In the Know about.appropriate Use of 3M Attest Rapid Readout Biological Indicators

Transcription

1 3M Attest Sterile U Web Meeting Jan 22, 2009 In the Know about.appropriate Use of 3M Attest Rapid Readout Biological Indicators ww.3m.com/atteststerileuonline 7/15 Modified per Inma s input. SDF Prepared Jan 09 by D. Larson In the Know about the Appropriate Use of 3M Attest Rapid Readout Biological Indicators.

2 Welcome Our Speaker: Dorothy Larson, 3M Technical Service Our Sponsor: 3M Attest Sterile U Network Housekeeping Questions Mute feature (*7 = unmute; *6 = mute) Chat feature Technical difficulties CE Credits Post session follow-up 2

3 Discussion Topics 1. Discuss Why Biological Indicators are Used 2. Discuss 3M Attest Rapid Readout Technology 3. Discuss how Biological Indicators are used for Monitoring the Steam Sterilization Process 4. Identify the Types of Steam Sterilization Processes 5. Discuss Load Control Monitoring 6. Questions 3 The Topics of Discussion are:

4 Biological Indicators Goal of Sterilization Process: To kill microorganisms You can t see sterility! 4 Why do we use biological indicators? The goal of the sterilization process is to kill microorganisms, and Sterile is defined as the absence of all living microorganisms. Since the sterile condition cannot be visually observed or inspected, biological indicators are used as a means of detecting whether or not sterility was achieved.

5 Biological Indicators BIs for testing the efficacy of a steam sterilization process, ever since when the first steam sterilizer was developed BIs are the only monitoring tool that Truly integrates all the parameters of sterilization Very sensitive at detecting lower temperatures as the result of air or steam quality problems 5 Spores were identified as the tool for testing the efficacy of a sterilization process when steam sterilizers were first developed in the late 1800s. Spores are very sensitive at detecting air or steam quality problems that result in lower temperatures inside the sterilizer chamber and/ or packs within the load. A biological indicator is the only indicator that truly integrates all the parameters of a sterilization process.

6 Biological Indicators AAMI ST79 Definition Test system containing viable microorganisms providing a defined resistance to a specified sterilization process 6 A Biological indicator is a test system containing viable microorganisms providing a defined resistance to a specified sterilization process.

7 Biological Indicators Formats... Spore Strips Spore Ampoules Self-contained Inoculated Carriers 7 There are several types of biological indicators available, but the most common type used in healthcare facilities are self-contained biological indicators.

8 Biological Indicators How they work... Spores are exposed to the sterilization process After processing, exposed spores immersed in optimized recovery media and incubated at optimal temperature Spore strips are transferred to medium using aseptic technique Self-contained designs allow immersion without transfer 8 So let s discuss how a biological indicator works! Spores are exposed to a sterilization process. After processing, the exposed spores are immersed in an optimized recovery media and incubated at optimal temperature. With spore strips, the strips are transferred to medium using aseptic technique. The self-contained design allows for immersion without transfer. After incubating, if the spores are viable, the result is a sterilization process failure.

9 Biological Indicators Performance Specifications ISO , (2006) Sterilization of health care products- Biological Indicators - Part 1: General ISO , (2006) Part 2: Biological indicators for ethylene oxide sterilization ISO , (2006) Part 3: Biological indicators for moist heat sterilization 9 And just as you follow AAMI, AORN, and other guidelines, we - as manufacturers - have our specific guidance documents to follow. For monitoring products, this slides lists the specific guidance documents that Manufacturers follow when developing biological indicators. Just like our standard Attest biological indicators, the 3M Attest rapid readout products comply with the performance requirements specified in these International documents. And, we re happy to share with you that we ve been 3 rd party certified by the British Standards Institute, which means they have reviewed our test methods and data. One thing the Standards specify is the minimum spore population, and d-value requirements, and this type of information is listed on the Quality Assurance Certificate that you receive with your Attest products.

10 Biological Indicators Using Biological Indicators AAMI ST79 Sterilizer manufacturers validate their sterilization cycles using BIs; therefore, routine sterilizer efficacy monitoring in health care facilities should also be conducted using BIs. Sterilizer manufacturers and medical device manufacturers find a cycle that kills spores then double the cycle and that is their minimum recommended sterilization cycle 10 Sterilizer manufacturers and medical device manufacturers use biological indicators to validate their cycles and products because biological indicators are the gold standard for monitoring the outcome of a sterilization process. That is why BIs are recommended by AAMI, AORN and CDC. And to validate a sterilization process, sterilizer manufacturer s place biological indicators in an AAMI 16 towel pack and in wrapped and unwrapped instrument trays. And then when they find a cycle that kills all the spores they double it and that becomes the minimum cycle that is recommended in their package inserts. Medical device manufacturers place spores inside of lumens and crevices, then find a cycle that kills all the spores then double it and that is the minimum cycle recommended in their package inserts.

11 Biological Indicators ANSI/AAMI ST Using biological indicators Rationale: The use of BIs provides evidence of efficacy by challenging the sterilizer with a large number of highly resistant bacterial spores. Biological monitoring provides the only direct measure of the lethality of a sterilization cycle. Sterilizer manufacturers validate their sterilization cycles using BIs; therefore, routine sterilizer efficacy monitoring in health care facilities should also be conducted using BIs. 11 AAMI states the following about the use of biological indicators. The use of BIs provides evidence of efficacy by challenging the sterilizer with a large number of highly resistant bacterial spores. Biological monitoring provides the only direct measure of the lethality of a sterilization cycle. Sterilizer manufacturers validate their sterilization cycles using BIs; therefore, routine sterilizer efficacy monitoring in health care facilities should also be conducted using BIs.

12 Biological Indicators 3M Attest Rapid Readout Biological Indicators - Enzyme-based early-readout (AAMI) - Rapid-action biological monitor/indicator (AORN) Fluorescence in 1 to 3 hours Visual color change in 24 to 48 hours for steam Conventional Biological Indicators Visual color change in 24 to 48 hours Manufacturer s incubation instructions should be followed AAMI ST79 Periodic verification of the early-readout with spore growth should be performed in accordance with the manufacturer s instructions and facility policy and procedures. 12 Now let s discuss the two types of biological indicators that are available. There are biological indicators with an enzyme-based early-readout, which is the 3M Attest Rapid Readout Biological Indicator, where results occurs in 1 or 3 hours for the steam BIs. With continued incubation of these BIs, a visual color change can be read in hrs when the surviving organisms grow out. The enzyme-based earlyreadout is a term used by AAMI. The term used by AORN is rapid-action biological monitor, or indicator. The other type of biological indicator is the standard, or conventional B.I. Conventional BIs can be incubated for a visual color change, which typically takes 24 to 48 hours for the surviving organisms to grow out. Both types of biological indicators contains spores. And always check with the manufacturer of the B.I. for appropriate incubation times and temperatures. Also, AAMI ST79 it states that Periodic verification of the early readout with spore growth should be performed in accordance with the manufacturers instructions and facility policy and procedures. This statement is referring to 3M Attest rapid readout biological indicators because of the wording early readout with spore growth. The period verification for Attest Rapid readout BIs is accomplished by incubating the Control BI for a visual ph colour change.

13 Biological Indicators Positive BI Control Incubate a positive BI Control each day a Test vial is incubated, and in each 3M Attest Auto-reader From same lot number as test BI Purpose: 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 13 We often receive inquiries about the proper use of a Control biological indicator, so let s review the purpose of running a Control BI. With any Biological Indicator test system, including the 3M Attest rapid readout biological indicator test system, it s 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, A control BI does not get processed, or sterilized, therefore all the spores are still viable. The BI positive control should be the same lot number as the Test, or Processed BI. AAMI ST79 states to incubate a positive control each day a B.I. test vial is incubated, and in each incubator that you re using. Running a daily positive control ensures: -you have the correct incubation temperature; -that the organisms in the biological indicator are viable, -that the medium can promote rapid growth, -and proper functioning of the 3M Attest Auto-reader. With Attest rapid readout biological indicators, you first need to have a fluorescent positive result. Then, after continued incubation, the Control BI will change visually from purple to yellow. If you do not have a fluorescent positive, then you cannot be assured that the BI Tests are valid. So running a control biological indicator is an important component of a biological indicator test system And, it s just good science!

14 Biological Indicators 14 Now let s take a couple of minutes to review the 3M Attest rapid readout biological indicator technology. To understand how it works you ll need to understand how the conventional, visual color change technology works. If spores survive the sterilization process they start to grow when they come in contact with the food containing medium. During this growth process a series of enzyme-catalyzed reactions occur and acid metabolites are produced which change the color of the medium to yellow. If all the spores survive, then the color change occurs quickly, typically within your standard 8-hour workshift. However, if only a few spores survive, it may take 24 to 48 hours for a yellow color change to occur. And the final incubation time is the time needed to ensure a negative biological indicator.

15 3M Attest Rapid Readout Biological Indicator Technology Non-fluorescent substrate Fluorescence Non-fluorescent substrate Substrate Active Enzyme Active Enzyme Active Enzyme Spore Spore Spore 15 The 3M Attest rapid readout technology detects the activity of a naturally occurring enzyme located in the spore and involved in spore growth and function. If the spore survives the sterilization process, the enzyme is active and reacts with a non-fluorescent substrate in the medium. This reaction results in the production of fluorescence and requires both incubation and a growth media. Basically the rapid readout technology measures the efficacy of the sterilization process earlier than the visual color change technology.

16 3M Attest 290 Auto-reader 16 This fluorescence is read in an auto-reader which is an incubator/fluorimeter combination. If the green light goes on, fluorescence was not produced indicating an acceptable sterilization process. If the red light goes on, fluorescence was produced indicating a sterilization process failure.

17 QUESTIONS 17

18 QUESTION: How often should you run a positive control? 18

19 ANSWER: How often should you run a positive control? -Each day that you use a Test BI, and -In each Auto-reader that you incubate a Test BI -If you change lot numbers 19 Of course the lot number must match the BI test. -Each day that you use a Test BI, and -In for every Auto-reader that you incubate a Test BI -And if you change lot numbers, remember to incubate a new control to match the Test BI lot number.

20 Use of Sterilization Process Monitoring Tools Quality control recommended practices ANSI/AAMI Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ST79:2006/A1:2008 AORN Recommended Practices for Sterilization in Perioperative Practice Setting (2008) AORN Recommended Practices for Selection and Use of Packaging Systems for Sterilization (2008) 20 Information about the use of the sterilization process monitoring tools is provided in the ANSI/AAMI Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ST79:2008, and AORN Recommended Practices for Sterilization in Perioperative Practice Setting (2008), and AORN Recommended Practices for Selection and Use of Packaging Systems for Sterilization (2008).

21 Sterilization Process Monitoring Monitoring Tools Physical monitors Chemical indicators Biological indicators Process challenge devices (PCDs) Test or challenge pack 21 It s important to point out that there are several steam sterilization process monitoring devices. These are the Physical Monitors, Chemical Indicators, and Biological Indicators. All of these monitoring tools have their advantages, and their limitations; and together they are used to make up a comprehensive quality assurance program.

22 Sterilization Process Monitoring Each monitoring tool plays a distinct and specific role in sterilization process monitoring, and each is indispensable to sterility assurance. Results Integrate results of all monitoring controls Determine if an effective sterilization process 22 The results of the monitoring tools are used to determine whether or not the sterilization process is effective and if the medical devices are safe for patient use. Today we re talking mainly about the use of Attest Rapid Readout Biological Indicators.

23 ANSI/AAMI ST79 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 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 23 3M Attest Rapid Readout Biological Indicators may be used for the 4 levels of testing as outlined in AAMI ST79: implant load; -for Routine Load Release, which is the testing of each non-implant and -for routine sterilizer efficacy monitoring, which is establishing a regular pattern of testing the efficacy of the sterilization process; -for sterilizer qualification testing, which is testing the sterilizer after events occur which could affect the ability of the sterilizer to perform; -and for product testing, which is testing of routinely processed items to ensure the effectiveness of the sterilization process and to avoid wet packs.

24 Routine Load Release Nonimplants 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 CI 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 24 For routine load release of non-implant loads, in addition to the physical monitors, and chemical indicators; -if desired, you may use a PCD containing a BI, a BI along with a Class 5 CI, or a class 5 integrating indicator. The data must be evaluated by someone who is trained and competent.

25 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 25 For routine load release of implant loads the release is similar to non-implant loads with one very important exception. A Process challenge device containing a BI and a Class 5 integrating indicator should be used in each load.

26 What is an Implant? Implant/implantable device According to FDA, device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. FDA may, in order to protect public health, determine that devices placed in subjects for shorter periods are also implants. 21 CFR 812.3(d) 26 ANSI/AAMI ST79 Let s define what an implantable device is. According to the FDA, an implant is a device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. FDA may, in order to protect public health, determine that devices placed in subjects for shorter periods are also implants.

27 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. 27 AAMI ST79 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. With Attest rapid readout biological indicators, you have results in as early as one or three hours for steam.

28 Routine Load Release Implant Loads Biological monitoring provides the only direct measure of the lethality of a sterilization cycle. BI PCD should contain a Class 5 integrating indicator Class 5 integrating indicator used to release implant in emergency situations Emergency situations should be defined 28 AAMI ST79 AAMI states that biological monitoring provides the only direct measure of the lethality of a sterilization cycle. The reason that BIs provide the greatest challenge to the sterilization process is because they contain spores, and if you can kill the BI you are killing the bioburden on the items in the load. But since Class 5 integrating indicators supply additional information, AAMI recommends that a Class 5 integrating indicator or an enzyme-only indicator be used in the biological indicator process challenge device for monitoring implant loads. This recommendations is made because the Class 5 integrating indicator provides additional information in emergency situations. For example, in a trauma situation, having an integrator in the process challenge device provides us with additional information used to make a decision to release the implant before the BI result is available. Note that the picture on this slide shows the 3M Attest Rapid 5 Steam-Plus Test pack, which is used to monitor the 270 deg F. prevac cycle, or the cycle you commonly refer to as your terminal loads. This product contains a biological indicator that has a 3-hour result, and a class 5 integrating indicator.

29 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 29 AORN:2008 AORN:2008 is even more stringent than AAMI ST79 when it comes to flash sterilization of loads containing implants. The AORN recommended practices are clear that implantable items should not be flash sterilized except in cases of emergency when other options are not available.

30 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. 30 AORN:2008 If the decision is made to flash an implant in an emergency situation, the AORN:2008 monitoring recommendations are similar to those in AAMI ST79. 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 chemical integrating indicator, 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 reaches its endpoint then the biological indicator can be incubated and the implant should be quarantined until the rapid-action BI result is negative. Again, the term Rapid-action biological indicator is the generic term used for 3M Attest Rapid Readout Biological Indicators.

31 QUESTIONS 31

32 Process Challenge Device (PCD) Definition Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process. process challenge device is used in place of test or challenge pack in AAMI ST79 Representative of load and creates the greatest challenge Equal to or greater than the most difficult item to sterilize Placed in most difficult area in sterilizer for the sterilant to penetrate 32 And just to review, the term PCD is another word for test packs or challenge packs. A PCD is a process challenge device. Whenever you challenge a sterilization process you use a process challenge device that is representative of the load and that provides the greatest challenge to the load. The PCD should be placed in the most difficult area in the sterilizer for the sterilant to penetrate.

33 Routine Load Release Nonimplants Class 5 Integrating Indicator PCD May be Used 33 On the left is an example of a Class 5 integrating indicator PCD that is not representative of the load. It is in a peel pouch and is hanging from the cart. The example on the right is a more appropriate representation for the load contents. It is a disposable test pack and is placed in the most challenging location on the bottom shelf over the drain.

34 Process Challenge Device (PCD) Depending on the application (type of testing being done) the PCD may contain 34 A Process challenge device may contain a biological indicator, a biological indicator with a class 5 integrating indicator, or a class 5 integrating indicator only. The Process challenge device you use will depend on the type of testing being performed.

35 Process Challenge Device (PCD) User assembled Challenge test pack or tray (e.g., AAMI 16-towel pack, flash tray) Commercially available FDA Cleared PCD Not available for flash sterilization 35 The process challenge device may be a user-assembled challenge test pack or tray or a test tray??? These user-assembled PCDs would include an AAMI 16-towel pack, or a test tray for flash cycles. Or the PCD could be a commercially available PCD. For example: A flash cycle is an example of where you would make your own PCD. Say you run everything unwrapped, then you would treat the BI and CI in the same manner and run unwrapped in a representative tray. 1) Loads that are processed in a large hospital steam sterilizer usually consist of mixed loads of wrapped sets, towel packs, and large closed, or rigid, containers. So for a mixed load of goods you might chose to use a commercially available FDA cleared PCD. 2) In a small table top, or counter top, steam sterilizer, quite often loads only consist of all peel pouches, so in that case placing a BI inside of a peel pouch is providing a challenge equivalent to the items being processed in the load.

36 QUESTIONS 36

37 Do You Know What Steam Sterilization Processes You Are Using? That is the first step for effective monitoring of the steam sterilization process 37 Do you know the steam sterilization processes you re using? The first step is to obtain the medical device manufacturers instructions for use. In order to know which 3M Attest rapid readout biological indicator to use, you first need to know the types of steam sterilization processes being used.

38 Types of Steam Sterilization Processes Gravity Displacement Dynamic-Air-Removal by Prevaccuum Steam-flush pressure-pulse (SFPP) 38 Two types of steam sterilization processes are used: Gravity Displacement and Dynamic- Air-Removal. The difference between the two is the method by which air is removed from the chamber. In gravity displacement sterilizers incoming steam displaces the air through a drain near the bottom of the sterilizer. In dynamic-air-removal cycles, air is actively removed from the chamber and load by either a prevacuum, which is a series of pressure and vacuum excursions, or a steam-flush pressure-pulse process which is a series of steam flushes and pressure pulses above atmospheric pressure.

39 Gravity Displacement Cycle Come-up Phase Incoming steam displaces air through drain Steam Injection Air Open 39 In gravity displacement sterilizers incoming steam displaces the air through a drain near the bottom of the sterilizer. In a gravity displacement sterilizer the steam injected into the chamber displaces the air to the bottom of the chamber and out of the drain line. This is called the come-up phase of the sterilization cycle.

40 Gravity Displacement Cycle Exposure Phase Closed Closed 40 When the temperature sensor in the drain senses that the chamber has reached the pre-selected temperatures, the drain closes and steam is no longer injected and the exposure phase begins. If the temperature drops during the exposure phase, additional steam is injected.

41 Profile of a Gravity Displacement Cycle Vacuum Pressure Come-up-phase Sterilization Phase Set point (exposure temperature) Drying phase Time 41 Here is a graphic representation of what was just described. It shows the come-up phase, the sterilization phase and the drying phase.

42 Dynamic-Air-Removal Prevacuum Series of pressure and vacuum excursions Steam-flush pressure-pulse (SFPP) Series of steam flushes and pressure pulses above atmospheric pressure 42 In dynamic-air-removal cycles, air is actively removed from the chamber and load by either a prevacuum, which is a series of pressure and vacuum excursions, or a steam-flush pressure-pulse process, which is a series of steam flushes and pressure pulses above atmospheric pressure.

43 Prevacuum Cycle Come-up Phase Closed Open 43 Here is an example of a prevacuum dynamic-air-removal steam sterilization process. During the come-up-phase of the prevacuum cycle, air is mechanically removed by a vacuum system. Older systems use a single deep vacuum to remove the air. New systems use a combination of three or four air purges and steam injections. In a steam-flush pressure pulse sterilizer, which may not be as familiar to you, the air is removed by pulses of steam instead of a vacuum.

44 Prevacuum Cycle Exposure Phase Open Closed 44 The end result is that steam is injected into the closed chamber and the exposure phase of the sterilization cycle starts when the appropriate temperature is reached at the drain. So if you select a 270 deg. cycle the exposure phase begins when the temperature of 270 deg. is reached.

45 Profile of a Prevacuum Cycle Vacuum Pressure Come-up phase Sterilization Phase Set point (exposure Temp.) Drying phase Time 45 Here is a graphic representation of what was just described. It shows the come-up phase where all the vacuums and steam injections occur, the sterilization phase and the drying phase.

46 Flash Sterilization Photo courtesy of Rose Seavey, The Children's Hospital - Denver Process designed for the steam sterilization of patient care items for immediate use High temperature ( F/ C) Gravity or dynamic-airremoval No dry time No storage 46 AAMI ST79 Lets 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 270F gravity cycle. It was called high temperature sterilization and that s because there were only 270 degree F. gravity sterilizers used in the OR. In the early 1990 s, pre-vacuum sterilizers started to be sold into operating rooms as flash sterilizers. Over the years, people have misused flash sterilizers, moving from the single dropped instrument to entire instrument sets because of lack of inventory. Flash sterilization involves a high temperature from F. The flash process can use either gravity-displacement or dynamic-air-removal cycles. No dry time is used and items cannot be stored for later use.

47 Flash Sterilization Packaging includes Perforated, mesh bottom, open surgical tray Rigid sterilization container system Protective organizing case Single-wrapped surgical tray 47 AAMI ST79 The type of packaging has expanded beyond using perforated, mesh bottom, open surgical trays. Other packaging includes: -rigid sterilization container systems -protective organizing cases, and -single-wrapped surgical trays.

48 QUESTIONS 48

49 3M Attest Rapid Readout Biological Indicator Monitoring Products for Steam Sterilization F/132 C, gravity F/132 C, dynamic-air-removal; 250 F/121 C, gravity 1296/1296F PCD/test pack F/132 C, dynamic-air-removal, 4 min; F/121 C; gravity, 40 min 41382/41382F PCD/test pack F/132 C, dynamic-airremoval, 4 min; F/121 C, gravity, 30 min 49 This slide shows the 3M Attest rapid readout biological indicators and Process Challenge Devices available, And this slide also lists the cycles each product is designed for. Notice on the top left is the blue cap biological indicator. The ONLY cycle you will ever use the blue cap BI for is the 270 deg. F. gravity cycle. For All other cycles, such as 270 deg. F prevac, or 250 deg. F gravity, you will use the brown cap BI, either by itself if you re sterilizing items unwrapped or when making your own process challenge device; or in a commercially available FDA-cleared PCD, such as the Rapid 5 pack, which you see on the bottom right hand corner of the slide.

50 Table Top Steam Sterilizers 50 For those of you that have table top steam sterilizers, here are some examples. Common brands are Midmark, Ritter, Tuttnauer, Pelton and Crane, and Statim. Table top sterilizers are typically gravity displacement cycles. These sterilizers are not connected to a facility boiler, rather distilled water is added by the operator to an on-board reservoir in the sterilizer.

51 3M Attest Rapid Readout Biological Indicator Monitoring Products for Table Top Steam Sterilizers F/132 C, gravity F/132 C, gravity 3M Attest 290 Auto-reader 51 This slide shows the 3M Attest rapid readout biological indicators for table top steam sterilizers and the cycles they should be used in. Note that there are no commercially available pre-assembled Process Challenge Devices available for table top steam sterilizers, therefore, you will need to make up a representative process challenge device. For table-top sterilizers the Biological indicator process challenge device 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. Note that Tthe 290 Auto-reader can be configured for all blue cap, all brown cap, or half blue and half brown, as shown here.

52 SETTING THE RECORD STRAIGHT Can Class 5 Integrating Indicators, or Class 6 Emulating Indicators be used in place of biological indicators? 52 Another question I ve been asked is if Class 5 Integrating Indicators, or Class 6 Emulating Indicators can be used in place of Attest rapid biological indicators?

53 SETTING THE RECORD STRAIGHT 53 Can Class 5 Integrating Indicators, or Class 6 Emulating Indicators be used in place of biological indicators? No, per AAMI ST79, the usage of chemical indicators has not replaced the usage of biological indicators The answer is NO, per AAMI ST79, the usage of chemical indicators has not replaced the usage of biological indicators

54 Science of Sterilization Chemical Monitors Regardless of their design, chemical monitors cannot be used in lieu of biological indicators and instrumented measurement of temperature/pressure/time during the validation of a steam sterilization process. Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control, PDA Journal of Pharmaceutical Science and Technology, Vol. 61, No. S-1: The PDA Journal of Pharmaceutical Science and Technology states that Regardless of their design, chemical monitors cannot be used in lieu of biological indicators and instrumented measurement of temperature/pressure/time during the validation of a steam sterilization process.

55 CASE STUDY Positive Biological Indicators Don t Shoot the Messenger! 55 Let s talk about a practical application with the use of Attest rapid readout biological indicators.

56 Positive Biological Indicators Unfortunately, sometimes the first question asked is WHAT IS WRONG WITH THE BI? Purpose of a BI is to identify when microorganisms are not killed which is a sterilization process failure CASE STUDY 56 Sometimes, the first question asked is What is wrong with the BI? That question comes up because sometimes people don t understand the sterilization process, or how biological indicators work, or might not have the right tools to help investigate and solve the problem. Sometimes it s easier to blame the biological indicator than to solve the sterilization process failure. Remember: The purpose of a BI is to identify when microorganisms are not killed! You want to know that everything is going good, but you also need to know when there is a sterilization process failure.

57 When a BI is Doing Its Job CASE STUDY Large Hospital Repeated positive BIs Entire peel pouch trapped in sterilizer drain screen Took six days to discover Now check drain on every shift 57 There was a large hospital that had called for help troubleshooting positive Attest rapid readout biological indicators. They monitor about 80% of their loads with biological indicators due to their high volume of implants. They were getting sporadic positive fluorescent biological indicator results. After six days of investigating, an entire peel pouch was found trapped in the sterilizer drain screen. It was apparently difficult to see because it was so tightly pressed to the bottom of the screen. As you can imagine, a pouch in the drain screen would lead to incomplete air removal. After removing the pouch, they no longer had positive biological indicator results. They also realized they were using the incorrect BI PCD, as having a BI placed inside of a peel pouch was not representative of their routine load.

58 Positive Biological Indicators Don t Shoot the Messenger! CASE STUDY What changed or was different about the sterilization process that microorganisms were not killed? 58 Remember to ask the question What changed, or what was different about the sterilization process that microorganisms were not killed?

59 Biological Indicator Monitoring Frequency If a BI PCD is not used in each load Don t know if spores are killed Affects what you need to recall 59 If you don t use a biological indicator in each load you will not know if the spores are killed, and you could risk the potential of releasing unsterile loads for patient use. Not running a biological indicator in every load also affects what you need to recall.

60 Sterilizer Cycle Variation Expertise of cleaning/ prep/pack personnel Condition of sterilizer equipment Expertise of sterilizer operator Available Utilities Usage: The less frequent the sterilizer is used the greater chance that an unnoticed event could affect sterilization 60 There are several factors to consider when determining how often to monitor your sterilizer. There is cycle to cycle variability with The expertise of the cleaning/prep/pack personnel. The expertise of the sterilizer operator. The general condition of the sterilizer equipment, And the available utilities. And the less frequently the sterilizer is used, the greater chance that an unnoticed event could affect sterilization.

61 Biological Indicator Monitoring Frequency Some facilities are moving to a higher standard of patient care by monitoring every sterilization load with a biological indicator. 61 One trend we ve seen across the country are facilities choosing to practice the highest standard of care by monitoring every sterilization load with a biological indicator process challenge device. One of the main reasons for moving to this practice is to minimize the disruption to patients, surgeons, operating rooms and sterile processing staff, whenever a recall needs to be initiated.

62 Biological Indicator 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 sets, are appropriately monitored Reduce risk and cost of healthcare-associated infections (HAIs) 62 Different facilities have different motivations for monitoring with a BI in every load, but other reasons we hear repeatedly include: - Having Universal Standard of patient care: so every patient receives the same level of sterilization monitoring regardless of the procedure. - The Cost and impact of a recall: Increasing the frequency of monitoring loads with BI s will reduce the depth and impact associated with a recall. - To be certain all implants, including those in loaners, are appropriately monitored: Standardizing around ELM could reduce the potential for human oversight, and - To Reduce the Risk and cost of healthcare-associated infections (HAIs): To reduce the likelihood that unsterilized instruments would be the cause of hospital acquired Infections which id under greater scrutiny for reimbursement. - The Prevention and control of infections becomes more critical, and it s really all about patient safety! Using a biological indicator 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.

63 Biological Indicator Monitoring Frequency 4. Implement Change - Update policies and procedures - Train staff 1. Develop a recommended policy Calculate est cost of monitoring each load Calculate est cost of a recall 3. Submit Proposal to Infection Control Committee 2. Enlist the support of the Infection Control Practitioner 63 Every Load Monitoring resources available at 3M.com/everyloadmonitoring There are tools available to help conduct cost calculations. 1. When Implementing every load BI monitoring -Develop a recommended policy -Calculate estimated cost of monitoring each load -Calculate estimated cost of a recall And then Enlist the support of the Infection Control Practitioner. Submit the Proposal to the Infection Control Committee, And finally, Implement the change by Updating your Policies and Procedures and training the staff.

64 QUESTIONS 64 We wanted to allow plenty of time for you to ask questions about the information we just covered. I ve asked 2 of my peers, Martha Young, and Susan Flynn, to assist me. This will be informal, and remember that there is no such thing as a stupid question! Andrew to remind them for muting and unmuting. Would someone like to start by asking a question?

65 Effect of Extended Cycles on 3M Attest Rapid Readout Biological Indicators Do extended steam sterilization cycles affect 3M Attest Rapid Readout Biological Indicators? SCIENTIFIC RESEARCH 65 ANSWER: We ve been asked whether extended steam sterilization cycles have any affect on 3M Attest rapid readout biological indicators.

66 Effect of Extended Cycles on 3M Attest Rapid Readout Biological Indicators 66 Study Methodology Three lots of 3M Attest 1292 Rapid Readout Biological Indicators Test: media ampoules exposed to prevacuum extended cycle (134 C 20 min, 20 min dry time) Controls: BIs with media not exposed to extended cycle Test and control BIs evaluated using appropriate methodology Fluorescent results recorded after 3 hours of So an internal study was performed using: -3 lots of 3M Attest 1292 rapid readout biological indicators. -The Test (or processed) media ampoules were exposed to a pre-vacuum extended cycle at 134 deg. C. for 20 minutes, with a 20 minute dry time. -The Control, or unprocessed, biological indicators with media not exposed to extended cycles were also included in this study. -The Test and Control biological indicators were evaluated using appropriate methodology and -Fluorescent results were recorded after 3 hours of incubation; and the visual growth results were recorded at 48 hours and at 7 days.

67 Effect of Extended Cycles on 3M Attest Rapid Readout Biological Indicators Study Results No statistically significant difference in test results between BIs assembled with exposed (test) and unexposed (control) media ampoules The study demonstrates that the ampoulized media in the 3M Attest Rapid Readout Biological Indicator functions properly after exposure to extended cycle conditions 67 The results showed: -there was no statistical significant difference in test results between the biological indicators assembled with Test and Control media ampoules. -The study demonstrates that the ampoulized media in the 3M Attest rapid readout biological indicator functions properly after exposure to extended cycle conditions.

68 QUESTION: We ve been told that it is okay to stop using biological indicators - is that true? No. Per AAMI ST79:2006/A:2008, biological indicators are used for these 4 levels of testing - - routine load release (implant loads) - routine sterilizer efficacy monitoring - sterilizer qualification testing - product testing 68 Question: We ve heard that it is O.K. to stop using biological indicators; is that true? The answer is No. The AAMI ST79:2008 update provides the same information as was in the previous 2006 document, with regards to the use of biological indicators. Biological Indicators are used for the 4 levels of testing that we discussed earlier: - for routine load release - for routine sterilizer efficacy monitoring*, - for sterilizer qualification testing, and - for product testing. You run a BI PCD weekly, but preferably daily for routine sterilizer efficacy monitoring which, again, is establishing a regular pattern of testing the efficacy of the sterilization process. And for routine load release of implant loads, a BI PCD should be ran with every load containing an implant.

69 QUESTION: We ve been told that it is okay to stop using biological indicators - is that true? APIC 2008 Denver, Colorado Dr. William Rutala* No professional organization (e.g., AORN) has recommended the use of Class 6 emulating indicators as a substitute for biological indicators and there are no data the demonstrate that it mimics a BI at suboptimal sterilization times. Follow AORN and CDC recommendations for usage of BIs. * Slides available on his web site: disinfectionandsterilization.org Slide Presentations: APIC - June 2008, Disinfection and Sterilization: Current Issues and New Technologies by Dr. Rutala 69 In addition, Dr William Rutala presented at the APIC annual meeting in June of The exact quote from his slide is listed here. No professional organization (for example, AORN) has recommended the use of Class 6 emulating indicators as a substitute for biological indicators and there are no data that demonstrate it mimics a BI at suboptimal sterilization times. He went on to say that you need to follow recommended practices for monitoring which he lists in his slides on his website.

70 Thank You! Thank you. This concludes the formal part of the presentation, and now for the remainder of this hour we d like to hear from you!

71 References: ANSI/AAMI Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ST79:2006/A1:2008 AORN Recommended Practices for Sterilization in Perioperative Practice Setting (2009) AORN Recommended Practices for Selection and Use of Packaging Systems for Sterilization (2009) ANSI/AAMI/ISO , Sterilization of health care products-chemical indicators-part 1: general requirements, 2005 ISO , (2006) Part 2: Sterilization of health care products-biological Indicators Part 1: General ISO , (2006) Part 2: Biological indicators for ethylene oxide sterilization ISO , (2006) Part 3: Biological indicators for moist heat sterilization 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 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