Water quality is an important aspect of medical device reprocessing because of the critical role it plays in ensuring the effectiveness of the process. Water can be a source of microorganisms and chemicals that can negatively affect reprocessing and thus device safety.

The Association for the Advancement of Medical Instrumentation (AAMI) provides expert guidance for settings such as hospitals and ambulatory surgery centers (ASCs) on issues including the reprocessing of instruments and devices. In October 2023, in response to what the organization said was an "extraordinary amount of interest," AAMI published a new standard that establishes requirements for the quality of water used to process medical devices. The standard, ANSI/AAMI ST108:2023, "Water for the processing of medical devices." This new standard revises and replaces AAMI TIR34:2014/(R)2021, which provided information and guidance on water quality for device reprocessing.

AAMI states its 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; and

• addresses emergency circumstances such as service interruptions and boil water advisories.

Infection Control Consulting Services (ICCS) assists central sterile processing departments (CSPDs) in maintaining strict compliance for reprocessing, including following nationally recognized guidelines and standards from the Centers for Medicaid & Medicare Services (CMS); accreditation organizations, including The Joint Commission; and organizations like AAMI. The ICCS team has extensive experience with monitoring the processes for pre-cleaning, high-level disinfection, sterilization, environmental cleaning and much more. ICCS also supports organizations that have undergone a survey that identified deficiencies associated with reprocessing and others in putting together a plan of correction.

Contact ICCS to learn what our team can do for your organization.