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Sterilization & Infection Prevention
tion, such as a sink, using a daily visual
inspection of the interior of processing
equipment, checking for residues, staining,
scaling, and discoloration. Critical
water requires more frequent monitoring;
if not properly maintained, the water
treatments can result in heightened microbial
levels, biofilm development, and
endotoxin.
In addition, the making of critical
water may affect the chemical attributes
of water, including pH, conductivity, total
alkalinity, and total hardness. For these
reasons, point-of-use critical water
should be tested monthly for endotoxins
and bacteria. Daily visual
inspections
should also be performed that include
inspection of the interior of processing
equipment for residues, staining, scaling,
and discoloration.
ST108 provides guidance for facilities
engineering on water treatment systems
installation and operation qualification
that describes general issues
associated with water treatment. It also
provides recommendations for unusual
events, including postconstruction and
extended shutdowns, extended boil
water alerts, steps to take after alerts
are lifted, and service interruptions.
There is also a section on the design
of water treatment systems, which
provides direction on production of the
desired quality of water. These may require
separate systems, each designed
to produce a particular water quality,
or they may be combined into a single
water treatment system. This section
integrates the water treatment systems,
pipework, treatment system configuration,
installation, and operation qualification
requirements, which includes a
validation plan.
Water quality is a foundational component
of medical device processing,
and managing water quality is a complex
and vital part of medical device processing.
The new ST108 provides critical
information regarding water quality
and serves as a valuable resource. For
more information about the standard
and how to obtain it, visit www.aami.
org. ORM
-Susan Klacik, BS, FCS,
ACE, CHL, CIS, CRCST,
AAMIF, is clinical educator
at the Healthcare Sterile
Processing Association
(HSPA) and its representative to AAMI.
Klacik has authored numerous articles
and represents IAHCSMM for regulatory
affairs dealing with sterilization
and disinfection.
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Table of Contents for the Digital Edition of orm_november-2023