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© 3M All Rights Reserved. 3M™ Attest™ Sterile U Web Meeting March 19, 2009 How Long Did They Go? Healthcare Facilities Share Flash Reduction Best Practices
2 © 3M All Rights Reserved. Welcome! Facilitator: Tammy Torbert, 3M Sterilization Assurance Speaker: 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:
3 © 3M All Rights Reserved. Discussion Topics 1.Define flash sterilization 2.Discuss the Association of periOperative Registered Nurses (AORN) and the Association for the Advancement of Medical Instrumentation’s (AAMI’s) recommended practice on flash sterilization 3.Discuss issues associated with flash sterilization 4.Describe an effective quality assurance program for flash sterilization 5.Discuss Flash Reduction Best Practices
4 © 3M All Rights Reserved. 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, 2009 – Recommended Practices for Selection and Use of Packaging Systems for Sterilization, 2009 – Recommended Practices for Surgical Instruments and Powered Equipment, 2009
5 © 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
6 © 3M All Rights Reserved. Flash Sterilization Process designed for the steam sterilization of patient care items for immediate use. AAMI ST79
7 © 3M All Rights Reserved. Flash Sterilization - History Reprocessing of dropped instruments mid-procedure Unwrapped, 270 deg. F. Gravity cycle only -No dry time High Temperature Sterilization AAMI ST79
8 © 3M All Rights Reserved. Flash Sterilization - Today High temperature ( °F/ °C) No dry time/ No storage Sterilization Process: - Gravity - Dynamic-air-removal Packaging expanded beyond mesh-bottom surgical tray AAMI ST79 Photo courtesy of Rose Seavey, The Children's Hospital - Denver
9 © 3M All Rights Reserved. Flash Sterilization - Packaging Perforated, mesh bottom, open surgical tray Rigid sterilization container system Protective organizing case Single-wrapped surgical tray AAMI ST79
10 © 3M All Rights Reserved. AORN recommends the use of rigid sterilization containers Reduce risk of contamination during transport to point of use Ease of presentation to sterile field AORN Flash Sterilization - Packaging
11 © 3M All Rights Reserved. Types of Steam Sterilization Processes Gravity Displacement Dynamic-Air-Removal by Prevaccuum Steam-flush pressure-pulse (SFPP) AAMI ST79
12 © 3M All Rights Reserved. Minimum Flash Cycle Times for Gravity Steam Sterilization Cycles Flash Sterilization Load ContentsTempTime(Min) Unwrapped nonporous items 270°F/132°C 275°F/135°C 3333 Unwrapped nonporous & porous items in mixed load 270°F/132°C 275°F/135°C 10 AAMI ST79
13 © 3M All Rights Reserved. Minimum Flash Cycle Times for Dynamic-Air-Removal Steam Sterilization Cycles Flash Sterilization Load ContentsTempTime(Min) Unwrapped nonporous items 270°F/132°C 275°F/135°C 3333 Unwrapped nonporous & porous items in mixed load 270°F/132°C 275°F/135°C 4343 AAMI ST79
14 © 3M All Rights Reserved. QUESTION: Review information in following table – is this a flash cycle? Sterilization Temperature270 deg. F. Sterilization Time4-minute exposure Sterilization MethodPrevacuum Packaging TypeRigid Container Dry TimeNone
15 © 3M All Rights Reserved. QUESTION: Review information in following table – is this a flash cycle? Sterilization Temperature270 deg. F. Sterilization Time4-minute exposure Sterilization MethodPrevacuum Packaging TypeRigid Container Dry TimeNone ANSWER: YES! Remember, flash sterilization is the steam sterilization of patient care items for immediate use!
16 © 3M All Rights Reserved. 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 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
17 © 3M All Rights Reserved. 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 AAMI ST79
18 © 3M All Rights Reserved. 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 AAMI ST79
19 © 3M All Rights Reserved. Sterilization Process Monitoring Tools Physical Monitors Chemical Indicators Biological Indicators
20 © 3M All Rights Reserved. Physical Monitors Verify that parameters of sterilization cycle are met Recording charts Gauges Tape Printouts Digital displays AORN & AAMI
21 © 3M All Rights Reserved. ANSI/AAMI/ISO , 2005 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
22 © 3M All Rights Reserved. Chemical Indicators Class 1: Process Indicators Use 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 AAMI ST79
23 © 3M All Rights Reserved. Chemical Indicators Class 2: Indicators for Specific Tests Equipment 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) AAMI ST79
24 © 3M All Rights Reserved. Chemical Indicators Internal CIs – Class 3, 4, 5 Tests 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 AORN & AAMI
25 © 3M All Rights Reserved. AORN Placement of internal chemical indicators AORN
26 © 3M All Rights Reserved. Chemical Indicator Placement Rigid container Place two CIs inside rigid containers Place one in each of two opposite corners AORN
27 © 3M All Rights Reserved. Chemical Indicator Placement Multi-layer container Place two CIs in each level of multi-level rigid container Place one in each of two opposite corners on each level AORN
28 © 3M All Rights Reserved. Chemical Indicator Placement Multi-level container Supplied by the manufacturer, holes in tray, has to be wrapped Place a CI in center on each level AORN
29 © 3M All Rights Reserved. Chemical Indicator Placement Wrapped instrument trays Place CI in geometric center, not on the top AORN
30 © 3M All Rights Reserved. Routine Load Release Nonimplants – Flash Sterilization Class 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 AAMI ST79
31 © 3M All Rights Reserved. Biological Indicators Definition Test system containing viable microorganisms providing a defined resistance to a specified sterilization process AAMI ST79
32 © 3M All Rights Reserved. 3M™ Attest™ Rapid Readout Biological Indicators - Flash Cycles 1291, Blue Cap BI 270°F/132°C, gravity 1292, Brown Cap BI 270°F/132°C, dynamic-air-removal
33 © 3M All Rights Reserved. Biological Indicators AAMI ST79 AAMI and AORN - Weekly, preferably daily and implants AAMI ST79 & AORN
34 © 3M All Rights Reserved. Routine Load Release Implant Loads “Emergency situations should be defined” AAMI ST79
35 © 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.” AORN
36 © 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 ) AAMI ST79
37 © 3M All Rights Reserved. Record Keeping “Documentation establishes accountability.” AORN Sterilization Recommended Practice AORN
38 © 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 Photo courtesy of Rose Seavey, The Children's Hospital - Denver
39 © 3M All Rights Reserved. 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 AORN
40 © 3M All Rights Reserved. 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 AAMI ST79
41 © 3M All Rights Reserved. Flash sterilization cycles Routine 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 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 dailyThree consecutive cycles After Bowie-Dick test if dynamic air-removalBefore Bowie-Dick test if dynamic air- removal
42 © 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 AAMI ST79
43 © 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 AAMI ST79
44 © 3M All Rights Reserved. Quality Assurance Program Sterilization Process Monitoring Monitoring 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 AAMI ST79
45 © 3M All Rights Reserved. If a biological indicator (BI) is positive, do you only recall that load? QUESTION:
46 © 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
47 © 3M All Rights Reserved. Biological Indicator Monitoring Frequency Why 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)
48 © 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
49 © 3M All Rights Reserved. Issues Associated with Flash Sterilization Time Pressures – skipped steps in cleaning/decontamination Flashing large and/or multiple trays – increases cycle and cooling time Loaner Instrumentation AAMI ST79
50 © 3M All Rights Reserved. Loaner Instrumentation Issues Patient Safety Timelines (flashing is not recommended) Communication (OR, SPD, Vendor) Quality –MDM Reprocessing Guidelines –Adequate time –Implants Potential for lost items
51 © 3M All Rights Reserved. Toxic Anterior Segment Syndrome - TASS The 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:
52 © 3M All Rights Reserved. Toxic Anterior Segment Syndrome - TASS Inadequate 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
53 © 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
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55 © 3M All Rights Reserved. SHARING FLASH REDUCTION “BEST PRACTICES”
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