ANSI/AAMI ST108:2023 “Water for the processing of medical devices” establishes a new standard for the quality of water from Central Sterile Water Systems used to process reusable medical devices. The new standard replaces the former Technical Information Report, TIR34:2014, which was simply a recommendation for water quality. ST108:2023 will allow the Joint Commission to flag facilities for not meeting the standard during an audit, giving healthcare facilities confidence that the water used in their sterile processing department is reaching the prescribed level of sterilization.
Improper water quality during the sterilization process of medical devices can lead to various adverse outcomes, including the degradation of equipment and distribution piping components. Of utmost importance is the implementation of a well-designed system to ensure the proper sterilization of medical tools, and ultimately reduce the occurrence of patient infections.
Water treatment is a comprehensive process that includes an arrangement of water purification equipment and associated piping, pumps, valves, and other appurtenances that together produce a specified quality of purified water and deliver it to the point of use. Haley Ward engineers are instrumental in designing and documenting the installation and arrangement of all components, collaborating closely with equipment manufacturers.
The new standard specifies the minimum requirements for the water quality necessary to effectively process medical devices intended for patient use. The key changes of the new standard include:
- Identifying the levels of water quality to be used during each stage of the sterilization process
- Identifying minimum water quality requirements with regards to pH, microbial levels, conductivity, and other properties
- Establishing roles and responsibilities for processing facilities to create a risk analysis
- Providing maintenance, monitoring, and quality improvement procedures for water treatment systems
- Outlining emergency procedures during an interruption of service
Haley Ward’s plumbing team boasts 30 years of experience working in medical facilities, offering expert water treatment recommendations that consistently meet or exceed industry standards. For further discussion about your specific needs, please contact Jason Bernier, Plumbing Design Professional, at (207) 283-9151.