First Steps to Meet AAMI ST108: Water for the Processing of Medical Devices ​

First Steps to Meet AAMI ST108:
Water for the Processing of Medical Devices

ANSI (American National Standard Institute) and AAMI (Association for the Advancement of Medical Instrumentation) released AAMI ST108 in August 2023. The standard provides guidelines for selecting the water quality necessary for the processing of categories of medical devices. The new standard replaces the previous Technical Information Report, AAMI TIR34.

What is covered in AAMI ST108?

Some of what’s covered in AAMI ST108 is:

  • Minimum requirements for water quality used at different stages in the process of medical devices.
  • Categories and requirements of water quality for medical device reprocessing.
  • Additional responsibilities for the Water Management Program (WMP) Team.
  • Selection of appropriate water quality.

 

Is my facility required to follow AAMI ST108?

AAMI ST108 is currently not a requirement. The voluntary standard is aimed at improving the water quality of medical device reprocessing in healthcare facilities. The goal is to increase awareness that water quality issues can contribute to adverse patient outcomes.

What are the first steps to meet AAMI ST108?

1. Barclay develops ASHRAE, CDC, CMS, and TJC compliant Water Management Programs and will incorporate the AAMI ST108 requirements into your building’s WMP. Your updated WMP will include:

  • A multidisciplinary team of internal and external individuals to the healthcare facility.
  • Define water quality needed for processing medical devices.
  • Verify testing requirements and outline water quality monitoring.

2. AAMI ST108 outlines categories and performance qualification levels of water quality for medical device processing for Utility Water, Critical Water, and Steam. Barclay can assist with baseline and ongoing monitoring testing through certified labs.

Water Quality Measurements include:

  • pH
  • Total Alkalinity
  • Bacteria
  • Endotoxins
  • Total Organic Carbon (TOC)
  • Color and Turbidity
  • Ionic Contaminants (Aluminum, Chloride, Conductivity, etc)


Contact Barclay for your Water Management Program and AAMI ST108 testing needs!

Contact Barclay Water Management, Inc.

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