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3M Health Care AcademySM

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A Review of Sterilization Methods and Recommended Monitoring Practices for Healthcare Facilities

July 27, 2016



Welcome!

Topic: A Review of Sterilization Methods and Recommended Monitoring Practices for Healthcare Facilities

Facilitators: Lori Hays, 3M Nikki Einerson, 3M

Larry!

© 3M 2016. All Rights Reserved 3

House Keeping

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• Type a question in the question box and click send.

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House Keeping

Continuing EducationEach 1 hour web meeting is approved by IAHCSMM, CBSPD and is 3M Health Care Provider approved by the California Board of Registered Nurses CEP 5770 for one contact hour.

Post webinar email• Link to Course Evaluation• CS Tech CE Certificate Included• Forward eMail to others in attendance


Susan Flynn

Technical Service Specialist

3M Employee

[email protected]

3M Sterilization Techline: 800-441-1922, Option 2

Disclosure


Learning Objectives

1. Discuss the different sterilization methods available in healthcare facilities

2. Describe the recommended practices for routine steam sterilizer efficacy testing

3. Describe the recommended practices for routine low temperature sterilizer efficacy testing

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© 3M 2016. All Rights Reserved© 3M 2015. All Rights Reserved3M Health Care AcademySM

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Discuss the different sterilization methods available in healthcare facilities

© 3M 2016. All Rights ReservedSource: “Guideline for Disinfection and Sterilization in Healthcare Facilities” 2008, CDC.

High efficacyPenetrabilityMaterials compatibility Rapid activityNon-toxicOrganic material resistanceAdaptabilityMonitoring capabilityCost effectiveness

Attributes of the Ideal Sterilant


Steam Sterilization

Image courtesy of Midmark Corporation

OF TERMINAL STERILIZATION IN

HEALTHCARE FACILITIES IS CONDUCTED WITH

STEAM UNDER PRESSURE

75-85%

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• Fast • Highly effective• Reliable• Relatively low cost• Easy to use• Readily available• Technology well understood• No toxicity or hazardous

residues

Steam Sterilization


• Many instruments are heat and/or moisture sensitive and cannot tolerate steam sterilization

• As minimally invasive and robotic surgical procedures increase, the need for low temperature sterilization is also increasing

Low Temperature Sterilization


Low Temperature Sterilization

http://www.quickmedical.com/summit-doppler/handheld-doppler-vascular-obstetrical-fetal-probes.html

Sterilization process using chemical gases or vapors at lower temperatures to process heat and moisture sensitive instruments

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Ethylene oxide

H2O2 gas plasmaH2O2 vaporOzone and H2O2

Low Temperature Sterilization Modalities


Gas at ambient temperature and pressureEO kills by alkylation of macromolecules (nucleic acids, proteins)Typical process temperatures 37ºC to 55ºCTypical exposure times 60 to 120 minutesHighly penetrating; minimal material interactionHealth care facility and industrial applications

Ethylene Oxide (EO, EtO)


100% Ethylene Oxide Sterilizers• EO delivered in single dose cartridges• Relatively smaller chamber sizes• Entire process maintained

in a vacuum• Aeration of load begins automatically

Ethylene Oxide Sterilization Processes

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Ethylene Oxide Aeration

During aeration, heated air is flushed through chamber to remove EO residuals from sterilized items

Consult the medical device manufacturer for recommended aeration times• Material composition of device• Structural composition of device• Intended application of the device


Advantages• Penetrability (lumens, packaging)• Materials compatibility• Cost Effective – Cycle-to-Cycle Basis

Limitations• Cycle time (aeration required)• EPA / OSHA compliance requirements

Ethylene Oxide Sterilization – Advantages and Limitations


Vapor Phase Hydrogen Peroxide (with plasma)

Vaporized Hydrogen Peroxide (without plasma)

Vaporized Hydrogen Peroxide (H2O2) Based Sterilization Systems

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Hydrogen peroxide sterilization• Introduced as a vapor into chamber• Dissociation into chemical radicals (e.g., OH-)• Kills by oxidizing macromolecules • Restrictions on channel length and diameter

Vaporized Hydrogen Peroxide (H2O2)


STERRAD™ NX

STERRAD™ is a registered trademark of Advanced Sterilization Products, a Johnson and Johnson Company.https://www.aspjj.com/us/product/sterilization

Vaporized Hydrogen Peroxide with Plasma

STERRAD™ 100SSTERRAD™ 100NX


Sterilant Containers

http://www.aspjj.com

Vaporized Hydrogen Peroxide with Plasma

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Vaporized Hydrogen Peroxidewithout Plasma

Amsco® V-PRO™ Systems• V-PRO™ 1• V-PRO™ 1 Plus• V-PRO™ Max

–136 liters

• V-PRO™ 60–60 liters

• Typical Process Temperature-- Approx. 50°C

• Typical Process Times- Vary by device to be sterilized- Range 28 minutes to 60 minutes

Amsco® and V-PRO™ are registered trademarks of Steris CorporationAmsco® and V-PRO™ are registered trademarks of Steris Corporation


Vaporized Hydrogen Peroxidewithout Plasma

http://www safmed.co.zahttp://www.hpnonline.comV-PRO™ is a registered trademark of Steris Corporation.


STERIZONE® VP4 Sterilizer

• Dual sterilants: H2O2 and O3

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Critical Process Variables ISO Symbol Sterilization Modality Critical Process Variables

SteamTimeTemperatureMoisture

Ethylene Oxide

TimeTemperatureRelative HumidityEO Concentration

Vaporized Hydrogen Peroxide

TimeTemperatureH2O2 Concentration

ANSI/AAMI/ISO 11140-1:2014 (Mfrs. Standard)



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Describe the recommended practices for routine steam sterilizer efficacy testing



Biological Indicators

Chemical Indicators

Physical Monitors

Sterilization Process Monitoring Tools

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Physical Monitors

Verify that parameters of sterilization cycle are met

• Recording charts

• Gauges

• Tape

• Printouts

• Digital displays

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



Type 1 Process Indicators

Type 2 Indicators for Use in Specific Tests

Type 3 Single Variable Indicators

Type 4 Multi-variable Indicators

Type 5 Integrating Indicators

Type 6 Emulating Indicators

Chemical Indicators

ANSI/AAMI/ISO 11140-1:2014 (Mfrs. Standard) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.2.1




Definition• Test systems containing viable

microorganisms providing a defined resistance to a specified sterilization process

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

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Biological IndicatorsHow they work

• Spores are exposed to the sterilization process• After processing, exposed spores immersed in optimized

recovery media and incubated at optimal temperature• Spore strips are transferred to medium using aseptic

technique• Self-contained designs allow immersion without transfer

Cap Glass Media Ampoule Plastic Sleeve with LabelCap Filter Spore Strip


© 3M 2016. All Rights ReservedANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.7.2.3, 10.7.3.3, 10.7.4.3

Biological Indicators Positive BI Control

Incubate a positive BI control each day that 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 to ensure:

• Correct incubation conditions• Viability of spores• Capability of medium to promote growth• Proper functioning of auto-reader and incubator• Good Science


© 3M 2016. All Rights ReservedANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 2.95

Process Challenge Device (PCD) Definition

“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

“Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process.”

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© 3M 2016. All Rights ReservedANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.4

Process Challenge Device (PCD)

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

•A BI

•A Class 5 Integrating CI

•A BI and 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 sterilization




ANSI/AAMI ST79 Section 10 Quality Control

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 testingTesting of the sterilizer after events occur which could affect the ability of the sterilizer to perform

Periodic product testingTesting of routinely processed items to ensure the effectiveness of the sterilization process and to avoid wet packs

Four levels of testing

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Routine Sterilizer Efficacy Monitoring

Divided into sections

• Sterilizers larger than 2 cubic feet

• Table-top sterilizers

• IUSS sterilization cycles

Photo courtesy of Rose Seavey, The Children's Hospital – Denver

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.7




270-275ºF dynamic-air removal sterilizers(i.e., Prevacuum or vacuum-assisted sterilizers)

Run Bowie-Dick test pack:

• Daily in an empty cycle

• Before BI PCD

• One pack per cycle

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.7.6.1, 10.7.6.3

BD test sheet with uniform color change



Sterilizers larger than 2 cubic feet

Routine Efficacy Monitoring with BI PCD

• AAMI 16-towel pack or commercially available disposable, FDA-cleared BI PCD

• Full load on bottom shelf over drain

• Weekly, preferably daily

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.5.3.2, 10.7.2.1, 10.7.2.2

Tech Service to add photo

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Test each type of cycle with a BI PCD

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





Table-Top SterilizersRoutine 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



IUSS: What cycle should we use for IUSS:Gravity or Dynamic-air-removal? What’s the difference?

“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.”

IUSS Cycles – “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, Section 7.2.2, 8.6.2.1

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Test each type of tray configuration that is used• For sterilizers >2 cubic feet - place the BI PCD on bottom shelf

over the drain in an otherwise, empty chamber

Representative BI PCD using one or more BIs and one or more CIs - empty tray configuration• Rigid sterilization container system• Perforated, mesh bottom, open surgical tray• Protective organizing case• Single-wrapped surgical tray

Routine Efficacy Monitoring with BI PCDIUSS Sterilization Cycles

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.3.2, 10.7.4.1, 10.7.4.2



IUSS AORN DocumentationLog 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)

AORN 2015 Guideline for Sterilization VII.g.1

― 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



What about Implant Loads for IUSS?

“Implantables should not be sterilized for immediate use.” (CDC, 2008)

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, IntroductionAORN 2016 Guideline for Sterilization RP V11.f

“Immediate use steam sterilization should not be used for implantable devices except in cases of defined emergency when no other option is available.” (AORN)

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ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.6.1,10.6.3AORN 2016 Guideline for Sterilization VII.f.1

Only Biological Indicator Results Can Be Used to Release Implants

“Every sterilization load containing implants should be monitored with a PCD containing a BI (a BI challenge test pack). A Class 5 integrating CI should be included in this PCD. Implants should be quarantined until the results of the BI testing are available.” (CDC, 2008)

“When IUSS of an implant is unavoidable, cycle selection should be determined by the manufacturer’s written instructions for use, and a biological indicator and a Class 5 chemical integrating indicator should be run with the load…” (AORN)



IUSS AORN Documentation Implants

A record describing what could have been done to prevent IUSS of the implant should be completed and used as part of a quality monitoring system

A record of IUSS of implants can be helpful in determining problems, trends, or circumstances that can be addressed to prevent IUSS of implants in the future

AORN 2016 Guideline for Sterilization, Rec. VII.g.2



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Describe the recommended practices for routine low temperature sterilizer efficacy testing

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Standards and Guidelinesfor Monitoring Low Temp Sterilizers• ANSI/AAMI ST41: 2008/(R ) 2012

Ethylene oxide sterilization in healthcare facilities: Safety and effectiveness

• ANSI/AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities• Section 9.5 Monitoring gaseous chemical sterilization

processes

• AORN - Guidelines for Perioperative Practice, 2016 Edition• Guideline for Sterilization



Physical Monitors

Chemical Indicators


Sterilization Process Monitoring Tools

Record Keeping



Physical Monitors

Operator should examine the printout/chart to verify cycle parameters were met and then initial

AAMI ST41:2008, Section 10, AAMI ST58, Section 9.5

“At the end of the cycle and before items are removed from the processing equipment, the operator should examine and interpret the printout to verify that cycle parameters were met and should initial it to allow later identification of the operator” (AAMI ST58)

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“Chemical indicators are sterilization process monitoring devices that are designed to respond with a chemical or physical change to one or more of the physical conditions within the sterilizing chamber. Chemical indicators assist in the detection of potential sterilization failures that could result from incorrect packaging, incorrect loading of the sterilizer, or malfunctions of the sterilizer.”

Chemical Indicators

AAMI ST58, Section 9.5.3.1



Chemical Indicators (CIs)

• External chemical indicator should be used on the outside of each package unless the internal indicator is visible

AAMI ST58, Section 9.5.3.2; AAMI ST41, Section 10.5.2.2.1



Chemical Indicators (CIs)

• Internal chemical indicator inside every package, tray, & containment device

AAMI ST58

AAMI ST58, Section 9.5.3.2; AAMI ST41, Section 10.5.2.2.2

“….An internal CI should be used inside each package, tray, containment device (rigid sterilization container system, instrument case, cassette, or organizing tray) to be sterilized. The CI should be placed in that area of the package, tray, or containment device that creates the greatest challenge to sterilant penetration.”

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Definition“Test system containing viable microorganisms and providing a defined resistance to a specified sterilization process.”

Low-temperaturesterilization modality Microorganism (spore) used in BI

EO Bacillus atrophaeusVH2O2 Geobacillus stearothermophilus

AAMI ST41, Section 2.14AORN Guideline for Sterilization, Recommendations XX.h.3, XX.h.4, and XX.h.5



Biological Indicators for Low Temperature Sterilization

Conventional Biological Indicators

Visual pH color change response

Result determined by user after 24 or 48 hours

Rapid Readout Biological Indicators

BI incubated in an auto-reader

Result provided after 4 hours of incubation



Biological Indicators• Run a daily positive control BI• Use a BI that is FDA-cleared to monitor the particular low

temperature sterilization modality• Incubate the BI following the manufacturer’s IFU

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Biological Indicators – VH2O2 (AAMI ST58)

AAMI ST58:2013, Section 9.5.4.3

AAMI ST58 Recommended BI Frequency of Use• “A PCD with the appropriate BI should also be

used at least daily, but preferably in every sterilization cycle”

“Rationale: The condition of the sterilizer equipment, the expertise of the sterilizer operator, and other factors determining the success or failure of a sterilization cycle could vary from one cycle to another”



Biological Indicators – VH2O2 (AAMI ST58)

Routine BI Test Procedure• Label the pouch

• Position pouch as recommended by the sterilizer manufacturer

• Run cycle

• Retrieve BI and incubate per BI manufacturer’s IFU

• Incubate control BI, having the same lot#, each day that test BIs are run

AAMI ST58:2013, Section 9.5.4.5



AAMI ST58:2013Section 9 Quality Control

• Acceptance criteria• Negative result from test BI• Positive result from control BI• Appropriate readings from physical monitors• CI with acceptable end-points

AAMI ST58:2013, Section 9.5.4.5.3

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Biological Indicators – VH2O2 (AORN)• Low-temperature hydrogen peroxide gas plasma sterilizers• Hydrogen peroxide vapor sterilizer

2016 AORN Guideline for Sterilization, Recommendation XX.h.4 and XX.h.5

AORN: “Routine sterilizer efficacy monitoring should be performed at least daily on each cycle type, preferably with

each load…”



BI PCDAAMI routine test pack or commercially available, FDA cleared BI PCD

Full load in centerFrequency: in each load

ANSI/AAMI ST41:2008, Section 10.7

Biological Indicators – EO (AAMI)



Routine Sterilizer Efficacy Monitoring - EO (AAMI)

Acceptance criteria

• Appropriate readings from physical monitors

• Appropriate readings from CIs

• Negative result from BI in PCD

• Positive BI control result

• Run a control BI, with matching lot #, each day

• Document all results in sterilization cycle record

ANSI/AAMI ST41:2008, Section 10

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Biological Indicators – EO (AORN)

2016 AORN Guideline for Sterilization, Recommendation XX.h.3

AORN: “Bacillus atrophaeus biological indicators should be used to test sterilizer efficacy. Sterilizer efficacy testing

should be performed with every load.”



Key LearningsSterilization process monitoring is a fundamental component of sterility assurance

Facility policies and procedures for sterilization process monitoring should be based on the current recommended practices and guidelines from AAMI and AORN

Ensure staff knows how to complete the necessary record keeping

Questions?

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References• ANSI/AAMI ST41: 2008/(R ) 2012

Ethylene oxide sterilization in healthcare facilities: Safety and effectiveness

• ANSI/AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities

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

• AORN - Guidelines for Perioperative Practice, 2016 Edition• Guideline for Sterilization

• Guideline for Disinfection and Sterilization in Healthcare Facilities 2008, CDC



Thank you!

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