Transcript Immediate Use Sterilization

Immediate Use Steam
Sterilization
Roger Hermen, CSPDT, CRCST
Sterile Processing Educator
Objectives
 To
review the process for Immediate Use
Steam Sterilization
 Discuss Competency Requirements for
Immediate Use Steam Sterilization
Times sure have changed….
In the beginning……
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OR cleaned, assembled and wrapped own
instruments
Limited choices for sterilization
• If nothing melted and indicators turned, everything
was ok!
Sterilization Concerns & Issues

Process is complex
 Requires staff to consistently follow all the
necessary steps each time to ensure the sterility
of the instruments to the point of use
 No margin for error
 Improper technique can result in the use of
contaminated instruments in surgery resulting in
serious consequences including surgical site
infections (SSI)
SSI Statistics (CDC, 2011)
 SSIs
affect 2 to 5 % of all patients
undergoing surgery
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3
300,000 patients each year
% mortality rate
 Increase of hospital length of stay 7 to 10
days
 Equates to increase costs of $3,000 to
$29,000 per SSI with upwards of $10
billion annually
2011 Multi-Society Position
Statement

Stressed the importance of education for the
personnel directly involved in reprocessing of
surgical instruments to the point of use
 Surgical and sterile processing personnel should
be knowledgeable regarding the different types
of steam sterilization cycles, standards and
practices, cleaning, decontamination and rinsing
processes, and correct aseptic transfer from the
sterilizer to the point of use (AORN, 2011a)
Current Standards &
Recommended Practices
Best Practices are evidenced based and
developed through sound principles,
scientific data (research) and expert
opinions
 AAMI
(Association for the Advancement of
Medical Instrumentation)
 AORN
 CDC
The Joint Commission
 Broadening
its scrutiny and examining
healthcare facility's sterilization practices
 Looking at the entire sterilization process
(cleaning and decontamination,
sterilization, storage or return to the sterile
field)
 Asking staff whether they followed
manufacturers' instructions and
recommendations for sterilization and
wrapping/packaging
Manufacturers Obligation for
Reusable Medical Devices
 Manufacturers
responsibility to provide
complete and comprehensive written
instructions on
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Handling
Cleaning
Disinfection
Testing
Packaging
Sterilization
HC Personnel Responsibility for
Reusable Medical Devices
 Obtain
and review manufacturers current
data and recommendations from each
manufacturer
 Ensure that they have the necessary
resources to follow manufacturers
instructions thoroughly
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OR Workroom Binder
OneSource On Line Subscription
Sterilization
A process designed to remove or destroy all
viable forms of microbial life, including
bacterial spores
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Steam (Gravity/Pre-Vac)
ETO Gas
Gas Plasma Hydrogen Peroxide (Sterrad)
Immediate Use Steam Sterilization
“FLASH”
The process of sterilizing patient care items
for immediate use
Pre-Vac cycles provide the shortest
allowable times to obtain a sterilized item
to transfer to the surgical field
Immediate-use steam sterilization
should only be used….
• When a one-of-a-kind instrument has been
contaminated and needs to be replaced to the
sterile field immediately
• When an item has dropped on the floor and is
needed to continue a surgical procedure
 When specific instruments are needed for an
emergency procedure
 When there is no other sterilization alternative
Immediate-use steam sterilization
should only be used….
When the device manufacturer’s written
instructions on cycle times, exposure times,
temperature settings and dry times are followed
 When items are dissembled and thoroughly
cleaned with detergent and water to remove soil,
blood, body fats and other substances
 When lumens are brushed and flushed under the
water with cleaning solution and rinsed
thoroughly
 When items are placed in a closed sterilization
container in a manner that allows steam contact
and aseptic transfer to the operating room

Clinical Competency
In order to maintain competency, each
member of the staff that performs flash
sterilization should receive competency
based training and should be evaluated
on an annual basis
Cleaning
All items must be sent through a mechanical
washer in SPD prior to any IUSS that
prepares the item for safe handling by
removing, usually with detergents, of all
adherent visible soil from the surfaces,
crevices, serrations, joints and lumens of
instruments/devices/equipment
Intra-operative Cleaning
 Instruments
are cleaned and or irrigated
with Sterile Water as they are used during
surgery
 This prevents blood and debris from drying
on instruments
 Normal Saline will cause pitting
Cleaning Points
 Follow
manufacturers recommendations
 Apply Personal Protective Equipment
(PPE)
Cleaning Points

Instruments with multiple parts should be
disassembled for cleaning
 Soft-bristle brushes should be used to clean the
instruments, with particular attention paid to
ratchets, serrations, and box locks (joints)
 Manual cleaning should be done while holding
the instrument and the brush under the water
level to prevent aerosolization of bacteria
Cleaning Agent
 Necessary
to make the cleaning process
more efficient and to protect the surgical
instruments' finish
 All detergents should be measured
carefully and used in accordance with the
manufacturers' instructions
Cleaning Agent
Asepti-Zyme Instrument
Cleaner
 Enzyme formulated to
remove and dissolve
proteinacious matter
 ½ to 1 ounce in 1
Gallon of Water
Wrapping
 Transport
the cleaned item to the prep and
pack area
 Choose appropriate packaging material
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Single Wrap
Rigid Container/Tray
 Place
Chemical Indicator inside of each
package or tray
Wrap
Transport items back to the
O.R. for further processing in
steam sterilizer
Steam Sterilizer

Place item into Sterilizer
 Choose the appropriate cycle
to start
 Complete ALL Documentation
for the appropriate Sterilizer
Steam Sterilization Log
Loading
 Patient Label with Name and medical record (MR) number
 Initials of person Loading the sterilizer
 Room #
 Implant & BI Lot #
 The reason for flash sterilization
 Load description, including each individual item in the load
 Load Cycle (i.e. 1, 2, 3, 4)
 It is imperative that all information is entered onto this form with
each cycle
 At end of cycle all BIs that have been run in the load must be given
to SPD so they can incubate the BI to assure that the BI has passed
 Results of the Quality Control Tests (i.e. Bowie-Dick test, biological
indicator) will be recorded on biological sheet in SPD after the BI
has passed incubation
Steam Sterilization Log
Unloading
 Verify exposure parameters on the Sterilizer
Gauge & Recording
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Temperature of 270-272 degrees F
Minimum exposure time for nonporous, non-lumened
items only is 3 minutes
Minimum exposure time for metal items with lumens
and porous items (eg. rubber, plastic) sterilized
together:
1. dynamic air removal (prevacuum) cycle: 4 min
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Name of person unloading contents
Unloading Contents
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After completion of the cycle, the wrapper and
the item within will be hot
 Personnel must wear sterile gloves and may use
sterile towels as "potholders" when removing
items from the sterilizer
 Once in the room, the wrapper can be opened
by the circulator
 The sterile items may then be removed by the
scrub person and taken to the sterile field
Quality Control
Biological Indicator
Bacterial spores in a carrier that serves to
demonstrate whether sterilization
conditions were met
Performed Daily and with loads containing
implants
Quality Control
Chemical Indicator
A device employed to monitor one or more
process parameters of the sterilization
cycle.
Consists of chemical/ink dye that provides a
distinct color change when exposed to the
sterilization process
Quality Control
Mechanical Indicator
A device that indicates sterilization cycle
conditions
Including time, temperature and pressure
Bowie Dick Test
Diagnostic test of a Pre-Vac steam
sterilizer’s ability to remove air from the
chamber
Performed Daily on Pre-Vac Sterilizers
Guidelines for Completion of
Competency
 OR
staff that utilize the Immediate Use
Steam Sterilizer will need to be signed off
by the appropriate person
 Competency for Immediate Use Steam
Sterilization will be kept in the employee
file
Questions