Immediate-Use Steam Sterilization Documentation

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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
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.
Learning Objectives
• Discuss appropriate handling of instruments sterilized for
immediate-use steam sterilization
• Describe recommended monitoring and record keeping
AUTOCLAVE CYCLES
EXP
DRY
TEMP
TIME
TIME
PRE-VAC
3
273
0
TYPE
CYCLE
ITEM
P1
Bowie Dick
Ortho, Neuro, Spine implants;
Pans of inst; Instruments w/lumens;
plastic; rubber; ACMI cysto sets;
ACMI rigid ureteroscopes
Saws; Drills; Midas; Anspach;
Morcellator; Dermatome; Mesher;
Sinus micro-debrider
Batteries; CUSA; Bone Mill
Arthrex shaver hand pieces;
Harmonic hand pieces
DeMayo knee positioner
PRE-VAC
10
270
1
P2
PRE-VAC
4
270
8
P3
PRE-VAC
4
270
1
P4
PRE-VAC
5
270
4
P5
GRAV
10
270
1
P6
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
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
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
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

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