What Every Infection Preventionist Should Know About the Critical Issues in the Steam Sterilization Process

Transcription

1 3M Attest Sterile U Web Meeting August 20, 2009 What Every Infection Preventionist Should Know About the Critical Issues in the Steam Sterilization Process Updated Aug 2009 by Martha Young

2 Welcome! Facilitator: Tammy Torbert, 3M Sterilization Assurance Speakers: Mary Kundus, 3M Technical Service and Martha Young, Martha L. Young, LLC SAVVY Sterilization Solutions Housekeeping: Questions; -Mute feature (*7=unmute; *6=mute) - Chat feature Technical difficulties CE Credits Post session follow-up For more information: 2

3 Disclosures Mary Kundus RN, BSN, MPH, CIC Supervisor, Technical Service 3M Employee Martha Young BS, MS, CSPDT Martha L Young, LLC Savvy Sterilization Solutions Sponsored by 3M marthalyoung1@aol.com 3

4 ? 3M Attest Products now includes Sterile U, a network of educational services and training resources, provided by 3M and dedicated to improving competency and confidence in the field of sterility assurance What is 3M Attest Products Sterile U 3M Attest Products Sterile U An educational resource provided by 3M Sterilization Assurance Designed to deliver relevant information to sterilization specialists A tool to gain CE credits A resource guide for sterilization issues 4 An unbiased source of technical and professional information

5 SterileUOnline Easily access CE credited in-services, sterilization best practices, standards updates, and FAQs from our Sterilization Tech Service Help Line Join Today! 5

6 Behavioral Course Objectives 1. Develop a loaner instrument policy and procedure 2. Discuss the extended cycle issue 3. Develop a recall policy and procedure 4. Discuss issues related to flash sterilization 5. Develop a policy and procedure for monitoring implants, routine sterilizer efficacy testing, and sterilizer qualification testing 6 Read objectives.

7 Sterilization Process Monitoring Monitoring Tools Physical monitors Chemical indicators Biological indicators Process challenge devices (PCDs) Test or challenge pack 7 During this presentation we will discuss several sterilization process monitoring devices. These are the Physical Monitors, Chemical Indicators, and Biological Indicators. We will also discuss process challenge devices or PCDs which use to be called test or challenge packs.

8 Process Challenge Device (PCD) Depending on the application (type of testing being done) the PCD may contain 8 A PCD may contain any of the above monitoring tools. The PCD you ll use will depend on what type of testing is being performed.

9 Flash Sterilization Process designed for the steam sterilization of patient care items for immediate use High temperature ( F/ C) Gravity or dynamic-air-removal No dry time No storage Photo courtesy of Rose Seavey, The Children's Hospital - Denver 9 AAMI ST79:2006 A1:2008 A2:2009 Introduction and Definition 2.50 Lets also define flash sterilization. Flash sterilization is the process designed for the steam sterilization of patient care items for immediate use. Originally, flash sterilization was used to reprocess dropped instruments mid-procedure, using the unwrapped method and a 270 F gravity cycle. It was called high temperature sterilization and that s because there were only 270 F gravity sterilizers used in the OR. In the early 90 s, pre-vacuum sterilizers started to be sold into OR s as flash sterilizers. Over the years, people have misused flash sterilizers, moving from the single dropped instrument to entire instrument sets because of a lack of inventory. Flash sterilization involves a high temperature from F. The process can use either gravity or dynamic-air-removal cycles. No dry time is used and items cannot be stored.

10 Flash Sterilization Packaging includes Perforated, mesh bottom, open surgical tray Rigid sterilization container system Protective organizing case Single-wrapped surgical tray 10 AAMI ST79:2006 A1:2008 A2:2009 Section And the type of packaging has expanded beyond using perforated, mesh bottom, open surgical trays. Other packaging includes: -rigid sterilization container systems -protective organizing cases -single-wrapped surgical trays

11 AORN 2009 RP for Sterilization-Flash Sterilization Recommends the use of rigid sterilization containers (IV.e.) Reduce risk of contamination during transport to point of use Ease of presentation to sterile field AORN states that in flash sterilization a Class 5 integrating indicator should be used inside each sterilizer container or tray (IV.h.) 11 AORN recommended practices for sterilization recommend the use of rigid sterilization containers designed and intended for flash sterilization cycles. The RP also states that flash-sterilized items are to be used immediately and not stored for later use. And that Class 5 integrating indicators should be used inside each sterilizer container or tray.

12 Loaner Instrumentation Best Practice Its all about Time! 12 Rose Seavey RN, BS, MBA, CNOR, CRCST, CSPDT Seavey, Rose. Just Say No! Don t Get Weighed Down By Instrument Sets That are Too Heavy. Managing Infection Control, April, 2006 Volume Six Issue 4. Lets discuss loaner instruments-it is all about time. The information in this section is provided by a Managing Infection Control inservice authored by Rose Seavey, and published in the April 2007 issue of Managing Infection Control which can be accessed from the web site listed on the first slide. Rose was the director of SPD at the Children s Hospital in Denver before retiring and starting her consulting company. She is also on the AORN board of directors. It s all about time.

13 Managing Loaner Instrumentation AORN 2009 RP for Sterilization Allow sufficient time for conventional sterilization methods: circumvent the need for flash sterilization (X.b.1.) Arrive 24 hours ahead of time Have loaner instruments delivered to decontamination for proper cleaning, preparation and packaging (X.c.1.) Sterilize implantable devices with a BI and a Class 5 integrating indicator (IV.h.) Quarantine until BI is negative (IV.h.1.) 13 The AORN recommended practice stresses the importance of planning to allow sufficient time to conduct in-house disassembly, decontamination, packaging and sterilization. That time is 24 hours. Loaner instruments need to be delivered to decontamination in SPD so these steps we just discussed are not eliminated. You do not want the wrapped instruments from another hospital going directly to patient use. You have no idea if they were processed correctly. Flash sterilization should not be used as a substitute for sufficient instrument inventory resulting from the late delivery of loaner instrumentation. And implantable devices should be monitored with a BI and a Class 5 integrating indicator and quarantined until the BI is negative.

14 Managing Loaner Instrumentation - Summary Facilities should develop and follow a Policy and Procedure to manage loaners Resources: Joint position paper created and adopted by ASHCSP and IAHCSMM AORN Recommended Practice for Sterilization in the Perioperative Practice Setting 2009 Managing Infection Control Journal in-service Loaner Instrumentation: Keeping Patient Safety First by Rose Seavey, April, 2007 Need adequate time to properly reprocess instrumentation: receive loaners at least by the evening before the procedure is scheduled Advantages to managing a loaner instrumentation include increased patient safety, less stress for all of you and lower costs 14

15 Role of Infection Preventionist CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Conduct infection control rounds periodically (e.g., annually) in high-risk reprocessing areas (e.g., the Gastroenterology Clinic, Central Processing); ensure reprocessing instructions are current and accurate and are correctly implemented. Document all deviations from policy. All stakeholders should identify what corrective actions will be implemented. Category 1B Pg 92, Quality Control, 19c. 15 Explore the opportunity of running a biological indicator in every load to provide the same standard of care to each patient.

16 Role of Infection Preventionist Managing Loaner Instrumentation Assist in developing policy based on AORN and AAMI recommended practices Assist in communicating policy to physicians and vendors Audit for compliance to established policy If policy is not followed assist in identifying barriers and collaborate on potential solutions 16

17 HOT TOPIC Do you know if you are running the correct sterilization cycles for the medical devices you are processing? 17 I think the most critical issue related to safely processing instruments is do you know if you are running the correct sterilization cycle for the medical devices you are processing? A standard 4 minute dynamic-air-removal (which includes prevacuum and steam flush pressure pulse sterilizers) may not be a long enough cycle to effectively process all medical devices. 17

18 Extended Steam Sterilization Cycle HOT TOPIC Cycles recommended by the Medical Device manufacture that are longer than the minimum sterilizer manufacturer FDA cleared cycles 18 And if you are not running the cycles recommended by the medical device manufacture the instruments are probably not sterile and the patient may get an infection. If you are not running the correct cycle the instruments may not be sterile and the patient may get an infection. 18

19 Joint Commission Statement on Flash Sterilization During survey will ask for up to date manufacturers instructions for use. All visible soil must be removed Sterilization must meet parameters (time, temperature, pressure) specified by manufacturer of sterilizer wrapping and instrument 19 In addition the Joint Commission surveyor is starting to ask to see your cleaning and sterilization instructions for use for medical devices to ensure you are properly cleaning and sterilizing those instruments. 19

20 Sterilization Process Obtain new instructions for use for all medical devices being processed Cleaning and packaging instructions Type of wrapper to use Can the instruments be placed inside a rigid container or do they need to be sterilized in the original container? Can I add more instruments to the tray or remove instruments? Where to place BIs and CIs in trays/containers (greatest challenge for air removal and steam penetration)? Sterilization methods Can I use flash sterilization? Sterilization cycles What is the most challenging tray in a family of products that I can use as my master tray for product testing? 20 A primary goal is to obtain new instructions for use for all medical devices being processed, especially the complex trays you own or are on loan. You need to obtain information on cleaning and packaging such as -what type of wrapper can be use -can I remove the instruments from the original tray and place inside of a rigid container? -can I add or take away more instruments fro the set Where can I place BIs and CIs in the trays/containers for routine for product testing that is the greatest challenge for air removal and steam penetration? What sterilization methods can I use? Flash? What are the sterilization parameters which should include type of air removal, time, temperature and dry time. Also ask what is the most challenging tray in each family of products that you can used ad the master product for product testing.

21 Sterilization Process Managing variety of steam sterilization exposure times Audit for compliance Impact of department throughput 21 And above all follow the MDMs instructions for use. Managing the variety of steam sterilization exposures can have an impact on throughput. Some people dedicate one sterilizer to running extended cycles. It s a good idea to audit for compliance to be sure staff are running trays with the appropriate cycle times.

22 Monitoring of Extended Cycles 22 No BI PCDs for monitoring extended cycles Perform product testing BIs and CIs inside trays Include BI PCD in load Look for correlation Routinely monitor as would other loads Use same BIs, CIs & BI PCDs and read the physical monitors Since a PCD is not available for extended cycles then it is important to perform product testing after you receive the new instructions for use from the medical device manufacturer. Product testing does not need to be done on all loaner instruments but on a set that is considered to be the most challenging in a family of products. Work with your vendor to identify this master product from a family of products. This testing is done by placing BIs and CIs inside the trays and running your standard BI PCD in the load to look for a correlation of results. If the BIs are not killed inside the tray or in the BI PCD in the load then contact the medical device manufacturer to determine why this might be happening. Routinely monitor using the same BIs, CIs and PCDs as you do now.

23 Monitoring Extended Steam Sterilization Cycles Physical Monitors Mark with correct date and sterilizer identification at beginning of cycles Check the cycle printout to verify cycle parameters were met and initial If not correct, do not release 23 AAMI ST79:2006 A1:2008 A2: And review and initial the physical monitors to make sure the correct cycle was run. This is the first step to ensure the correct sterilization process parameters are run for the load. Physical monitors should be marked with the correct date and sterilizer identification at the begging of the cycle. Physical monitors should also be read and verified by initialing at end of cycle. If not correct, do not use load.

24 Role of Infection Preventionist Extended Cycles Audit Compliance to: Having and following updated MDMs package inserts Product testing on the most challenging set in the family (referred to as master product ) Reading and initialing physical monitors for all loads run in SPD and OR 24

25 SETTING THE RECORD STRAIGHT If a biological indicator (BI) is positive, only that load needs to be recalled False 25 Read the questions. CLICK to show the answer. 25

26 26 How To Do a Recall AAMI & AORN If determined to be an operator error e.g.,.. using incorrect sterilization cycle No recall, don t use load, determine reason for failure, correct and reprocess load If not operator error or don t know reason Recall all items processed since last negative BI and reprocess AORN:2009 RP for Sterilization XVI.c.1. AAMI ST79:2006 A1:2008 A2: Determine reason for failure, correct and retest sterilizer depending on reason for failure If you determine that the sterilization process failure for that load was a result of an operator error such as the result of choosing the incorrect cycle for the load, then you only recall or don t use that load. Then you determine the reason the failure, correct and reprocess the load. CLICK. If the reason for the sterilization process failure is not an identifiable human error for that load, then all items processed since the last negative BI should be considered unsterile, retrieved and reprocessed no matter what were the results of the Class 5 integrating indicator and other monitors used in some of those loads. Determine the reason for the failure, correct and retest depending on that reason.

27 How To Do a Recall AAMI & AORN Remove sterilizer from service and notify facility engineering Notify affected departments and physicians Identify problem, implement correction, retest sterilizer Document all work efforts 27 Other steps to take are listed in this slide.

28 BI Monitoring Frequency Some facilities are moving to a higher standard of patient care by monitoring every sterilization load with a biological indicator. 28 The disruption to patients, surgeons, ORs and SPD staff caused by a recall brings us to our next Continuous Quality Improvement topic: BI Monitoring Frequency. One trend we see across the country is facilities electing to practice the highest standard of care by monitoring every sterilization load with a biological indicator process challenge device. Would anyone who is doing every load BI monitoring please share with us how they reached that decision and the advantages.

29 BI Monitoring Frequency Why monitor every load? Universal standard of patient care Cost and impact of a recall To be certain all implants, including those in loaners, are appropriately monitored Ensure every type of sterilization cycle used is monitored Ensure every type of packaging used in flash sterilization is monitored Reduce risk and cost of healthcare-associated infections (HAIs) Reduces variability and the chance for errors Every Load Monitoring resources available at 3M.com/everyloadmonitoring 29 Different facilities have different motivations for making the switch but reasons we hear repeatedly include: (discuss slide) Using a biological indicator process challenge device (PCD) in every load, along with thorough decontamination of all devices and proper equipment maintenance, provides you with the highest probability of assurance that you re killing the bioburden on all items in the load. Since BIs measure the sterilization process directly, 3M considers running a BI PCD in every load to be the Gold Standard for patient safety and improved patient outcomes. Following Standards and standardizing on practices reduces variability and the chance for errors, and helps ensure that every load of instruments is sterile for every patient.

30 Role of Infection Preventionist Recall Assist in developing a recall policy that meets the AAMI and AORN recommended practices Audit for compliance to policy - if a positive BI occurs, recall back to the last negative BI Explore the opportunity of monitoring every sterilization load with a biological indicator in all departments to provide the same standard of care to each patient 30 Explore the opportunity of running a biological indicator in every load to provide the same standard of care to each patient.

31 Routine Load Release Implants Physical monitors External process indicator (Class 1) on every package Internal CI (Class 3, 4 or 5) inside every package A PCD containing a BI and a Class 5 integrating indicator Evaluation of all data by an experienced, knowledgeable person Do not distribute load if any data suggests a sterilization process failure 31 AAMI ST79:2006 A1:2008 A2: Table 6 Here is how implant loads should be released. Discuss each bullet. Stress a PCD containing a BI and a Class 5 integrating indicator should be used in each load.

32 Only Biological Indicator Results Can Be Used to Release Implants The load should be quarantined until the results of the BI testing are available. (CDC, 2003a) Releasing implants before the BI results are known is unacceptable and should be the exception, not the rule. 32 AAMI ST79:2006 A1:2008 A2: The AAMI recommend practice states that loads containing implantables should be monitored with a biological indicator process challenge device and the load quarantined until the BI testing is available. Releasing implants before the BI results are known is unacceptable.

33 Routine Load Release Implant Loads BI PCD should contain a Class 5 integrating indicator used to release implant in emergency situations (10.6.1) Emergency situations should be defined. (10.6.3) 33 AAMI ST79:2006 A1:2008 A2:2009 The reason that BIs provide the greatest challenge to the sterilization process is because they contain spores. If you can kill the BI you are killing the bioburden on the items in the load. But since these CIass 5 integrating indicator do supply additional information, ST79 recommends that a Class 5 integrating indicator be used in the BI PCD for monitoring implant loads. This recommendations is made because the Class 5 integrating indicators provides additional information in emergency situations. For example, in a trauma situation, having an integrator in the PCD provides us with additional information used to make a decision to release the implant before the BI result is available. Emergency situations should be in your policies and procedures and developed by: -infection preventionist -the surgeon -and risk management What does your facility define as medical emergency situation?? Some facilities define this as loss of life or limb situation. AAMI ST79 goes on to say that steps should be taken to reduce the frequency of emergency release of implantable items. For example, ongoing periodic reviews of the exception forms and implant logs could reveal consistent patterns of events that are causing emergency release that could be corrected.

34 Early Release Implant Loads If documented medical exceptions dictate release of implant before BI result Use implant log and an exception form Critical that this documentation be fully traceable to the patient 34 AAMI ST79:2006 A1:2008 A2: , Annex L If it is not possible to quarantine the load until the biological indicator is negative because of a documented medical exception then all the other monitoring results should be read and recorded and an implant log and exception form used before the load is released. This should be the exception not the rule. This emergency situation must be traceable to the patient.

35 Early Release Implant Loads Exception Form for Premature Release of Implantable Device/Tray Name of implant Name of patient Name of surgeon Reason for premature release What could have prevented the premature release 35 AAMI ST79:2006 A1:2008 A2: , Annex L In Annex L of ST79 two forms are provided an implantable devices load record to document all implant loads and an exception form to document premature release of implants before the BI results are known. The name of the patient and implant are documented as well as the name of the surgeon, the reason the implant was released early, and what could have prevented the premature release. ST79 clearly states that premature release of implants should be the exception not the rule. In addition to filling out an implant log sheet an implant exception form should be filled out for each implant that is prematurely released. The form should include the information noted here, including a reason for the premature release and what could have prevented it.

36 Implant Loads Flash Cycles Flash sterilization should not be used for implantable devices except in cases of emergency when no other option is available. Photo courtesy of Rose Seavey, The Children's Hospital - Denver 36 AORN:2009 RP for Sterilization IV.a. AORN:2009 states that Flash sterilizer should not be used for implantable devices except in cases of emergency when no other option is available.

37 Implant Loads Flash Cycles In an emergency, when flash sterilization of an implant is unavoidable, a rapid-action BI and a Class 5 chemical integrating indicator (or enzyme-only indicator) should be run with the load. The implant should be quarantined on the back table and should not be released until the rapid-action BI provides a negative result. 37 AORN:2009 RP for Sterilization IV.h. and IV.h.1. AORN:2009 is even more stringent than AAMI ST79 when it comes to monitoring flash sterilization of loads containing implants. The recommended practices state that if flash sterilization of an implant is unavoidable due to an emergency, a rapid-action BI and a Class 5 CI should be run with the load. If the Class 5 CI does not reach its end point then the implant should be immediately reprocessed. If the Class 5 CI does reach its endpoint then the biological indicator (BI) can be incubated and the implant should be quarantined until the rapid-action BI result is negative.

38 Flash Sterilization AORN Documentation Log or data base to trace sterilized items used on patients should include: Information on each load Item(s) processed Patient receiving the item(s) Cycle parameters used (e.g., temperature, duration of cycle) Day and time cycle is run Operator information Reason for flash sterilization 38 AORN:2009 RP for Sterilization IV.i.1. AORN states that for flash loads: All the information listed on this slide needs to be part of the sterilization records for each load to track flashed items to each patient. AORN also recommends that the reason for flash sterilization be documented for each load and states that insufficient instrumentation is not an acceptable reason for flashing.

39 SETTING THE RECORD STRAIGHT A Class 5 Integrating Indicator can be used for routine release of implants NO 3M All Rights Reserved. Read the question. CLICK for the answer. 39

40 Role of Infection Preventionist Sterilization and Monitoring Implants Assist in developing implant monitoring policy based on AORN and AAMI recommended practices including emergency early release of implants Audit Compliance: BI PCD with Class 5 Integrating Indicator in every implant load Implants not released before a negative BI If defined emergency, release with a passed Class 5 Integrating Indicator and documented on the exception form No Flash sterilization of implants Documentation of flash sterilization loads - traceable to patient Explore the opportunity of running a BI in every load so an implant is never processed without a BI 40 Explore the opportunity of running a biological indicator in every load to provide the stame standard of care to each patient.

41 HOT TOPIC Can Class 6 Emulating Indicator PCDs replace the use of Biological Indicators? No 41 The hot topic is can Class 6 Emulating Indicator PCD replace the use of Biological Indicators? The answer is no and now I will tell you why. 41

42 Chemical Indicators Class 1 Process Indicators Class 2 Indicators for use in Specific Tests Class 3 Single Variable Indicators Class 4 Multi-variable Indicators Class 5 Integrating Indicators Class 6 Emulating Indicators 42 ANSI/AAMI/ISO , 2005 Sterilization of health care products-chemical indicators - Part 1: General requirements First lets look at the 6 classes of chemical indicators defined in ANSI/AAMI/ISO , 2005 standard for chemical indicators. It is important to make sure you are using chemical indicators that meet this new standard. The ANSI/AAMI/ISO document specifically states the class numbers have no hierarchical significance. The term No hierarchical significance means that an indicator with a higher number is not necessarily better than a indicator with a lower number; the numbers merely designate the type of indicator and when they were developed. You choose the class of CI based on the information you need.

43 Classes of Chemical Indicators Class 5: Integrating Indicators (Internal CIs) Designed to react to all the critical variables Response correlates to a BI 43 Class 6: Emulating Indicators Designed to react to all the critical variables Response does not correlate to a BI Cycle specific Not new technology 1996 Not widely used in Europe Next, lets compare Class 5 integrating indicators to Class 6 emulating indicators so you understand the difference. Class 5 integrating indicators are designed to measure all critical variables of the sterilization process and their performance is correlated to a BI. That is why they should be used in the BI PCD to monitor implant loads. Class 6 emulating indicators are designed to measure all critical variables of the sterilization process but there response is not correlated to a BI. Class 6 emulating indicators are cycle specific. Class 6 technology is not new. This class of indicator was defined in an ISO chemical indicator document in An example of a Class 6 emulating indicator is the indicator shown which was developed for France because the standard cycle they use is 18 minute prevacuum cycle to inactivate prions. This 3M indicator is not available in the US. Based on the information I have this indicator is really only used in France and some in Poland and not extensively across Europe.

44 OR Manager, Jan 2009 Vol 24, No 1 CDC sterilization, disinfection guideline William Rutala, PhD, MPH 44 44

45 Class 6 Chemical Indicators FDA Did FDA clear this product to release implants instead of waiting for the BI result? NO Information posted on In FDA letter posted on the sterile process website states: FDA cleared this device as a Chemical Indicator It is NOT a Biological Indicator and should not be used in place of a BI

46 Chemical Indicators Class 6: Emulating Indicators Usage is not covered in AORN 2009 or AAMI ST79:2006, A1:2008, A2:2009 recommended practices NOTE 1-This edition of ANSI/AAMI ST79 does not cover the use and application of Class 6 emulating indicators. (A2:2009) 46 Read slide.

47 Role of Infection Preventionist Using Class 6 Emulating Indicators to Replace the Use of Biological Indicators Assist in developing policy and procedures for the appropriate use of chemical and biological indicators based on AORN and AAMI recommended practices Audit for compliance to policy 47 Explore the opportunity of running a biological indicator in every load to provide the stame standard of care to each patient.

48 Comply to Recommended Practices BIs should be used To release implants which should be quarantined until the BI is negative For routine sterilizer efficacy monitoring For sterilizer qualification testing For product testing Class 5 integrating indicators Use as an Internal CI May be used to release non implant loads Should be in BI PCD for implant loads and only used to release the load in emergency situations 48 Read this slide which summarizes how BIs and Class 5 integrating indicators are to be used based on the existing AAMI and AORN recommended practices.

49 ANSI/AAMI ST79:2006 A1:2008 A2:2009 Section 10 Quality Control Four levels of testing Routine load release Testing of each non-implant and implant load Routine sterilizer efficacy monitoring Establishing a regular pattern of testing the efficacy of the sterilization process 49 Sterilizer qualification testing Periodic product testing Testing of the sterilizer after events occur which could affect the ability of the sterilizer to perform Testing of routinely processed items to ensure the effectiveness of the sterilization process and to avoid wet packs There are four different levels of testing required by AAMI.

50 Any Questions? 50

51 The Following Slides Provide More Information For You review Routine load release of nonimplants Routine sterilizer efficacy monitoring frequency recommendations for steam and low temperature sterilization Monitoring the minimum effective concentration (MEC) of high level disinfectants How to perform routine sterilizer efficacy monitoring and sterilizer qualification testing 51 51

52 Routine Load Release Nonimplants 52 Physical monitors External process indicator (Class 1) on every package Internal CI (Class 3, 4 or 5) inside every package Optional monitoring of load with a PCD containing a BI BI and a Class 5 Integrating Indicator Class 5 Integrating Indicator Evaluation of all data by an experienced, knowledgeable person Do not distribute load if any data suggests a sterilization process failure AAMI ST79:2006 A1:2008 A2: Table 6 For routine load release on nonimplants you need to use a variety of monitoring tools. These include: -physical monitors -an external CI on the outside of each package -an internal CI on the inside of each package -if desired, a PCD containing a BI or a BI and a Class 5 integrating indicator or a Class 5 integrating indicator The advantage of having a BI in the load is detection of a sterilization process failure sooner which reduces the risk of patient involvement. All the data must be evaluated by someone who is trained and competent. If any monitoring tool suggests that the sterilization process was a failure, the load should not be released for use. AAMI reminds us that load release should be an active decision.

53 Routine Sterilizer Efficacy Monitoring Frequency Recommendations AAMI ST79:2006 A1:2008 A2: Biological indicators should be used within PCDs for routine sterilizer efficacy monitoring at least weekly, but preferably every day that the sterilizer is in use. 53 AAMI states that a BI should routinely be used at least weekly, preferable every day the sterilizer is in use.

54 Routine BI Monitoring Frequency Low Temperature Sterilization 54 EO Every load Quarantine implants until BI results known (AAMI ST41: , AORN) Liquid Peracetic Acid Daily (AORN RP for Sterilization:2009 XVI.h.6.) Hydrogen Peroxide Gas Plasma Daily (MDM) Daily but preferably each load (AAMI ST58: , AORN) Quarantine implants until BI result known (AORN) Ozone Each Load (MDM) Daily but preferably each load (AAMI ST58: , AORN) MDM = Medical Device Manufacturer CLICK:For low temperature sterilization monitoring all the recommended practices state that every Ethylene Oxide load must be monitored with a BI and implants must be quarantined until the BI result is known. CLICK: For hydrogen peroxide gas plasma the manufacturer recommends monitoring daily. The AAMI Chemical sterilization and high level disinfection in health care facilities, ANSI/AAMI ST58, 2006 document states that this system should also be monitored at least daily, preferably in every sterilization cycle. CLICK: For the ozone sterilization systems, the manufacturer s recommendations are to run a biological indicator in each load as is done in ethylene oxide. AAMI has the same recommendation. The daily monitoring was met to be for table top chemi-clave sterilizers and the every load for the hydrogen peroxide gas plasma and ozone sterilization process. CLICK: AORN states that liquid peracetic acid sterilization processes should be monitored daily.

55 Monitoring the Minimum Effective Concentration (MEC) of High Level Disinfectants Test the solution before each use To ensure solution is at or above the MEC and still effective to use Manual or automated endoscope reprocessors AAMI ST58: The AAMI Chemical sterilization and high-level disinfection in health care facilities recommended practice document, ST58:2006, states that the minimum effective concentration of liquid chemicals should be monitored before each use. This monitoring recommendation if for both manual and automated procedures. This is to ensure that the solution is at or above the minimum effective concentration and is still effective to use.

56 Biological Indicators Positive BI Control Incubate a positive BI control each day a test vial is incubated in each incubator or auto-reader From same lot number as test BI Purpose is to validate the test system is working and ensure Correct incubation conditions Viability of spores Capability of medium to promote growth Proper functioning of auto-reader and incubator Good Science 56 With any BI test system, it is necessary to run a positive BI control to validate that the system is working. A positive control is a vial taken directly out of the box that is not processed so all the spores are still viable. The BI positive control should be from the same lot as the test vial. The AAMI ST79 document states to incubate a positive control each day a BI test vial is incubated. Running a daily positive control ensures that: -the correct incubation conditions occur -the organisms in the biological indicator are still viable -the medium can still promote rapid growth -the incubator temperature is correct. If you have no positive control result you have no idea what is happening and cannot depend on the test results. This is just good science.

57 Routine Sterilizer Efficacy Monitoring Sterilizer Qualification Testing Routine Efficacy Testing Establishing a regular pattern of testing the efficacy of the sterilization process Qualification Testing Testing of sterilizer after events occur that affect the ability of the sterilizer to perform Sterilizer installation Relocation Malfunction Major repairs of sterilizer or utilities) Sterilization process failures 57 AAMI ST79:2006 A1:2008 A2: AAMI ST79 defines sterilizer efficacy testing as the testing you do routinely to evaluate the effectiveness of the sterilization process. The AAMI ST79 states that sterilizer qualification testing is performed whenever an event occurs that may effect the performance of the sterilizer. These events include: -after it is installed -after relocation -after malfunctions -after major repairs of the sterilizer or utilities -and after sterilization process failures

58 Sterilizer Qualification Testing Major repairs of steam sterilizer Repairs outside the scope of normal maintenance Examples: Weld repairs of pressure vessel Replacement of chamber door or piping assembly Rebuilds or upgrades of controls Major repairs of utilities Changes to the utilities connected to the sterilizer Examples: Water-main break Annual boiler maintenance Additional equipment loads Installation of new boilers 58 AAMI ST79:2006 A1:2008 A2: For sterilizer qualification testing normal preventive maintenance such as rebuilding of solenoid valves, is not considered major repair. A major repair is defined as any repair outside the scope of normal maintenance such as -weld repairs of the pressure vessel -replacement of the chamber door or a major piping assemble -or rebuild or upgrades of controls You must receive a copy of sterilizer maintenance so you can determine if this testing is required Major repairs of utilities that require sterilizer qualification testing include: -water-main break -annual boiler maintenance -Additional equipment loads -Installation of new boilers You need to have your facility maintenance people inform you when these changes are made so that the testing can be completed.

59 Routine Sterilizer Efficacy Monitoring Sterilizer Qualification Testing Test each type of cycle with a BI PCD Gravity-displacement 132 C to 135 C 270 F to 275 F Gravity-displacement 121 C 250 F Dynamic-air-removal 132 C to 135 C 270 F to 275 F Flash 132 C to 135 C 270 F to 275 F Flash Single wrapper or other packaging 132 C to 135 C 270 F to 275 F 59 AAMI ST79:2006 A1:2008 A2: , The AAMI ST79 document says that if a sterilizer is designed and used for multiple types of cycles then each type of sterilization cycle should be tested because they each create a different challenge to the sterilization process.

60 Routine Sterilizer Efficacy Monitoring Sterilizer Qualification Testing AAMI ST79:2006 A1:2008 A2: , NOTE 2- If a sterilizer will run the same type of cycle (e.g., dynamic-air-removal at 132 C to 135 C [270 F to 275 F] for different exposure times (e.g., 4 minutes and 10 minutes), then only the shortest cycle time needs to be tested. 60 AAMI ST79:2006 and A1:2008 states that if you run a 270 F dynamic-air-removal sterilizer for 4 and 20 minutes then you only need to routinely test the 4 minute or shortest cycle. That is unless the cycle contains an implant.

61 Bowie-Dick Test Pack for F Dynamic-Air-Removal Steam Sterilizers Routine Efficacy Testing Run Bowie-Dick Test Pack: Daily in an empty cycle Before BI PCD One pack Qualification Testing Run Bowie-Dick Test Pack: After BI PCDs One pack in three consecutive cycles BD test sheet with uniform color change 61 AAMI ST79:2006 A1:2008 A2: For F dynamic-air-removal steam sterilizers, both routine efficacy and qualification testing includes the use of Bowie-Dick test packs. If you are flashing in a F dynamic-air-removal steam sterilizer you should run a BD test pack daily. Routine Monitoring In dynamic-air-removal sterilizers, a BD test pack is run daily in an empty load for routine sterilizer efficacy testing before the BI testing. Sterilizer Efficacy Monitoring For sterilizer qualification testing, one BD pack is run in three consecutive empty cycles after the BI testing. A uniform color change is needed for the sterilizer to be placed into use..

62 Sterilizers Larger than 2 Cubic Feet Routine Efficacy Testing BI PCD: AAMI 16 towel pack or commercially available disposable, FDA cleared BI PCD Full load on bottom shelf over drain Weekly, preferably daily Qualification Testing BI PCD: AAMI 16 towel pack or commercially available disposable, FDA cleared BI PCD Empty load on bottom shelf over drain Three consecutive cycles Follow with BD testing (empty load) Three consecutive cycles 62 AAMI ST79:2006 A1:2008 A2: For routine sterilizer efficacy testing for sterilizers greater than 2 cubic ft, the Process Challenge Device is the AAMI 16 towel pack or commercially available disposable, FDA cleared BI PCD. The PCD is placed in a FULL LOAD, on the bottom shelf, over the drain. And the recommended frequency is weekly preferably daily. Let s compare that to qualification testing, or the testing done after an event. For qualification of steam sterilizers, the same PCD used for routine testing is used. But the PCD is placed in an EMPTY chamber and you must run three consecutive cycles, each with a BI PCD, followed by three consecutive cycles with a BD Test Pack. This order is flipped from what you may have done in the past.

63 Table Top Sterilizers Routine Efficacy Testing BI PCD Representative of package or tray routinely processed and most difficult to sterilize Contain items normally present during routine sterilization Full load in cold point (check with sterilizer manufacturer) Weekly, preferably daily Qualification Testing BI PCD Representative of package or tray routinely processed and most difficult to sterilize Contain items normally present during routine sterilization Full load in cold point (check with sterilizer manufacturer) Three consecutive cycles 63 AAMI ST79:2006 A1:2008 A2: For routine sterilizer efficacy testing for table-top sterilizers the BI PCD should be representative of the most difficult package or tray to sterilizer and have the same contents. The BI PCD should be placed in the coldest spot recommended by the sterilizer manufacturer. The recommended frequency is weekly, preferably daily. Let s compare that to qualification testing, or the testing done after an event. For qualification of steam sterilizers, the same BI PCD used for routine testing is placed in a full load and run three consecutive cycles. A full load is used in a table-top sterilizer because that is the greatest challenge to the limited amount of steam available during the cycle.

64 64 Flash Sterilization Routine Efficacy Testing Representative BI PCD* using one or more BIs and one or more CIs Perforated, mesh bottom, open surgical tray Rigid sterilization container system Protective organizing case Single-wrapped surgical tray Test each type of tray configuration used AAMI ST79:2006 A1:2008 A2: Qualification Testing Representative BI PCD* using one or more BIs and one or more CIs Perforated, mesh bottom, open surgical tray Rigid sterilization container system Protective organizing case Single-wrapped surgical tray Select one representative tray * No commercial BI PCDs are available for flash sterilization For routine sterilizer efficacy testing of flash sterilization, place one or more BIs and CIs in all the tray configurations used. Place the BI PCD on the bottom shelf over the drain. Also use a Bowie-Dick test daily in dynamic-air-removal sterilizers even if you do not run wrapped packs. For sterilizer qualification testing of flash sterilization, place one or more BIs and CIs in one type of tray configurations used. Place the BI PCD on the bottom shelf over the drain. Repeat this testing in three consecutive empty cycles. In dynamic-air-removal sterilizers, then run a BD test in three consecutive empty cycles.

65 Flash Sterilization 65 Routine Efficacy Testing Representative BI PCD(s) Placed on bottom shelf over the drain Otherwise empty chamber Weekly, preferably daily After Bowie-Dick test if dynamic air-removal AAMI ST79:2006 A1:2008 A2: Qualification Testing Representative BI PCD Placed on bottom shelf over the drain Otherwise empty chamber Three consecutive cycles Before Bowie-Dick test if dynamic air-removal For routine sterilizer efficacy testing of flash sterilization, place one or more BIs and CIs in all the tray configurations used. Place the BI PCD on the bottom shelf over the drain. Also use a Bowie-Dick test daily in dynamic-air-removal sterilizers even if you do not run wrapped packs. For sterilizer qualification testing of flash sterilization, place one or more BIs and CIs in one type of tray configurations used. Place the BI PCD on the bottom shelf over the drain. Repeat this testing in three consecutive empty cycles. In dynamic-air-removal sterilizers, then run a BD test in three consecutive empty cycles.

66 Routine Sterilizer Efficacy Monitoring Sterilizer Qualification Testing Stream line the number of cycles and types of packaging used in flash sterilization to reduce the amount of routine sterilizer efficacy testing performed 66 There is an advantage to stream lining the number of cycles and types of packaging used in flash sterilization to reduce the amount of routine sterilizer efficacy testing performed. Running a BI in each load will ensue that all types of cycles and packaging used are routinely tested.

67 BI PCD Testing - Summary Type of Testing Sterilizers > 2 cu ft Table-Top Sterilizers Flash Sterilization Routine Efficacy Testing Full Load Full Load Empty Load Qualification Testing Empty Load 3 Cycles Full Load 3 Cycles Empty Load 3 Cycles 67 AAMI ST79:2006 A1:2008 A2: Remember that you need to due both the routine and qualification testing. Routine testing is a regular pattern of testing the efficacy of the sterilization process so testing is done in full loads, except in flash sterilizers. Qualification testing determines if the sterilizer is still working after an event takes place that could effect its ability to perform. This testing is done in empty loads, except for the table-top sterilizer.

68 Role of Infection Preventionist Routine and Qualification Testing Assist in developing policy and procedures for routine sterilizer efficacy testing and sterilizer qualification testing based on AORN and AAMI recommended practices Audit for Compliance with Policy Correct BI and PCD are run for the sterilization cycle being used Correct reading and interpretation of physical, external and internal CIs Incubation of positive control from the same lot each day a test vial is incubated Class 5 Integrating Indicator run inside each Flash sterilizer container or tray Routine testing of all types of cycles used in all sterilizers and all types of tray configurations used in Flash sterilization For sterilizer qualification testing of all types of cycles used in all sterilizers but only one type of tray configuration in Flash sterilizers 68 Read the slide.

69 References Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI/ISO Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ST79: 2006, A1:2008 and A2:2009. ANSI/AAMI/ISO Sterilization of health care products-chemical indicators-part 1: general requirements , 2005 Association of perioperative Registered Nurses (AORN) Recommended Practices for Sterilization in Perioperative Practice Setting, 2009 Practices for Selection and Use of Packaging Systems for Sterilization, 2009 Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, The references from AAMI that will be discussed in this presentation are listed on the slide.

70 How to Purchase AAMI Standards for Your Reference Library AAMI documents can be purchased through AAMI by credit card using the following four options: Internet: Call: Fax: Mail: AAMI Publications, P.O. Box 0211, Annapolis Junction, MD Or through AORN Bookstore 70

71 To order the new AAMI ST79 Amendments AAMI ST79:2006 with A1:2008 and A2:2009 Follow these instructions At Market Place News Click on AAMI ST79 Book Find it on list of products and add to shopping cart Download free product (ST79 Amendments 1-PDF) Print and save to your hard drive 71

72 How to Purchase AORN Standards for Your Reference Library AORN Standards can be purchased through AORN using the following options: Internet: Call: x 1 or x 1 (Monday-Friday, 8AM to 4:30PM mountain standard time) Fax: By mail: AORN, Inc., Customer Service/Book Orders, 2170 South Parker Road, Suite 300, Denver, CO , USA 72

73 Presenter Biography Mary Kundus, RN, BSN, MPH, CIC Mary Kundus is the supervisor of technical service for the 3M Infection Prevention Laboratory. She has over 17 years experience in infection control in the areas of acute care, ambulatory, long-term care and rehabilitation healthcare settings. Mary is certified in infection control and is an active member of the Association for Practitioners in Infection Control and Epidemiology (APIC). In addition she is a member of several AAMI working group committees that are developing recommended practices. 73

74 Presenter Biography 74 Martha Young, BS, MS, CSPDT President of Martha L Young, LLC SAVVY Sterilization Solutions Martha Young has over twenty five years of experience in the area of sterilization and disinfection. Ms. Young lectures around the world and has numerous publications on infection prevention with an emphasis on improving the performance of the sterilization process. She recently retired after 31 years with 3M and has a consulting company for healthcare manufacturers and providers. She is a member of IAHCSMM, AORN (Professional/Practice Issues Chair for AORN specialty assembly for Sterile Processing Materials Management) and APIC and a certified Central Sterile Processing and Distribution Technician. She is a member of several AAMI working group committees that are developing recommended practices and the Special Technical Editor for the 3M sponsored inservice in Managing Infection Control. Ms. Young was named in 2007 by HPN as one of the 30 Pros to Know who are the most influential in Healthcare Sterile Processing.