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


"The importance of monitoring water quality to prevent problems with microbial proliferation cannot be overemphasized."  


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.  

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February 5th, 2024 from 1:00-3:00pm Eastern

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This educational training session aims to familiarize participants with the newly established standard ANSI/AAMI ST108:2023, Water for the processing of medical devices. The training will comprehensively cover the content of the document, enabling end-users to effectively incorporate the recommendations outlined in the new standard.

The training will adopt a systematic approach, delving into each section of the document to provide attendees with the necessary information for successful implementation. Special attention will be given to emphasizing the significance of an interdisciplinary team and clarifying the roles and responsibilities of each team member. Participants will also learn about the importance of conducting a risk analysis and gain insights into selecting appropriate water categories for different stages of the processing sequence.

Additionally, the training will cover essential topics such as water treatment processes and systems. Attendees will understand the significance of verifying water quality parameters during the installation of new water treatment systems through the installation qualification process. Furthermore, they will gain knowledge on the ongoing monitoring of water quality and preventive maintenance practices.

To ensure comprehensive understanding, the training will conclude by providing guidance on utilizing the informative annexes included in the standard ANSI/AAMI ST108:2023. By the end of the training, participants will be equipped with the knowledge and tools necessary to effectively implement the standard recommendations in their respective contexts.


Over the course of two (2) hours, the attendee will be able to:

  • Demonstrate an understanding of the significance of maintaining water quality within Central Processing.
  • Identify and articulate the requirements for ensuring water quality in the reprocessing of reusable medical devices.
  • Recognize indicators that indicate a water quality problem and effectively communicate the potential impact on patients to all levels of management.


Healthcare Facility Sterile Processing Professionals 


Terra Kremer, BS 

Director of Microbiological Quality

Johnson & Johnson 

Co-Chair, AAMI ST-WG 95

Lean Six Sigma Black Belt

Erin Kyle, DNP, RN

Editor in Chief: Guidelines for Perioperative Practice

Association of Perioperative Registered Nurses (AORN)

Co-Chair, AAMI ST-WG 95