3 M Attest Sterile U Web Meeting March

3 M™ Attest™ Sterile U Web Meeting March 19, 2009 How Long Did They Go? Healthcare Facilities Share Flash Reduction Best Practices

Welcome! Facilitator: Tammy Torbert, 3 M Sterilization Assurance Speaker: Dorothy Larson, 3 M Technical Service Panelist: Francis Zieman, 3 M Technical Service Housekeeping: Questions; -Mute feature (*7=unmute; *6=mute) -“Chat” feature Technical difficulties CE Credits Post session follow-up For more information: www. 3 M. com/Attest. Sterile. UOnline 2 © 3 M 2009. All Rights Reserved.

Discussion Topics 1. Define flash sterilization 2. Discuss the Association of peri. Operative 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 3 5. Discuss Flash Reduction Best Practices © 3 M 2009. All Rights Reserved.

Quality Control Recommended Practices § ANSI/AAMI Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ST 79: 2006/A 1: 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 4 © 3 M 2009. 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 5 © 3 M 2009. All Rights Reserved.

Flash Sterilization Process designed for the steam sterilization of patient care items for immediate

Flash Sterilization - History Reprocessing of dropped instruments midprocedure Unwrapped, 270 deg. F. Gravity cycle only -No dry time High Temperature Sterilization 7 AAMI ST 79 © 3 M 2009. All Rights Reserved.

Flash Sterilization - Today High temperature (270 -275°F/ 132135°C) No dry time/ No storage Sterilization Process: - Gravity - Dynamic-air-removal Packaging expanded beyond meshbottom surgical tray Photo courtesy of Rose Seavey, The Children's Hospital - Denver 8 AAMI ST 79 © 3 M 2009. All Rights Reserved.

Flash Sterilization - Packaging § 9 Perforated, mesh bottom, open surgical tray § Rigid sterilization container system § Protective organizing case § Single-wrapped surgical tray AAMI ST 79 © 3 M 2009. All Rights Reserved.

Flash Sterilization Packaging AORN recommends the use of rigid sterilization containers § Reduce risk of contamination during transport to point of use § Ease of presentation to sterile field 10 AORN © 3 M 2009. All Rights Reserved.

Types of Steam Sterilization Processes Gravity Displacement Dynamic-Air-Removal by § § 11 AAMI ST

Flash Sterilization Minimum Flash Cycle Times for Gravity Steam Sterilization Cycles Load Contents 12 Temp 270°F/132° Unwrapped nonporous C items 275°F/135° C 270°F/132° Unwrapped nonporous & C porous items in mixed 275°F/135° load. ST 79 AAMI C © 3 M 2009. All Rights Reserved. Time(Min ) 3 3 10 10

Flash Sterilization 13 Minimum Flash Cycle Times for Dynamic-Air-Removal Steam Sterilization Cycles Time(Min Load Contents Temp ) 270°F/132° Unwrapped nonporous C 3 items 275°F/135° 3 C 270°F/132° Unwrapped nonporous & C 4 porous items in mixed 275°F/135° 3 load. ST 79 AAMI C © 3 M 2009. 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 14 © 3 M 2009. All Rights Reserved.

QUESTION: Review information in following table – is this a flash cycle? Sterilization Temperature Sterilization Time Sterilization Method 270 deg. F. Packaging Type Dry Time Rigid Container None 4 -minute exposure Prevacuum ANSWER: YES! Remember, flash sterilization is the steam sterilization of patient care items for immediate use! 15 © 3 M 2009. All Rights Reserved.

ANSI/AAMI ST 79 Section 10 Quality Control Four levels of testing Routine load release Testing of each non-implant and implant load Routine sterilizer Establishing a regular pattern of testing the efficacy monitoring efficacy of the sterilization process 16 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 © 3 M 2009. 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 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 17 AAMI ST 79 © 3 M 2009. All Rights Reserved.

Routine Load Release Implants § § § 18 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 ST 79 © 3 M 2009. All Rights Reserved.

Sterilization Process Monitoring Tools § Physical Monitors § Chemical Indicators § Biological Indicators 19

Physical Monitors Verify that parameters of sterilization cycle are met § Recording charts §

ANSI/AAMI/ISO 11140 -1, 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 21 © 3 M 2009. 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 § 22 AAMI ST 79 © 3 M 2009. All Rights Reserved. Designed to react to one or more of the critical process variables

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 270275°F dynamic-air removal sterilizers (i. e. , vacuum assisted sterilizers) 23 AAMI ST 79 © 3 M 2009. 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 § 24 AORN & AAMI

AORN Placement of internal chemical indicators 25 AORN

Chemical Indicator Placement Rigid container § § 26 AORN © 3 M 2009. All

Chemical Indicator Placement Multi-layer container § § 27 AORN © 3 M 2009. All Rights Reserved. Place two CIs in each level of multi-level rigid container Place one in each of two opposite corners on each level

Chemical Indicator Placement Multi-level container Supplied by the manufacturer, holes in tray, has to

Chemical Indicator Placement Wrapped instrument trays Place CI in geometric center, not on the

Routine Load Release Nonimplants – Flash Sterilization Class 5 Integrating Indicator PCD for releasing flash loads § PCD must be representative of load – – § 30 Open surgical tray Rigid sterilization container Protective organization case Single-wrapped surgical tray Class 5 Integrating Indicator also serves as internal CI AAMI ST 79 © 3 M 2009. All Rights Reserved.

Biological Indicators Definition Test system containing viable microorganisms providing a defined resistance to a

3 M™ Attest™ Rapid Readout Biological Indicators - Flash Cycles 1291, Blue Cap BI

Biological Indicators AAMI ST 79 AAMI and AORN - Weekly, preferably daily and implants

Routine Load Release Implant Loads “Emergency situations should be defined” 34 AAMI ©ST 79

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 rapidaction BI provides a negative result. ” 35 AORN © 3 M 2009. 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 10. 5. 3. 2) 36 AAMI ST 79 © 3 M 2009. All Rights Reserved.

Record Keeping “Documentation establishes accountability. ” AORN Sterilization Recommended Practice 37 AORN © 3

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 38 AORN © 3 M 2009. 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 39 AORN

Routine Sterilizer Efficacy Monitoring Sterilizer Qualification Testing Routine Efficacy Testing Establishing a regular pattern of testing the efficacy of the sterilization process Qualification Testing of sterilizer after events occur that affect the ability of the sterilizer to perform § § § AAMI ST 79 40 © 3 M 2009. All Rights Reserved. Sterilizer installation Relocation Malfunction Major repairs of sterilizer or utilities Sterilization process failures

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 Test each type of tray configuration – Select one representative tray Must always test the open surgical tray configuration 41 Place on bottom shelf over the drain in otherwise empty chamber Weekly, preferably daily Three consecutive cycles After Bowie-Dick test if dynamic airremoval Before Bowie-Dick test if dynamic airremoval © 3 M 2009. 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 § § 42 Equal to or greater than the most difficult item to sterilize Placed in most difficult area in sterilizer for the sterilant to penetrate AAMI ST 79 © 3 M 2009. 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 43 AAMI ST 79 © 3 M 2009. All Rights Reserved.

Quality Assurance Program Sterilization Process 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 ST 79 44 © 3 M 2009. All Rights Reserved.

QUESTION: If a biological indicator (BI) is positive, do you only recall that load?

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 items processed since last negative BI § Reprocess all retrieved items 46 © 3 M 2009. 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) 47 © 3 M 2009. 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 48

Issues Associated with Flash Sterilization § Time Pressures – skipped steps in cleaning/decontamination § Flashing large and/or multiple trays – increases cycle and cooling time § 49 Loaner Instrumentation AAMI ST 79 © 3 M 2009. 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 50 © 3 M 2009. 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” 51 Nick Mamalis, MD, Toxic Anterior Segment Syndrome Journal of Cataract and Refractive Surgery 2006; 32: 324 -333. © 3 M 2009. 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 §Recommended Impuritiespractices of autoclave steam” for cleaning and sterilizing intraocular surgical instruments, J Cataract Refract Surg, Vol 33, June 2007 52 © 3 M 2009. All Rights Reserved.

AAMI ST 79 2008 Amendments - Annex N (informative) Toxic anterior segment syndrome (TASS) and the processing of surgical instruments § Follow Mfr’s. cleaning and sterilization instructions 53 § 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 © 3 M 2009. All Rights Reserved.