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Immediate-Use Steam Sterilization. Continuing Education Contact Hours. Participants must complete the entire presentation/seminar to achieve successful completion and receive contact hour credit. Partial credit will not be given.
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Continuing Education Contact Hours • Participants must complete the entire presentation/seminar to achieve successful completion and receive contact hour credit. Partial credit will notbe given. • All of the presenters are employees of STERIS Corporation and receive no direct compensation other than their normal salaries for participation in this activity. • STERIS Corporation is an approved provider of continuing nursing education by the California Board of Registered Nursing, provider number CEP 11681 for 1 contact hour along with IAHCSMM and CBSPD. • STERIS Corporation is providing the speakers and contact hours for this activity. However, products referred to or seen during this presentation do not constitute a commercial support by the speakers.
Learning Objectives • Discuss appropriate handling of instruments sterilized for immediate-use steam sterilization • Describe recommended monitoring and record keeping
Immediate-Use Steam Sterilization • Intended for emergency use only • Immediate patient use • To process single items
Large Trays and Multiple Trays not Recommended • Heat up time • Total cycle time • Instrument cooling time • Risk of contamination during transfer
Cycles for Immediate-Use Steam Sterilization • Gravity commonly known as “flash” cycle • Dynamic Air Removal (Prevacuum) • Express
Phases of Immediate-Use Steam Sterilization • Conditioning phase • Sterilization phase • Exhaust phase
Gravity Cycle • Inefficient passive process • Uses gravity in conditioning and exhaust • Steam displaces air in the chamber by gravity • Dry time not necessary
Gravity Exposure Parameters • Non-Porous Cycle • All metal items only • Non-lumen items •Minimum Exposure Time • 3 Minutes at 270° F (132° C)
Gravity Exposure Parameters • Porous Cycle • Mixed materials • Lumen/cannulated items •Minimum Exposure Time • 10 Minutes at 270° F (132° C)
Prevacuum Cycle • More efficient method of air removal from the chamber • Uses mechanical process of four steam injections and vacuum pulses in conditioning phase • Added when more complex devices manufactured
Prevacuum Exposure Parameters • Porous and non-porous • Mixed material items • Lumen/cannulated item •Minimum Exposure Time • 4 Minutes at 270° F (132° C) • 3 Minutes at 275° F (134° C)
Gravity vs. Prevacuum Gravity Prevacuum
(Association for the Advancement of Medical Instrumentation) • Addresses safe and effective immediate-use steam sterilization processes • Always follow manufacturer’s instructions for use • Work practices include proper decontamination • Immediate transfer using aseptic technique • ANSI/AAMI ST79:2010
(Association of periOperative Nurses) • Use of closed sterilization container or tray • Used only when there is insufficient time to process by the preferred wrapped or container method • Should not substitute for insufficient instrument inventory • AORN Perioperative Standards and Recommended Practices, 2010
Appropriate Work Practices • Scenario #1: Dr. Kool has his specialty instruments that he brings in from his office for every procedure. What is the first thing that you do with his instrumentation?
Scenario #2 • Dr. Kool’s gold-plated microscissors took a dive off the sterile field, tips down. Because there is only one pair of these gold-plated microscissors, what is your next step? The sterile processing department is on the third floor and you are on the first floor.
During Decontamination •Protect yourself • Use enzymatic cleaners and detergents • Rinse instruments thoroughly
Decontamination of Instruments • Refer to manufacturer instructions • Manual or mechanical • Appropriate brushes
Preparation for Sterilization • Inspect instruments • Position for proper air removal • Flush lumens vs. non-flushed lumens
Appropriate Containers • Rigid containers approved for immediate-use steam sterilization • Follow manufacturer’s instructions for use • Perforated or mesh bottom trays
Sterilizer to Point-of-Use Transfer • Excellent aseptic technique • Path of transport • Strict traffic control
Quality Assurance Monitoring • Physical Monitoring • Chemical indicators • Biological indicators
Physical Monitoring • Real time assessment of sterilization cycle • Check before and after each cycle • Provides earliest detection of malfunction • Legal documents
Chemical Monitoring • Chemical indicators do not verify sterilization • Indicates exposure to the sterilizing process • Minimum recommendation of one chemical indicator per tray • Chemical indicators not considered porous
Chemical Monitoring Six Classes of Chemical Indicators (Defined by AAMI, based on specificity) Class 1 – Process Indicators Class 2 – Indicators for use in specific tests (Bowie-Dick) Class 3 – Single parameter indicators Class 4 – Multi-parameter indicators Class 5 – Integrating indicators Class 6 – Emulating indicators
Residual Air Removal Test Class 2 Indicator: Bowie-Dick Test • Checks air removal system/air leaks • Performed on prevacuum cycles only
Class 5 Integrator • Front moving chemical indicator • Monitors all critical variables of sterilization • Correlated to BI • Monitors more of the sterilization cycle than a BI
Class 6 Emulator • Responds to all critical variables • Performance correlated to the sterilization cycle • Monitors more of sterilization cycle
Biological Monitoring • Test BI • Control BI • Positive BI • Procedure
What About Implants? • FDA: • … a device that is placed into a surgically or naturally formed cavity of the human body… intended to remain for a period of one year or more is an implantable device. “ ”
AAMI and AORN Agree and State: “ Flash sterilization of IMPLANTABLE devices is not recommended: however, if it is unavoidable, full traceability to the patient shall be maintained. AAMI ST79:2010 ”
Releasing Implants with BI If the implants are released from quarantine before the outcome of the BI monitor is known: •Documentation of premature release of implants must be kept •Exception form for premature release of implantable devices/ trays must be completed
Example Documentation form for premature release of implantable devices AAMI ST79:2010
Example Exception form for premature release of implantable devices. AAMI ST79:2010
Immediate-Use Steam Sterilization Documentation • Epidemiological tracking • Traceability of sterilization cycle to patient • Ongoing assessment of items flash sterilized
Documentation • Recommended documentation for each cycle • Patient’s name • Contents of the sterilization load • Type of sterilization cycle used • Cycle parameters • Staff person’s signature
Action Plan • Appropriate work practices are utilized • Audit plan to monitor practice • Yearly education review
Evaluation and Registration • Thank you for attending this CE activity. • Please complete and submit the evaluation form. • For more information on the CE credentialed programs offered, go to http://university.steris.com
References • Comprehensive guide to steam sterilization and sterility assurance in health care facilities; Association for the Advancement of Medical Instrumentation, ANSI/AAMI ST79:2010 Arlington, VA. • Standards Recommended Practices and Guidelines; Recommended Practices for Sterilization in the Perioperative Practice Setting, Association of Perioperative Registered Nurses (AORN) (Denver, CO: AORN, 2010). • Central Service Technical Manual, 7th Edition, IAHCSMM (International Association of Healthcare Central Service Materiel Management), 2007.
Express Cycle • Metal instruments ONLY (non-porous) • NO LUMENS, no mixed materials • NO complex medical devices • Single wrap – reusable or disposable • Wrapper protects sterile goods during transfer • Transfer aseptically • Wear sterile gloves to transfer • No shelf life
Express Cycle Parameters • Preset by manufacturer • 5 Minutes conditioning time • 4 Minutes at 270° F (132° C) • 3 Minutes dry time • Total cycle time = 12 minutes