Even parameters for considering the quality of water used for ultrasonic cleaning devices (pictured) are covered in the first-of-its-kind standard.

A new standard that establishes the quality of water used to process reusable medical devices heralds “a huge shift for the healthcare industry,” in the words of Terra Kremer, a microbiological quality expert and co-chair of the AAMI working group that developed the standard.

The first standard of its kind, ANSI/AAMI ST108:2023, Water for the processing of medical devices, “has garnered an extraordinary amount of interest within the sterile processing, water quality, and regulatory communities and we are excited about its publication,” said Matt Williams, AAMI vice president of standards. Nearly 120 subject matter experts and alternates participated in the standard’s development under the auspices of the AAMI Sterilization Standards Committee.

“This document will provide much needed direction on the minimum requirements for water quality necessary to effectively process medical devices intended for patient use,” Williams added. 

“Adoption of this standard will position healthcare organizations to have confidence that the water that they are using in each state of reusable medical device processing is achieving the prescribed level of cleanliness and sterilization,” said Erin Kyle, editor in chief of guidelines for perioperative practice at the Association of periOperative Registered Nurses and co-chair of the working group that developed the standard. “Healthcare organizations will be equipped with the information they need to monitor and control their water quality.”

ANSI/AAMI ST108 revises and replaces AAMI TIR:34:2014/(R)2021. Unlike the technical information report, the standard provides clear requirements for every stage of medical device processing. “TIR34 is not a requirement. Elevating its content to a standard will encourage most healthcare facilities to voluntarily conform with best practices for device processing water quality,” Kremer explained.

Complementing Joint Commission, CMS Requirements

The new standard can be used to avoid the consequences of using water that is of inadequate quality during the cleaning and sterilization of medical devices. Water impurities can have a wide range of adverse effects, the standard notes, such as:

• Damage, biofilm buildup, and increased microbial load or endotoxin content on medical devices.
  
  
• Decreased effectiveness of cleaning agents and degradation of the water system or processing equipment.
  
  
• Infection, toxicity, and fever reactions in patients, which can contribute to adverse patient events and outcomes.
  
  
• Environmental health and safety risks to personnel.

ST108 complements a 2022 water management standard from the Joint Commission and a 2017 requirement by the Centers for Medicare and Medicaid Services for health facilities to have a water management program and staff responsible for overseeing and implementing the program, with requirements for water quality production and a risk assessment.

ANSI/AAMI ST108 specifies the minimum requirements for the water quality and steam purity necessary to effectively process medical devices intended for use on a patient. The new standard:

1. Identifies the categories of water quality that should be used during each stage of sterile processing.
2. Provides a risk analysis and establishes roles and responsibilities for processing facilities.
3. Quantifies water quality given pH, microbial levels, conductivity, and other properties.
4. Establishes maintenance, monitoring, and quality improvement procedures for water treatment systems.
5. Addresses emergency circumstances such as service interruptions and boil water advisories.

“This standard directs the user to qualify the water system and maintain it, so the water quality remains in a state of control,” Kremer said. “For the first time, the points for where water is tested is specified and a cross-functional team is identified as directly responsible for water quality within a healthcare system.”

Coming to Consensus and Future Plans for Additional Guidance

Given the size and diversity of the team responsible for ANSI/AAMI ST108, which includes experts from industry, healthcare delivery organizations, regulatory agencies, and academia, coming to consensus took time. According to the co-chairs, the working group researched and discussed water quality parameters, values, and supporting scientific information to reach meaningful consensus.

“AAMI Sterilization Working Group 95, Water Quality for Reprocessing Medical Devices, consisted of over 170 members that represented industry, regulatory/government, users, and general interest stakeholders,” noted Thomas Kim, Director of Standards, AAMI, who helped guide the group. “The consensus body brought together a diverse group of stakeholders across the sterilization, water management, medical device and equipment manufacturers, healthcare practitioners, testing laboratories, and regulatory communities.”

“It is always difficult for a committee to align on specific acceptance criteria,” Kremer added. “We did this by utilizing data from the industry to set realistic water quality requirements, where patient safety was our top objective.”

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.

Following this standard’s publication, the AAMI working group is planning a technical information report to walk healthcare delivery organizations through each step of the water qualification process. This is the “logical next step” to promote adoption of the standard and support patient safety, Kremer said.

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