Compliance with ANSI/AAMI ST108 Whitepaper

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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.

This ST108 briefing covers:

• Understanding ANSI/AAMI ST108: Key requirements, risks of outdated systems, and financial impact.
• Challenges & solutions: Addressing water quality issues to ensure regulatory success.
• Why short-term fixes fail: Risks of chemical sanitization, incremental upgrades, and reactive maintenance.
• Thermal vs. cold-water systems: Ensuring consistent water quality without chemical dependency.
• The hidden costs of chemicals: Compliance risks, operational burdens, and sustainability concerns.
• Sustainability & efficiency: Chemical-free solutions for lower costs and environmental benefits.
• Traceability & cybersecurity: Secure data management, remote monitoring, and compliance tracking.
• Strategic lifecycle costing: Managing CAPEX, OPEX, and TOTEX for long-term financial planning.
• Proven expertise & performance guarantees: 15+ years of R&D, validated case studies, and industry-leading warranties.
• Testimonials: Real-world success in achieving compliance, reliability, and efficiency.

Many healthcare facilities continue to operate with cold water systems that demand frequent chemical treatments or attempt to extend the lifespan of outdated infrastructure through incremental improvements. However, these strategies fail to address the long-term needs of patient safety and regulatory compliance. This paper illustrates how hot water systems incorporating thermal sanitization offer a future-proof solution, ensuring consistent reliability, adherence to standards, and optimized cost-efficiency for SPD water purification.

Use the form below to request access to the full whitepaper and discover how a thermally sanitised hot water system can help your SPD meet ANSI/AAMI ST108 with confidence.

One of our team will review your request and be in touch with you shortly. You can also use the form to request or arrange your complimentary AAMI ST108 consultation with an expert from Envirogen.