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STERILIZATION & INFECTION PREVENTION
BY SUSAN KLACIK
New water quality standard released by AAMI
ater is a major component of
medical device processing. It
is used in cleaning solutions,
rinse water, and to generate steam for
sterilization. Because of its crucial role
in medical device processing, the Association
for the Advancement of Medical
Instrumentation (AAMI) determined it
was necessary to upgrade the Technical
Information Report (TIR34 Water for the
reprocessing of medical devices) to a
standard.
In August, AAMI released this new
standard on water quality: ANSI/AAMI
ST108:2023 Water for the processing
of medical devices. It describes multiple
levels of water quality and steam purity
suitable for medical device processing.
It also provides acceptable water performance
qualification levels for utility
water, critical water, and steam, and
it describes the water treatment processes
that can be utilized to produce
water of the quality to meet the needs
of medical device processing.
This standard applies to all areas in
a healthcare facility that process medical
devices. Most medical device processing
occurs in a sterile processing
department; however, there are other
areas that clean and sterilize or perform
high-level disinfection on medical
devices. These areas may include surgery,
endoscopy, dental clinics, or cardiac
labs that process transesophageal
echocardiography (TEE) probes.
ST108 provides valuable guidance
for the quality of water delivered to the
point of use for manual and mechanical
medical device processing. Specifically,
it defines water types based on the various
stages of processing. The following
are included in this document:
* Responsibility for the water management
program
* Importance of water quality
* Adverse effects of water impurities
on medical device processing
* Categories and requirements of
water quality for medical device processing
www.ormanager.com
W
*
Selection of water of the appropriate
quality
* Purity requirements of water used to
generate steam
* Effective water treatment and qualification
*
Considerations for ongoing maintenance,
monitoring and quality improvement
of the water treatment
system
* Troubleshooting water quality issues.
The facility's water management program
should be performed by a multidisciplinary
team for water management,
which is also recommended by
The Joint Commission. The team should
include senior leadership or a sponsor
with authority to allocate resources, and
a water treatment specialist along with
key stakeholders from sterile processing,
facilities engineering, infection prevention
and control, clinical engineering,
and surgery.
This team is responsible for complying
with the physical environment as
well as infection prevention and control
accreditation standards. Further, it is responsible
for developing, implementing
and documenting all applicable requirements
of the Water Management Program,
and it is accountable and responsible
for actions to ensure water safety
and quality. Team members should be
knowledgeable about water systems
and associated processes in use.
A Risk Analysis section is included
in the standard since water quality issues
can contribute to adverse patient
events and outcomes. Inadequate water
quality used on a medical device can
result in ineffective cleaning and disinfection,
device malfunction during use,
toxic residues remaining on a device
causing tissue irritations, patient infections,
and pyrogenic reactions. A risk
analysis should be performed to reduce
or eliminate the risks associated with
poor water quality. There are specific
water quality performance indicators
that should be monitored to assure the
correct water quality is being used.
Types of water quality
Water quality requirements when processing
a medical device are determined
by the processing stage in use.
There are different types of water quality,
and the terminology used to refer to
them is based on the water treatment
process utilized with associated quality
requirements during the process, not
the location of use.
For example, the term " tap water "
may be used to refer to the water coming
out of the sink tap; however, the
water quality is actually " potable. " Potable
water is a specific type of water
that has been treated by a municipal
water treatment facility and delivered in
such a manner that it meets the specifications
of the Environmental Protection
Agency (EPA) guidelines for direct or
indirect human consumption.
The standard describes three types
of water quality and provides specific
performance qualification levels of water
quality for each. All three levels are required
to meet the water quality measurement
values as defined in the standard.
Utility
water is mainly used for flushing,
cleaning solutions, and intermediate
rinsing, such as between cleaning
and disinfection. Utility water treatment
removes excessive dissolved minerals
and other undesirable characteristics to
provide a level of assurance of compatibility
with the cleaning agent recommended
for medical device processing
or materials of construction of the instruments.
The need for water treatContinued
on page 15
OR Manager | Nov/Dec 2023 13
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