0. Immediate-Use Steam Sterilization

1. 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.
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 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.

2. Learning Objectives
Discuss appropriate handling of instruments sterilized for immediate-use steam sterilization
Describe recommended monitoring and record keeping

3. AUTOCLAVE CYCLES TYPE EXP TIME TEMP DRY TIME CYCLE ITEM PRE-VAC 3 273
AUTOCLAVE CYCLES 
TYPE
EXP TIME
TEMP
DRY TIME
CYCLE
ITEM
PRE-VAC 3
273 P1
Bowie Dick 10
270 1 P2
Ortho, Neuro, Spine implants; Pans of inst; Instruments w/lumens; plastic; rubber; ACMI cysto sets; ACMI rigid ureteroscopes 4 8 P3
Saws; Drills; Midas; Anspach; Morcellator; Dermatome; Mesher; Sinus micro-debrider P4
Batteries; CUSA; Bone Mill 5 P5
Arthrex shaver hand pieces; Harmonic hand pieces
GRAV P6
DeMayo knee positioner
DO NOT FLASH--USE STERIS OR MEDIVATOR
 Storz cameras, light cords, flexible scopes, fiberoptic breast retractor
02/2010 lgr

4. Immediate-Use Steam Sterilization
Intended for emergency use only
Immediate patient use
To process single items

5. Large Trays and Multiple Trays not Recommended
Heat up time
Total cycle time
Instrument cooling time
Risk of contamination during transfer

6. Cycles for Immediate-Use Steam Sterilization
Gravity commonly known as “flash” cycle
Dynamic Air Removal (Prevacuum)
Express

7. Phases of Immediate-Use Steam Sterilization
Conditioning phase
Sterilization phase
Exhaust phase

8. Gravity Cycle Inefficient passive process
Uses gravity in conditioning and exhaust
Steam displaces air in the chamber by gravity
Dry time not necessary

9. Gravity Exposure Parameters
Non-Porous Cycle
All metal items only
Non-lumen items
• Minimum Exposure Time
3 Minutes at 270° F (132° C)

10. Gravity Exposure Parameters
Porous Cycle
Mixed materials
Lumen/cannulated items
• Minimum Exposure Time
10 Minutes at 270° F (132° C)

11. 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

12. 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)

13. Gravity vs. Prevacuum
Gravity
Prevacuum

14. (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

15. (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

16. 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?

17. 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.

18. During Decontamination
• Protect yourself
Use enzymatic cleaners and detergents
Rinse instruments thoroughly

19. Decontamination of Instruments
Refer to manufacturer instructions
Manual or mechanical
Appropriate brushes

20. Preparation for Sterilization
Inspect instruments
Position for proper air removal
Flush lumens vs. non-flushed lumens

21. Appropriate Containers
Rigid containers approved for immediate-use steam sterilization
Follow manufacturer’s instructions for use
Perforated or mesh bottom trays

22. Sterilizer to Point-of-Use Transfer
Excellent aseptic technique
Path of transport
Strict traffic control

23. Quality Assurance Monitoring
Physical Monitoring
Chemical indicators
Biological indicators

24. Physical Monitoring Real time assessment of sterilization cycle
Check before and after each cycle
Provides earliest detection of malfunction
Legal documents

25. Chemical Monitoring Indicates exposure to the sterilizing process
• 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

26. 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

27. Residual Air Removal Test
Class 2 Indicator: Bowie-Dick Test
Checks air removal system/air leaks
Performed on prevacuum cycles only

28. 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

29. Class 6 Emulator Responds to all critical variables
Performance correlated to the sterilization cycle
Monitors more of sterilization cycle

30. Biological Monitoring
Test BI
Control BI
Positive BI
Procedure

31. “ ” 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. “ ”

32. 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 ”

33. 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

34. Example
Documentation form for premature release of implantable devices
AAMI ST79:2010

35. Example Exception form for premature release of implantable devices.
AAMI ST79:2010

36. Immediate-Use Steam Sterilization Documentation
Epidemiological tracking
Traceability of sterilization cycle to patient
Ongoing assessment of items flash sterilized

37. 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

38. Example of Immediate-Use Steam Sterilization Log

39. Action Plan Appropriate work practices are utilized
Audit plan to monitor practice
Yearly education review

40. Evaluation and Registration
Thank you for attending this CE activity.
Please complete and submit the evaluation form.
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41. 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.
The following references have been used in the preparation of this presentation…

42. 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

43. 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