In this video, David Swiderski summarizes AAMI ST108 and explains what is needed to comply with it. Excerpted and adapted with permission from a training webinar presented to LAMPS water management plan users.
Updated January 14, 2025
What is the overall purpose of AAMI ST108?
AAMI (Association for the Advancement of Medical Instrumentation) Standard ST108 defines water quality levels for various stages of medical device processing to ensure patient safety.
The standard applies to devices such as:
- Automatic endoscope reprocessors (AERs)
- Ultrasonic sterilizers
- Autoclaves
- Local steam generators
ST108 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.
Who Manages AAMI ST108 Compliance in Your Facility?
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, ACHC 07.02.06, and CMS QSO17-30. ST108 suggests that the team include:
- Executive sponsor (senior leader)
- Water treatment specialist
- Facilities engineering personnel
- Infection prevention personnel
- Medical device processing staff
- Clinical engineering and surgical staff
What testing is required by AAMI ST108?
ST108 requires a lot of testing! “Utility water” used for washing devices, steam condensate used for sterilization, and “critical water” used for reprocessing, sterilizing, and rinsing 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., conductivity, pH, total organic carbon, turbidity)
What are the Key Challenges in Meeting the AAMI ST108 Standard?
- High cost of frequent testing and data entry
- Resource allocation for consistent monitoring
- Interpretation of “frequent testing” requirements
How can AAMI ST108 Testing be Streamlined?
Testing 18 parameters at points of use (POUs) – in utility water, critical water and steam – is no small task. To reduce the time and cost burden, plan carefully and automate as much as possible:
- Automate testing: Sensors can be used to automate the testing of several parameters (see Table 4 of ST108) including pH, conductivity, and turbidity.
- Automate the laboratory and reporting processes: Tests performed by laboratories can be semi-automated if the lab is integrated with documentation and reporting software (e.g., LAMPS Complete). Samples are collected and sent to the lab for tests of one or more parameters per sample. With an integration, the sample data is sent electronically to the lab directly from the software chain of custody that is filled out while collecting the samples. After the lab finishes the analyses, the test results are reported electronically, directly into the software.
Other non-microbial parameters can be tested with handheld or tabletop devices. The test results will ideally be entered in the same software (e.g., LAMPS Complete) that processes the sensor data and lab test results so that the ST108 reports show results from all the tests.
Tests with handheld devices may have a lower initial cost than tests with sensors or by labs but a higher ongoing cost for consumables and replacements. The higher labor burden may be the biggest cost of the manual tests.
What are the AAMI ST108 compliance requirements?
Expectations for hospitals will likely become clearer in 2024 after AAMI finishes and publishes its “Guidance on Healthcare Implementation and Use of AAMI ST108” (TIR119/Ed.1. Any updates of CMS QSO17-30, Joint Commission EC.02.05.02, or DNV requirements will also clarify expectations. For example, facilities need clarification on reporting requirements, the number of points of use (POUs) to test, and terms such as “frequently” and “more frequently.”
What are the key steps to getting started with AAMI ST108 compliance?
Some key steps in getting started with AAMI ST108 include:
- Identify testing points. Establish all points requiring testing.
- Select vendors. Choose vendors for sampling, lab analysis, and remediation.
- Implement software. Use a cloud solution such as LAMPS Complete for data management and reporting.
- Upgrade equipment. Ensure all necessary equipment meets the new standards.
Why is AAMI ST108 Compliance Important for Patient Safety?
Adhering to AAMI ST108 minimizes infection risks and ensures medical devices meet optimal sterilization standards, directly impacting patient safety and care quality.
David Swiderski is the Senior Technical Strategist at HC Info.
If your water management program is in LAMPS, see Training Note 3.008 about using LAMPS for ST108 data.
What suggestions should be added to this article about complying with AAMI ST108? Please comment below.
Very helpful article. Exciting times in the world of water quality.
Thank you for your kind words, Thomas! You are right these are exciting times!
David,
What is the best way to incorporate the AAMI and ISO standards in a contract? Water Certification, and Routine Testing?
Hello,
Is there a time frame when this should be in compliance? And for the water filtration system, Does the water company installing it need to be certified with ST108 compliance?
Mike Thanks for your comment. I would make sure your IFU’s have not changed to AAMI ST108 if so to meet manufacturer’s recommendations you will need to supply this quality water. I recently got a message back from the Joint Commission, who mentioned they are still waiting for CMS and looking at R3 reports and have no immediate plans regarding AAMIST108. The standard applies to water quality, and there is no “certified” AAMI system. There are FDA Medical Device 510k approvals for dialysis which are often confused with the ST108 standard and the end devices in SPD are FDA 510k approved, but so far, the ST108 only defines the water quality a system should supply.
When will the standard be enforced