Implementing AAMI Standard ST108 for Medical Device Water Quality

AAMI (Association for the Advancement of Medical Instrumentation) Standard ST108 defines levels of water quality to make medical devices safe for patients. 

The standard applies to water provided to devices such as automatic endoscope reprocessors (AERs), ultrasonic sterilizers, autoclaves, and local steam generators.

ST108 requires testing of water at various stages of medical device processing:

  • Utility water used for washing devices
  • Steam condensate used for sterilization
  • Critical water used for reprocessing, sterilizing, and rinsing

Water must be tested for a total of about 18 parameters including:

  • Microbial parameters (e.g., heterotrophic bacteria; endotoxins)
  • Chemical parameters (e.g., dissolved minerals; metals)
  • General water quality parameters (e.g., pH, total organic carbon, turbidity, conductivity, total organic carbon)

AAMI ST108 is important for protecting health and life. It became an ANSI standard on August 4, 2023. It may become a requirement of other standards (Joint Commission EC.02.05.02) and for product manufacturer warranties. 

AAMI ST108 indicates that the medical device processing water quality requirements should be managed by the same team that oversees the water management program (WMP) required by Joint Commission Standard EC.02.05.02 and CMS QSO17-30

Streamlining AAMI ST108 Testing in LAMPS

Testing 18 parameters at points of use (POUs) – in utility water, critical water and steam – is no small task. LAMPS Complete reduces the AAMI ST108 burden:

  • LAMPS provides a place to enter information on your AAMI ST108 water systems.
  • IoT sensors integrated with LAMPS can be used to automate the testing of several parameters including pH, conductivity, and turbidity.
  • Tests performed by laboratories integrated with LAMPS can be semi-automated. You enter the sample data and the lab populates LAMPS with the test results.
  • Tests taken with handheld or tabletop devices can also be entered in LAMPS, providing one place to store your data.
  • All the test results – from sensors, labs, and sampling devices – show in the LAMPS proprietary AAMI ST-108 report. You can simply show the report to an inspector.

See How it Works

If you already have a water management plan (WMP) in LAMPS, go to Training Note 3.008 to watch the video. The video and instructions in the training note provide a good overview of AAMI ST108 and show you steps for setting up your LAMPS WMP for AAMI ST108.

If you do not have a water management plan (WMP) in LAMPS, click to schedule a demo or ask a question about AAMI ST108.