Hot Topics from the 3M Tech Line Webinar 11.20.14 FINAL …multimedia.3m.com/.../hot-topics-from-the-3m-tech-line-handouts.pdf · 12/11/2014 · Topic: Hot Topics from the 3M Tech
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• 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)
SITUATION: Cycle programmed for 270 deg. F., 4-minutes exposure, per written instructions from the Medical Device Manufacturer
Maximum temperature reached 269.9 deg. F.
Bowie-Dick Test passed- Bowie-Dick: Test - a daily test run in prevacuum sterilizers to evaluate the efficacy of a vacuum system to remove residual air from the chamber
BI PCD: Negative BI
The temperature for a cycle was not achieved, but the biological indicator in the load passed. Can we release the load?
What if the desired temperature for a cycle was not achieved?
Physical monitors (10.5.1) "If the interpretation of the physical monitors suggests inadequate steam processing, the contents of the load should not be dispensed or used.”
Acceptance criteria (10.7.4.4) “An acceptable process is evidenced by negative results from all BIs in the PCD and appropriate readings from physical monitors and CIs, showing that the sterilization cycle was correct and complete.”
Multi-society Position Statement on Immediate-Use Steam Sterilization (IUSS)
Evolution of flash sterilization
“Immediate use” is broadly defined as the shortest possible time between a sterilized item’s removal from the sterilizer and its aseptic transfer to the sterile field. Immediacy implies that a sterilized item is used during the procedure for which it was sterilized and in a manner that minimizes its exposure to air and other environmental contaminants. A sterilized item intended for immediate use is not stored for future use, nor held from one case to another.“
Multi-society Position Statement on Immediate-Use Steam Sterilization (IUSS)
Evolution of flash sterilization “Sterilization process monitoring is essential to ensure that sterilization practices are efficacious.”
Sterilization personnel should be educated regarding the different types of steam sterilizers and types of steam sterilization cycles.
“Sterilization cycles with little or no dry time are efficacious when used in compliance with validated written instructions provided by the device manufacturers, sterilization equipment manufacturers, and (if applicable) container manufacturers and when done in accordance with professional guidelines.”
“Process designed for the cleaning,steam sterilization, and delivery of patient care items for immediate use. Previously known as flash sterilization.”
Gravity or dynamic-air-removal Little or No dry time No storage Item(s) transferred immediately to the point of use
“Implantables should not be sterilized for immediate use (CDC, 2008).”
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
AORN Recommended Practices for Sterilization in Perioperative Practice Setting
Immediate Use Steam Sterilization (IUSS)• “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.)
2014 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
We use our large steam sterilizer for running both terminal loads and immediate use cycles. How should the daily testing be done in this “combination” sterilizer?
“Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process.”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
Section 10 Quality control Using the appropriate PCD, in the appropriate manner for the size and type of sterilizer, is critical to successful and accurate results. (10.7)
“NOTE - If a sterilizer will run the same type of cycle (e.g., dynamic-air-removal at 132ºC to 135ºC [270ºF to 275ºF] for different exposure times (e.g., 4 minutes and 10 minutes), then only the shortest cycle time needs to be tested.”
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
According to ANSI/AAMI ST79, for sterilizers larger than 2 cubic feet and for table-top sterilizers, routine sterilizer efficacy monitoring with a biological indicator process challenge device is done in:
According to ANSI/AAMI ST79, for immediate-use steam sterilization, routine sterilizer efficacy monitoring with a biological indicator process challenge device is done in:
SterilizerRepairs outside the scope of normal maintenance Examples:•Weld repairs of pressure
vessel•Replacement of chamber
door or piping assembly•Rebuilds or upgrades of
controls
UtilitiesChanges to the utilities connected to the sterilizerExamples:•Water-main break•Annual boiler maintenance•Additional equipment loads•Installation of new boilers
“Chemical indicators verify that one or more conditions necessary for sterilization have been achieved within the package and/or at a specific location within the load.”
Process IndicatorsUse 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
“Peel pouches should not be used within wrapped sets or containment devices unless the pouch manufacturer can supply documented validation for this practice.”
“The impervious plastic side of a peel pouch in contact with devices within sets may prevent sterilant from contacting the devices.”*
*AORN RP for Selection and Use of Packaging Systems for Sterilization, Recommendation VII.bANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 8.3.4
New tools to help investigate wet packs and loadsTable P.1 Moisture Assessment ChecklistProcessingClinical PracticeSet and Load Content and ConfigurationSterilizer Process
Sterilizer or Utility MalfunctionsBoiler SystemSteam Delivery System (Piping)Sterilizer PerformanceEnvironmental Issues
Wet packs should not be released for use Repackage, replace chemical indicators (CIs)
Disposable products (e.g. gauze or cotton balls) should be discarded
Review the sterilizer cycle conditions Drying cycle length and temperature Set contents, weight, & density (especially metal mass) Loading of the sterilizer and position of wet pack
Reprocess after detecting the error or probable cause of the wet pack
Perform process audits to ensure adherence to packaging procedures
• 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
• 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