New AAMI Standard on Water Quality for Medical Device Processing

The Association for the Advancement of Medical Instrumentation (AAMI) has published a new standard that establishes requirements for the quality of water used to process medical devices. The first standard of its kind, ANSI/AAMI ST108:2023, Water for the processing of medical devices, revises and replaces AAMI TIR34:2014/(R)2021, which provided information and guidance on water quality for device reprocessing.

ST108 provides clear requirements for every stage of medical device processing. Matt Williams, AAMI vice president of standards said, “ANSI/AAMI ST108 has garnered an extraordinary amount of interest within the sterile processing, water quality, and regulatory communities and we are excited about its publication. This guidance document will provide much needed information on the minimum requirements for water quality necessary to effectively process medical devices intended for patient use.”

The new standard: 

• • Identifies the categories of water quality that should be used during each stage of sterile processing.
  • Provides a risk analysis and establishes roles and responsibilities for processing facilities.
  • Assesses water quality based on factors such as pH, microbial level, conductivity, and other properties.
  • Establishes maintenance, monitoring, and quality improvement procedures for water treatment systems.
  • Addresses emergency circumstances such as service interruptions and boil water advisories.

AAMI’s Water Quality for Medical Device Processing Working Group developed ANSI/AAMI ST108 by reaching a consensus on research-based evidence and industry best practices. Its members, including experts from industry, healthcare delivery organizations, regulatory agencies, and academia expect the new standard will have major implications for healthcare providers and the healthcare industry at large.

Terra Kremer, co-chair of AAMI’s Water Quality for Medical Device Processing Working Group said:

The release of this document will be a huge shift for the healthcare industry. The current document AAMI TIR34 makes recommendations, but elevating its content to a standard will encourage healthcare facilities to voluntarily conform with best practices for device processing water quality. 

Erin Kyle, editor in chief of guidelines for perioperative practice at the Association of periOperative Registered Nurses (AORN), stated:

Adoption of this standard will position health care organizations to have confidence that the water that they are using in each stage of reusable medical device processing is achieving the prescribed level of cleanliness and sterilization.

ANSI/AAMI ST108’s novel requirements for water quality provide the foundation for improved patient outcomes and offer clear conformance criteria for organizations involved in processing reusable medical devices in healthcare facilities.

For those interested, AAMI will also host an educational session led by Terra Kremer and Erin Kyle on October 5, 2023, to further explain the standard’s requirements.