ST79: Essentials for ASCs - 3M...

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ST79: Essentials for ASCs

January 21, 2015

© 3M 2015 All Rights ReservedToday’s meeting time: 1 - 2 p.m. CST

2015 All Rights Reserved.© 3M

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DISCLOSURE STATEMENT

Dorothy Larson

Technical Service RepresentativeInfection Prevention Division3M Health Care

Sterilization Tech Line 1-800-441-1922 Option 2

© 3M 2015 All Rights Reserved

Learning Objectives


Discuss AAMI ST79 and the need for the recommended practice.

Discuss the different types of steam sterilization processes and cycle parameters.

Describe the different types of sterilization monitoring devices, including PCDs.

Describe routine load release for implants and non-implants.

ANSI/AAMI ST79Comprehensive guide to steam sterilization and sterility assurance in health care facilities

•A voluntary, nonprofit organization

•Writes recommended practices and standards

•Purpose is to assist health care professions and industry with the use, acceptance, and advancement of medical technology


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ANSI/AAMI ST79Comprehensive guide to steam sterilization and sterility assurance in health care facilities

•Promote Sterility Assurance

•Quality of Care

•Policy and Procedure Development


How do AAMI Standards relate to ANSI and ISO Standards?

ANSI/AAMI•ANSI - American National Standards Institute•Coordinates the development and promotion of U.S. voluntary

standards, representing the U.S. in setting international standards

ANSI/AAMI/ISO•International Standards Organization

•Writes standards that apply across the world


EFFICACY OF STEAM STERILIZATION(AAMI ST79 INTRODUCTION – OVERVIEW)

1 • Lowering and limiting bioburden

2• Appropriately preparing devices

3 • Selecting the correct sterilization parameters

4• Maintaining the sterility of sterilized items until used

Why is the AAMI ST79 Recommended Practice needed?


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• Types of steam sterilization processes• Cycle parameters• Terminal and Immediate Use Steam Sterilization


Types of Steam Sterilization Processes• GRAVITY DISPLACEMENT

– Incoming steam displaces residual air through a port or drain in or near the bottom of the sterilizer chamber

• DYNAMIC-AIR-REMOVAL

Prevaccuum

» Series of pressure and vacuum excursions

Steam-flush pressure-pulse (SFPP)

» Series of steam flushes and pressure pulses above atmospheric pressure

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 2.25, 2.26 © 3M 2015 All Rights Reserved

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Cycle Selection: Gravity or Dynamic-air-removal

“The reusable medical device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized.”

“The written IFU of the device manufacturer should always be followed.”

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 7.2.2 © 3M 2015 All Rights Reserved

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Healthcare Facility ResponsibilityOBTAIN AND ADHERE TO MANUFACTURER’S WRITTEN

INSTRUCTIONS

• Cleaning

• Cycle type

• Exposure time

• Temperature

• Drying time (if recommended)

Reconcile cycle parameter differences between the Sterilizer Manufacturer, Device Manufacturer, and Packaging Manufacturer

AORN RP for Sterilization in Perioperative Practice Setting, RP VI.b. and VII.a.2. © 3M 2015 All Rights Reserved

Section 8.6 Sterilization Parameters


ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 8.6

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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Immediate-Use Steam Sterilization (IUSS)

• 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 term Immediate Use Steam Sterilization (IUSS)


http://www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdfANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013

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• Agreed on terminology transition from “Flash Sterilization” to the term Immediate Use Steam Sterilization (IUSS)• 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.pdfANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013



“Process designed for the cleaning, steam sterilization, and delivery of patient care items for immediate use. Previously known as flash sterilization.”

Little or No dry time

No storage Item(s) transferred immediately to the point of use

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 2.61, 8.6.2.1, and IntroductionAORN RP for Sterilization in Perioperative Practice Setting, RP VII

Sterilization of unwrapped trays of instruments for immediate use is not recommended.“Implantables should not be sterilized for immediate use (CDC, 2008).”

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“Unless a device manufacturer specifically recommends the use of gravity cycles, dynamic air removal cycles should be the cycle of choice.” (8.6.2.1)


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

Immediate-Use Steam Sterilization (IUSS)AORN RP for Sterilization“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.)


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

CMS and IUSS2014 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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• Sterilization Process Monitoring Devices• Process Challenge Devices• Documentation


Quality control recommended practices• 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)


Sterilization Process Monitoring


Goal of Sterilization Process:

To kill microorganisms

You can’t see sterility!

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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


Critical VariablesCritical Variables

• Parameters identified as being essential to the sterilization process (and required monitoring)

• For example, the critical variables for steam sterilization to be effective are:

Time Temperature Steam

ANSI/AAMI/ISO 11140-1:2005/(R)2010 (Mfrs. Standard)


Physical Monitors

Verify that parameters of sterilization cycle are met• Recording charts, Gauges

• Printouts

• Digital displays

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

Limitations• Generally only monitor one

location in the sterilizer• Conditions not revealed in the

temperature recording, such as:

• Improper packaging

• Improper loading procedures

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

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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

Sterilizers that do not have recording devices should not be used.

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


Chemical Indicator Classifications

CLASS 1 PROCESS INDICATORS – EXTERNAL CI

CLASS 2 INDICATORS FOR USE IN SPECIFIC TESTS

INTERNAL CIS: CLASS 3, 4, 5, 6

CLASS 3 SINGLE VARIABLE INDICATORS

CLASS 4 MULTI-VARIABLE INDICATORS

CLASS 5 INTEGRATING INDICATORS

CLASS 6 EMULATING INDICATORS

Ref: ANSI/AAMI/ISO 11140-1, 2005 Sterilization of health care products-Chemical indicators -Part 1: General requirements

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.2.1


Chemical IndicatorsCLASS 1: PROCESS INDICATORSEXPOSURE CONTROL (E.G., INDICATOR TAPES)

Use 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


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Chemical Indicators

CLASS 2: INDICATORS FOR SPECIFIC TESTS

TESTING STERILIZER PERFORMANCE

Bowie-Dick Test monitors efficacy of air

removal and steam penetration in 270-275°F

vacuum assisted sterilizers

BOWIE-DICK TESTS CAN DETECTAir leaks, Inadequate air removal, Inadequate steam penetration, Presence of non-condensable gases (air or gases from boiler additives)



Bowie-Dick Test


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

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Chemical Indicators – Internal CIsCLASS 3: SINGLE VARIABLE INDICATORS (INTERNAL CIS)

Designed to react to one of the critical variables

Indicates exposure to a sterilization process at a stated value (SV) of the chosen variable

Do not provide as much information as Class 4, 5, or 6

CLASS 4: MULTI-VARIABLE INDICATORS (INTERNAL CIS)

• Designed to react to two or more of the critical variables

• Indicates exposure to a sterilization cycle at stated values of the chosen variables



Chemical Indicators – Internal CIsCLASS 5: INTEGRATING INDICATORS (INTERNAL CIS)

• Designed to react to all critical variables • Stated values equivalent to the performance requirements for BIs (ISO 11138 series: 2006)

• Testing conducted in a resistometer, under ideal saturated steam sterilization conditions

• Response must correlate to a BI at three time/temperature relationships • 250°F/121°C, 275°F/135°C, and at one or more temperatures in

between• Stated value at 250°F/121°C must be >16.5 min

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 &A3:2012 & A4:2013, Section 10.5.2.1


Chemical Indicators CLASS 6: EMULATING INDICATORS (INTERNAL CIS)

–Designed to react to all critical variables

–Stated value generated from the critical variables of the specific sterilization process

–Cycle verification indicators

“Class 6 emulating indicators are cycle-specific; that is, they should be used only in the specific cycles for which they are labeled.”

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.2.1 and 10.5.2.2

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Biological Indicators

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 2.7

Definition• Test systems containing viable microorganisms providing a

defined resistance to a specified sterilization process

Biological IndicatorsWith enzyme-based early-readout (AAMI)

• Fluorescence in 30 minutes to 3 hours• Visual color change in 24 to 48 hours

Conventional• Visual color change in 10 - 48 hours

Manufacturer’s incubation instructions should be followedANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.3.1“Periodic verification of the early-readout with spore growth should be performed in accordance with the manufacturer’s instructions and facility policy and procedures.”

Biological Indicators - Positive BI ControlIncubate a positive BI control each day a test vial is incubated in each incubator or auto-reader

• From same lot number as test BI

Purpose is to verify the test system is working and ensure• Correct incubation conditions

• Viability of spores

• Capability of medium to promote growth

• Proper functioning of auto-reader and incubator

Good Science

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.7.2.3, 10.7.3.3, 10.7.4.3

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Process Challenge Device (PCD) Definition“Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process.”

• ‘Process challenge device’ is used in place of ‘test’ or ‘challenge pack’ in AAMI ST79

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, Section 2.95© 3M 2015 All Rights Reserved

Process Challenge Device (PCD)

Depending on the application (type of testing being done) the PCD may contain…

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.4

A BI A BI & a Class 5 Integrating CI

A Class 5 Integrating CI

A Class 6 Emulating CI


Process Challenge Device (PCD)• User assembled

• Challenge test pack or tray (e.g., AAMI 16-towel pack, IUSS containment device)

• Commercially available, FDA Cleared• Not available for IUSS

• Not available for Table-top sterilizers

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.4© 3M 2015 All Rights Reserved

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Documentation“Documentation demonstrates compliance with regulatory

and accrediting agency requirements and identifies trends and quality improvement opportunities.”

AORN Recommended Practices for Sterilization in Perioperative Practice Setting RP XVIII

Documentation

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.3.2

• Sterilizer and load records• Load contents• Date and time of cycle• Exposure time and temperature• Initials of operator• Biological results• Chemical indicator results

• Records of sterilizer repair, maintenance and calibration

• Maintain records for time determined by risk manager


IUSS Sterilization AORN Documentation• Log or database to trace sterilized items used on patients should include:• Information on each load

• Item(s) processed• Patient on whom the items were used• Type of cycle (e.g., gravity-displacement, dynamic-air-removal)• Cycle parameters used (e.g., temperature, duration of cycle)• Monitoring results• Day and time cycle was run• Operator information (i.e., person who initiated the cycle, person who

retrieved the item from the sterilizer)• Reason for IUSS

AORN Recommended Practices for Sterilization in Perioperative Practice Setting RP VII.g.1.© 3M 2015 All Rights Reserved

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•Load Release – Nonimplants and Implants•Testing a Combination Sterilizer•Routine Efficacy Monitoring



• Physical monitors• External process indicator (Class 1) on every package• Internal CI (Class 3, 4, 5 or 6) inside every package• Optional monitoring of load with a PCD containing a

• BI• BI and a Class 5 CI • Class 5 integrating indicator• Class 6 emulating indicator

• Evaluation of all data by an experienced, knowledgeable person• Do not distribute load if any data suggests a sterilization process failure

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.6.1,10.6.2

Routine Load Release Nonimplants


• Physical monitors• External process indicator (Class 1) on every package• Internal CI (Class 3, 4, 5 or 6) inside every package• A PCD containing a BI and a Class 5 integrating indicator

- Class 6 CI in a PCD may be used in addition to the BI PCD

• Evaluation of all data by an experienced, knowledgeable person• Do not distribute load if any data suggests a sterilization process failure

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.6.1,10.6.2

Routine Load Release Implants

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Routine Sterilizer Efficacy Monitoring“Combination” sterilizer - Example

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

Which cycles should be routinely monitored with a BI PCD?


Combination Sterilizer – Sterilizers > 2 cu. ft.EXAMPLE, Cont.

Bowie-Dick Test Pack - (prevacuum)Run empty-chamber warm-up cycle first, to pre-heat the chamber.

Empty chamber

IUSS cycle: BI PCD - Place a BI inside container, along with a CI

No instrumentsEmpty chamber

Terminal cycles: BI PCD First load(Each different cycle type)

Implant Loads: Include PCD that contains a BI + Class 5 CI

Implantloads

Frequency of Monitoring with a BI PCD: Weekly, preferably daily, AAMI ST79 Section 10 - Table 6


Table-Top Steam Sterilizers• ROUTINE EFFICACY MONITORING WITH A BI PCD

• Representative of the package or tray routinely processed• Most difficult to sterilize

• Contains items normally present during routine sterilization• Full load in cold point (check with sterilizer Mfr.)• Bowie-Dick Test – Check with Sterilizer Manufacturer

Frequency of Monitoring with a BI PCD: Weekly, preferably daily, AAMI ST79 Section 10 - Table 6

Routinely Process: User-assembled BI PCD:

Peel pouches BI + CI inside peel pouch

Wrapped instruments BI + C inside wrapped tray

Peel pouchesWrapped instruments

BI + CI inside wrapped tray

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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 PCDFrequency of Monitoring with a BI PCD: Weekly, preferably daily

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.5.3.2, 10.6.1,10.6.2, 10.7.3.1, 10.7.3.2, 10.7.4.1, 10.7.4.2


Key Learnings:

According to ANSI/AAMI ST79, for sterilizers larger than 2 cubic feet, routine sterilizer efficacy monitoring with a BI PCD is done in a/an ___________ chamber.

According to ANSI/AAMI ST79, for immediate-use steam sterilization, routine sterilizer efficacy monitoring with a BI PCD is done in a/an _______ chamber.

Facility policies and procedures on sterilization process monitoring should be based on the recommended practices and guidelines from AAMI, AORN, and the CDC.

Take the time to do proper documentation.

fully loaded

empty


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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


How to Purchase AAMI Standards for Your Reference Library

• AAMI documents can be purchased through AAMI by credit card using the following four options:

• Internet: http://marketplace.aami.org • Call: 1-877-249-8226• Fax: 301-206-9789• Mail: AAMI Publications, P.O. Box 0211, Annapolis Junction, MD 20701-0211


References• Centers for Medicare & Medicaid Services

• Center 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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