Immediate-Use Steam Sterilization

• 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)

Gravity vs. Prevacuum

Gravity Prevacuum

• 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

Quality Assurance Monitoring

• Physical Monitoring

• Chemical indicators

• Biological indicators

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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

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

“ ”

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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

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Example

Documentation form for premature release of implantable devices

AAMI ST79:2010

36

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

Example of Immediate-Use Steam Sterilization Log

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

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