What is ANSI/AAMI ST108?
The Association for the Advancement of Medical Instrumentation (AAMI), an organization accredited by the American National Standards Institute (ANSI), has recently published ANSI/AAMI ST108:2023, a standard that defines new requirements and best practices for the water used in the sterilization of medical equipment. ST108 replaces the older standard, TIR:34:2014/(R)2021 with more stringent guidelines and requirements for sterile processing departments. Medical facilities will be expected to make changes to conform with the standards set by ST108.
According to the standard itself, ST108 “defines multiple levels of water quality and steam purity suitable for medical device processing, and it describes the water treatment processes that can be utilized in order to produce water of the quality to meet each of these categories.”
How to Get Started with ST108
Ensuring compliance with ST108 might seem daunting at first, but Sterile Processing departments and hospital facilities really only need to follow a few simple steps to achieve safe, compliant water quality.
Have your water quality assessed by professionals. Step 1 of implementation of new water standards should always be to have current water audited by water treatment experts. This will determine if the water requires treatment, and the type and scope of treatment that might be required.
Create/Update and Implement a Water Treatment Plan. Once you know what water needs to be treated, a plan should be created and carried out to provide the correct quality water to sterile processing areas.
Routine Monitoring. ST108 stresses the importance of routinely monitoring water quality across all points of use to ensure consistent and safe water quality. Regularly re-assessing water quality is highly recommended.
Fact Water can provide ST108 compliant treatment systems and equipment, as well as offer water management and monitoring services.
Key Takeaways from ANSI/AAMI ST108
ST108 differs from the previous standard, TIR:34 in several ways that will be significant for many medical institutions:
- Roles and Responsibility: ST108 requires facilities to establish a multi-disciplinary water management team which will be “responsible for compliance with the local code, infection prevention and control accreditation standards.”
- Steam: In addition to previously defined categories of water quality (Critical Water and Utility Water) Steam has been defined as its own category of water quality, with its own criteria that must be monitored and maintained.
- Categories and Performance Qualification: Parameters and qualification criteria for levels of water quality have been expanded and further defined from the previous standard.
- Routine Monitoring: Water quality monitoring has been emphasized in ST108, with specific duties for the responsible personnel outlined and described. ST108 provides comprehensive guidance on how to ensure systems remain consistently effective and compliant to maximize patient safety. This includes regular monitoring and audits of water treatment systems.
When will ST108 be Implemented?
ST108 is already an ANSI standard as of August 2023. Many medical facilities are preparing for changes and updates to their existing procedures based on the new standard. AAMI is currently in the process of publishing its “Guidance on Healthcare Implementation and Use of AAMI ST108,” which will further clarify and expound upon expectations set out in ST108, and will likely prompt many facilities to take action on the new standard ST108.
What is sterile processing?
Sterile processing is the process of cleaning and disinfecting medical devices so that they can be safely used in surgical procedures. Because water is used in most sterile processing, ST108 emphasizes that water quality is highly important to ensure best results. Sub-par water quality can lead a range of negative effects such as:
- Corrosion, pitting, biofilm buildup and increased microbial load on medical devices.
- Decreased effectiveness of cleaning agents.
- Degradation of the water system or processing equipment via biofouling and/or scaling.
- Risks to patient safety, including increased risk of the spread of infections, toxicity, and pyrogenic reactions.
Are you Prepared for AAMI ST108?
AAMI ST108 is a standard the emphasizes strict and ongoing water treatment. For many sterile processing departments, this might mean making large changes to the way water is handled.
Fact Water is here to serve all your water needs – including full system audits and the development of water treatment plans to help meet new standards like AAMI ST108.