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AAMI TIR34 – WATER FOR THE REPROCESSING OF MEDICAL DEVICES


HOW TO ENSURE ADEQUATE WATER QUALITY FOR YOUR STERILE PROCESSING DEPARTMENT

The new standard, AAMI ST108, was published in August 2023, providing updated
water quality requirements for sterile processing. > Learn More  

In order to educate and provide guidance to healthcare facility personnel, the
Association for the Advancement of Medical Instrumentation (AAMI) publishes a
comprehensive Technical Information Report (TIR) called TIR34 – Water for the
reprocessing of medical devices. This article will review the definition of
water quality, the importance in sterile processing, adverse affects of poor
water quality, and how the AAMI TIR 34 guidelines help ensure adequate water
quality. 



Water Quality Defined

Water, which can exist as a solid, liquid, or vapor, consists of one atom of
oxygen and two atoms of hydrogen bonded together by their shared electrons. In
terms of water purity, anything that is not an H+ or OH- ion is considered a
contaminant or impurity.

The Environmental Protection Agency (EPA) identifies contaminants to regulate in
drinking water to protect public health.1 The Agency sets regulatory limits
for the amounts of certain contaminants in water provided by public water
systems. Local public water systems treat water to these standards to make it
potable (safe to drink). However, despite this treatment, water can become
re-contaminated with chemicals and microorganisms as it is distributed through
the municipality’s piping infrastructure. This contamination can be
problematic for many applications that use this potable water. Sterile
Processing in hospitals is one such application.

Water Quality is Important in Sterile Processing

Water quality is an important consideration in all stages of medical device
reprocessing. The primary objective of medical device reprocessing is to ensure
that a device is safe for patient use and does not cause an adverse event in the
patient.2 3

It is important that personnel who reprocess medical devices (or use them in
procedures) understand how the quality of the facility’s water can have an
impact on the reprocessing equipment, as well as the devices and instruments
themselves. It is also important that personnel recognize that the quality of
water should be regularly monitored to ensure that the control measures in place
are working properly.

Water Treatment

Water treatment includes a collection of water purification devices and
associated piping, pumps, valves, and gauges that together produce purified
water of a specified quality and deliver it to the point of use. Water purity is
an indication of the extent to which impurities (e.g., dissolved organic and
inorganic solids and microbial contaminants, ionic, and chemical) have been
removed.

AAMI TIR34: 2014/(R)2017

This living document is intended to provide guidelines on the quality of water
that should be used in each stage of medical device reprocessing for each
category of medical device. It also includes annexes that provide technical
information to water maintenance personnel (i.e., personnel such as Facilities
Engineering/Management who are involved in water treatment and distribution in
the facility) to guide them in configuring and monitoring water treatment
systems.

More specifically, AAMI TIR34: 2014/(R)2017 includes the following:

 * Covers the quality of the water used to clean, rinse, disinfect, and
   sterilize medical devices.
 * Defines water types on the basis of hardness, pH, microorganism levels,
   endotoxin levels, and other characteristics. The following topics are
   covered:
   * Importance of water quality and effective water treatment
   * Categories of water quality for medical device reprocessing
   * Selection of water quality
   * Water treatment systems
   * Monitoring of water quality
   * Strategies for microorganism control
   * Personnel considerations
   * Continuous quality improvement
   * Troubleshooting water quality issues
 * Provides definitions of terms and a bibliography
 * Annexes contain technical details pertaining to water treatment and
   monitoring for the benefit of water maintenance personnel

Categories of Water Quality for Medical Device Reprocessing

 * Utility Water - water that comes from the tap that may require further
   treatment
   * Used for flushing, washing, rinsing
 * Critical Water - water that is extensively treated to ensure microorganisms,
   inorganic, and organic materials are removed
   * Used for the final rinse or steam generation


CATEGORIES AND RECOMMENDED LEVELS OF WATER QUALITY FOR MEDICAL DEVICE
REPROCESSING

Types of Water
Water Use   Utility Water¹
Flushing/Washing/Rinsing   Critical Water
Final Rinse²/Steam Specifications Units       Hardness mg/L < 150³   < 1
Conductivity
(mg/L = ppm) µS/cm < 500   < 10 pH⁴   6-9   5-7 Chlorides mg/L < 250   < 1
Bacteria cfu/mL n/a < 10⁵ < 10 Endotoxin EU/mL n/a < 20⁵ < 10

Note 1 - This is the quality of water that might come from the tap but might
need some form of treatment to achieve these specification.
Note 2 - If this is the final rinse prior to sterilization of a critical device.
Note 3 - If hardness is greater than 150 mg/L, a water softener is recommended
unless used for washing and the cleaning chemistry is capable of handling higher
levels of hardness.
Note 4 - For boiler-treated steam, most boilers are treated to maintain a pH of
7.5 or 8.5. Any treatment of water that goes into boilers should be in
accordance with the sterilizer and boiler manufactures’ written IFU.
Note 5 - After high-level disinfection.

 

References:

Author: Jeffrey Holland, BSCEM, MBA, Director of Health Science, Evoqua Water
Technologies

¹ United States Environmental Protection Agency -
https://www.epa.gov/dwstandardsregulations; 2018
² AAMI TIR34: 2014/®2017 - Water for the reprocessing of medical devices
³ ANSI/AAMI ST79:2017 - Comprehensive guide to steam sterilization and sterility
assurance in health care facilities

NOTE: This primer is intended to provide a general overview of the importance of
water quality for sterile processing, as well as the AAMI TIR34: 2014/(R)2017
guidelines. It is not intended act as a substitute for healthcare personnel
reading the full AAMI TIR34 document, additional industry, guidelines, or
medical device manufacturers’ Instructions for Use (IFU).


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