Understanding ANSI/AAMI ST108:2023 Water Standards
Are you in compliance?
In 2023, the Association for the Advancement of Medical Instrumentation (AAMI) has published, ANSI/AAMI ST108:2023 – Water for the Processing of Medical Devices. This new standard replaces AAMI TIR34:2014, the standard that previously set requirements for processing and cleaning of medical devices. This new standard is directed at providing medical professionals with information and requirements specifically for the water used in these processes. The unique usage of this water requires that they meet strict performance standards not only for chemical makeup, but also for microbiological contamination.
From the AAMI website:
Adverse Effects of Poor Water Quality
Water impurities can have adverse effects to medical device processing, including:
- Adverse effects to the PRODUCT:
- Corrosion, pitting, scaling
- Biomass build-up
- Increase microbial load or endotoxin content
- Adverse effects to the PROCESS:
- Decreased effectiveness of detergents
- Degradation of the water system (biofouling or scaling)
- Adverse effect to the PATIENT:
- Infection
- Toxicity
It is important that sterile processing personnel understand the water quality issues that can contribute to adverse patient events and be aware of some of the gross indicators that suggest that there may be problems with the water quality.
The following table details the basic parameters that need to be monitored for the different types of water used in processing.
In addition to the general requirements that are monitored on a monthly or quarterly basis depending on type of water (utility, critical or steam) the following ionic contaminates need to be evaluated annually.
Black Labs recommends that a facility should test their water systems according to the standards above that are applicable to water type and usage. We provide full-service laboratory analysis for all the analytes required by ANSI/AAMI ST108:2023.
Endotoxin Testing
Occasionally, endotoxin may be desired or requested outside of regulatory needs, traditionally as a part of the systems validation. Black Labs recommends that a follow up sample should be done shortly after remedial action is taken, typically within 24 hours. Since these numbers represent a point-in-time of testing, it would be prudent to establishing testing on a routine basis to identify trends and potentially prevent an endotoxin issue that may be evolving.
