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3M™ Attest™ Sterile U Web Meeting March 19, 2009Prepared March, 2009 by Dorothy Larson How Long Did they Go? Healthcare Facilities Share Flash Reduction Best Practices How Long Did They Go? Healthcare Facilities Share Flash Reduction Best Practices © 3M All Rights Reserved.
Welcome! Facilitator: Tammy Torbert, 3M Sterilization AssuranceSpeaker: Dorothy Larson, 3M Technical Service Panelist: Francis Zieman, 3M Technical Service Housekeeping: Questions; -Mute feature (*7=unmute; *6=mute) -“Chat” feature Technical difficulties CE Credits Post session follow-up For more information: © 3M All Rights Reserved.
Discussion Topics Define flash sterilizationDiscuss the Association of periOperative Registered Nurses (AORN) and the Association for the Advancement of Medical Instrumentation’s (AAMI’s) recommended practice on flash sterilization Discuss issues associated with flash sterilization Describe an effective quality assurance program for flash sterilization Discuss Flash Reduction Best Practices The Objectives for today are to: -Define what flash sterilization is; -Discuss the AORN and AAMI recommended practices on flash sterilization; -Discuss Issues associated with flash sterilization; -Describe an effective Quality Assurance program for flash sterilization; and -Discuss Flash Reduction Best Practices! © 3M All Rights Reserved.
Quality Control Recommended PracticesANSI/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 Recommended Practices for Selection and Use of Packaging Systems for Sterilization, 2009 Recommended Practices for Surgical Instruments and Powered Equipment, 2009 Information for today’s presentation is mainly from 2 sources documents. The ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, and 3 Recommended Practices published by the Association of periOperative Registered Nurses, or AORN. They are: the Recommended Practices for Sterilization in Perioperative Practice Setting, Recommended Practices for Selection and Use of Packaging Systems for Sterilization, and Recommended Practices for Surgical Instruments and Powered Equipment. © 3M All Rights Reserved.
AAMI and AORN AAMI Guidelines for the use, care and/or processing of medical device or system to ensure a device is used safely and effectively and its performance will be maintained AORN Standards and recommended practices serve as the basis for policies and procedures Promote safety and optimal outcomes for patients The AAMI and AORN guidelines are voluntary, unless if you live in the state of New Jersey they have adopted the AAMI Recommended Practice as their law. AAMI provides guidelines for the use, care, and/or processing of a medical device or system to ensure that a device is used safely and effectively, and that its performance will be maintained. AAMI also states that these guidelines are intended to be achievable. The AORN Standards and Recommended Practices serve as the basis for policies and procedures. The guidelines promote safety and optimal outcomes for patients. © 3M All Rights Reserved.
Flash Sterilization Process designed for the steam sterilization of patient care items for immediate use. So what is the definition of flash sterilization? It is the process designed for the steam sterilization of patient care items for immediate use. AAMI ST79 © 3M All Rights Reserved.
Flash Sterilization - HistoryReprocessing of dropped instruments mid-procedure Unwrapped, 270 deg. F. Gravity cycle only -No dry time High Temperature Sterilization Originally, flash sterilization was used to reprocess instruments that were dropped during the middle of a procedure. Those Items were processed using the unwrapped method in a 270 deg. F gravity cycle with no dry time. It was called “high temperature sterilization” because there were only 270 deg. F gravity sterilizers that were used in the OR. But then in the early 1990s, prevacuum sterilizers started to be sold into Operating Rooms as Flash sterilizers. AAMI ST79 © 3M All Rights Reserved.
Flash Sterilization - TodayHigh temperature ( °F/ °C) No dry time/ No storage Sterilization Process: - Gravity - Dynamic-air-removal Packaging expanded beyond mesh-bottom surgical tray Today Flash sterilization involves a high temperature, ranging from °F; with minimal, or no dry time. Thus, items cannot be stored for later use. Today, the sterilization process used may be either gravity or dynamic-air-removal cycles; and The type of packaging has expanded beyond using only perforated, mesh bottom, open surgical trays. Over the years, people have misused flash sterilizers, moving from the single dropped instrument to sterilizing entire instrument sets because of a lack of inventory and scheduling! Photo courtesy of Rose Seavey, The Children's Hospital - Denver AAMI ST79 © 3M All Rights Reserved.
Flash Sterilization - PackagingPerforated, mesh bottom, open surgical tray Rigid sterilization container system Protective organizing case Single-wrapped surgical tray As mentioned, the type of packaging has expanded beyond using only perforated, mesh-bottom, open surgical trays. Other packaging includes: -rigid sterilization container systems, -protective organizing cases, and -single-wrapped surgical trays. AAMI ST79 © 3M All Rights Reserved.
Flash Sterilization - PackagingAORN recommends the use of rigid sterilization containers Reduce risk of contamination during transport to point of use Ease of presentation to sterile field The AORN recommended practices for sterilization recommends the use of rigid sterilization containers that are specially designed and intended for flash sterilization cycles. The reason for this is to reduce the risk of contamination during transport of items to the point of use, and for the ease of presentation to the sterile field. The Recommended Practice also states that flash-sterilized items are to be used immediately and not stored for later use. AORN © 3M All Rights Reserved.
Types of Steam Sterilization ProcessesGravity Displacement Dynamic-Air-Removal by Prevaccuum Steam-flush pressure-pulse (SFPP) 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. AAMI ST79 © 3M All Rights Reserved.
Flash Sterilization Minimum Flash Cycle Times for Gravity Steam Sterilization Cycles Load Contents Temp Time(Min) Unwrapped nonporous items 270°F/132°C 275°F/135°C 3 Unwrapped nonporous & porous items in mixed load 10 This table shows the minimum load contents and times to process unwrapped nonporous items (e.g., instruments) and unwrapped non porous and porous items in a 270°F/132°C and 275°F/135°C, gravity displacement flash steam sterilizer as recommended in the AAMI ST79 recommended practice. As with all sterilization methods, the recommendations of the manufacturer of the sterilizer, packaging material, and the items being sterilized must be followed. AAMI ST79 © 3M All Rights Reserved.
Flash Sterilization Minimum Flash Cycle Times for Dynamic-Air-Removal Steam Sterilization Cycles Load Contents Temp Time(Min) Unwrapped nonporous items 270°F/132°C 275°F/135°C 3 Unwrapped nonporous & porous items in mixed load 4 This table shows the load contents and minimum times to process unwrapped nonporous items (e.g., instruments) and unwrapped non porous and porous items in a 270°F/132°C and 275°F/135°C, dynamic-air-removal flash steam sterilizer as recommended in AAMI ST79. As with all sterilization methods, the recommendations of the manufacturer of the sterilizer, packaging material, and the items being sterilized must be followed. 1. For wrapped items (i.e., rigid containers and containment devices), check with the manufacturer of the containers and instruments for sterilization process instructions. 2. If processing single wrapped trays in the express cycle, check with the sterilizer manufacturer for sterilization process instructions. 3. If processing lumens, check with the manufacturer of the instruments for sterilization process instructions. AAMI ST79 © 3M All Rights Reserved.
QUESTION: Review information in following table – is this a flash cycle?Sterilization Temperature 270 deg. F. Sterilization Time 4-minute exposure Sterilization Method Prevacuum Packaging Type Rigid Container Dry Time None Does the information contained in this table represent a flash sterilization cycle? The sterilization temperature is set at 270 deg. F., the exposure time is 4-minutes, the sterilization method chosen is prevacuum, the items are placed in a closed, rigid container, and there is no dry time. © 3M All Rights Reserved.
QUESTION: Review information in following table – is this a flash cycle?Sterilization Temperature 270 deg. F. Sterilization Time 4-minute exposure Sterilization Method Prevacuum Packaging Type Rigid Container Dry Time None ANSWER: YES! Remember, flash sterilization is the steam sterilization of patient care items for immediate use! As we discussed, flash sterilization involves high temperatures, such as 270 deg. F. The sterilization cyle can be either air removal method: gravity, or dynamic-air removal, such as pervacuum. When there is minimal, or no dry time the items cannot be stored for later use.. So the answer is YES, this is a flash sterilization cycle. Remember, flashing is the steam sterilization of patient care items for immediate use. © 3M All Rights Reserved.
ANSI/AAMI ST79 Section 10 Quality ControlFour 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 Testing of the sterilizer after events occur which could affect the ability of the sterilizer to perform Periodic product testing Testing of routinely processed items to ensure the effectiveness of the sterilization process and to avoid wet packs 1 2 3 There are 4 levels of testing as outlined in AAMI ST79, and we’ll cover how these levels apply specifically to flash sterilization. -The first level of testing is Routine Load Release, which is the testing of each non-implant and implant load; -There is Routine sterilizer efficacy monitoring, which is establishing a regular pattern of testing the efficacy of the sterilization process; -There is Sterilizer qualification testing, which is testing the sterilizer after events occur which could affect the ability of the sterilizer to perform; -And finally, Product testing, which is testing of routinely processed items to ensure the effectiveness of the sterilization process and to avoid wet packs. 4 © 3M All Rights Reserved.
Routine Load Release NonimplantsPhysical 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 To release non-implant loads, you will use physical monitors (such as the sterilizer gauges and tape printouts), external chemical indicators, and Internal chemical indicators. And if desired, you may use a process challenge device containing a BI, a BI along with a Class 5 Integrating Indicator, or a class 5 integrating indicator only. The data must be evaluated by someone who is trained and competent, and do not distribute the load if any data suggests a sterilization process failure. AAMI ST79 © 3M All Rights Reserved.
Routine Load Release ImplantsPhysical 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 For implant loads the release is similar to non-implant loads with one important exception. A Process challenge device containing a BI and a Class 5 integrating indicator should be used in each load. AAMI ST79 © 3M All Rights Reserved.
Sterilization Process Monitoring ToolsPhysical Monitors Chemical Indicators Biological Indicators Let’s take a brief look at the monitoring tools available for the routine load release of non-implant and implant loads. © 3M All Rights Reserved.
Physical Monitors Verify that parameters of sterilization cycle are met Recording charts Gauges Tape Printouts Digital displays Physical monitors verify that the parameters of the sterilization cycle have been met. Physical monitors are the charts, gauges and printouts on the equipment. Physical monitoring is needed to detect malfunctions as soon as possible, so that appropriate corrective actions can be taken. This is the first step in stopping usage of medical devices that may not be correctly processed. AORN & AAMI © 3M All Rights Reserved.
Class 1 Process Indicators ANSI/AAMI/ISO , Sterilization of health care products-Chemical indicators - Part 1: General requirements 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 AAMI ST79 defines CIs as: “Devices used to monitor the presence or attainment of one or more of the parameters required for a satisfactory sterilization process, or are used in specific tests of sterilization equipment.” There are six classes of chemical indicators based on the new 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. What this means is the class number is not as important as the information provided by the chemical indicators in that class. © 3M All Rights Reserved.
Chemical Indicators Class 1: Process IndicatorsUse with individual units to indicate that the unit has been directly exposed to the sterilization process Exposure Control (e.g., indicator tapes) Distinguish between processed and unprocessed units Designed to react to one or more of the critical process variables Class 1 Process Chemical Indicators are used for exposure control to identify processed from unprocessed medical devices. The recommended practices state that an external chemical indicator should be used inside each package unless the Internal chemical indicator is visible. If the external chemical indicator is not changed do not use the package. AAMI ST79 © 3M All Rights Reserved.
Chemical Indicators Class 2: Indicators for Specific TestsEquipment Control Testing sterilizer performance Bowie-Dick Test monitors efficacy of air removal and steam penetration in °F dynamic-air removal sterilizers (i.e., vacuum assisted sterilizers) Class 2 indicators are intended for use in specific test procedures as defined in relevant sterilizer/ sterilization standards. An example is the Bowie-Dick PCD, or test pack. AAMI ST79 © 3M All Rights Reserved.
Chemical Indicators Internal CIs – Class 3, 4, 5Tests conditions inside individual packs Internal chemical indicator inside each package Use inside each pack, wrapped tray, flash tray or container in area least accessible to sterilant – identifies sterilant penetrated Pack control tests the conditions inside individual packs by using internal Chemical Indicators. AAMI ST79 suggests using Class 4 or Class 5 integrating Chemical Indicators inside each pack, wrapped tray, flash tray or container in the area least accessible to sterilant. Using an internal CI is the only way to determine if sterilant has penetrated through the packaging. AORN & AAMI © 3M All Rights Reserved.
AORN Placement of internal chemical indicators AORNAORN provides very specific guidance on the placement of internal chemical indicators. AAMI ST79 suggest using a Class 4 or 5 CI because these classes provide the most information than a Class 3. Using an internal chemical indicator is the only way to determine if sterilant has penetrated through the packaging. AORN © 3M All Rights Reserved.
Chemical Indicator PlacementRigid container Place two CIs inside rigid containers Place one in each of two opposite corners For rigid containers, the greatest challenge to air removal and steam penetration is the corners of the container. Place a chemical indicator inside the rigid container in opposite corners, so there are two indicators inside on this level. AORN © 3M All Rights Reserved.
Chemical Indicator PlacementMulti-layer container Place two CIs in each level of multi-level rigid container Place one in each of two opposite corners on each level For multi-layer containers, place two chemical indicators in each level of a multi-level rigid container. If more than one layer, place a chemical indicator in each of two opposite corners on each level. AORN © 3M All Rights Reserved.
Chemical Indicator PlacementMulti-level container Supplied by the manufacturer, holes in tray, has to be wrapped Place a CI in center on each level When monitoring a container system supplied by the medical device manufacturer that has multiple levels, AORN recommends placing one chemical indicator in the center of each level. Each level creates a different challenge to air removal and steam penetration, especially when there are different types of boxes and containment devices on each level. AORN © 3M All Rights Reserved.
Chemical Indicator PlacementWrapped instrument trays Place CI in geometric center, not on the top For Wrapped Fabric Packs and Wrapped Instrument Trays, place a chemical indicator in the geometric center rather than laying the indicator on the top. AORN © 3M All Rights Reserved.
Routine Load Release Nonimplants – Flash SterilizationClass 5 Integrating Indicator PCD for releasing flash loads PCD must be representative of load Open surgical tray Rigid sterilization container Protective organization case Single-wrapped surgical tray Class 5 Integrating Indicator also serves as internal CI As I mentioned earlier, one of the release criteria options for non-implant loads is monitoring with the Class 5 integrating indicator challenge pack. The Process Challenge device should be representative of the load. Remember that the Class 5 integrating indicator in an appropriate challenge test pack can service as the internal chemical indicator and to release loads not containing implants. For example, when flashing you may be placing the Class 5 integrator inside the rigid container, or in an unwrapped tray that you’re sterilizing. AAMI ST79 © 3M All Rights Reserved.
Biological IndicatorsDefinition Test system containing viable microorganisms providing a defined resistance to a specified sterilization process Biological Indicators are used for load release. A Biological indicator is a test system containing viable microorganisms providing a defined resistance to a specified sterilization process. AAMI ST79 © 3M All Rights Reserved.
3M™ Attest™ Rapid Readout Biological Indicators - Flash Cycles1292, Brown Cap BI 270°F/132°C, dynamic-air-removal 1291, Blue Cap BI 270°F/132°C, gravity This slide shows the Attest rapid readout biological indicators and lists the cycles each product is designed for. Note the blue cap BI in is for 270 deg. F. gravity cycles and the brown cap BI is for 270 deg. F dynamic-air-removal cycles. The results are read in a 3M™ Attest™ Auto-reader/incubator, © 3M All Rights Reserved.
Biological Indicators AAMI ST79AAMI and AORN - Weekly, preferably daily and implants AAMI ST79: If a sterilizer is designed and used for multiple types of cycles, each type of sterilization cycle should be tested because they each create a different challenge to the sterilization process AAMI ST79 & AORN © 3M All Rights Reserved.
Routine Load Release Implant Loads“Emergency situations should be defined” Emergency situations should be in your policies and procedures and developed by: -infection prevention and control, the surgeon, and risk management. 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.” AAMI ST79 © 3M All Rights Reserved.
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.” If the decision is made to flash an implant in an emergency situation, the AORN 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. This recommendations is made because the Class 5 integrating indicator provides additional information in emergency situations 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. The term “Rapid-action biological indicator” is the generic term used for 3M™ Attest ™ Rapid Readout Biological Indicators. ---- 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. AORN © 3M All Rights Reserved.
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.” (section ) This is because biological indicators 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 biological indicators, therefore, routine sterilizer efficacy monitoring in health care facilities should also be conducted using BIs. AAMI ST79 © 3M All Rights Reserved.
“Documentation establishes accountability.”Record Keeping “Documentation establishes accountability.” AORN Sterilization Recommended Practice This is a great quote from AORN. Record keeping documents the materials that have been processed and the results of the sterilization process monitoring. This monitoring uses load labels on each package, paper or electronic log systems or individual filing of documents. A record keeping system is needed to identify packs that need to be recalled because of a sterilization process failure or an expired shelf life date and for determining the reason for sterilization process failures. AORN © 3M All Rights Reserved.
Implant Loads - Flash Cycles“Flash sterilization should not be used for implantable devices except in cases of emergency when no other option is available.” AORN has very stringent guidelines 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. Photo courtesy of Rose Seavey, The Children's Hospital - Denver AORN © 3M All Rights Reserved.
Flash Sterilization - AORN DocumentationLog 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 AORN states for flash loads that there be a Log or Database to trace sterilized items used on patients. The log should include the following information about each load: -the item(s) processed -the patient receiving the item(s) -cycle parameters used (for example, temperature and duration of the cycle) -the day and time the cycle is run -operator Information, and -the reason for flash sterilization. AORN states that insufficient instrumentation is not an acceptable reason for flashing. This information should be part of the sterilization records for each load to track flashed items to each patient. AORN © 3M All Rights Reserved.
Routine Sterilizer Efficacy Monitoring Sterilizer Qualification TestingRoutine 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 Now we’ll briefly review Sterilizer efficacy testing, which is the testing you do routinely to evaluate the effectiveness of the sterilization process. And sterilizer Qualification testing, which is performed whenever an event occurs that may effect the performance of the sterilizer. These sterilizer events include, -Sterilizer installation, -After sterilizer relocation, -After malfunction -After major repairs of steirlizr or utilities, and After sterilization process failures. AAMI ST79 © 3M All Rights Reserved.
Flash sterilization cyclesRoutine Efficacy Testing: 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 Test each type of tray configuration – Must always test the open surgical tray configuration Select one representative tray Place on bottom shelf over the drain in otherwise empty chamber Weekly, preferably daily Three consecutive cycles After Bowie-Dick test if dynamic air-removal Before Bowie-Dick test if dynamic air-removal Now let’s compare differences in Routine Sterilizer Efficacy Testing to when you’re doing Qualification Testing For routine efficacy testing, place the biological indicator and Chemical indicators in all the tray configurations that are routinely used. You must also always test the open surgical tray configuration. Place the biological indicator process challenge device on the bottom shelf over the drain. And run a Bowie-Dick test daily in dynamic-air-removal sterilizers (even if you do not run wrapped packs). For sterilizer qualification testing, place the biological indicator and chemical indicators in only one type of tray configuration used. Place the BI PCD on the bottom shelf over the drain. Repeat this testing in three consecutive empty cycles. Note that when doing qualification testing In dynamic-air-removal sterilizers you will run the BD test in three consecutive empty cycles before running the BI PCD. © 3M All Rights Reserved.
Process Challenge Device (PCD) Definition“Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process.” 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 A process challenge device is an item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process. 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. AAMI ST79 © 3M All Rights Reserved.
Process Challenge Device (PCD)User assembled Challenge test pack or tray ( e.g., flash tray) *Note there are no commercially available – FDA Cleared PCDs available for flash sterilization Note that there are no commercially available, FDA-cleared process challenge devices available for flash sterilization. The process challenge device for flash cycles would be a user-assembled challenge test pack or tray. For example, if you run everything unwrapped, then you would treat the biological and chemical indicator in the same manner and run unwrapped in a representative tray. AAMI ST79 © 3M All Rights Reserved.
Quality Assurance Program Sterilization Process MonitoringMonitoring Tools Physical monitors Chemical indicators Biological indicators Process challenge devices (PCDs) Test or challenge pack Results – Integrate results of all monitoring controls; determine if an effective sterilization process To summarize, we talked today about the various tools and how they each have their role in monitoring the steam sterilization process. An effective quality assurance monitoring program is comprised of Physical Monitors, Chemical Indicators, and Biological Indicators. It is important to understand the value of the products you’re using, and 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. AAMI ST79 © 3M All Rights Reserved.
QUESTION: If a biological indicator (BI) is positive, do you only recall that load? When you have a biological indicator, do you only need to recall that load? © 3M All Rights Reserved.
QUESTION: If a BI is positive, do you only recall that load?ANSWER: If determined to be an operator error e.g.,.. using incorrect sterilization cycle No recall, don’t use load If not operator error or don’t know reason Recall all items processed since last negative BI Reprocess all retrieved items If you determine that the sterilization process failure for the load was a result of an operator error, such as the result of choosing the incorrect cycle for the load, then only reprocess that one load. If the reason for the sterilization process failure is not due to an identifiable human error, then all items processed in that sterilizer since the last load having a negative biological indicator should be considered unsterile, retrieved and reprocessed. © 3M All Rights Reserved.
Biological Indicator Monitoring FrequencyWhy monitor every load? Universal standard of patient care Reduces variability and chance for errors To be certain all implants, including those in loaners sets, are appropriately monitored To ensure all cycle types used are tested with a BI To ensure all types of packaging used in flash sterilization are tested with a BI To reduce the risk, cost, and impact of a recall To reduce the risk/cost of healthcare-associated infections (HIAs) Because of the concerns surrounding patient safety, and considering all the variables in your daily operations, many facilities have chosen to monitor every load with a biological indicator. Monitoring with a BI in every load: -provides a universal standard of patient care -reduces variability and the chance for errors -helps staff be certain that all implants, including those in loaner sets, are appropriately monitored -ensures that all cycle types used are tested with a BI -ensures all types of packaging used in flash sterilization are tested with a BI -reduces the risk, cost, and impact of a recall, and -reduces the risks and costs of healthcare-associated infections. © 3M All Rights Reserved.
The Joint Commission Organizational policies/procedures should be based on most stringent: Laws and regulations Accepted practice guidelines Current scientific knowledge And, are consistent throughout facility Finally, make sure your policies and procedures are up to date and reflect the laws and regulations, accepted practice guidelines, current scientific knowledge, and information from relevant literature and clinical standards so you are prepared for passing a survey by The Joint Commission. © 3M All Rights Reserved.
Issues Associated with Flash SterilizationTime Pressures skipped steps in cleaning/decontamination Flashing large and/or multiple trays increases cycle and cooling time Loaner Instrumentation The steam sterilization process has four phases that are significantly dependant on each other to produce and maintain a sterile product. The efficacy of saturated steam sterilization depends on: A reliable system for lowering and limiting bioburden before sterilization; Appropriately preparing devices for sterilization; Selecting the correct sterilization parameters; and Establishing and implementing controls to maintain the sterility of sterilized items until they are used. Items requiring flash sterilization are needed immediately and therefore, time pressures may cause staff to skip vital steps in the cleaning and other decontamination processes. Reduction of bioburden by efficient cleaning is a crucial step in preparation of devices for sterilization of any method. It has been well documented that when items are not properly cleaned they cannot be sterilized, therefore putting patients at risk. There are also risks involved to the worker if correct decontamination processes are not followed.(2) “Failures in instrument cleaning have resulted in transmission of infectious agents.”(1) Because of the risks involved to both patients and healthcare professionals, flash sterilization should not be used as an excuse for inadequate instrument inventory.(1) Attempting to clean instruments in a scrub sink or hand sink is not acceptable, and will contaminated the sink normally used for handwashing/scrubbing. Decontamination should always be done in a designated area, by personnel wearing appropriate personal protective equipment (PPE) with the appropriate cleaning agents, tools and water quality. Flash sterilization should be reserved for single items however, we know in the “real world” large instrument trays and multiple trays are being flashed. Flashing large and/or multiple trays results in increased challenges. The large metal mass increases the heat up time, which increases the total cycle time. The cooling time is also a factor. Many manufacturers’ instructions warn us not to cool instruments with sterile water because it could have an ill effect on the metal. Not waiting for the instruments to cool could cause burns to the patient. Flash sterilization should not be used as a substitute for sufficient instrument inventory resulting from the late delivery of loaner instrumentation.” Medical Device Manufacturer (MDM) - -Cycle selection -Instruments used for intraocular surgery need special characteristics of the instruments and sensitive nature of the eye and to avoid TASS. AAMI ST79 © 3M All Rights Reserved.
Loaner Instrumentation IssuesPatient Safety Timelines (flashing is not recommended) Communication (OR, SPD, Vendor) Quality MDM Reprocessing Guidelines Adequate time Implants Potential for lost items The Flash of Loaner Instrument issues to consider are extensive: Patient Safety Timelines (flashing is not recommended) Communication (OR, SPD, Vendor) Quality MDM written re-processing guidelines Adequate time to clean, inspect, inventory, wrap, sterilize, cool, document, and track large volume of loaner trays Implants: BI results before releasing Potential for lost items Frequently inadequate information provided by Medical Device manufacturer (e.g. reprocessing instructions, inventory of trays) Often complex instruments with which staff is unfamiliar. Heavy instruments: does loaner comply with AORN & AAMI 25 pound limit (including packaging) or container manufacturer’s pound restriction? Plastic trays – dry times © 3M All Rights Reserved.
Toxic Anterior Segment Syndrome - TASSThe Issue: serious damage to a patient’s intraocular tissue and vision loss as a result of contaminants in the eye during ophthalmic surgery Causes: contaminated irrigating fluids; antiseptics; antibiotic ointments; powder from surgical gloves “Most cases of TASS appear to result from inadequate instrument cleaning and sterilization” Nick Mamalis, MD, Toxic Anterior Segment Syndrome Journal of Cataract and Refractive Surgery 2006; 32: The Toxic Anterior Segment Syndrome, or TASS issue, has been studied by Dr. Mamalis (from Utah), for over 15 years. There have been periodic outbreaks of TASS that have been reported, and has led to the removal of such things as contaminated fluids and ointments from the marketplace. An ongoing concern to sterile processing professionals is the issue of improper, or ineffective, cleaning and sterilization. It reminds us that if an item is not clean you can not effectively sterilize it, although you may be running the proper cycle. So let’s look at these issues a little further. © 3M All Rights Reserved.
Toxic Anterior Segment Syndrome - TASSInadequate or inappropriate instrument cleaning “Detergents Heat stable endotoxin from overgrowth of gram-negative bacilli in water baths or ultrasonic cleaners Degradation of brass containing surgical instruments from plasma gas sterilization Impurities of autoclave steam” Recommended practices for cleaning and sterilizing intraocular surgical instruments, J Cataract Refract Surg, Vol 33, June 2007 © 3M All Rights Reserved.
AAMI ST Amendments - Annex N (informative) Toxic anterior segment syndrome (TASS) and the processing of surgical instruments Follow Mfr’s. cleaning and sterilization instructions Adequate inventory-time for processing Designated cleaning area and dedicated equipment Precleaned immediately Transport in closed containers PPE Appropriate cleaning agent & water of appropriate quality as specified by the Mfr. Sterilization according the Mfr’s. instructions Maintenance of cleaning and sterilization equipment, boilers and water filtration systems Training © 3M All Rights Reserved.
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! © 3M All Rights Reserved.
SHARING FLASH REDUCTION “BEST PRACTICES”2008 Quality Process Improvement Projects Improving case cart completeness Audit compliance w/ Policy and Procedure X Item traceability to the patient level Implement Loaner Policy Increase % of certified staff 2008 Quality Process Improvement Projects Improving case cart completeness Audit compliance w/ Policy and Procedure X Item traceability to the patient level Implement Loaner Policy Increase % of certified staff We wanted to allow plenty of time for you to ask questions about the information we just covered. I’ve asked my peer, Francis Zieman, to assist me. This will be informal, and remember that there is no such thing as a stupid question! Tammy: remind them for muting and unmuting. Would someone like to start by asking a question? © 3M All Rights Reserved.
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