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Clinical intelligence for supply chain leadership
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INSIDE THE
CURRENT ISSUE |
September 2013 |
CS Connection |
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Immediate-use sterilization
should not be convenient-use practice
by Kara
Nadeau Della Vecchia
In
recent years the healthcare industry has turned a critical eye toward
immediate-use steam sterilization (IUSS) — formerly known as flash
sterilization — because its use in inappropriate clinical situations can
increase the risk of healthcare-associated infections (HAIs). But the use of
IUSS is still prevalent among healthcare facilities, with many using this
sterilization practice out of convenience rather than out of necessity as it
was intended. If continued use of IUSS is the reality, then how do
facilities ensure it is being used appropriately and safely?
IUSS in
healthcare today
Numerous healthcare industry
associations, including the Association for the Advancement of Medical
Instrumentation (AAMI), Association of periOperative Registered Nurses (AORN)
and the International Association of Healthcare Central Service Materiel
Management (IAHCSMM), have issued guidelines and recommendations on when and
how to use IUSS (see sidebar below), but in reality, facilities often use
this sterilization method outside these parameters to compensate for limited
time, money and staff resources. For example, many turn to IUSS when loaner
instrument sets arrive at their facilities without adequate time to
reprocess them correctly. IUSS is also frequently used when facilities have
insufficient inventory levels to support procedural volume.
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Bob
Marrs |
"When I go into hospitals and
look at their sterilization logs, the staff will often tell me they
typically utilize immediate-use sterilization for one-of-a-kind instruments
that are dropped, but as I dig into their logs I find that this scenario
accounts for less than 1 percent of all IUSS cycles," said Bob Marrs, BA,
CRCST, CIS, CHL, Director, Consulting Services/Field Operations,
Aesculap. "Most
facilities are using IUSS for turnover, whether it’s turnover of their own
sets, one-of-a-kind instruments where they don’t have enough, or
loaner/vendor trays — and all three of those reasons are the wrong reasons."
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Lena Burgess |
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Renee
Turmann |
Lena Burgess, Clinical
Operations Director for Integrated Medical
Systems International Inc. (IMS) has seen facilities with an IUSS rate
as high as 45-50 percent but she points out that most facilities have a goal
that ranges from 3-6 percent. Her colleague, Renee Turmann, BS, CSPDT, CSPM,
CFER, Manager of Web Based Education and Compliance for IMS, adds:
"The current ‘word on the
street’ is that IUSS is now seen in a negative light. In the past, it was
just something one HAD to do to compensate for the lack of inventory. Today
it is seen as a failure to uphold the standard of care for all patients."
While most everyone agrees
that healthcare organizations must reduce their use of IUSS, the individual
facilities themselves face the challenge of getting the necessary resources,
policies and procedures in place to achieve this industry-wide goal.
According to Martha Page, RN, Clinical Education Specialist for
STERIS Corporation,
minimizing the use of IUSS could pose a burden to facilities in the short
term, but in the long term, it will contribute to both the financial
viability of the organizations and the safety of their patients by reducing
the risk of HAIs.
"This practice, if improperly
used, is now thought to be an associated risk factor for surgical site
infections, the reporting of which can have a negative effect on a
healthcare facility," said Page. "In addition, healthcare facilities that
are already strapped by budget cuts and decreased reimbursement are heeding
the recommendations from multiple national professional organizations to
reduce the use of IUSS. On the positive side, this acute attention to issues
around IUSS has led to an increased awareness by staff of IUSS best
practices."
Scott Kaczmarek, Clinical
Operations Director for IMS, agrees the benefits of minimizing or
eliminating IUSS outweigh the cost and effort.
"Facilities looking to limit —
or eliminate completely — the use of IUSS need to commit to the type of
investment necessary to succeed," said Kaczmarek. "This is often a fairly
substantial financial investment, coupled with extensive staff training and
accountability efforts. Ensuring process standardization across the board to
improve patient outcomes by lessening the opportunity for deviations of
protocol are more than worth the investment in the long run."
Best
practices for safe and effective IUSS
We looked to industry
associations, experts and representatives to provide the following IUSS best
practices.
Policies and procedures
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Martha Page |
Having a solid policy in place
that states under which conditions IUSS is permitted and what procedures
must be followed when using IUSS enables a hospital to rein in the practice
so that it is used only as intended. Page provides her recommendations on
what factors facilities should include in their IUSS policies:
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Statements of purpose
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Specific decontamination instructions
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Steps for choosing the correct sterility
monitoring device
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Selection of the proper sterilization cycle
(which must be recommended and validated by the manufacturer of the
instrument)
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Transport steps to the point of use
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Proper documentation of the IUSS cycle
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Rose
Seavey |
In addition to an overall IUSS
policy, Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT, President and CEO,
Seavey Healthcare Consulting LLC., urges healthcare facilities to have in
place policies and procedures specific to loaner instrumentation. While Seavey notes that many facilities require vendors to deliver sets to
decontamination 24 to 48 hours prior to a case, IAHCSMM recommends an even
longer lead time — at least two working days (48 hours) for existing loaner
sets and three working days (72 hours) for new sets.1
"A facility must have a good
strong loaner instrumentation policy in place backed by all the powers that
be, including administration, infection prevention and control, quality and
safety, to ensure those items arrive in time for testing and sterilization,"
said Seavey.
Education and training
The multi-society IUSS
position statement, published by AAMI and endorsed by numerous healthcare
industry organizations (AAMI, AAAHC, AORN, APIC, ASC Quality Collaboration,
IAHCSMM), emphasizes the need for sterile processing department (SPD)
personnel to have thorough education and training around sterilization to
ensure IUSS is performed in compliance with hospital and industry
guidelines. The statement reads:
"Personnel involved in
reprocessing should be knowledgeable and capable of exercising critical
thinking and judgment, and should implement standardized practices. The
supervising organization is responsible for ensuring appropriate training,
education, and competency of staff and ensuring that the necessary related
resources are provided."2
Seavey agrees: "Staff training
is number one," she states. "Anybody who sterilizes instruments should have
critical thinking skills and understand that sterilization is a complex
process. It’s a lot more than just putting items into a sterilizer and
pushing a button. Staff members have to ensure that instruments are cleaned
and sterilized appropriately. In many instances with IUSS, they are in such
a hurry that they may skip steps and risk contamination."
Page stresses that education
and training are of the "utmost importance," and suggests that training for
all staff involved in the process of IUSS include the following topics:
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Steam sterilization
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Manufacturers’ instructions for use
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The purpose and proper use of sterility
assurance products
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The care and handling of rigid container
systems validated for IUSS
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Proper cleaning and decontamination of
instruments prior to IUSS
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Techniques to transport items from the
sterilizer to the point of use
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Dorothy
Larson |
"Overall there seems to be a
better understanding of IUSS across the healthcare industry," adds Dorothy
Larson,
3M Sterilization Technical Service Representative. "Through
certification, staff members become knowledgeable of the recommended
practices and guidelines. Hospitals should also require that annual
competencies include training on the current recommended best practices
around IUSS."
Documentation
A critical step to reducing or
eliminating IUSS is determining when and why a healthcare facility is using
IUSS outside of its intended use. With the Joint Commission placing greater
scrutiny on product sterilization, facilities are being driven to better
document their sterilization practices and can use this knowledge to help
identify gaps in processes and resources that contribute to the
inappropriate use of IUSS.
Multi-Society IUSS position statement
The IUSS position
statement published by AAMI and endorsed by numerous healthcare
industry organizations (AAMI, AAAHC, AORN, APIC, ASC Quality
Collaboration, IAHCSMM) defines IUSS as:
"The shortest
possible time between a sterilized item’s removal from the
sterilizer and its aseptic transfer to the sterile field.
Immediacy implies that a sterilized item is used during the
procedure for which it was sterilized and in a manner that
minimizes its exposure to air and other environmental
contaminants. A sterilized item intended for immediate-use is not
stored for future use, nor held from one case to another."1
AAMI’s ST79
Landmark Recommended Practice for Hospital Steam Sterilization
states that IUSS can be performed when deemed appropriate and when
all of the following conditions are met2:
• The device
manufacturer’s written instructions on cycle times, exposure
times, temperature and dry times are followed.
• Items are
disassembled and thoroughly cleaned with detergent and water to
remove soil, blood, body fats, and other substances
• Lumens are
brushed and flushed under the water with cleaning solution and
rinsed thoroughly.
• Items are placed
in a closed sterilization container or tray, validated for
immediate-use sterilization, in a manner that allows steam contact
and aseptic transfer to the operating room.
In regards to when
IUSS is appropriate to use, the American Association of
periOperative Registered Nurses (AORN) states3:
• IUSS should be
kept to a minimum and should be used only in selected clinical
situations and in a controlled manner.
• Immediate-use
steam sterilization should be used only when there is insufficient
time to process by the preferred wrapped or container method
intended for terminal sterilization.
• Regarding
implants, there is an exception that IUSS can be used in defined
emergencies when no other option is available.
The multi-society
IUSS position statement notes that IUSS should NOT be performed on
the following devices1:
• Implants, except
in a documented emergency situation when no other option is
available
• Post-procedure
decontamination of instruments used on patients who may have
Creutzfeldt-Jakob disease (CJD) or similar disorders
• Devices or loads
that have not been validated with the specific cycle employed
• Devices that are
sold sterile and intended for single-use only
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1. Immediate-Use
Steam Sterilization Position Statement
http://www.aami.org/publications/standards/
ST79_Immediate_Use_Statement.pdf
2. ST79: AAMI’s
Landmark Recommended Practice for Hospital Steam Sterilization,
http://www.aami.org/
publications/standards/st79.html
3. Recommended
Practices for Sterilization in the Perioperative Practice Setting,
American Association of periOperative Registered Nurses (AORN),
http://www.aorn.org |
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"Documentation can help a
facility determine if its IUSS usage is related to inadequate inventory,
scheduling conflicts or some other issues," said Seavey. "For example, a
facility might pinpoint that it’s using IUSS frequently on a certain day of
the week and uncover the issue where OR staff is scheduling all of its total
knee cases on that day and doesn’t have enough instruments to turn around.
Or maybe they are scheduling 20 eye cases in one day with only two sets of
instruments — that’s not OK."
"Facilities have started
monitoring sterilization more closely to meet Joint Commission requirements
but they could do a better job of what they are tracking," said Marrs. "When
we look at an IUSS sterilization log it will often state something like
‘item sterilized, Dr. Jones.’ I’ll ask the hospital how Dr. Jones is
feeling, they’ll ask me why and I’ll point out that their log indicates that
Dr. Jones was sterilized that morning. Although I’m making a joke, it drives
home the critical point that having Dr. Jones on the log doesn’t help. A
facility needs to be specific about the items being flashed."
AAMI’s Landmark Recommended
Practice for Hospital Steam Sterilization (AAMI ST:79) states specifically
that a facility should track; a) the assigned lot number, including
sterilizer identification and cycle number, b)the general contents of the
load, c) the duration and temperature of the exposure phase of the cycle, d)
the signature or other identification of the operator; and e) the date and
time of the cycle.3
Inventory management
The multi-society IUSS
position statement states that healthcare facilities should have "instrument
inventories (that are) sufficient to meet anticipated surgical volume and
permit the time to complete all critical elements of reprocessing."2 With
many facilities using IUSS to compensate for inadequate inventories, this is
an area that warrants greater scrutiny by healthcare organizations.
To help healthcare facilities
better manage existing inventory, Marrs recommends they standardize their
surgical instrumentation to help staff identify and assemble sets more
quickly and correctly. He also suggests they optimize their instrument sets
to reduce the number of instruments in the tray.
"I often find twenty different
manufacturers or more in a single instrument set. This adds to confusion
with assembly and increases surgeon dissatisfaction as they are forced to
deal with pattern inconsistency," said Marrs. "Standardizing and optimizing
instrument sets decreases turnover time and counting in the operating
rooms."
Communication and
collaboration
Communication and
collaboration among multiple internal stakeholders, including the SPD,
operating room (OR), infection control, materials management and
administration, as well as external vendors, is critical to reducing the use
of IUSS by ensuring a healthcare facility has the necessary resources and
processes in place to perform proper sterilization.
"Facilities can reduce IUSS
practices by, most importantly, having a "game plan" in place for their
surgical days," said Turmann. "Getting ahead of the ‘known’ events make the
‘unknown’ events easier to deal with. A huge part of achieving this is
making sure the SPD and the OR are in constant communication with each other
throughout the day with each party making the other aware of any expected
shortages in instrumentation or devices. There are several examples of this
and one is when the OR lets the SPD know they had to open a duplicate tray
or peel pack due to a contamination of the first tray or peel packed item.
Sounds simple, but it is easily forgotten when both teams have a hectic
day."
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Stephen Kovach |
Stephen Kovach, Director of
Education at Healthmark Industries, points to a specific example of where
collaboration among multiple departments within healthcare facilities has
improved sterilization practices for certain ophthalmic procedures thereby
reducing the risk of a dangerous complication that resulted from inadequate
sterilization practices.
"We are seeing more teamwork
among OR, SPD, physicians and administrators to reduce IUSS," said Kovach.
"One of the best examples of where healthcare facilities have collaborated
to ensure proper instrument sterilization is the toxic anterior segment
syndrome (TASS) concern. Widespread publicity following recent TASS
outbreaks prompted hospitals to evaluate how they schedule cases, their
inventory levels, their cleaning processes and the verification of these
processes to reduce the occurrences of TASS nationwide."
Adherence to manufacturers’
instructions for use
The multi-society IUSS
position statement reads: "The device manufacturer’s written instructions
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,
and the packaging (if used)."2
The document goes on to note
that if the manufacturer’s instructions for use (IFU) is not compatible with
the sterilizer instructions or the instructions for the container/ wrapper,
or if the IFU is "unclear, incomplete, or requires processes or cycles that
are not available in the health care facility," then the facility should
contact the manufacturer for more guidance. It states: "If differing
instructions cannot be resolved and the instrument is urgently needed, the
device manufacturer’s instructions must be followed."
"To ensure the IUSS process is
both safe and effective, one must first begin with knowing everything there
is to know about the product or device that is to be sterilized including
whether the product is even approved to go through the IUSS cycle," said
Turmann. "A person can obtain this knowledge through the product
manufacturer, specifically by reading the manufacturer’s recommendations on
the process. The operator should also know everything there is to know about
the machine running the IUSS cycle. If they do not, they should have an
expert on site to assist them. We have reached a point in
healthcare where it is no longer safe to just ‘wing it’. As
healthcare workers we must ensure we are following directions."
Moving
ahead
It’s clear that while IUSS is
becoming less prevalent in some hospitals, it’s here to stay in most — at
least for now. In healthcare, as in other complex industries, change doesn’t
happen overnight so it’s critical that all stakeholders — clinicians, SPD
professionals, clinicians, administrators, vendors and others that impact or
are impacted by sterilization practices — come together to ensure IUSS is
performed in an effective manner, and only when appropriate, to protect
patient safety.
"I believe facilities should
be doing everything in their power to reduce or eliminate this practice,"
said Marrs. "It is true that when performed correctly, it is a safe
practice. I also believe that every patient deserves and is entitled to the
same standard of care. When patient number one, two and three receive
terminally sterilized devices and patient number four, five and six receive
the same devices that have been subject to IUSS they are not receiving the
same standard of care."
"When we see IUSS in a
different light, as a failure in practice, a short cut and a last resort, we
will then reduce the national numbers significantly, allowing patients to
all receive terminally sterilized surgical instrumentation for their
surgical procedures," adds Turmann. 
References
1. IAHCSMM
Position Paper on the Management of Loaner Instrumentation,
http://www.iahcsmm.org/pdfs/IAHCSMM_Position_Paper_%20
Management_of_Loaner_Instrumentation_070111.pdf
2. Immediate-Use
Steam Sterilization Position Statement
http://www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdf
3. ST79: AAMI’s
Landmark Recommended Practice for Hospital Steam Sterilization,
http://www.aami.org/publications/standards/st79.html

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