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DISCLOSURE STATEMENT
Dorothy Larson
Technical Service RepresentativeInfection Prevention Division3M Health Care
Multi-society Position Statement on Immediate-Use Steam Sterilization (IUSS)EVOLUTION OF FLASH STERILIZATION• “Immediate use” i.e. item is removed from sterilizer and aseptically transferred to the sterile field• Agreed on terminology transition from “Flash Sterilization” to the term Immediate Use Steam Sterilization (IUSS)• Personnel should be knowledgeable and competent • Standardized practices should be implemented• Critical reprocessing steps (cleaning, decontamination, and aseptic transport) must be followed• Device manufacturer's written reprocessing instructions should be followed
“Process designed for the cleaning, steam sterilization, and delivery of patient care items for immediate use. Previously known as flash sterilization.”
Little or No dry time
No storage Item(s) transferred immediately to the point of use
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 2.61, 8.6.2.1, and IntroductionAORN RP for Sterilization in Perioperative Practice Setting, RP VII
Sterilization of unwrapped trays of instruments for immediate use is not recommended.“Implantables should not be sterilized for immediate use (CDC, 2008).”
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Immediate-Use Steam Sterilization (IUSS)
“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)
Immediate-Use Steam Sterilization (IUSS)AORN RP for Sterilization“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.)
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
CMS and IUSS2014 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
BOWIE-DICK TESTS CAN DETECTAir leaks, Inadequate air removal, Inadequate steam penetration, Presence of non-condensable gases (air or gases from boiler additives)
• Fluorescence in 30 minutes to 3 hours• Visual color change in 24 to 48 hours
Conventional• Visual color change in 10 - 48 hours
Manufacturer’s incubation instructions should be followedANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.3.1“Periodic verification of the early-readout with spore growth should be performed in accordance with the manufacturer’s instructions and facility policy and procedures.”
Biological Indicators - Positive BI ControlIncubate a positive BI control each day 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 ensure• Correct incubation conditions
Process Challenge Device (PCD) Definition“Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process.”
• ‘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
• Sterilizer and load records• Load contents• Date and time of cycle• Exposure time and temperature• Initials of operator• Biological results• Chemical indicator results
• Records of sterilizer repair, maintenance and calibration
• Maintain records for time determined by risk manager
IUSS Sterilization AORN Documentation• Log 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)• 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
• Physical monitors• External process indicator (Class 1) on every package• Internal CI (Class 3, 4, 5 or 6) inside every package• Optional monitoring of load with a PCD containing a
• BI• BI and a Class 5 CI • Class 5 integrating indicator• Class 6 emulating indicator
• Evaluation of all data by an experienced, knowledgeable person• Do not distribute load if any data suggests a sterilization process failure
• Physical monitors• External process indicator (Class 1) on every package• Internal CI (Class 3, 4, 5 or 6) inside every package• A PCD containing a BI and a Class 5 integrating indicator
- Class 6 CI in a PCD may be used in addition to the BI PCD
• Evaluation of all data by an experienced, knowledgeable person• Do not distribute load if any data suggests a sterilization process failure
Table-Top Steam Sterilizers• ROUTINE 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
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
Routine Efficacy Monitoring with a BI PCDFrequency of Monitoring with a BI PCD: Weekly, preferably daily
According to ANSI/AAMI ST79, for sterilizers larger than 2 cubic feet, routine sterilizer efficacy monitoring with a BI PCD is done in a/an ___________ chamber.
According to ANSI/AAMI ST79, for immediate-use steam sterilization, routine sterilizer efficacy monitoring with a BI PCD is done in a/an _______ chamber.
Facility policies and procedures on sterilization process monitoring should be based on the recommended practices and guidelines from AAMI, AORN, and the CDC.
References• 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