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IUSS cycle frequency; differentiating sanitization,
disinfection and sterilization
by Ray Taurasi
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Q How many
Immediate Use Steam Sterilization (IUSS) cycles are acceptable during
a one-month timeframe? I have not been able to find that information
in any of the AAMI or AORN guidelines. In surveying my colleagues at
various hospitals I have gotten a multitude of different answers. We
have an accreditation inspection coming up and I don’t want to be
cited for not following regulations.
A There
are no regulations, guidelines or standards stating how many IUSS
cycles are acceptable to run during any specific timeframe.
Sterilization process failures are a major concern and pose a serious
risk to patient safety and well-being. It makes more sense to place
great emphasis on each and every sterilization cycle regardless of
whether the cycle is IUSS or a traditional terminal cycle.
It is imperative that every single
step and detail in the reprocessing/sterilization process is performed
precisely in accordance with the medical device and equipment
manufacturers’ instruction for use (IFU). There are absolutely no
short cuts in the sterilization process. All policies and procedures
must be followed for cleaning, disinfection, inspection, assembly,
instrument positioning, packaging, loading sterilizer, sterilizer
operation, cycle settings, monitoring, documentation, and adherence to
aseptic techniques.
Clearly, sterilization is a complex
and very precise process and one that cannot be rushed. For that
reason all professional entities agree and recommend that the use of IUSS be reserved for true emergency and/or unanticipated events.
Having inadequate instrumentation to meet surgical case load needs is
not considered an emergency or unanticipated event. Surveyors from
CMS, TJC, and other accrediting bodies will be looking at the efficacy
of the entire sterilization process, not merely how many IUSS cycles
are run. They will also assess your adherence to professional
guidelines and standards relative to managing and monitoring all
sterilization processing, including IUSS.
As a quality improvement initiative,
you may want to consider benchmarking your own IUSS cycle rates
against themselves to demonstrate that you are managing the process
and implementing measures to reserve the use of IUSS to the
unanticipated events. Calculate your IUSS rates by dividing the number
of IUSS cycles per month by the number of procedures per month.
QIs
it essential to sanitize all soiled items returned to CS, or is
decontamination/disinfection sufficient prior to sterilization?
A It
is important to realize that decontamination (cleaning), sanitization,
disinfection and sterilization are each different and unique
processes. The first step in reprocessing involves thorough cleaning
which is the removal of soil from used materials. The second step
involves a microbicidal process such as sanitization, or disinfection.
The objective of decontamination is to protect individuals from
disease caused by contact with pathogenic organisms on soiled medical
devices. Thorough cleaning, while an essential first step, may not
always be sufficient to ensure that an item is safe to handle.
Currently, there is no standard to measure just how "clean" or
safe-to-handle an object must be. Therefore, to ensure that harmful
microorganisms are destroyed, a microbicidal process may be employed.
Medical devices that have been contaminated by blood, body fluids or
large microbial populations must always be subjected to a microbicidal
process after cleaning. Deciding which process to use is a
risk-versus-benefit decision for each item you process. Therefore, a
clear understanding of these processes is imperative.
Sanitization is suitable for
easily-killed microorganisms and can reduce the number of microbial
contaminants on an inanimate surface to a relatively safe level.
Following thorough cleaning, the objects are rinsed in hot water or
steam-purged for a designated period of time depending on method used.
Examples of sanitizing equipment include cart washes, steam guns, and
dishwashers. Sanitization is adequate for items that only come in
contact with the surface of unbroken skin. Disinfection provides a
higher level of safety and can be used on work surfaces, medical
devices and equipment that have come in contact with highly
contaminated substances, body fluids and blood. The disinfection
process may be accomplished either by a thermal or chemical exposure.
Pasteurization is an example of a thermal disinfection process. It
involves exposing an object to a hot water bath at between 150 and 170
degrees Fahrenheit for 30 minutes. Contact with water at or above 180
to 205 degrees Fahrenheit for one minute can provide an intermediate
level of disinfection. This is the process used in automated
instrument washers during the final rinse.
Chemical disinfection processes
employ various liquid chemicals that contain agents such as quaternary
ammonium compounds, iodophors, hydrogen peroxide, phenolics, chlorine
compounds and glutaraldehydes. Chemical disinfection can be a
complicated process, and careful selection of the appropriate chemical
for each medical device or piece of equipment is imperative. Labeling
will identify a chemical’s active ingredients and concentrations and
provide the scope and spectrum of microbicidal activity. Directions
for use must be followed precisely, including required contact time
and temperature. It is essential to follow the device manufacturer’s
IFU for proper cleaning and disinfection.
As noted previously, thorough
cleaning is a critical step and if not done effectively, can impede
the efficacy of the disinfection process. To monitor the efficacy of
the cleaning process all automated washers (e.g., instrument washers,
cart washers, ultra-sonics and automated endoscope reprocessor) should
be tested weekly, preferably daily, in accordance with AAMI ST79
standards. There are specific testing tools and devices available for
the various automated washers which verify the performance of the
equipment. The cleaning efficacy of medical devices can be verified
with testing devices that detect residuals of organic matter such as,
blood, carbohydrates, and proteins.
Ray Taurasi is Eastern Regional Director of Clinical Sales and
Services for
Healthmark Industries. His healthcare career spans over
three decades as an administrator, educator, technologist,
consultant and international speaker. He is a member of AORN, AHA,
SGNA, AAMI, former president of IAHCSMM and was a faculty member at
numerous colleges teaching in the divisions of business
administration and health sciences.
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