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
High efficacyPenetrabilityMaterials compatibility Rapid activityNon-toxicOrganic material resistanceAdaptabilityMonitoring capabilityCost effectiveness
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
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
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
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
“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.”
“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.”
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.”
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
“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)
“….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.”
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”
• Acceptance criteria• Negative result from test BI• Positive result from control BI• Appropriate readings from physical monitors• CI with acceptable end-points
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.
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
