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Compliance audit illustration related to ANSI/AAMI ST108 water standards

When Regulators Look at Water: What a Recent Warning Letter Teaches Hospitals About Compliance

September 9, 2025

By Kenneth Mayer

An August 2025 FDA Warning Letter to a U.S. device manufacturer (not named here) put a spotlight on water systems, sampling methods, and documentation. The takeaways map neatly to what hospitals must[…]

ANSI/AAMI ST108:2023 requires complying with water filtration and purification levels to reduce SSIs

Where the Water Meets the Instrument: Debunking 5 Misconceptions ST108 Table 6

July 28, 2025

By Kenneth Mayer

When it comes to water quality in sterile processing, it’s not just about what’s in the tank — it’s about what’s coming out of the faucet. Since the release of ANSI/AAMI ST108:2023,[…]