ANSI/AAMI Publishes STM 108 Water for the Processing of Medical Devices

November 9, 2023

Proper water quality is crucial for effective sterile processing. ANSI/AAMI ST108, published in Aug 2023 (replacing the former guidance document AAMI TIR34) provides standards for maintaining water quality necessary for the processing of categories of medical devices and addresses water treatment equipment, water distribution and storage, quality control procedures for monitoring water quality, strategies for bacterial control, and environmental considerations. 
Jonathan A. Wilder from Quality Processing Resource Group, LLC emphasized ST108's importance, stating it defines suitable water types for processing, and preventing complication. According to Wilder, ST108's requirements limit the contaminants in safe drinking water most likely to cause problems in medical device processing. Table 2 of ST108, lists allowable contaminant levels from the draft standard. 


ST108 covers:

1. Why do we need another technical consensus standard for building water systems?

2. What do normative and informative sections of ANSI/ASHRAE Standard 514 describe for risk management for building water systems?

3. How will ANSI/ASHRAE Standard 514 impact existing Water Management 

4. Programs that are aligned with ANSI/ASHRAE Standard 188?

5. How can healthcare facilities proactively prepare their programs for alignment with ANSI/ASHRAE Standard 514?


Jonathan A. Wilder further explains that “TIR34’s requirements table is far less comprehensive and lumps steam condensate and critical water together, which does not reflect the reality of house steam vs. “clean” steam (actually “process” steam which is made from critical water). One thing to note is that there are a lot more contaminants to check in ST108. These things do not belong on instruments and they certainly do not belong in the patient. A specific, important item is that the acceptance level for iron ions in utility water has been cut in half.”


See his Aug 2, 2022 article entitled The Future of Water for Processing Medical Devices.


In summary, ST108's detailed instructions will revolutionize sterile processing, ensuring efficient, safe, and high-quality medical instrument sterilization.

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