hot topics from the 3m tech line webinar 11.20.14 final...

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3M Infection Prevention Solutions

© 3M 2014. All Rights Reserved.

3M™ Sterile U Network3M™ Sterile U Web Meeting – November 20, 2014

Today’s meeting times: 9:00 a.m., 11:00 a.m., and 1:00 p.m. Central Standard Time

To hear audio, call 800-937-0042 and enter access code 7333633Phone lines are muted. Audio will commence when the webinar begins.

© 3M 2014. All Rights Reserved.2


Welcome!Topic: Hot Topics from the 3M Tech Line

Facilitators: Christophe de Campeau, 3M Susan Flynn, 3M

Speaker: Dorothy LarsonHousekeepingQuestions

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For more information: www.3M.com/3MSterileU



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Disclosure Statement

Dorothy Larson

3M CompanyInfection Prevention DivisionSterilization Technical Services

Tech Line 1-800-441-1922, option “2”



Learning Objectives

Discuss hot topics from the 3M Sterilization Tech Line

Discuss solutions based on applicable standards and recommended practices



References

• Association for the Advancement of Medical Instrumentation (AAMI)

• Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text)

• Association of periOperative Registered Nurses (AORN)

• AORN Recommended Practices for Sterilization in PerioperativePractice Setting (2014)

• AORN Recommended Practices for Selection and Use of Packaging Systems for Sterilization (2014)

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Verifying Cycle printout tapes

Immediate Use Steam Sterilization

Testing a “Combination” Sterilizer

Qualification Testing

Double Peel Pouching

Wet Packs



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 ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.1



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

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 , Section 10.5.1

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3M Infection Prevention Solutions 10

© 3M 2014 All Rights Reserved.10

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The temperature for a cycle was not achieved, but the biological indicator in the load passed. Can we release the load?




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SITUATION: Cycle programmed for 270 deg. F., 4-minutes exposure, per written instructions from the Medical Device Manufacturer

Maximum temperature reached 269.9 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. Can we release the load?




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The temperature for a cycle was not achieved, but the biological indicator in the load passed.

Release the load

Reprocess the load

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What if the desired temperature for a cycle was not achieved?

Physical monitors (10.5.1) "If the interpretation of the physical monitors suggests inadequate steam processing, the contents of the load should not be dispensed or used.”

Acceptance criteria (10.7.4.4) “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 ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.1, 10.7.4.4




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Monitoring Tools• Physical monitors

• Bowie-Dick tests

• Chemical indicators

- External, Internal

• Biological indicators

• Process challenge devices (PCDs)test packs or challenge packs

Sterilization Process Monitoring



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What is considered Immediate Use Steam Sterilization?

What about eye cataract procedures where there are 2 sets used all morning and they are not dried post-sterilization?

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Immediate-use Steam Sterilization

• April/2010 Summit included representatives from 12 key organizations, accreditation bodies and agencies

• Produced a multi-society Position Statement

• Agreed on terminology transition from “Flash Sterilization” to the termImmediate Use Steam Sterilization (IUSS)



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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

http://www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdf



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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.“


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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.”




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Immediate-Use Steam Sterilization (IUSS)

“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, 2008).”

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 2.61, IntroductionAORN RP for Sterilization in Perioperative Practice Setting, RP VII

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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.2.)

• “A Class 5 chemical integrating indicator or a class 6 indicator should be used within each sterilizer container or tray. Class 6 indicators are cycle-specific and should be used only in the specific cycles for which they are labeled." (Sterilization RP VII.c.3.)

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CMS and IUSS

2014 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

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf




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What about eye cataract procedures where there are 2 sets used all morning and they are not dried post-sterilization?

Yes

No



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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?

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Terminal Sterilization

“terminal sterilization: Process whereby

product is sterilized within its sterile barrier

system.” (ST79, section 2.133)

”The process of sterilizing a packaged item.*”

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated Text), Section 2.133*CSSD Dictionary and Reference Guide



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Class 2 Chemical IndicatorsBowie-Dick Test

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013



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Class 2 Chemical IndicatorsBowie-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

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.7.6.5 and 10.8.1

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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

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013



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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

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013



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Section 10 Quality control Using the appropriate PCD, in the appropriate manner for the size and type of sterilizer, is critical to successful and accurate results. (10.7)

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013

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Gravity-displacement 132ºC to 135ºC 270ºF to 275ºF

Gravity-displacement 121ºC 250°F

Dynamic-air-removal 132ºC to 135ºC 270ºF to 275ºF

“IUSS” 132ºC to 135ºC 270ºF to 275ºF

“IUSS”Single wrapper or other

packaging

Test each type of cycle with a BI PCD

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.3.2



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Test each sterilization cycle type used

“NOTE - If a sterilizer will run the same type of cycle (e.g., dynamic-air-removal at 132ºC to 135ºC [270ºF to 275ºF] for different exposure times (e.g., 4 minutes and 10 minutes), then only the shortest cycle time needs to be tested.”




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Sterilizers larger than 2 cubic feet • AAMI 16 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 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

Routine Efficacy Monitoring with a BI PCD

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According to ANSI/AAMI ST79, for sterilizers larger than 2 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



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According to ANSI/AAMI ST79, for immediate-use steam sterilization, routine sterilizer efficacy monitoring with a biological indicator process challenge device is done in:

An empty chamber

A fully loaded chamber



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Routine Sterilizer Efficacy Monitoring“Combination” sterilizer

Cycle Temp. Exposure/ Dry Time

Monitor with BI PCD?

Prevacuum“Terminal” Mixed load

270°F 4 min. exp., 30 min. dry

Gravity-Displacement “Terminal”


Prevacuum“Immediate-Use Sterilization”


Which cycles should be routinely monitored with a BI PCD?

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Routine Sterilizer Efficacy Monitoring“Combination” sterilizerWhich cycles should be routinely monitored with a BI PCD?

Cycle Temp. Exposure/ Dry Time

Monitor with BI PCD?

Prevacuum“Terminal” Mixed load

270°F 4 min. exp., 30

min. dry

Gravity-Displacement “Terminal”

250°F30 min. exp., 45 min. dry

Prevacuum“Immediate-Use Sterilization”

270°F 4 min. exp., 1

min. dry



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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”?

Do we need to run a series of Biological Indicators and Bowie-Dick Tests after any incident, or only after certain occurrences?



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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

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated Text), Section 10.5.3.2, 10.8

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3 + 3 = 6Qualification TestingPrevacuum sterilizers > 2 cubic feet

6 Consecutive Cycles

3 Biological Indicator Process Challenge Devices (BI PCDs) – no load

3 Bowie-Dick tests

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text), Section 10.5.3.2, 10.8




Qualification TestingMajor Repairs

© 3M 2014. All Rights Reserved.

SterilizerRepairs outside the scope of normal maintenance Examples:•Weld repairs of pressure

vessel•Replacement of chamber

door or piping assembly•Rebuilds or upgrades of

controls

UtilitiesChanges to the utilities connected to the sterilizerExamples:•Water-main break•Annual boiler maintenance•Additional equipment loads•Installation of new boilers

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated Text), Section 10.6.4



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Is Qualification Testing necessary when….

#1) the boiler loses pressure?

#2) power is temporarily interrupted to test the backup generator and sterilizer says “power failure”?

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Is it acceptable to double-pouch items for steam sterilization?

- If so, where would you place the internal chemical indicator?




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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 pouch has been validated for this use.”

Reprinted from ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 with permission of Association for the Advancement of Medical Instrumentation, Inc. © 2014 AAMI





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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 ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.2.2.2AORN:2014, RP: Packaging Systems V

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How do you use peel pouches at your health care facility, for steam sterilization?

Always double-pouch

Always single-pouch

Predominantly single-pouch




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Internal Chemical Indicators (CI)

Internal CI – Class 3, 4, 5, or 6

• Class 3 Single Variable Indicators

• Class 4 Multi-variable Indicators

• Class 5 Integrating Indicators

• Class 6 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 11140-1:2005 /(R)2010 (Mfrs. Standard)ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:201 & A4:2013, Section 10.5.2.1, 10.4




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Class 1 Chemical Indicators - External CIs

Process IndicatorsUse with individual units to indicate that the unit has been directly exposed to the sterilization process - Distinguish between processed and

unprocessed units

- Designed to react to one or more of the critical process variables

ANSI/AAMI/ISO 11140-1:2005 /(R)2010 (Mfrs. Standard)ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.2.1

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49 © 3M 2012. All rights reserved.ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012, Section 8.5.2

Correct Sterilizer Loading for Paper-Plastic Pouches

Reprinted from ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 &A3:2012 with permission of Association for the Advancement of Medical Instrumentation, Inc. © 2012 AAMI




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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.”*

*AORN RP for Selection and Use of Packaging Systems for Sterilization, Recommendation VII.bANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 8.3.4




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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 ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.2.2.2

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Please clarify: If there is only one wet pack in a load does the entire load need to be recalled?




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How many packages from a load, with moisture present “in” or “on” them is considered a wet load?

1 or more

2 or more

3 or more




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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 2 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 ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Annex P

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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 of a package.

Wet packs need to be reprocessed.

Wet packs may indicate the steam quality is poor.

All of the above.




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WET PACKSAAMI ST79 Annex P Moisture Assessment

New tools to help investigate wet packs and loadsTable P.1 Moisture Assessment ChecklistProcessingClinical PracticeSet and Load Content and ConfigurationSterilizer Process

Sterilizer or Utility MalfunctionsBoiler SystemSteam Delivery System (Piping)Sterilizer PerformanceEnvironmental Issues

Figure P.1 Moisture Assessment Flow Chart

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Annex P




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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 temperature 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 ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, section 8.3.1

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Questions?




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References

• Association for the Advancement of Medical Instrumentation (AAMI)

• Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text)

• Sterilization of health care products-chemical indicators-Part 1: general requirements. ANSI/AAMI/ISO 11140-1, 2005/(R) 2010

• Multi-society Position Statement on Immediate-Use Steam Sterilization, accessed 11.13.14 at http://www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdf




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References

Centers for Medicare & Medicaid ServicesCenter for Clinical Standards and Quality/Survey & Certification Group

• http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf

• Association of periOperative Registered Nurses (AORN) Perioperative Standards and Recommended Practices (2014)• Recommended Practices for Sterilization in Perioperative Practice

Setting• Recommended Practices for Selection and Use of Packaging

Systems for Sterilization

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References

The International Association of Healthcare Central Service Materiel Management

CSSD Dictionary and Reference Guide (2010)




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Thank You!

Next 3M™ Sterile U Web Meeting:

Date: December 11, 2014Title: What a Gas...A Review of Today's Low

Temperature Sterilization Options

hot topics from the 3m tech line webinar 11.20.14 final...

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