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Sterilization & Infection Prevention
Continued from page 13
Further reading
ment at this stage varies from location
to location-and possibly from season
to season. The water treatment system
manufacturer should be consulted to
validate that the treatment process will
be adequate for the specific characteristics
of the incoming tap water.
Critical water is a type that meets
the water quality measurement values
as described in AAMI standards. To
achieve these values, the water generally
requires extensive treatment. It
does include primary treatment, which
is typically reverse osmosis (RO) or deionization
(DI), storage, and distribution
and can include final treatment to provide
a level of assurance that microorganisms
and inorganic and organic material
are removed from the water. This
water is mainly used for the final rinse
after high-level disinfection and/or for
the final rinse for critical devices prior
to sterilization. It can also be used as
feedwater for process steam, which is
a specific type of generated steam, and
may not be the type used at all healthcare
facilities.
Steam is defined as vaporized water
produced by a centralized boiler or a
generator/heat exchanger near the sterilizer.
Most steam used in healthcare facilities
is from a centralized system that
is used for many other purposes. This
is referred to as plant or house steam.
The steam is generated in this centralized
system and transferred through an
extensive amount of piping to the sterilizer.
The
other types of steam are located
close to the sterilizer: " process " steam
is created by using critical water, and
" clean/pure " steam is created using a
pure steam generator fed with water for
injection.
For all three types of water, a table
is provided that presents the specific
categories and performance qualification
levels of water quality for medical
device processing. These specifications
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The following annexes provide valuable information
that assist with the understanding
and implementation of this standard:
➤ Annex A Guidance on the application of
the normative requirements
➤ Annex B Risk analysis
➤ Annex C Automated Endoscope Reprocessor
(AER)
➤ Annex D Water used in cleaning and
moist heat processes
of Water Quality Measurement and Ionic
Contaminants are thoroughly described.
Water quality predominately used
and recommended for cleaning medical
devices is utility water. It can also
be used for the initial rinse to remove
soil loosened by the cleaning process
and for removing cleaning agent residues.
Critical water should be used as
the final rinse during cleaning for semicritical
devices and for devices that will
contact the bloodstream or other sterile
areas of the body. The final stage
in rinsing requires water that does not
have excessive levels of organics and
inorganics.
Guidance is provided for water quality
used for mechanical processing
equipment, such as washer-disinfectors
and ultrasonic cleaners, to achieve
cleaning and decontamination results.
Guidance for monitoring
Routine monitoring is necessary to assure
that the water quality is maintained
and does not deteriorate over time. If
water quality is not monitored, the water
treatment system could become heavily
contaminated with metals, microorganisms,
or other contaminants. Unmonitored
water quality could also contribute
to corrosion, staining, and increased
microbial levels after processing. Water
quality should also be monitored after
service interruptions and restoration of
supply, boil-water situations, repairs, or
disinfection of the distribution system.
➤ Annex E Water treatment technologies
➤ Annex F Water treatment system design
➤ Annex G Routine monitoring of water
treatment equipment & produced water
quality
➤ Annex H Maintaining Microbiological
Quality
➤ Annex I Typical presentation of water
quality issues during the processing of
medical devices.
This new standard provides guidance
as to what requires monitoring, how
often, and by whom. Water is monitored
from the time it enters the facility until
use. Most monitoring is performed by facilities
engineering/water maintenance
personnel to verify that the specified
water quality is delivered to the points
of use. The results of water quality monitoring
should be reviewed by those involved
with medical device processing
throughout the entire healthcare facility,
and corrective actions should be taken
if the parameters are outside of acceptable
limits.
Point-of-use monitoring should be
performed by medical device processing
personnel. If water quality monitoring
shows any excursions outside of
those typically seen values, it can serve
as a warning of potential issues. The
monitoring program is an opportunity
to address possible problems to anticipate
repair or replacement of water
treatment equipment or processes. An
investigation of water outside of the
monitoring excursion limits should be
performed to find the reason and associated
risks, then mitigate wherever
possible. Water maintenance personnel
should inform medical device processing
personnel if they are aware of issues
with water quality during times
when the water quality is not adequate.
The utility water in medical device
processing should be monitored for bacteria
quarterly at each point-of-use locaOR
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