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
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
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)
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
“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)
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)
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
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)
“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.”
“….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
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
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
