Water Purity Standard ST108

Presented by Andrew Rodriguez from Nalco Water 

ANSI/AAMI ST108:2023 Water for the processing of medical devices

ANSI/AAMI ST108:2023 is a critical step forward for patient safety.

The professionals responsible for the processing of medical devices prior to use are experiencing increasing challenges including: the increasing complexity of modern medical devices with hidden, difficult to access areas (e.g., lumens and complex mechanisms) where clinical soil can become lodged; and the emerging and reemerging incidence of “superbugs” that must be removed or inactivated for patient safety but are able to survive processing in situations where soil removal is incomplete. Any limitation on or diminishment of cleaning efficacy can lead to patient morbidity or mortality and decreased device use life. Water of the appropriate quality for the processing of medical devices prior to clinical use is an important part of the solution to these problems. 

A common factor in the processing of medical devices is the use of water. While medical devices cleared by the U.S. Food and Drug Administration’s (FDA) for sale into the health care market have been provided with validated processing instructions and procedures, these procedures may not be completely effective if water of specified quality is not used. Similarly, cleaning agents work better, and devices are rinsed more thoroughly if the water is of the specified quality. Each health care facility may require a specific approach to treating water for processing needs based on a variety of factors.