Water quality standard boosts healthcare industry

As healthcare facilities increasingly focus on patient safety and infection prevention, effective water management has become a critical aspect of medical device processing. To address this, ANSI/AAMI ST108:2023 was introduced last year as a new, comprehensive standard for water quality systems in device reprocessing.

This standard, built on years of guidance and technical revisions, provides a clear framework for healthcare organizations to ensure proper water quality during decontamination, disinfection and sterilization processes.

The journey toward ST108:2023 began with the release of AAMI TIR34: 2014/(R)2017, which offered initial guidance for managing water quality in medical device reprocessing. Over the past decade, this technical report has evolved into a full-fledged standard with expanded requirements for water system performance, testing and team collaboration, offering healthcare organizations a detailed roadmap for compliance.

Strengthening existing water management systems

Healthcare organizations likely have existing water management procedures that align with elements of ST108:2023. However, a thorough review of current practices is essential to identify opportunities for building upon these systems rather than starting from scratch.

Medical device manufacturers often specify water quality requirements in their instructions for use (IFUs) for different stages of device processing. These requirements should be a cornerstone of any water management plan. Additionally, hospitals must implement strategies to reduce the presence of biological agents like Legionella in their water distribution systems.

Key components of an effective water management system include:

• Clear roles and responsibilities for the water management team;
• A comprehensive risk analysis,
• Routine water quality monitoring, and
• Regular system maintenance and performance qualification.

Adapting to local regulations

In the U.S., some states have already integrated the requirements of ST108:2023 into their regulations, which means healthcare organizations in those regions may be required to comply with the new standard sooner rather than later. Therefore, it’s important for healthcare leaders to assess whether their current water management plans meet respective national and local regulation standards.

Preparing for future requirements

Although the Accreditation Commission for Health Care (ACHC) does not plan to change its standards related to water quality systems in 2025, healthcare facilities should begin preparing for future compliance with ST108:2023. Improvements to water processing systems often require careful planning, time and funding, so early preparation can help avoid future disruptions.

Key considerations for implementation

When preparing to implement ST108:2023, healthcare organizations should ask:

1. Are device and equipment IFUs being followed? Identify the water quality requirements for each stage of the device processing cycle, from decontamination to sterilization.
2. What types of water are defined and required in your facility? Understand the distinction between utility water, critical water and steam, and ensure that each is processed and used according to the standard.
3. Is the water management team multidisciplinary? Expand the team’s scope to include key personnel involved in device processing, such as central sterilization staff and clinical engineering personnel.

Monitoring and continuous improvement

To ensure the efficacy of water systems in producing disinfected and sterilized medical devices, organizations must engage in routine monitoring. Meaningful metrics should include checking for corrosion, biofilm buildup, scaling and potential microbial contamination. Monitoring these factors not only protects the integrity of medical devices but also ensures the safety of patients and personnel.

By starting with a gap analysis and expanding the water management team, healthcare organizations can begin taking actionable steps toward full compliance with ST108:2023. Preparing now will enable smoother transitions when upgrades to water systems are required, whether driven by regulatory changes or accreditation standards.

As water quality continues to be a critical factor in effective medical device processing, healthcare facilities have a clear opportunity to strengthen their systems in line with this updated standard. By addressing potential gaps and incorporating cross-functional expertise, organizations can ensure better patient outcomes and safer environments for both staff and those receiving care.

Richard L. Parker, MBA, CHFM, CLSS-HC, FASHE, FACHE, is Associate Director, Physical Environment and Life Safety at Accreditation Commission for Health Care, Inc. (ACHC), where he provides guidance to customers and surveyors in the ASC and hospital programs. Prior to joining ACHC full-time, Richard was an accreditation surveyor while also serving as Executive Director of Facilities for a 615-bed hospital system in Arizona.