Welcome! How do I get a CE Certificate?

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M Sterile U Network M Sterile U Web Meeting November 0, 0 Today s meeting times: 9:00 a.m., :00 a.m., and :00 p.m. Central Standard Time To hear audio, call 800-97-00 and enter access code 7 Phone lines are muted.

Topic: Hot Topics from the M Tech Line Facilitators: Christophe de Campeau, M Susan Flynn, M Speaker: Dorothy Larson Housekeeping Questions Mute feature (*7 = unmute; * = mute) Chat feature Technical

1 M Sterile U Network M Sterile U Web Meeting November 0, 0 Today s meeting times: 9:00 a.m., :00 a.m., and :00 p.m. Central Standard Time To hear audio, call and enter access code 7 Phone lines are muted. Audio will commence when the webinar begins. Welcome! Topic: Hot Topics from the M Tech Line Facilitators: Christophe de Campeau, M Susan Flynn, M Speaker: Dorothy Larson Housekeeping Questions Mute feature (*7 = unmute; * = mute) Chat feature Technical difficulties Post session follow-up For more information: How do I get a CE Certificate? Next week, all of today s meeting participants will be sent an containing instructions for obtaining a CE Certificate for today s meeting. The will be sent to the address you provided when you logged-in to today s meeting. If there are others listening with you today who did not log-on, you may forward the CE certificate to them.

2 Disclosure Statement Dorothy Larson M Company Infection Prevention Division Sterilization Technical Services Tech Line , option Learning Objectives Discuss hot topics from the M Sterilization Tech Line Discuss solutions based on applicable standards d and recommended d practices References Association for the Advancement of Medical Instrumentation (AAMI) Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0 (Consolidated Text) Association of perioperative Registered Nurses (AORN) AORN Recommended Practices for Sterilization in Perioperative Practice Setting (0) AORN Recommended Practices for Selection and Use of Packaging Systems for Sterilization (0)

Verifying Cycle printout tapes Immediate Use Steam Sterilization Testing a Combination Sterilizer Qualification Testing Double Peel Pouching Wet Packs 7 7 What does it mean to verify a cycle printout

3 Verifying Cycle printout tapes Immediate Use Steam Sterilization Testing a Combination Sterilizer Qualification Testing Double Peel Pouching Wet Packs 7 7 What does it mean to verify a cycle printout tape? Physical Monitors (e.g., cycle printout tapes) verify that parameters of sterilization cycle are met. ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0, Section Physical Monitors Marked with correct date and sterilizer identification at beginning of cycle Read & verified by initialing at end of cycle If not correct, do not release load 9 ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0, Section 0.. 9

4 The temperature for a cycle was not achieved, but the biological indicator in the load passed. Can we release the load? The temperature for a cycle was not achieved, but the biological indicator in the load passed. Can we release the load? SITUATION: Cycle programmed for 70 deg. F., -minutes exposure, per written instructions from the Medical Device Manufacturer Maximum temperature reached 9.9 deg. F. Bowie-Dick Test passed - Bowie-Dick: Test - a daily test run in prevacuum sterilizers to evaluate the efficacy of a vacuum system to remove residual air from the chamber BI PCD: Negative BI The temperature for a cycle was not achieved, but the biological indicator in the load passed. Release the load Reprocess the load

5 What if the desired temperature for a cycle was not achieved? Physical monitors (0..) "If the interpretation of the physical monitors suggests inadequate steam processing, the contents of the load should not be dispensed or used. Acceptance criteria (0.7..) An acceptable process is evidenced by negative results from all BIs in the PCD and appropriate readings from physical monitors and CIs, showing that the sterilization cycle was correct and complete. ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0, Section 0.., Sterilization Process Monitoring Monitoring Tools Physical monitors Bowie-Dick tests Chemical indicators - External, Internal Biological indicators Process challenge devices (PCDs) test packs or challenge packs What is considered Immediate Use Steam Sterilization? What about eye cataract procedures where there are sets used all morning and they are not dried post-sterilization?

Immediate-use Steam Sterilization April/00 Summit included representatives from key organizations, accreditation bodies and agencies Produced a multi-society Position Statement Agreed on terminology

6 Immediate-use Steam Sterilization April/00 Summit included representatives from key organizations, accreditation bodies and agencies Produced a multi-society Position Statement Agreed on terminology transition from Flash Sterilization to the term Immediate Use Steam Sterilization (IUSS) Multi-society Position Statement on Immediate-Use Steam Sterilization (IUSS) Evolution of flash sterilization "Immediate use i.e. item is removed from sterilizer and aseptically transferred to the sterile field Personnel should be knowledgeable and competent Standardized practices should be implemented Critical reprocessing steps (cleaning, decontamination, and aseptic transport) must be followed Device manufacturer's written reprocessing instructions should be followed Multi-society Position Statement on Immediate-Use Steam Sterilization (IUSS) Evolution of flash sterilization Immediate use is broadly defined as the shortest possible time between a sterilized item s removal from the sterilizer and its aseptic transfer to the sterile field. Immediacy implies that a sterilized item is used during the procedure for which it was sterilized and in a manner that minimizes its exposure to air and other environmental contaminants. A sterilized item intended for immediate use is not stored for future use, nor held from one case to another

7 Multi-society Position Statement on Immediate-Use Steam Sterilization (IUSS) Evolution of flash sterilization Sterilization process monitoring is essential to ensure that sterilization practices are efficacious. Sterilization personnel should be educated regarding the different types of steam sterilizers and types of steam sterilization cycles. Sterilization cycles with little or no dry time are efficacious when used in compliance with validated written instructions provided by the device manufacturers, sterilization equipment manufacturers, and (if applicable) container manufacturers and when done in accordance with professional guidelines Immediate-Use Steam Sterilization (IUSS) 0 Process designed for the cleaning, steam sterilization, and delivery of patient care items for immediate use. Previously known as flash sterilization. Gravity or dynamic-air-removal Little or No dry time No storage Item(s) transferred immediately to the point of use Implantables should not be sterilized for immediate use (CDC, 008). ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0, Section., Introduction AORN RP for Sterilization in Perioperative Practice Setting, RP VII 0 0 xx AORN Recommended Practices for Sterilization in Perioperative Practice Setting Immediate Use Steam Sterilization (IUSS) Immediate use steam sterilization (IUSS) should be kept to a minimum and should be used only in selected clinical situations and in a controlled manner. (Sterilization RP VII) Biological and chemical indicators should be used to monitor sterilizer efficacy and to assess whether conditions of sterilization have been achieved. (Sterilization RP VII.c..) A Class chemical integrating indicator or a class indicator should be used within each sterilizer container or tray. Class indicators are cycle-specific and should be used only in the specific cycles for which they are labeled." (Sterilization RP VII.c..) 7

CMS and IUSS 0 Memo to State Survey Agency Directors on Immediate Use Steam Sterilization (IUSS) in Surgical Settings - IUSS replaces the term flash sterilization Survey Procedures Consistent with

8 CMS and IUSS 0 Memo to State Survey Agency Directors on Immediate Use Steam Sterilization (IUSS) in Surgical Settings - IUSS replaces the term flash sterilization Survey Procedures Consistent with professionally acceptable standards of practice for IUSS. For example: IUSS reserved for immediate use needs Process to ensure IUSS is not used for implants; single-use devices; devices not validated for the specific cycle Instruments are cleaned and disinfected according to MIFU prior to IUSS Personnel are trained and have had their competency verified What about eye cataract procedures where there are sets used all morning and they are not dried post-sterilization? Yes No We use our large steam sterilizer for running both terminal loads and immediate use cycles. How should the daily testing be done in this combination sterilizer? 8

Terminal Sterilization terminal sterilization: Process whereby product is sterilized within its sterile barrier system. (ST79, section.) The process of sterilizing a packaged item.

9 Terminal Sterilization terminal sterilization: Process whereby product is sterilized within its sterile barrier system. (ST79, section.) The process of sterilizing a packaged item.* ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 (Consolidated Text), Section. *CSSD Dictionary and Reference Guide Class Chemical Indicators Bowie-Dick Test ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0 Class Chemical Indicators Bowie-Dick Test Uniform color change Use If not uniform, shut down and report to supervisor Remain in use Retest Call for repair Re-qualify if major repair 7 ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0, Sections and

Routine Sterilizer Efficacy Monitoring Establishing a regular pattern of testing the efficacy of the sterilization process Frequency of Monitoring with a Biological Indicator Process Challenge Device

10 Routine Sterilizer Efficacy Monitoring Establishing a regular pattern of testing the efficacy of the sterilization process Frequency of Monitoring with a Biological Indicator Process Challenge Device (BI PCD) Weekly, preferably daily 8 ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0 8 8 Process Challenge Device (PCD) 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 9 ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0 9 9 Section 0 Quality control Using the appropriate PCD, in the appropriate manner for the size and type of sterilizer, is critical to successful and accurate results. (0.7) ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:

11 Routine Sterilizer Efficacy Monitoring Test each type of cycle with a BI PCD Gravity-displacement ºC to ºC 70ºF to 7ºF Gravity-displacement ºC 0 F Dynamic-air-removal ºC to ºC 70ºF to 7ºF IUSS ºC to ºC 70ºF to 7ºF IUSS Single wrapper or other packaging ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0, Section 0... Routine Sterilizer Efficacy Monitoring Test each sterilization cycle type used NOTE - If a sterilizer will run the same type of cycle (e.g., dynamic-air-removal at ºC to ºC [70ºF to 7ºF] for different exposure times (e.g., minutes and 0 minutes), then only the shortest cycle time needs to be tested. ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0, Section 0.7. Routine Efficacy Monitoring with a BI PCD Sterilizers larger than cubic feet AAMI towel pack or commercially available disposable, FDA cleared BI PCD Full load on bottom shelf over drain Table Top Sterilizers BI PCD should be representative ti of the package or tray routinely processed, and most difficult to sterilize Contains items normally present during routine sterilization Full load in cold point (check with sterilizer Mfr.) Immediate Use Steam Sterilization Cycles BI PCD placed on bottom shelf over the drain Otherwise empty chamber Each type of tray configuration used should be tested

12 According to ANSI/AAMI ST79, for sterilizers larger than cubic feet and for table-top sterilizers, routine sterilizer efficacy monitoring with a biological indicator process challenge device is done in: An empty chamber A fully loaded chamber According to ANSI/AAMI ST79, for immediateuse steam sterilization, routine sterilizer efficacy monitoring with a biological indicator process challenge device is done in: An empty chamber A fully loaded chamber Routine Sterilizer Efficacy Monitoring Combination sterilizer Which cycles should be routinely monitored with a BI PCD? Cycle Temp. Exposure/ Dry Time Monitor with BI PCD? Prevacuum 70 F min. exp., Terminal Mixed load 0 min. dry Gravity-Displacement Terminal 0 F 0 min. exp., min. dry Prevacuum Immediate-Use Sterilization 70 F min. exp., min. dry

13 Routine Sterilizer Efficacy Monitoring Combination sterilizer Which cycles should be routinely monitored with a BI PCD? Cycle Temp. Exposure/ Dry Time Monitor with BI PCD? Prevacuum Terminal Mixed load 70 F min. exp., 0 min. dry Gravity-Displacement Terminal Prevacuum Immediate-Use Sterilization 0 F 70 F 0 min. exp., min. dry min. exp., min. dry Do we need to run a series of Biological Indicators and Bowie-Dick Tests after any incident, or only after certain occurrences? For example, when the boiler loses pressure or when power is temporarily interrupted to test the backup generator and the sterilizer now says power failure? Qualification Testing Why? To determine if the sterilizer is working after an event that could effect its ability to perform. When? After sterilization process failures when the cause is not immediately identifiable After sterilizer installation, relocation, malfunction After major steam or utility repairs 9 ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 (Consolidated Text), Section 0...,

+ = Qualification Testing Prevacuum sterilizers > cubic feet Consecutive Cycles Biological Indicator Process Challenge Devices (BI PCDs) no load Bowie-Dick tests 0 ANSI/AAMI ST79:00 & A:00 & A:0 &

14 + = Qualification Testing Prevacuum sterilizers > cubic feet Consecutive Cycles Biological Indicator Process Challenge Devices (BI PCDs) no load Bowie-Dick tests 0 ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0 0 (Consolidated Text), Section 0..., Qualification Testing Major Repairs Sterilizer Repairs outside the scope of normal maintenance Examples: Weld repairs of pressure vessel Replacement of chamber door or piping assembly Rebuilds or upgrades of controls Utilities Changes to the utilities connected to the sterilizer Examples: Water-main break Annual boiler maintenance Additional equipment loads Installation of new boilers ANSI/AAMI ST79:00 & A:00 M & Infection A:0 & Prevention A:0 (Consolidated Solutions Text), Section 0.. M 0. All All Rights Reserved. Is Qualification Testing necessary when. #) the boiler loses pressure? #) power is temporarily interrupted to test the backup generator and sterilizer says power failure?

15 Is it acceptable to double-pouch items for steam sterilization? - If so, where would you place the internal chemical indicator? Plastic-Paper Pouches Appropriate use If double pouching, outer package must be larger; paper side faces paper and plastic side faces plastic Double packaging in paper-plastic pouches should not be performed without documentation from the manufacturer that the paper-plastic plastic pouch has been validated for this use. Reprinted from ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 with permission of Association for the Advancement of Medical Instrumentation, Inc. 0 AAMI ANSI/AAMI ST79:00 & A:00 M Infection & A:0 Prevention & A:0 Solutions & A:0, Section 8.. Plastic-Paper Pouches Chemical Indicator Placement ANSI/AAMI ST79 The CI should be placed in that area of the package considered least accessible to steam penetration. AORN ST79 CI should be placed in area within package presenting a challenge for air removal and sterilant contact (V.b.) ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0, Section 0... AORN:0, RP: Packaging Systems M Infection V Prevention Solutions

Integrating Indicators Class Emulating Indicators Chemical indicators verify that one or more conditions necessary for sterilization have been achieved within the package and/or at a specific

16 How do you use peel pouches at your health care facility, for steam sterilization? Always double-pouch Always single-pouch Predominantly single-pouch Internal Chemical Indicators (CI) Internal CI Class,,, or Class Single Variable Indicators Class Multi-variable Indicators Class Integrating Indicators Class Emulating Indicators Chemical indicators verify that one or more conditions necessary for sterilization have been achieved within the package and/or at a specific location within the load. ANSI/AAMI/ISO 0-:00 /(R)00 (Mfrs. Standard) ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0, Section 0..., Class Chemical Indicators - External CIs Process Indicators Use with individual units to indicate that the unit has been directly exposed to the sterilization process - Distinguish i between processed and unprocessed units - Designed to react to one or more of the critical process variables 8 ANSI/AAMI/ISO 0-:00 /(R)00 (Mfrs. Standard) ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0, Section

Correct Sterilizer Loading for Paper-Plastic Pouches Reprinted from ANSI/AAMI ST79:00 & A:00 & A:0 &A:0

0 AAMI 9 ANSI/AAMI ST79:00 & A:00 & A:0 & A:0, Section 8.. M 0. All rights reserved.

the pouch manufacturer can supply documented validation for this practice.

b ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0, Section 8.

17 Correct Sterilizer Loading for Paper-Plastic Pouches Reprinted from ANSI/AAMI ST79:00 & A:00 & A:0 &A:0 with permission of Association for the Advancement of Medical Instrumentation, Inc. 0 AAMI 9 ANSI/AAMI ST79:00 & A:00 & A:0 & A:0, Section 8.. M 0. All rights reserved. Plastic-Paper Pouches Peel pouches should not be used within wrapped sets or containment devices unless the pouch manufacturer can supply documented validation for this practice. The impervious plastic side of a peel pouch in contact with devices within sets may prevent sterilant from contacting the devices. * 0 *AORN RP for Selection and Use of Packaging Systems for Sterilization, Recommendation VII.b ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0, Section Internal Chemical Indicators The contents of a package with a non-responding chemical indicator should not be used Quarantine remainder of load until BI results are known If no BI, decide on recall based on physical monitors and other CI results ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0, Section

or more or more or more If there is only one wet pack in a load, does the entire load need to be recalled?

18 Please clarify: If there is only one wet pack in a load does the entire load need to be recalled? How many packages from a load, with moisture present in or on them is considered a wet load? or more or more or more If there is only one wet pack in a load, does the entire load need to be recalled? Visible moisture left in or on a package after sterilization and the proper cooling period should be considered a wet pack. If moisture is present on or in or more packages, the load should be considered a wet load. Moisture may be in the form of visible dampness, droplets, or puddles of water on or within a pack. ANSI/AAMI ST79:00 & A:00 M Infection & A:0 Prevention & A:0 Solutions & A:0, Annex P 8

19 Why are wet packs a concern? Moisture on or within a package can create a pathway for microorganisms to migrate from the outside to the inside id of a package. Wet packs need to be reprocessed. Wet packs may indicate the steam quality is poor. All of the above. M Confidential M 0. All Rights Reserved. WET PACKS AAMI ST79 Annex P Moisture Assessment New tools to help investigate wet packs and loads Table P. Moisture Assessment Checklist Processing Clinical Practice Set and Load Content and Configuration Sterilizer Process Sterilizer or Utility Malfunctions Boiler System Steam Delivery System (Piping) Sterilizer Performance Environmental Issues Figure P. Moisture Assessment Flow Chart ANSI/AAMI ST79:00 & A:00 M Infection & A:0 Prevention & A:0 Solutions & A:0, Annex P Wet Packs Wet packs should not be released for use Repackage, replace chemical indicators (CIs) Disposable products (e.g. gauze or cotton balls) should be discarded Review the sterilizer cycle conditions Drying cycle length and temperaturet Set contents, weight, & density (especially metal mass) Loading of the sterilizer and position of wet pack Reprocess after detecting the error or probable cause of the wet pack Perform process audits to ensure adherence to packaging procedures ANSI/AAMI ST79:00 & A:00 M Infection & A:0 Prevention & A:0 Solutions & A:0, section

20 Questions? M Confidential M 0. All Rights Reserved. References 9 Association for the Advancement of Medical Instrumentation (AAMI) Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:00 & A:00 & A:0 & A:0 & A:0 (Consolidated Text) Sterilization of health care products-chemical indicators-part : general requirements. ANSI/AAMI/ISO 0-, 00/(R) 00 Multi-society Position Statement on Immediate-Use Steam Sterilization, accessed.. at Statement.pdf 9 9 M Confidential M 0. All Rights Reserved. References Centers for Medicare & Medicaid Services Center for Clinical Standards and Quality/Survey & Certification Group Certification/SurveyCertificationGenInfo/Downloads/Survey- and-cert-letter--.pdf 0 Association of perioperative Registered Nurses (AORN) Perioperative Standards and Recommended Practices (0) Recommended Practices for Sterilization in Perioperative Practice Setting Recommended Practices for Selection and Use of Packaging Systems for Sterilization 0 0 M Confidential M 0. All Rights Reserved. 0

21 References The International Association of Healthcare Central Service Materiel Management CSSD Dictionary and Reference Guide (00) M Confidential M 0. All Rights Reserved. Thank You! Next M Sterile U Web Meeting: Date: December, 0 Title: What a Gas...A Review of Today's Low Temperature Sterilization Options

3M s Sterilization Tech Line FAQs Sandra Velte, BA, CSPDT

3M Sterile U Sterilization Assurance Continuing Education 3M s Sterilization Tech Line FAQs Sandra Velte, BA, CSPDT May 2013 Objectives After completion of this self-study activity, the learner will be