Understanding The Fundamental Principles of the ST108 Standard

During the second half of 2023, the Association for the Advancement of Medical Instrumentation (AAMI) published a new Standard called ANSI/AAMI ST108:2023. The Standard, replacing AAMI TIR34:2014/(R)2021 provides guidance to the medical device processing industry to effectively manage and maintain a water quality level for their daily operations to help prevent healthcare-associated infections (HAI). The Standard categorizes water quality according to its intended use: utility water for flushing, washing, and intermediate rinsing, critical water for a final rinse after high-level disinfection, and steam for use in sterilization equipment.

The Standard provides quality specifications for select physicochemical parameters in various categories of water. A few of the parameters can be measured in the field, such as color and turbidity, pH, and total alkalinity. For other water quality conditions laboratory testing is necessary to monitor the total bacterial and bacterial endotoxin concentration, total organic carbon (TOC), and ionic contaminants such as aluminum, copper, and zinc.

Who does this impact?

This announcement from late 2023 was a significant one for the Healthcare Industry. Previous documentation provided guidance, but with the release of the ST108 Standard, all healthcare facilities are now strongly encouraged to adopt best practices to achieve medical device processing water quality outlined in the standard.

Additionally, the Water Treatment Industry and Water Testing Laboratories have seen a significant increase in testing requests from various healthcare facilities in their respective service areas.

Facility Managers, Medical Device Processing Personnel, Infection Control Specialists, Clinical Engineering Personnel, Water Treatment Consultants, and Third-Party Testing Laboratories are all contributors to a comprehensive approach and fostering a culture of excellence in healthcare settings.

What needs to be done?

It is important to regularly monitor and periodically audit healthcare water systems to ensure compliance, and to identify improvement opportunities as a result. Water management plans should also be revised to align with this Standard to ensure all water treatment and monitoring practices meet the requirements of ST108.

The adoption of this Standard will position healthcare organizations as well as service providers to have confidence that the water in use during each stage of reusable medical device processing meets the prescribed level of cleanliness and sterilization.

How can Q Laboratories help?

Established in 1966, Q Laboratories has over 50 years of experience within the water testing industry. Even though the ST108 Standard release is recent, Q Laboratories has been analyzing the parameters included in the ST108 Standard for decades. Today, from our state-of-the-art 33,000 sq/ft. laboratory we connect the most current technologies to the water treatment industry and provide unmatched customer service. Reach out to us today!

To learn more about AAMI please visit: https://www.aami.org/about-aami/about-aami