recommendation for action The plan should also specify who is responsible for implementing particular aspects of the program when specific milestones should be completed and what results the facility expects to achieve gt Implement the program Some of the more challenging aspects include Ensuring that all personnel on all shifts are trained Obtaining supplier support for in service training on the use of the protective devices that will be implemented Making supplies readily available and removing sharps that are to be replaced by protective devices gt Evaluate the p
30. ing a Surgical Fire Risk Assessment Score www christianacare org FireRisk Assessment to its perioperative forms for verifying the surgical site and patient iden tification Mathias 2006 Before surgery the surgical team is required to identify and assess several fire risk potentials includ ing for example the use of alcohol based skin prep solutions and the use of open oxygen sources on the face The initia tive at this healthcare system has served to stimulate collaborative communication among surgical team members Formal training and drills are recom mended by ECRI Institute and APSF APSF commissioned ECRI Institute to produce a training video on surgical fires The 18 minute video is available as a free download from the APSF website www apsf org tresoutces_video php the orga nization also offers DVDs of the video at no charge ECRI Institute s surgical fire prevention and extinguishment educational 369 guidance ARTICLE posters are available for free downloading see the Resources FDA s Center for Devices and Radio logical Health CDRH convened a meeting in 2010 with representatives from a variety of healthcare organizations to dis cuss ways to collaborate to prevent surgical fires www fda gov Drugs DrugSafety SafeUselnitiative ucm239511 htm The result of that ongoing initiative is a page on FDA s website posted in October 2011 that ageregates surgical fire prevention information and educa
31. ionships between departments particularly IT and clinical engineering since these two groups have a direct responsibility for convergence and change management gt Remember that help desks are typically the first point of contact for problems relating to change management and health IT Education training and good escalation procedures can help to ensure that help desks respond to prob lems with the appropriate urgency Resources Health Devices 10 Questions about IEC 80001 1 What You Need to Know about the Upcoming Standard and Networked Medical Devices Guidance Article 2010 May CE IT Collaboration Putting the Pieces Together Guidance Article 2009 May Coping with Convergence A Road Map for Successfully Combining Medical and Information Technologies Guidance Article 2008 Oct Data Transfer Problems between Imaging Devices and PACS Could Result in Misdiagnosis Hazard Report 2008 Dec Look Who s Talking A Guide to Interoperabil ity Groups and Resources Guidance Article 2011 Jun www ecri org gt HEALTH DEVICES NOVEMBER 2011 367 guidance ARTICLE Physiologic Monitoring A Guide to Network ing Your Monitoring Systems Evaluation 2011 Oct see particularly the discussion of change management on pages 326 7 Health Devices PowerPoint presentation Coping with Convergence A Road Map for Combining Medical and Information Technologies E
32. itional resources Association for the Advancement of Medical Instrumentation AAMI Infusing patients safely Priority issues from the AAMI FDA infusion summit 2010 Also available www aami org infusionsummit AAMI_FDA_ Summit_Report pdf Food and Drug Administration U S Infusion pump glossary online 2010 Apr 22 cited 2011 Apr 11 Available from Internet www fda gov MedicalDevices ProductsandMedicalProcedures GeneralHospitalDevicesandSupplies InfusionPumps ucm202502 htm Infusion pump improvement initiative white paper online 2010 Apr cited 2011 May 5 Available from Internet www fda gov MedicalDevices ProductsandMedicalProcedures GeneralHospitalDevicesandSupplies InfusionPumps ucm205424 htm Infusion pump risk reduction strategies for facility administrators and managers online 2010 Apr 22 cited 2011 Apr 21 Available from Internet www fda gov MedicalDevices ProductsandMedicalProcedures GeneralHospitalDevicesandSupplies InfusionPumps ucm205410 htm What is an infusion pump online 2010 Apr 22 cited 2011 May 5 Available from Internet www fda gov MedicalDevices ProductsandMedicalProcedures GeneralHospitalDevicesandSupplies InfusionPumps ucm202495 htm Kirkbride G Vermace B Smart pumps implications for nurse leaders Nurs Admin O 2011 Apr Jun 35 2 110 8 Pinkney S Trbovich P Fan M et al Do smart pumps actually reduce medication errors Hum Factors Horiz 2010 64 9
33. ity for back up response Battery replacement every 24 hours Implement two way communication devices Elevate leads OfF Alaris tocrists priority that would allow a nurse to request help Develop an alarm escalation scheme O Who receives initial alarm notification for each type of alarm O Who receives back up alarm notification E C l 1 for each type of alarm I nstitute O Time intervals per escalation The Discipline of Science The Integrity of Independence 2011 ECRI INSTITUTE 5200 BUTLER PIKE PLYMOUTH MEETING PA 19462 1298 MS11564 4 guidance ARTICLE GENERAL RECOMMENDATIONS In addition to the specific advice provided for each hazard in the Top 10 list there are certain recommendations that should be followed throughout your facility gt Ensure that device related safety is a corporate priority gt Ensure that all clinical staff are qualified trained licensed or certified for the equipment and treatments offered gt gt Ensure that device problems and incidents are included in a facility wide adverse event reporting system Encourage staff to report all events including near misses to the manufacturer ECRI Institute and the appropriate regulatory agency e g FDA Institute a standard procedure to assess reported events including near misses and establish criteria for determining when events require further analysis including root cause analysis Design the rep
34. jury gt How likely is it Does it happen often or very rarely gt How widespread is it If it occurs is it likely to affect a great number of people or will the effects be very confined gt Is it a high profile problem Has it been reported in the media and are you likely to be under pres sure to deal with it quickly and conspicuously Although this article focuses on specific tech nology hazards there are steps you should be taking throughout your facility to make your safety initiatives as effective as possible See the box titled General Recommendations on page 362 for a list of those steps Finally we urge you to share this list with others throughout your facility The hazards in this list affect a wide variety of departments and personnel including risk management hospital administration clinicians clinical engineering information technology IT nurse managers and materials management We encourage you to alert staff in those areas to this list and its recommendations 2011 ECRI Institute Member hospitals may reproduce this page for internal distribution only The Risks That Should Be at the Lop of Your Prevention Lust m3 Alarm Hazards Many medical devices in the hospital such as physi ologic monitors including telemetry monitors ventilators infusion pumps and dialysis units rely on alarms to help protect patients But the alarm systems on these devices can also be the source
35. l iref allsearch Centers for Disease Control and Prevention National Institute for Occupational Safety and Health The Stop Sticks campaign campaign uset s guide and resources Available from Internet www cdc gov niosh stopsticks Institute for Safe Medication Practices Needlestick injury due to label issue with Lovenox unit dose injection online ISMP Med Saf Alert 2010 Jul 23 Available from Internet www ismp org newsletters acutecare articles lovenox_alert_v5_layout_1 pdf Jagger J Berguer R Phillips EK et al Increase in sharps injuries in surgical settings versus nonsurgical settings after passage of national needlestick legislation J Am Coll Surg 2010 Apr 210 4 496 502 Massachusetts Department of Public Health Occupational Health Surveillance Program Sharps injuries among hospital workers in Massachusetts 2009 findings from the Massachusetts Sharps Injury Surveillance System Boston MA Massachusetts Department of Public Health 2010 Also available www mass gov Eeohhs2 docs dph occupational_health injuries_ hospital_2009 pdf Tosini W Ciotti C Goyer F et al Needlestick injury rates according to different types of safety engineered devices results of a French multicenter study Infect Control Hosp Epidemiol 2010 Apr 31 4 402 7 9 Anesthesia Hazards due to Incomplete Pre use Inspection Each year we receive reports of staff members discovering serious problems with anesthesia equipment just
36. llow them Remember to periodically repeat training to ensure that staff remain familiar with the protocols and to address turnover Also monitor adhetr ence to protocols Be alert to the possi ble need for revisions to protocols and training when a new endoscope model is added to your inventory Resources Health Devices Clear Channels Ensuring Effective Endoscope Reprocessing Guidance Article 2010 Oct Clearing Up Confusion about the Steris System 1E ECRI Institute s Perspective on Its Appropriate Use Guidance Article 2010 Dec Survey Results Hospitals Status Regarding Steris System 1 Replacement Safety Note 2010 Dec Health Devices Resource Center Steris System 1 https members2 ecri org Components HDJournal Pages SterisSystem 1 ResourceCenter aspx Additional resources Food and Drug Administration U S Preventing cross contamination in endoscope reprocess ing safety communication from FDA CDC and the VA online 2009 Nov 19 cited 2011 Oct 10 Available from Internet www fda gov MedicalDevices Safety AlertsandNotices ucm190273 htm Government Accountability Office U S VA healthcare weaknesses in policies and oversight governing medical supplies and equipment pose risks to veterans safety online 2011 May 3 cited 2011 Oct 10 Available from Internet www gao gov products GAO 11 391 Pennsylvania Patient Safety Authority The dirt on flexible endoscope
37. nfusion programming mistakes such as mistyping data or entering it into the wrong field can have severe adverse effects including death Infusion pump technology has evolved over the years to address many safety issues the most nota ble improvement being the introduction of smart pumps But preventable errors including misprogramming do still occur While administration is the area where errors are most likely to affect the patient Kirkbride and Vermace 2011 the entire infusion process needs to be examined This involves many healthcare profession als doctors nurses and pharmacists who perform various tasks that also may be ripe for mistakes For example medication orders may be illegible drugs and solutions may be incorrectly prepared and a medica tion may be given to the wrong patient Ensuring infusion safety requires team work among many departments within a facility and collaboration with infusion pump manufacturers 2011 ECRI Institute Member hospitals may reproduce this page for internal distribution only In April 2010 FDA issued a white paper FDA 2010 Infusion Pump Improvement Initiative about improving infusion pump safety and announced that it would be reviewing reported problems and investigat ing current devices in order to aid in the development of safer and more effective infusion technologies and practices An FDA AAMI Infusion Device Summit held in October 2010 identified a few h
38. ologists and medical physicists are accessible to all clinical staff for consultations and education regarding the appropriate use of diag nostic imaging gt Ensure that radiation doses are as low as reasonably achievable while maintaining acceptable diagnostic image quality Validate all study protocols before rou tine clinical use gt Record and audit radiation doses gt Provide guidance to radiologists and technologists regarding image quality and dose gt Recommend applicable radiation dose mitigation technologies Radiation Therapy Resources Health Devices Alerts ECRI Institute Health Devices Alerts Database Analysis Radiation Therapy Accession No S0209 2011 Mar 25 ECRI Institute Responds to Recent News Coverage of Radiation Therapy Overexposure Incidents Accession No S0198 2010 Jan 28 ECRI Institute s Patient Safety Blog Inamdar R Radiation Therapy A Double Edged Sword 2010 Jun 2 www ecri org blog Lists Posts Post aspx ID 33 ECRI Institute web conference Radiation Therapy Errors Protecting Patients from Harm 2010 May 19 Recording and CD ROM toolkit available for purchase www ecti org Conferences AudioConferences Pages Radiation_Therapy_Errors aspx Additional resources Bogdanich W As technology surges radiation safeguards lag N Y Times 2010 Jan 26 Also available www nytimes com 2010 01 27 us 27radiation htmlPemc etal Case s
39. orting system to be nonpunitive gt gt Before putting devices into service look for outstanding hazard notices or other safety problems such as those reported in Health Devices Alerts earliest planning stages For existing care programs make sure that these steps are implemented and that com pliance with established protocols is monitored Resources Health Devices Alarm Notification for Physiologic Monitoring Could You Benefit from a New Strategy Guidance Article 2007 Jan Alarm Notification Problem Spotlighted in Boston Globe Is All Too Common Safety Note 2010 Apr The Hazards of Alarm Overload Keeping Excessive Physiologic Monitoring Alarms from Impeding Care Guidance Article 2007 Mar A Lifesaving Reminder Improper Use of Ventilator Alarms Places Patients at Risk Hazard Report 2009 Apr Poster Strategies to Improve Monitor Alarm Safety available free of charge at wwwectiorg Documents Monitor 20Alarm 20Safety_ Poster 20Presentation pdf Health Devices Resource Center Physiologic Monitoring https members2 ecti org Components HDJournal Pages ResourceCenter_PhysMon aspx See particularly the pages on managing alarm overload alarm notification strategies and alarm enhancement technologies 362 HEALTH DEVICES NOVEMBER 2011 gt www ecri org ECRI Institute s Alarm Safety Resource Site www ecti org Forms Pages Alarm_Safety_Resoutce aspx
40. re to notify relevant staff A lack of adequate alarm notification and response protocols Failure to promptly troubleshoot and correct leads off alarms or frequent nuisance alarms caused by artifact 359 guidance ARTICLE THE HAZARDS AT A GLANCE Alarm hazards Enteral feeding misconnections Surgical fires Needlesticks and other sharps injuries Se ee a Alarm safety continues to receive atten tion For example in early 2011 the Boston G obe published a series of articles review ing periodic efforts by FDA and the Joint Commission to address alarm fatigue And on October 4 and 5 2011 a summit on alarm safety was held to achieve a consen sus on alarm safety problems and develop specific action plans It was co convened by ECRI Institute the Association for the Advancement of Medical Instrumentation AAMI FDA the American College of Clinical Engineering ACCE and the Joint Commission ECRI Institute has produced a poster called Strategies to Improve Monitor Alarm Safety It is shown on page 361 You can also download a free copy at www ecti org Documents Monitor 20Alarm 20Safety_ Poster o20Presentation pdf Recommendations Reducing alarm related adverse incidents and setting up an alarm management pro gram ate very complex tasks They require in depth assessment of the organization as a whole as well as each individual care area Trying to fix one item in isolation
41. review of these procedures should be conducted 2011 ECRI Institute Member hospitals may reproduce this page for internal distribution only gt Be aware of the above mentioned Sentinel Event Alert issued by the Joint Commission gt Ensure that systems are properly installed commissioned and maintained gt Perform acceptance testing for new systems as well as for system updates and modifications and ensure that the integrated systems as a whole meet device performance specifications For radiation therapy this would involve the simulation treatment planning delivery and record and verify systems Specific Recommendations for Radiation Therapy gt Ensure that standard patient treatment procedures are documented and fol lowed including performing indepen dent double checks and conducting time outs as appropriate gt Develop and use standard checklists for each step of patient treatment gt Ensure that new treatment techniques ate validated before use gt Assess whether your existing test ing equipment is adequate for today s advanced treatment systems gt Examine the need for immediate or future additional staffing training or professional development activities gt Verify that an appropriate subset of key parameters e g radiation beam output is tested regularly and frequently as part of an ongoing quality control program Specific Recommendations for CT gt Ensure that radi
42. rm limits to individual patients to ensure that the appropriate staff are notified of clini cally significant alarms gt Establish alarm notification and response protocols that ensure that each alarm will be recognized that the appropriate caregiver will be alerted and that the alarm will be promptly addressed Clearly assign responsibilities to staff including who is responsible for recognizing the alarm once it is issued by the device who is responsible for delivering the necessary alarm information e g existence of an alarm condition identity of affected patient reason for alarm alarm priority to the responsible caregiver and who is directly responsible for addressing the alarm Establish backup coverage protocols to ensure that someone responds promptly when the primary caregiver is not available Ensure that the correct pager phone is assigned to the correct caregiver e g that it is properly programmed to account for staff ing changes from shift to shift Establish policies to control alarm silencing modification and disabling For new care areas be sure to consider the issues discussed above from the 2011 ECRI Institute Member hospitals may reproduce this page for internal distribution only STRATEGIES TO IMPROVE MONITOR ALARM SAFETY Delineation of Responsibility Technology Capabilities amp Configuration gtient safety SA anc tht
43. rogram s effectiveness annually using the above recommenda tions for guidance Resources Health Devices Needlestick Prevention Devices Disposable Syringes and Injection Needles Evaluation 2007 Aug Sharps Disposal Containers Evaluation 2003 Jul many of the containers rated in this Evalu ation are still on the market and the technology guidance is still valid Still Getting Stuck Protective Devices Alone Won t Always Prevent Needlestick Injuries Hazard Report 2009 Sep Health Devices Alerts Cardinal Health Bard Huber Plus Non cor ing Needle Safety Infusion Sets Needle Tip May Protrude from Safety Sheath Creating Potential for Needlestick Injury Accession No A13426 2010 Feb 3 Health Devices PowerPoint presentation Sharps Safety Maintaining an Effective Sharps Injury Prevention Program ECRI Institute Special Report Sharps Safety and Needlestick Prevention 2nd edition 2003 this publication includes our evaluations of more than 90 protective devices many of which are still on the market Additional resources Bae SH Mark B Fried B Use of temporary nurses and nurse and patient safety outcomes in acute care hospital units Health Care Manage Rev 2010 Oct Dec 35 4 333 44 Batchelor L Toddler pricked by contami nated needles online 2010 Oct 22 cited 2010 Oct 26 Available from Internet www cnn com 2010 US 10 22 us child needles index htm
44. tates currently recetve home healthcare FDA has identified three unique challenges of the home environment caregiver knowl edge environmental unpredictability and device usability In the area of device usability FDA outlines the following con cerns Many of the devices used in the home are older and have no labeling or instructions for use or maintenance with ECRI INSTITUTE REPRINT POLICY ECRI Institute makes reprints of individual articles or complete publications available for educational purposes The purchase and use of these reprints are subject to restrictions including those imposed by copyright law and our strict no commer cialization policy For further information contact Client Management Services by phone at 1 610 825 6000 ext 5891 or by e mail at clientservices ecri org 2011 ECRI Institute Member hospitals may reproduce this page for internal distribution only them And if they do the instructions are not typically written for the lay user Further patients usually cannot choose the device they use in the home it is either prescribed by a doctor or depends on the patient s insurance or medical equipment supply company Finally some devices pur chased on the Internet may not come with instructions covering use or maintenance ot information about compatible accesso ries FDA 2010 Recommendations gt Assess the patient and caregiver s before prescribing any medical devic
45. that anesthesia units and related equipment are safe for patient use we recommend that the appropriate staff member or members e g anesthe 372 HEALTH DEVICES NOVEMBER 2011 gt www ecri org gt gt siologists anesthesia technicians or nurse anesthetists do the following Before the first case of the day per form an equipment inspection that includes the model specific manu facturer prescribed full check of the anesthesia unit Before each subsequent case make sure that any inspection of the anesthesia unit is at minimum the manufacturer prescribed abbreviated check for that model of anesthesia unit If you re unsure whether you re using the correct procedure for the anesthesia unit models in your inventory contact the manufacturer Ensure that staff members or anyone responsible for pre use checks is famil iar with the procedure and the critical need to perform it in its entirety Facility policy should clearly indicate which staff member or members is responsible for performing the check This is particularly important in facilities where the procedure is split up among different roles for example the anesthesia provider performs some steps and the anesthesia technicians perform others Include in the inspection not just the anesthesia unit but also other impor tant devices and accessories e g airway suctioning equipment manual resusci tators that may not be specified in the proced
46. ticle 2009 Oct Posters available free of charge at wwweecti org sureical_fires Surgical Fire Prevention Emergency Procedure Extinguishing a Surgical Fire Health Devices PowerPoint presentation New Clinical Guide to Surgical Fire Prevention Additional resources American Society of Anesthesiologists Task Force on Operating Room Fires Caplan RA Barker SJ et al Practice advisory for the preven tion and management of operating room fires Anesthesiology 2008 May 108 5 786 801 Also available www asahq org sitecore content Lifeline Anesthesia Topics media Lifeline Anesthesia 20Topics OR 20Fires 20 Practice20Guidelines ashx Anesthesia Patient Safety Foundation APSF Prevention and management of operating room fires video Indianapolis APSF 2010 Also available www apsf org resources_video php Food and Drug Administration U S Preventing surgical fires collaborating to reduce preventable harm 2011 Oct cited 2011 Oct 18 Available from Internet www fda gov Drugs DrugSafety SafeUselnitiative PreventingSurgicalFires Joint Commission Preventing surgical fires Sen tinel Event Alert 2003 Jun 24 issue 29 Also avail able www jointcommission org assets 1 18 SEA_29 PDE Mathias JM Scoring fire risk for surgical pa tients OR Manager 2006 Jan 22 1 19 20 8 Needlesticks and Other Sharps Injuries Exposure to bloodborne pathogens hepatitis B virus HBV hepatitis
47. tional tools see the Resoutces Recommendations gt If you don t already have one imple ment a surgical fire prevention and management program including train ing based on the recommendations for preventing and extinguishing surgical fires presented in our October 2009 Guidance Article gt To minimize the risks posed by oxygen enriched atmospheres become familiar with and implement the new clinical recommendations on oxygen delivery from APSF and ECRI Institute Again see out October 2009 Guidance Article and educational posters for details The cote point of these recommendations is that with certain limited exceptions the traditional practice of open delivery of 100 oxygen should be discontin ued during head face neck and upper chest surgery Only air should be used for open delivery to the face provided that the patient can maintain safe blood oxygen saturation without supplemental oxygen If the patient cannot do this secure the airway with a laryngeal mask airway or tracheal tube to prevent the excess oxygen from contaminating the surgical site gt The surgical team should have a time out before the case begins and assess any fire risks Ensure that this time out is conducted effectively 370 HEALTH DEVICES NOVEMBER 2011 gt www ecri org Resources Health Devices New Clinical Guide to Surgical Fire Prevention Patients Can Catch Fire Here s How to Keep Them Safer Guidance Ar
48. ttings involve limited direct supervision of caregivers and equipment performance These factors increase the risk that problems errors and hazards may go undetected or unreported Often devices that are used in the home are not designed with the lay user in mind They are frequently very difficult to use or very complex and in fact may sometimes be identical to devices used in the hospital by clinicians In addition there may be inadequate training for the patient or caregiver Since June 2010 ECRI Insti tute has published three Hazard Reports related to problems with medical devices used in the home all of them involving devices that were not inherently easy to use One report noted that an alarm could be disabled on an oxygen concentrator when a low flow flowmeter is placed on 2011 ECRI Institute Member hospitals may reproduce this page for internal distribution only the device in another model specific variations in how ventilator parameters are set could cause improper ventilation in the third pressing a specific key on an enteral feeding pump could cause it to appear to be infusing even though an occlusion exists See the three Health Devices articles listed in the Resources FDA is also concerned about hazards involving medical devices in use in the home and launched an initiative in April 2010 to scrutinize the issues with these devices According to FDA approximately 7 6 million individuals in the United S
49. tudies when medical radiation goes awry N Y Times 2010 Jan 26 Also available www nytimes com 2010 01 27 us 27RADIATIONSIDEBAR html Radiation offers new cures and ways to do harm N Y Times 2010 Jan 23 Also available www nytimes com 2010 01 24 health 24radiation html ref health Bogdanich W Rebelo K They check the medical equipment but who is checking up on them N Y Times 2010 Jan 26 Also available www nytimes com 2010 01 27 us 27sideradiation html Hendee WR Herman MG Improving patient safety in radiation oncology Med Phys 2011 Jan 38 1 78 82 Joint Commission Radiation risks of diagnostic imaging Sentinel Event Alert 2011 Aug 24 issue 47 Also available www jointcommission org assets 1 18 SEA_471 PDF National Council on Radiation Protection and Measurements NCRP Ionizing radiation www ecri org gt HEALTH DEVICES NOVEMBER 2011 363 guidance ARTICLE NEW SELF ASSESSMENT TOOL ADDED TO TOP 10 HAZARDS RESOURCE CENTER We re adding a brand new feature to our Top 10 Technology Hazards Resource Center the Health Technology Hazard Self Assessment Tool It allows you to gauge your risk of experiencing any of the hazards on our Top 10 list For each of the hazards you can send a brief survey to an appropriate person at your facility who answers questions about how the relevant devices or systems are being used The survey tool processes the answers and gener ates a bar graph that rates your level o
50. undred types of pump issues and erouped them into 13 clarion themes AAMI then assembled an Infusion Device Safety Council with members from academia device suppliers healthcare facil ities regulatory agencies industry groups and ECRI Institute which is tackling the 13 clarion themes in 10 workgroups Read ers can learn more about the council and get involved at www aami org foundation htsc infusion index html The proceed ings from the safety summit are listed in the Resources Recommendations gt View infusion pumps as part of an overall medication delivery system since infusion pumps are likely to become integrated with other informa tion systems e g pharmacy informa tion system electronic medical record EMR Determine the pumps com patibility with safety systems that are currently in place gt In addition to considering the hospi tal s current needs vendor support and costs when choosing new infusion pump technology focus on the technol ogy s possible integration with future medication safety systems as well as its usability For example consider ask ing the pump supplier for the names of other sites that have integrated the pump with information systems from the major providers gt Develop appropriate drug libraries for clinical areas that use infusion pumps The libraries should have standardized concentrations of commonly used drugs and solutions To determine appropriate
51. ure for the unit Make sure the pre use check procedure is easily accessible If a hard copy of the procedure is required make sure that it is physically attached to the anesthesia unit or is placed in some other equally prominent location Many later model anesthesia units perform much of the procedure semiautomatt cally or display step by step procedures onscreen However any manual por tions of the procedure such as those that must be performed or confirmed by a human should be specified on the attached hard copy checklist gt Be sure to document the results of the pre use inspection to allow providers to confirm that all necessary steps have been performed Resources Health Devices Anesthesia System Pre use Checks The Importance of Performing a Complete Check on a Consistent Basis Evaluation box article 2006 Jul Dangerous Misconnection Goes Undetected by Datex Ohmeda ADU s Pre use Check Hazard Report 2009 Feb Additional resource American Society of Anesthesiologists Recommendations for pre anesthesia checkout procedures online 2008 cited 2011 Oct 10 Available from Internet http asatest asahq otg clinical fda htm 10 Poor Usability of Home Use Medical Devices As the US population rapidly ages and the number of individuals living with chronic conditions increases more patients are receiving medical care in their homes Unlike hospitals and nursing homes home cate se
52. ws or equipment chemicals that are no lon ger in use at the facility When developing or reviewing proto cols ensure that all steps are addressed and documented in adequate detail from precleaning of equipment at the treatment site to safe and aseptic trans port of equipment back to the treatment site for subsequent use Typical steps in a reprocessing protocol are described in our October 2010 Guidance Article Clear Channels Ensuring Effective Endoscope Reprocessing If your facility reprocesses endos copy equipment using a reprocessing unit such as an automated endoscope reprocessor a liquid chemical steriliza tion system or a gas plasma sterilizer ensure that Endoscopes and related equipment in your facility s inventory are com patible with the reprocessor and its disinfecting sterilizing agent The appropriate channel adapters are available to connect the endo scope to the reprocessor and staff are familiar with the correct endo scope connector combinations Also ensure that staff have access to information on the correct combinations and know where this information is located if there are any questions Staff are familiar with and ad here to appropriate reprocessor maintenance schedules including the periodic replacement of par ticulate and bacterial filters Ensure that documented protocols are readily available to staff and that staff are trained to understand and fo
Download Pdf Manuals
Related Search