September 29, 2014
Michael Cain
Senior Product Marketing Manager
Getinge USA, Inc.
Proper Decontamination and
Immediate-use Steam Sterilization
Session Objectives
• Review the driving needs to replace
Flash Sterilization with IUSS
• Identify the major emphasis in the
guidance document for IUSS
• Discuss the decontamination
challenges for the OR with IUSS
• Discuss the challenges for adoption
and compliance
• Discuss a Quality System approach
between the OR and CS/SPD
Flash Sterilization
Flash sterilization is in contrast
to traditional “terminal
sterilization” cycles where
instruments are sterilized within
wrappers or rigid containers
designed to maintain the
instruments’ sterility and allow
the devices to be stored and
transported for later use.
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September 29, 2014
Flash Sterilization
“Flash sterilize” describes steam
sterilization cycles where
unwrapped medical devices
(instruments) are subjected to
an abbreviated (short) steam
exposure time @ sterilization
temperature, with little or no
drying time. . .
. . . and then used promptly after
the cycle completion, without
being stored for future use.
Reasons for FLASH Sterilization
• Contaminated dropped instrument
• Inadequate instrument inventories
• Booking cases back-to-back
• Items not available from SPD when needed
oNot aware of the turn-around time
required for wrapped sterilization from
SPD
• Instrument(s) needed for an emergency
procedure
• Specialized instruments sterilized only by
the “unwrapped” method prior to use
Unacceptable Reasons for FLASH Sterilization
• Insufficient instrumentation
for scheduled cases
• Items not available from
SPD as requested
• Putting surgeons’ schedules
ahead of patient safety
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September 29, 2014
Flash Sterilization is No Longer Appropriate
Convenience and poor
oversight compromise the
effectiveness of “emergency
flash sterilization”.
Improper processes can lead
to the use of contaminated
instruments in surgery
resulting in serious
consequences, including
surgical site infections (SSI).
Flash Sterilization is No Longer Appropriate
• SSI or healthcare associated
infection (HAI) is the No. 1
concern of improper “flash”
sterilization
• According to the CDC, SSI’s
affect 2 to 5 percent of all
patients undergoing surgery
• This equals about 300,000
patients each year
Flash Sterilization Is No Longer Appropriate
• Patients with SSI have a 3% mortality rate
• SSI’s increase hospital stays by 7 to 10 days
• The increased hospital stays equates to increased cost of
$3,000 to $29,000 per SSI with upward of $10 billion in extra
cost annually (CDC 2011).
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September 29, 2014
Flash Sterilization is No Longer Appropriate
• There are many causes of
SSI’s and improper
sterilization is just one factor.
• Nonetheless, reducing
reliance on “flash” sterilization
improves quality and safety,
and reduces risk to the patient.
• And we are here for the
patients!
“Flash” Sterilization is now “Immediate-Use
Steam Sterilization”
AAMI, AORN, APIC and other health
and safety organizations have
agreed that “flash sterilization” is an
antiquated term that does not fully
describe the various steam
sterilization cycles now in use to
process items NOT intended to be
stored for later use.
Current IFU requirements may
require longer exposure times and/or
use of single wrappers or containers
designed to allow for aseptic transfer
of an item from the sterilizer to the
sterile point-of-use.
Immediate-Use Steam Sterilization
Best Practices
According to AORN recommended practices, immediate-use
steam sterilization should only be used in selected clinical
situations. Those situations include the following:
• 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
(AORN, 2011b)
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Immediate-Use Steam Sterilization
Best Practices
AAMI ST79 is a comprehensive document covering best
practices for steam sterilization. The document states that IUSS
can be performed when deemed appropriate and when all of the
following conditions are met:
1) Items are disassembled and thoroughly cleaned with
detergent and water to remove soil, blood, body fats and
other substances.
2) Lumens are brushed under water with a cleaning solution
and rinsed thoroughly.
3) Items are placed in a closed sterilization container or tray,
validated for IUSS, in a manner that allows steam contact
with all instrument surfaces and subsequent aseptic
transfer to the operating room.
4) The device manufacturer’s written instructions (IFU) on
cycle times, exposure times, temperature settings and dry
times are followed.
Immediate-Use Steam Sterilization
Best Practices
• Condition No. 1
• Items are disassembled and
thoroughly cleaned with
detergent and water to
remove soil, blood, body
fats and other substances
Immediate-Use Steam Sterilization
Best Practices
• Condition No. 2
• Lumens are brushed under
water with a specified
cleaning solution and rinsed
thoroughly with treated
water
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September 29, 2014
Immediate-Use Steam Sterilization
Best Practices
Pre-cleaning, cleaning, disinfection and rinsing are
critical for effective sterilization. Users must follow the
manufacturer’s written instructions for use (IFU) and
complete all required processing steps regardless of
the sterilization exposure parameters being used.
Devices to be sterilized for immediate-use are to be
decontaminated by the same critical processes as
devices for terminal sterilization, per the
manufacturer’s IFU.
AAMI ST79 Guidelines on Cleaning
Methods
• Should be validated and specified by
device manufacturer (7.2.2 &
7.5.3.1)
• Cleaning may be accomplished
manually, mechanically, or by a
combination of both methods
(7.5.3.1)
• Any device should be able to be
manually cleaned (7.5.3.2)
Device Manufacturer Perspective
Stryker Instructions for Cleaning, Sterilization, Inspection and Maintenance of
Orthopaedic Medical Devices; 2012
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Immediate-Use Steam Sterilization
Best Practices
Health Care Facilities are
required to follow these
instructions.
This is not a problem for the
centralized SPD because
the SPD is designed,
equipped and staffed with
trained personnel to handle
a wide range of
reprocessing requirements
and can adapt to changing
IFU requirements.
Example of a Small 2-Zone
SPD
Immediate-Use Steam Sterilization
Best Practices
This can be a problem for the
OR because the sub-sterile
area is not typically designed
with a dedicated space that is
equipped and staffed with
trained personnel for
immediate use or terminal
sterilization.
Consider a dedicated
decontamination room on the
floor with the operating
rooms.
Immediate-Use Steam Sterilization
Best Practices
This dedicated OR work room
can include –
• Soiled reception
• Sorting
• Cleaning & disinfection
• Transport to central SPD
• Immediate-use steam
sterilization for the operating
rooms on the floor
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Immediate-Use Steam Sterilization
Best Practices
Proper decontamination will
include a combination of manual
cleaning and mechanical
cleaning processes
Is your OR designed for
decentralized decontamination?
Four Factors of Cleaning. . .
• Time: The duration of the
cleaning process.
• Action: The amount and type
of mechanical energy used for
the cleaning process.
• Chemistry: Refers to the type
and concentration of chemicals
used in the process.
• Temperature: The
temperature or temperatures
used during the cleaning
process.
We know these four factors by the acronym TACT
TACT Factors are Interdependent
Devices must be cleaned –
• For the proper amount of time
• With proper action/impingement
• Using the correct chemical
detergents
• At the proper temperature(s)
TACT is a “closed circle”
A Change in one factor will cause a
change in the other factors. . .
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Washer-Disinfector Process
Different levels of FACTORS work together to produce effective
cleaning
• Provides more aggressive
mechanical cleaning action
• Utilizes multiple chemical
additives to attack soils
• Varies and controls water
temperatures between 90F
and 190F in different phases
• Allows for controlled reduction
in process or cycle time
* Mechanical cleaning also reduces risk of cross-contamination
Manual Cleaning Sink Process
Understand the different relationship of cleaning factors in a manual
process
• Less aggressive mechanical
action
• Limited chemical additives to
assist the cleaning process
• Limited range of water
temperatures; no heater; no
controls; no disinfection
• Manual cleaning is more labor
intensive, demanding more
time
* Risk of cross-contamination is higher for manual cleaning
Immediate-Use Steam Sterilization
Best Practices
What do conditions 3 and 4 mean
for you?
3) Items are placed in a closed
sterilization container or tray,
validated for IUSS, in a manner
that allows steam contact with all
instrument surfaces and
subsequent aseptic transfer to the
operating room.
4) The device manufacturer’s
written instructions (IFU) on cycle
times, exposure times,
temperature settings and dry
times are followed.
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Immediate-Use Steam Sterilization
Best Practices
Immediate-use steam sterilization cycles must comply with the
device manufacturer’s instructions for use – including the type of
sterilizer, the cycle parameters and the approved aseptic wrapper
or container, when applicable.
The requirement to use an approved wrapper or container has
shifted Flash or IUSS cycles away from GRAVITY to Pre-Vac
Flash Sterilization
Historical Perspective
Surgery may need to decontaminate
and flash sterilize a single instrument
or instrument set for quick turnaround
and use in a procedure.
The term “flash” comes from the
abbreviated exposure time of the
unwrapped device(s) in a steam
sterilization cycle.
Original “flash” cycles were modified
gravity cycles. WHY?
Why use gravity cycles for “flash”?
Flash Sterilization – DAR Cycle
Historical Perspective
Prevac cycles were too slow!
Pre-vacuum Cycle Phases
1.
2.
3.
4.
5.
6.
7.
8.
9.
Start – door seals, jacket warms chamber
Purge – steam enters chamber, while air is purged through the chamber drain
Conditioning – positive pressure and negative vacuum pulses continue to heat load
and purge air (dynamic air removal)
Heat Up – steam pressure builds to selected exposure temperature and pressure
Exposure – timing begins for selected exposure time and temperature
Exhaust – chamber drain opens and ejector water creates vacuum in chamber to
exhaust steam
Drying – ejector water controls vacuum in chamber for selected dry time
Air-in – chamber returns to atmospheric pressure
Cycle Complete – door can be opened
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Flash Sterilization – Gravity Cycle
Historical Perspective
Original “flash” cycles were modified
gravity cycles. Why use gravity cycles
for IUSS”?
Gravity cycles do not employ 3 to 4
positive to negative vacuum pulses,
which requires additional cycle time.
Gravity cycles employ only positive
pressure, downward displacement to
remove air from the chamber.
Air detector testing or Bowie & Dick
testing is not required for gravity
cycles.
Flash Sterilization – Gravity Displacement
Historical Perspective
STEAM STERILIZERS
Typical Applications
Model: Small volume steam sterilizer
Chamber: 17” x 17” to 21” x 21”
Loads:
 2 trays to 3 trays maximum,
wrapped or in containers
 Single or multiple instruments,
porous or non-porous, wrapped or
unwrapped
Cycles: Prevac or Gravity combination
OR Suites: Primarily used for
immediate-use steam sterilization at
point of need.
CS/SPD: Centralized STAT or IUSS
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STEAM STERILIZERS
Typical Applications
Model: Medium volume steam sterilizer
Chamber: 26.5” x 26.5”
Loads:
 4 trays to 12 trays
 wrapped or inside containers
 single or multiple instruments,
unwrapped porous or non-porous
Cycles: Prevac or Gravity combination
CS / SPD: Capable of running prevac /
gravity IUSS cycles. However, typically
used to process large volumes of
wrapped sets using high-vacuum
dynamic-air-removal cycles.
Immediate-Use Steam Sterilization
Best Practices
Four factors are required to ensure
effective steam sterilization:
 adequate exposure time
 exposure temperature
 presence of moisture
 removal of air
Adherence to these basic principles
ensures safe and efficacious steam
sterilization outcomes by health care
facilities.
Immediate-Use Steam Sterilization
Best Practices
What about wet instruments resulting
from significantly reduced drying
times?
Devices processed with IUSS cycles
can be expected to be wet due to little
or no drying time.
Sterilization cycles with little or no
drying time are efficacious when used
in compliance with validated written
instructions provided by the device
manufacturers, sterilization
equipment manufacturers, and (if
applicable) container manufacturers
and when done in accordance with
profession guidelines.
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September 29, 2014
“Flash” Sterilization is now “Immediate-Use
Steam Sterilization”
The new guidance reminds us
that Current IFU requirements may
specify different exposure
times or temperatures and/or
use of single wrappers or
containers designed to allow
for aseptic transfer of an item
from the sterilizer to the sterile
point-of-use.
Immediate-Use Steam Sterilization
Best Practices – Follow Device IFU
We can no longer rely on the same old
stand-by “flash” sterilization cycles of
past times.
Surgery is now more technologically
advanced and with it, surgical
instruments are more complex.
We need the device manufacturers to
provide users with validated cleaning
and sterilization instructions, including
IUSS when appropriate!
Immediate-Use Steam Sterilization
Best Practices – Follow Device IFU
The device manufacturer’s
written instructions (IFU) for
reprocessing any reusable
device must be followed.
The cycle parameters required
to achieve sterilization are
determined by:
• The design of an instrument
• The characteristics of the
load
• The sterilizer capabilities
• The packaging (if used)
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Immediate-Use Steam Sterilization
Best Practices – Follow Device IFU
IFU
Do you have them?
Do you have all of them?
Immediate-Use Steam Sterilization
Best Practices – Follow Device IFU
• If desired, use trays to contain
instruments provided in sets.
• Double wrap instruments in
accordance with local procedures,
using wrapping techniques such as
those described in ANSI/AAMI
ST79: 2010.
• Use a validated, properly
maintained and calibrated steam
sterilizer.
• Effective steam sterilization can be
achieved using the following cycles.
• NO IUSS Instructions
Immediate-Use Steam Sterilization
Best Practices – Follow Device IFU
This IFU provides instructions for
terminal sterilization by:
• Prevacuum Cycle
• 270° – 275°F
• Wrapped or type container
• Gravity Cycle
• 250° – 254°F
• Wrapped or type container
• 270° – 275°F
• Wrapped or type container
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Immediate-Use Steam Sterilization
Best Practices – Follow Device IFU
The same IFU provides instructions
for flash or IUSS sterilization by:
• Prevacuum Cycle
• 270°F (132°C) only
• 3 minutes non-porous
• 4 minutes non-porous & porous
• Wrapped only
• Gravity Cycle
• 270°F (132°C) only
• 3 minutes non-porous
• 10 min. non-porous & porous
• Wrapped only
Immediate-Use Steam Sterilization
Best Practices – Follow the Device IFU
IUSS instructions only for individual instruments. Not intended for loaded
cases or implants. Use the following parameters:
• Unwrapped instruments only
• 4 minute exposure
• A minimum of 3 (three) pulse prevacuum cycle (DAR)
• 132°C (270°F) exposure temperature
• No drying time specified
Immediate-Use Steam Sterilization
Best Practices – Follow the Device IFU
• Additional IUSS instructions for the user -
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Immediate-Use Steam Sterilization
Best Practices – Follow the Device IFU
• It can be a real problem if the OR
team needs to sterilize a dropped
or emergency instrument during a
procedure!
• Who can identify the instrument
and connect the IUSS process to
the device IFU?
• What if the IFU - IUSS cycle
parameters are not available on the
OR sterilizer?
• If you decide to sterilize the device
w-o the IFU instructions, sterility of
the device is in question and
patient safety could be at risk.
Immediate-Use Steam Sterilization
Best Practices - Caution
The device manufacturer’s instructions are not
always compatible with the sterilizer
instructions or the instructions of the container
/ wrapper.
Device manufacturers’ instructions are
sometimes unclear, incomplete, or require
processes or cycles that are not available in
your facility.
Where instructions conflict or are insufficient,
the device manufacturer should be contacted
for more information/guidance.
If differing instructions cannot be resolved and
the instrument is urgently needed – the device
manufacturer’s instructions must be followed.
Immediate-Use Steam Sterilization
Best Practices - Caution
In addition to all the recommended practices
and guidelines you should be observing, the
multi-society position document addresses the
instances when IUSS should never be
performed.
IUSS should never be performed on the
following devices:
 Implants, except in a documented emergency
when no other option is available.
 Post-procedure decontamination of instruments
used on patients who may have CreutzfeldtJakob disease (CJD) or similar disorders.
 Devices or loads that have NOT been validated
with the specific cycle to be employed.
 Devices that are sold sterile and intended for
single-use only. (AORN, 2011a)
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Immediate-Use Steam Sterilization
Best Practices – Process Monitoring
Sterilization process monitoring is
essential to ensure that sterilization
processes are efficacious.
Examples of process monitors
include:
 Physical monitors such as
print-outs and data logging
 Biological indicators (BI)
 Chemical indicators (CI)
Immediate-Use Steam Sterilization
Best Practices – Quality System
Quality management is essential to
ensure compliance with processes
and relating those processes to
outcomes (KPI’s).
Document what you are going to do
– and do what you document.
Utilize electronic record keeping
wherever possible.
• Document IUSS events:
 what instrument / device?
 why IUSS used?
 followed IFU?
 room & surgeon
 patient ID #
Immediate-Use Steam Sterilization
Best Practices – Quality System Overview
• Processes –
 Review your IUSS cycles and parameters for relevance
• Documents and records –
 Document your IUSS goals, strategy, tactics and procedures
 Make certain you have your IFU’s on file
 Study availability of electronic tracking, reporting & record keeping
• Facilities –
 Study availability of dedicated decontamination room with IUSS
sterilizer in the sub-sterile space
 Review workflow access from OR’s to IUSS sterilizer
 Review workflow access from SPD to the OR suites
 Verify utilities and sterilizer validation is up to specs
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Immediate-Use Steam Sterilization
Best Practices – Quality System Overview
• People, Training & Experience –
 Personnel involved in reprocessing should be knowledgeable and
capable of exercising critical thinking and judgment, and should
implement standardized practices.
 Sterilization personnel should be educated regarding the different
types of sterilizers (i.e. pre-vacuum versus gravity displacement) and
the different types of steam sterilization cycles (including IUSS cycles)
used in health care facilities.
 The supervising organization is responsible for ensuring appropriate
training, education, and competency of staff and ensuring that the
necessary related resources are provided.
o Examples of education and certification resources include the Certification
Board for Sterile Processing and Distribution (CBSPD); and the
International Association of Healthcare Central Service Material
Management (IAHCSMM).
Immediate-Use Steam Sterilization
Best Practices – Quality System Overview
• People, Training & Experience –
o Examples of standards and practices can be found with the Association for
Advancement of Medical Instrumentation (AAMI); the Association of
periOperative Registered Nurses (AORN) and the Centers for Disease
Control and Prevention-Healthcare Infection Control Practices Advisory
Committee (CDC-HICPAC).
 The regulatory or accrediting agency should evaluate whether the
organization’s leaders ensure that training, education and resources are
provided and the competency of staff is validated.
• Equipment & Materials –
 Will you maintain sterilizer(s) in the OR for IUSS applications?
 Will you need sinks, ultrasonic and instrument washer in the OR?
 What role will SPD play in the need for IUSS instrumentation?
Immediate-Use Steam Sterilization
Best Practices – Quality System Overview
• Equipment & Materials –
 Instrument inventories should be sufficient to meet anticipated
surgical volume and permit the time to complete all critical elements of
reprocessing.
 Implement an electronic OR scheduling system connected to SPD
 Implement an instrument tracking / asset management system that
can provide the following features:
o
o
o
o
o
o
o
tracks instrument inventory thru all processes to stock levels
capable of fast-tracking instrumentation
capable of tracking IUSS events and outcomes
syncs with the OR scheduling software
provides scheduling conflicts in advance
tracks repairs out of stock; and upon return
tracks loaner sets into stock for scheduling; and for return pick-up
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Immediate-Use Steam Sterilization
Best Practices – Quality System Overview
• Review & Checking –
 Coordination and communication between SPD staff and OR staff
 Common goals with vested interest from both sides, with no hidden
agendas
 Shared responsibilities, accountabilities and reporting
Thank You
IUSS – Facing the Challenges
References & Resources
• Association for the Advancement of
Medical Instrumentation: Comprehensive
Guide to Steam Sterilization and Sterility
Assurance: ST-79: 2010; Annex I, 2010,
Annex II, 2011, Annex III, 2012
• Association of periOperative Registered
Nurses, AORN Recommended Practices
for Sterilization (2011a; 2011b)
• Certification Board for Sterile Processing
and Distribution (CBSPD), 2 Industrial
Park, Suite 3, Alpha, NJ 08865
• International Association of Healthcare
Central Service Materiel Management
(IAHCSMM), 213 West Institute Place,
Suite 307, Chicago, IL 60610
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