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21/07/2016
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3M Health Care AcademySM
© 3M 2016. All Rights Reserved
3M Business Name
A Review of Sterilization Methods and Recommended Practices for Healthcare Facilities PART II:Terminal Low Temperature Sterilization
July 21, 2016
3M Health Care AcademySM
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Welcome!
Topic: A Review of Sterilization Methods and Recommended Practices for Healthcare Facilities PART II: Terminal Low Temperature Sterilization
Facilitators: Christophe de Campeau, 3M Ryan Rozinka – 3M
Larry!
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House Keeping
From the GoToWebinar page:• Click on the orange box with a
white arrow to expand your control panel (upper right-hand corner of your screen).
• 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
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Susan Flynn
Technical Service Specialist
3M Employee
3M Sterilization Techline: 800-441-1922, Option 2
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Learning Objectives
1. Discuss the low temperature sterilization methods available in healthcare facilities
2. Discuss the different types of sterilization monitoring tools
3. Describe the recommended practices for routine lowtemperature sterilizer efficacy testing
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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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• 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
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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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© 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
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Ethylene oxide
H2O2 gas plasmaH2O2 vaporOzone and H2O2
Low Temperature Sterilization Modalities
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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)
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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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Time (Hours)
Condition Exposure Exhaust Aerate
Cha
mbe
r Pre
ssur
e
Negative Pressure
100% Ethylene Oxide Cycle
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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
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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
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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)
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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
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Sterilant Containers
http://www.aspjj.com
Vaporized Hydrogen Peroxide with Plasma
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Typical Process Temperatures• ≤ 55°C
Typical Process Times• Range: 24 minutes to 55 minutes
Chamber size• 30 liters to 142 liters
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
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Vaporized Hydrogen Peroxidewithout Plasma
http://www safmed.co.zahttp://www.hpnonline.comV-PRO™ is a registered trademark of Steris Corporation.
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Critical Process Variables ISO Symbol Sterilization Modality Critical Process
Variables
Ethylene OxideTimeTemperatureRelative HumidityEO Concentration
Vaporized Hydrogen PeroxideTimeTemperatureH2O2 Concentration
ANSI/AAMI/ISO 11140-1:2014 (Mfrs. Standard)
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STERIZONE® VP4 Sterilizer
• Dual sterilants: H2O2 and O3
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Discuss the different types of sterilization monitoring tools and their recommended use
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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
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Physical Monitors
Chemical Indicators
Biological Indicators
Sterilization Process Monitoring Tools
Record Keeping
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Physical Monitors
• Time, temperature, and pressure recorders
• Displays• Digital printouts• Gauges
AAMI ST58, Section 9.5.2.1
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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
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Chemical Indicators (CIs)
AAMI ST58
AAMI ST58:2013, Section 9.5.3.2
“NOTE---Chemical indicators used in health care facilities are medical devices that require FDA premarket clearance. The intended use statement in the labelling of the CI should specify the sterilization methods and systems with which it can be used.”
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Biological Indicators
Description“Biological indicators consist of viable spores in or on a carrier, sometimes (as in the case of self-contained BIs) accompanied by incubation media. Biological indicators provide the only direct measure of the lethality of the sterilization process.”
AAMI ST41, Section 10.5.3.1
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Biological Indicators
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 stearthermophilus
AAMI ST41, Section 2.14AORN Guideline for Sterilization, Recommendations XX.h.3, XX.h.4, and XX.h.5
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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• Self-contained BI allows immersion without transfer
Cap Glass Media Ampoule Plastic Sleeve with LabelCap Filter Spore Strip
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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
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Rapid Readout Technology – VH2O2 BI
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Rapid Readout Technology – VH2O2 BI
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Rapid Readout Technology – VH2O2 BI
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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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Describe the recommended practices for routine low temperature sterilizer efficacy testing
3M Health Care AcademySM
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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
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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 (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
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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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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”
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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
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AAMI ST58:2013Section 9 Quality Control
• Daily control BI
• 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…”
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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)
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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.”
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Routine Sterilizer Efficacy Monitoring GuidanceLow Temperature Sterilizers
Sterilization Modality AAMI AORN
Ethylene Oxide (EO) PCD with BI in every load
BI used in every load (XX.h.3)
Hydrogen Peroxide (H2O2) Gas Plasma
Sterilizer
PCD with BI daily but preferably every cycle
At least daily on each cycle type, preferably with each
load (XX.h.4)
Hydrogen Peroxide (H2O2) Vapor Sterilizer
PCD with BI daily but preferably every cycle
At least daily on each cycle type, preferably with each
load (XX.h.5)
AAMI– Association of Advancement Medical Instrumentation AAMI ST41:2008(R)2012 & AAMI ST58:2013AORN - 2016 Edition Guidelines for Perioperative Practice. Guideline for Sterilization.
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Key LearningsLow temperature sterilizers are essential for reprocessing critical devices that cannot tolerate steam sterilization
Facility policies and procedures for low temperature sterilizer 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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Next Live Webinar
Date: Thursday August 18, 2016
Title: An Anatomy of Liquid Disinfectants, Liquid Chemical Sterilants, and Terminal Sterilization with Ethylene Oxide
Register: www.mmm.com/IPEd
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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
• AORN - Guidelines for Perioperative Practice, 2016 Edition• Guideline for Sterilization
• Guideline for Disinfection and Sterilization in Healthcare Facilities 2008, CDC