Immediate-Use Steam Sterilization
Dec 17, 2015
• Participants must complete the entire presentation/seminar to achieve successful completion and receive contact hour credit. Partial credit will not be 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.
Continuing Education Contact Hours
Learning Objectives
• Discuss appropriate handling of instruments sterilized for immediate-use steam sterilization
• Describe recommended monitoring and record keeping
AUTOCLAVE CYCLES
TYPEEXP TIME
TEMPDRY TIME
CYCLE ITEM
PRE-VAC 3 273 0 P1 Bowie Dick
PRE-VAC 10 270 1 P2
Ortho, Neuro, Spine implants; Pans of inst; Instruments w/lumens; plastic; rubber; ACMI cysto sets;
ACMI rigid ureteroscopes
PRE-VAC 4 270 8 P3Saws; Drills; Midas; Anspach;
Morcellator; Dermatome; Mesher; Sinus micro-debrider
PRE-VAC 4 270 1 P4 Batteries; CUSA; Bone Mill
PRE-VAC 5 270 4 P5Arthrex shaver hand pieces;
Harmonic hand piecesGRAV 10 270 1 P6 DeMayo knee positioner
DO NOT FLASH--USE STERIS OR MEDIVATOR
Storz cameras, light cords, flexible scopes, fiberoptic breast retractor
02/2010 lgr
Immediate-Use Steam Sterilization
• Intended for emergency use only
• Immediate patient use
• To process single items
• Heat up time
• Total cycle time
• Instrument cooling time
• Risk of contamination during transfer
Large Trays and Multiple Trays not Recommended
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)
• 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 for the Advancement of Medical Instrumentation)
• 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
(Association of periOperative Nurses)
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
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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
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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
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
“ ”
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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
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
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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