The Association for the Advancement of Medical Instrumentation (AAMI) has established a new standard, ANSI/AAMI ST108:2023, critical for sterile processing departments (SPDs). Replacing the previous AAMI TIR34 guidelines, ST108 emphasizes a stringent approach to water treatment, application, and monitoring for safe and effective reprocessing of medical devices.
Water plays a vital role throughout the medical device reprocessing cycle. It’s used for:
However, unlike tap water, sterile processing demands high-purity water to guarantee device safety. Contaminated water can harbor microorganisms and endotoxins (toxins from gram-negative bacteria) that compromise sterility and potentially cause patient infections.
ST108 defines three water categories with specific quality requirements:
Utility Water: This is the starting point, typically tap water. Depending on the facility’s source, it may require further treatment to meet the standards for the next two categories.
Critical Water: This highly treated water is used for the final rinse cycle of reprocessed devices or for steam generation in sterilizers. ST108 outlines specific parameters for critical water, including:
Several treatment methods can achieve critical water quality, including:
Steam: ST108 also addresses the quality of steam used for sterilization. While generated from critical water, the standard outlines monitoring procedures to ensure it remains free of contaminants.
ST108 places significant emphasis on the entire water management system within the SPD. Key aspects include:
AAMI ST108 elevates the importance of water quality in sterile processing. By implementing a robust water treatment system, adhering to distribution and storage protocols, and maintaining a rigorous monitoring program, healthcare facilities can ensure the safety and efficacy of reprocessed medical devices, ultimately protecting patient health.