Transcript Slide 1

Immediate-Use-Steam
Sterilization (IUSS)
Are Your Instruments Sterile
or Did They Just Get Hot?
Presented by SPSmedical
• Largest sterilizer testing Lab
in North America and now a
part of Crosstex International,
a Cantel Medical Company
• Develop and market sterility
assurance products that offer
advanced technologies
• Provide full day sterilization
Seminars and on-site Facility
sterilization audits
• Corporate member: CSA and
AAMI, serving on numerous
sterilization working groups
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Cantel Medical Corp.
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Program Objectives
After viewing this program, participants will be able to…
• define IUSS according to AAMI,
• explain AAMI’s recommended criteria for IUSS,
• describe the two most common reasons for IUSS,
• identify 10 ways to reduce IUSS.
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Immediate-Use Steam
Sterilization (IUSS)
IUSS of surgical instruments raises
many concerns if not done properly, as
stated in AAMI Standards and AORN Recommended
Practices.
Today’s program will discuss AAMI Standards and
AORN Recommended Practices for IUSS, along with
ways to reduce IUSS.
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“Flash” Sterilization
changes to “Immediate-Use”
AAMI, AORN and other organizations have agreed that
“flash” is an antiquated term that does not fully describe
the various steam sterilization cycles now used to on
items not intended to be stored for later use.
“Immediate-Use” is broadly defined
as the shortest possible time between
a sterilized item’s removal from the
sterilizer and its aseptic transfer to
the sterile field.
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Immediate-Use Steam
Sterilization (IUSS)
is defined by AAMI as…
“process designed for the steam sterilization of patient
care items for immediate use”
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AAMI ST79 A4:2013
Comprehensive guide to steam sterilization and
sterility assurance in health care facilities
Considered the bible of sterilization,
this comprehensive guide to steam
sterilization in healthcare facilities
covers all aspects of facility design,
personnel and instrument reprocessing procedures.
Including IUSS!
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AAMI ST79 A4:2013
Comprehensive guide to steam sterilization and
sterility assurance in health care facilities
Sterilization for immediate use should meet the following
criteria:
a) The item or items have been through a cleaning process
consistent with all devices processed within the facility. Once
clean, they are placed within a container or package intended
for immediate use. Sterilizing unwrapped is not recommended.
b) Cycle time (i.e. gravity-displacement, dynamic air removal,
etc.) and parameters should be selected according to the
sterilizer manufacturer’s written instructions for use (IFU) and
compliant with specific IFU for the device or devices.
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AAMI ST79 A4:2013
Comprehensive guide to steam sterilization and
sterility assurance in health care facilities
Sterilization for immediate use should meet the following
criteria:
c) Since IUSS cycles usually have little or no dry time, the items
processed are assumed to be wet at the conclusion of the cycle.
d) The processed item(s) must be transferred immediately, using
aseptic technique, from the sterilizer to the actual point of use,
usually the sterile field in an ongoing surgical procedure.
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Immediate-Use Steam Sterilization
The same critical reprocessing steps must be followed
as a safe process does not include short-cuts. A
sterilized item intended for immediate use is not stored
for future use, nor held from one case to another.
Cleaning, decontamination and rinsing are critical and
users must follow and complete all required processing
steps regardless of the sterilizer exposure parameters
being used. The device MFG’s written instructions for
use (IFU) must be followed.
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EXAMPLE - MFG’s Cleaning IFU
SYMMETRY Orthopedic Instruments
1.
2.
3.
4.
5.
6.
7.
Submerge in enzymatic detergent.
Flush port with 50 ml enzymatic detergent.
Soak for 10 min in protein soluble detergent.
Scrub with soft bristled brush (agitate instrument
while scrubbing).
Rinse with warm tap water (38-49°C)
Flush port with 50 ml warm tap water.
Place in bath of warm water (agitate by hand for at least
1 min). Repeat this process 2 additional times.
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EXAMPLE - MFG’s Cleaning IFU
SYMMETRY Orthopedic Instruments
8.
Ultrasonic for 10 min with neutral pH detergent (flush
port with 50 ml prepared detergent before sonication).
9.
Flush port with clean tap water (3 times).
10. Rinse for at least 1 min with tap water.
11. Dry with clean, lint free cloth.
12. Inspect.
13. Lubricate tip mechanism and finger slot (do not
lubricate flush port).
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EXAMPLE MFG’s Cleaning IFU
Zimmer Orthopedic Surgical Instruments
1. Completely submerge instruments in enzyme
solution and allow to soak for 20 min.
2. Rinse in tap water for minimum of 3 min.
3. Ultrasonic clean for 10 min.
4. Rinse in purified water for at least 3 min.
5. Repeat sonication and rinse steps.
6. Remove excess moisture from the instrument with
a clean, absorbent and non-shedding wipe.
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EXAMPLE - MFG’s Cleaning IFU
BAUSCH + LOMB Storz Ophthalmic Instruments
Bausch + Lomb is pleased to announce the availability of new cleaning
instructions for our surgical instruments marketed under the Storz Ophthalmic
Instrument and Bausch + Lomb Instrument brands.
Manual Cleaning
1. Disassemble the instrument as applicable and inspect the
instrument for damage or corrosion.
2. Pre-rinse the instrument by holding it under cold running water
for at least 30 seconds, rotating the instrument to expose all
surfaces and cavities to flowing water. Additional rinsing may be
necessary depending on the size and extent of soiling of the
instrument.
3. Place the instrument into a suitable clean basin filled with fresh
neutral pH cleaning solution prepared according to the directions
of the solution manufacturer. Use only cleaning solutions that are
labeled for use with medical devices or surgical instruments.
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EXAMPLE - MFG’s Cleaning IFU
BAUSCH + LOMB Storz Ophthalmic Instruments
Ensure that the instrument is fully immersed in the cleaning
solution. The following conditions were validated using a neutral
pH detergent (Steris ProKlenz NpH) and a severe organic soil
challenge (Biomedical Instrumentation and Technology
2007;41(4):324-331).
4. Using a soft cleaning brush gently scrub all surfaces of the
instrument while keeping the instrument submerged in the
cleaning solution for at least 5 minutes. Clean the instrument until
all visible soil has been removed.
5. Rinse the instrument by holding it under cold running water for
at least 30 seconds, rotating the instrument to expose all surfaces
and cavities to flowing water. Additional rinsing may be
necessary depending on the size of the instrument and the amount
of soil.
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EXAMPLE - MFG’s Cleaning IFU
BAUSCH + LOMB Storz Ophthalmic Instruments
6. Place the instrument in an ultrasonic bath filled with fresh
neutral pH cleaning solution and sonicate for 5 minutes. Use only
cleaning solutions that are labeled for use with medical devices or
surgical instruments. Ensure that the instrument is fully immersed
in the cleaning solution. Do not overload the ultrasonic bath or
allow instruments to contact one another during cleaning. Do not
process dissimilar metals in the same ultrasonic cleaning cycle.
7. WARNING: Do not process powered instruments in an
ultrasonic cleaner.
8. The cleaning solution should be changed before it becomes
visibly soiled. The ultrasonic bath should be drained and cleaned
each day it is in use or more frequently if visible soiling is
evident.
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EXAMPLE - MFG’s Cleaning IFU
BAUSCH + LOMB Storz Ophthalmic Instruments
Follow the instructions of the manufacturer for the cleaning and
draining of the ultrasonic bath.
9. Repeat steps 4-6 as necessary if visible soil remains on the
instrument.
10. Rinse the instrument by holding it under warm (27˚C – 44˚C;
80˚F – 100˚F) running water for at least 30 seconds, rotating the
instrument to expose all surfaces and cavities to flowing water.
Additional rinsing may be necessary depending on the size of the
instrument.
11. If the instrument has lumens the lumens should be flushed
using a syringe filled with 50cc of warm distilled or deionized
water using a stopcock as follows:
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EXAMPLE - MFG’s Cleaning IFU
BAUSCH + LOMB Storz Ophthalmic Instruments
a. Place syringe tip into a beaker of warm (30˚C – 40˚C/85˚F –
105˚F) distilled or deionized water and fill to the 50cc mark.
b. Connect the end of the syringe to the center stopcock fitting.
c. Rotate the stopcock lever to the male Luer fitting (irrigation) or
to the female Luer fitting (aspiration) to allow fluid flow to the
appropriate Luer fitting.
d. Connect the stopcock to the appropriate Luer connector on the
instrument.
e. Push on the syringe plunger to force fluid through the lumen
into another beaker for proper disposal. Do not draw flushing
fluid back through the lumen. Disconnect the syringe. Disconnect
the syringe/stopcock from the instrument.
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f. Repeat steps A-E at least three times, for each lumen.
g. Fill the syringe with 50cc of air, reattach the stopcock, and
push on the plunger to force air through each lumen. Disconnect
the syringe/stopcock from the instrument.
NOTE: The CX7120 Universal Maintenance Kit contains a syringe and
stopcock suitable for cleaning instrument lumens.
12. Immerse the instrument in clean basin containing fresh
deionized or distilled water and soak for at least three minutes.
13. Immerse the instrument in second clean basin containing
fresh deionized or distilled water and soak for at least 3 minutes.
14. Perform a final rinse of the instrument with sterile distilled or
deionized water for at least 30 seconds, rotating the instrument to
expose all surfaces and cavities to flowing water.
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AAMI ST79 A4:2013
Comprehensive guide to steam sterilization and
sterility assurance in health care facilities
IUSS should only be considered if all the following conditions
are met:
a) Work practices ensure proper cleaning and decontamination,
inspection, and arrangement of instruments into the
recommended sterilizing tray or other containment devices
before sterilization.
b) The physical layout of the department or work area ensures
direct delivery of sterilized items to the point of use (e.g. the
sterilizer door opens into an area either within or directly
adjacent to the procedure room).
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AAMI ST79 A4:2013
Comprehensive guide to steam sterilization and
sterility assurance in health care facilities
IUSS should only be considered if all the following conditions
are met:
c) Procedures are developed, followed and audited to ensure
aseptic handling and personnel safety during transfer of the
sterilized items from the sterilizer to the point of use.
d) The item is needed for use immediately following IUSS.
Implantables should not be sterilized for immediate use (CDC 2008).
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FDA definition of an implant:
A device that is placed into
a surgically-or naturallyformed body cavity with the
intention of remaining there
for a period of 30 days or
more.
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Immediate-Use Steam
Sterilization
Traditionally, flash was recommended for emergency use
only (e.g. a dropped instrument) using an unwrapped tray
or pan and processing at 270°F/132°C for 3 or 10 min in a
gravity displacement steam sterilizer.
Today, IUSS has been expanded for use in gravity and
dynamic air removal cycles; and a variety of packaging
systems, including: protective organizing
cases, single layer wrap, and sealed
sterilization containers.
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Traditional Flash Sterilization
Gravity Displacement (270-275°F/132-135°C)
3 min. exposure – unwrapped nonporous item
10 min. exposure – unwrapped mixed nonporous
and porous items
The above “shortened” flash cycles were recommended
for a single instrument or a few at a time. A full gravity
displacement cycle is 15 minutes exposure at this
temperature. Drying time was 0 or 1 min; therefore,
instruments came out of the sterilizer hot and wet.
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IUSS
Gravity Displacement (270-275°F/132-135°C)
3 min. exposure - per device manufacturer’s IFU
10 min. exposure - per device manufacturer’s IFU
? min exposure – per device manufacturer’s IFU
Dynamic air removal (270-275°F/132-135°C)
3 min. exposure - per device manufacturer’s IFU
4 min. exposure - per device manufacturer’s IFU
? min exposure – per device manufacturer’s IFU
Note: There are devices that require “extended” cycles as well as
those that cannot be processed in gravity displacement cycles.
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MFG’s Instructions
SYNTHES Power Drive 530.100
Wrapped
Prevacuum
Temperature
Minimum Exposure Time
132-135°C/270-275°F
24 minutes
Gravity Displacement – Not recommended
Unwrapped (Flash) is same as wrapped parameters
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MFG’s Instructions
Zimmer
►
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MFG’s Instructions
DePuy Large Bone
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MFG’s Instructions
Device
DePuy Hand Innovation
Method
Gravity
Prevacuum
Parameters
270°F for 20 min
270°F for 10 min
Medtronic Midas Rex
Gravity
Prevacuum
270°F for 25 min
270°F for 4 min
Aesculap 4S Spine Set
Stryker Spine Set
Abbott Spine Set
Scientix SACP System
Prevacuum
Prevacuum
Prevacuum
Prevacuum
270°F for 10 min
270°F for 15 min
270°F for 15 min
273°F for 18 min
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Sterile or Just Hot?
IUSS of an instrument or instrument sets
in the wrong sterilizer mode or the wrong
exposure time, will certainly get hot, but
they will not be sterile.
IUSS has unique challenges; and therefore, is not
recommended by AAMI, AORN or The Joint
Commission for routine use or implants.
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Question:
What are the
common reasons for
IUSS?
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Immediate-Use Steam
Sterilization
The two most common reasons for IUSS are:
1. Lack of inventory:
• Case volume requiring same instruments
• Scheduling back to back blocks that require the
same instruments
• Vendors not delivering instruments in time
• CSSD/SPD not reprocessing instruments in time
• Surgeon’s personal instruments being used
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Immediate-Use Steam
Sterilization
2. Lack of communication:
• Surgeons not contacting vendors with enough time
to deliver instruments
• OR not contacting CSSD/SPD with enough time to
reprocess instruments
• Staff and Vendors limited knowledge regarding
best practices, e.g. not knowing how long it takes
to properly reprocess instruments
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Immediate-Use Steam
Sterilization
CSSD/SPD needs to educate the hospital/vendors:
• time it takes to decontaminate soiled instruments
using best practices;
• time it takes to inspect, assemble, package and
sterilize instruments using best practices;
• quickest possible turnaround time (staff & equipment);
• and, average turnaround time
Improved communication it the quickest
and most cost effective way to reduce IUSS!
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Question:
How can healthcare
facilities reduce
IUSS?
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10 Ways To Reduce IUSS
1. Update Policy & Procedures to reflect national standards.
2. Clearly define what your facility considers “emergency”
situations and in-service personnel.
3. Educate personnel as to risks associated with IUSS and how
to terminally sterilize instruments.
4. Review all logs of all IUSS cycles to document what
instruments are being processed using IUSS.
5. Review each instrument manufacturer’s written instructions
for use (IFU) to understand terminal sterilization cycle(s)
validated for these devices.
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10 Ways To Reduce IUSS
6. Based on manufacturer’s IFUs, determine parameters
needed to terminally sterilize these devices.
7. Use this information to allow enough time when
scheduling cases involving these instruments.
8. Purchase additional instruments if case scheduling
conflicts with terminal sterilization.
9. Adjust all steam sterilizer IUSS cycles to terminal
cycles – including appropriate dry times.
10. Hold all personnel (staff and vendors) accountable to
comply with all Policies & Procedures.
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Association of periOperative Registered Nurses
Perioperative Standards and Recommended Practices
For Inpatient and Ambulatory Settings
IUSS should be kept to a minimum
and should be used only in selected
clinical situations and in a controlled
manner.
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Association of periOperative Registered Nurses
Perioperative Standards and Recommended Practices
For Inpatient and Ambulatory Settings
IUSS may be associated with increased risk of infection
to patients. Time constraints may result in pressure to
personnel to eliminate or modify one or more steps in the
cleaning and sterilization process.
http://www.mc.vanderbilt.edu/documents/infectioncontrol/files/Zuckerman%20Fl
ash%20Sterilization%20AJIC%202012.pdf
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IUSS Sterility Assurance
A class 5 chemical integrating indicator or a class 6
indicator should be used within each sterilization
container or tray used for IUSS.
Class 5
Class 6
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Association of periOperative Registered Nurses
Perioperative Standards and Recommended Practices
For Inpatient and Ambulatory Settings
IUSS should not be used for implantable devices except
in cases of defined emergency when no other option is
available. Implants are foreign bodies and they increase
the risk of in surgical site infection.
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IUSS Sterility Assurance
When IUSS of an implant is unavoidable, cycle
selection should be determined by the manufacturer’s
written instructions for use, and a biological indicator
and a class 5 chemical integrating indicator should be
run with the load.
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IUSS Record keeping
Documentation of cycle information and monitoring
results should be maintained in a log (electronic or
Manual).
These records should include the items processed,
patient items were used on, type of cycle, cycle
parameters, monitoring results, date and time, operator
information and reason for IUSS.
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Conclusion
Because there are increased risks associated with IUSS,
it should be kept to a minimum and only used in select
clinical situations. While the delivery of non-sterile
instruments certainly is not a leading cause of SSIs, it
has been documented by the CDC as one of the causes.
I hope the information we have shared with you
today regarding IUSS, helps you to provide
the best patient care!
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Thank You!
Chuck Hughes
VP, Infection Prevention Consulting Services
Cantel Medical c/o SPSmedical Supply Corp.
6789 W. Henrietta Road · Rush, NY 14543 USA
(800) 722-1529 · E-mail: [email protected]
Certified as a Health Education teacher, Chuck has worked for over 25 years in the
manufacturing industry in areas of Regulatory Affairs, R&D, Marketing, Microbiology
and Sterilization Training. He is a corporate member AORN, AST, IAHCSMM, SGNA
and numerous other organizations, including AAMI and CSA where he contributes to
sterilization standards. A popular speaker at regional, national and international
healthcare conferences, Chuck has visited thousands of healthcare facilities during
his career providing sterilization consulting services that include fee based and
complementary audits of instrument reprocessing areas.
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REFERENCES:
Association for the Advancement of Medical Instrumentation
(AAMI). (2013). ANSI/AAMI ST 79:A2013 Comprehensive guide
to steam sterilization and sterility assurance in healthcare facilities,
Amendment 2. Arlington, VA: AAMI.
Association of periOperative Nurses (AORN). (2014).
Perioperative Standards and Recommended Practices. Denver:
AORN, Inc.
Centers for Disease Control and Prevention (CDC). (2008).
Guideline for Disinfection and Sterilization in Healthcare Facilities,
Atlanta, GA.
U.S. Food and Drug Administration (FDA). Silver Spring, MD
20993. www.fda.gov
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