Compliance with ANSI/AAMI ST108 Whitepaper

A Strategic Approach to SPD Water Purification

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Adherence to ANSI/AAMI ST108:2023, the definitive standard for water quality in medical device reprocessing, is paramount for the sustained operational efficiency of Sterile Processing Departments (SPDs). In today’s healthcare landscape, robust infection control is a critical imperative, directly influencing the prevention of healthcare-associated infections (HAIs).

Implementing a validated water purification system for reusable medical device processing is a foundational element of effective infection prevention and regulatory compliance.

Meeting the rigorous requirements of ST108 necessitates a collaborative, multidisciplinary approach to water system management. Facilities teams are responsible for the critical tasks of installation, validation, and ongoing maintenance, ensuring consistent water quality. SPD personnel, alongside staff in endoscopy units, dental clinics, and other specialty departments, are tasked with the continuous monitoring of processing equipment and medical devices. This integrated framework fosters shared accountability in resource allocation, budget planning, and system oversight, enabling data-driven decision-making and mitigating compliance risks.

This strategic briefing will address the inherent limitations of legacy water treatment systems, and the potential risks associated with chemical-dependent solutions. Furthermore, it will demonstrate how Envirogen’s EndoTherm solutions offer a proactive, future-proof approach to meeting and exceeding ST108 standards.