Meet ST108 Standards at your Healthcare Facility

Aligning with ANSI/AAMI ST108:2023 Requirements

Water quality is pivotal in healthcare environments, especially in sterile processing and the reprocessing of critical medical devices. At
Chemstar WATER, we recognize the indispensable nature of water purity in safeguarding patient health and ensuring regulatory compliance. Our solutions are explicitly designed to help healthcare facilities meet—and exceed—the rigorous benchmarks set by the
ANSI/AAMI ST108:2023 standard.

What is ANSI/AAMI ST108:2023?

The ANSI/AAMI ST108:2023 standard represents a major advancement from the previous AAMI TIR34:2014 guidance. This updated standard enforces more stringent protocols for water system design, ongoing monitoring, analytical testing, and thorough maintenance. By establishing binding requirements for sterile processing departments, the standard underscores the necessity of delivering consistently high-quality water in device reprocessing.
Chemstar WATER stands as your strategic partner in navigating these regulatory evolutions, ensuring that your water treatment systems are precisely tailored to meet the latest demands.

The Critical Importance of Water Quality

Suboptimal water quality can compromise both the safety and efficacy of medical device processing, potentially causing corrosion, heightened microbial loads, and other adverse effects that jeopardize patient health. By proactively identifying and managing water-related concerns, sterile processing teams can avert device contamination and minimize the risk of infection.
Chemstar WATER’s comprehensive approach ensures that each stage of reprocessing receives water of suitable purity, ultimately safeguarding patient outcomes.

Key Actions for Facility Managers

1. Installation Qualification (IQ):
   Chemstar WATER collaborates directly with facility managers to define and validate precise acceptance criteria for water treatment system installation. Our expertise in engineering design and installation guarantees that systems are operationally ready and compliant from the outset.
2. Operational Qualification (OQ):
   We verify that all water treatment equipment, alerts, and control mechanisms function according to defined parameters. Our specialists develop validation protocols centered on critical quality attributes, helping your facility define and sustain alert/action levels aligned with
   ANSI/AAMI ST108:2023.
3. Performance Qualification (PQ):
   Our team confirms system efficacy by establishing definitive alert and action thresholds for water quality metrics. We supply extensive documentation and facilitate the creation of a robust validation maintenance plan, incorporating change-control processes for regular system reviews and requalifications.
4. Monitoring and Control:
   Chemstar WATER offers advanced, continuous monitoring platforms designed to track microbial levels across all water types utilized in device reprocessing. By rapidly addressing potential biofilm formation or microbial surges, we help preserve system integrity and maintain compliance.
5. Water System Design Considerations:
   We integrate best-in-class technologies—such as UV disinfection, submicron filtration, and reverse osmosis—to impede microbial proliferation. Our emphasis on precise usage assessments ensures that you receive a system sized to your facility’s actual water demands, preventing the costly pitfalls of overdesign.

How Chemstar WATER Supports Healthcare Facilities

• System Design and Installation:
  Our specialized water treatment solutions address the unique challenges of medical device reprocessing. From conceptual design through commissioning, we ensure adherence to
  ANSI/AAMI ST108:2023 and your operational requirements.
• Validation and Documentation:
  With in-depth expertise in validation protocols and recordkeeping, Chemstar WATER guarantees that your facility’s water treatment strategy meets the new standard’s strict requirements.
• Monitoring Solutions:
  We implement real-time water quality tracking to help you maintain consistent microbial control. These assessments and alerts preserve the performance and safety of your water system.
• Maintenance and Support:
  Our comprehensive service programs and proactive maintenance routines are designed to prevent system failures, ensuring uninterrupted, compliant operation.
• Compliance and Advisory:
  Navigating regulatory requirements can be challenging. Chemstar WATER provides expert guidance to align your practices with
  ANSI/AAMI ST108:2023 and other relevant industry standards.
• Training and Education:
  We offer tailored training materials for healthcare personnel, clarifying both the significance of water quality and the optimal operation of water treatment systems for medical device reprocessing.

Key Updates and Implementation Steps

Under ANSI/AAMI ST108:2023, healthcare facilities must establish a multidisciplinary water quality team and adhere to expanded definitions for water types—utility water, critical water, and steam. Each category addresses a distinct stage of device reprocessing, emphasizing the specialized treatment needed for each application.

For full compliance, facilities should conduct a detailed water quality evaluation, implement suitable treatment plans, verify water specifications for each step of device processing, and maintain ongoing monitoring. These measures are fundamental to delivering the level of water quality required for safe, effective medical device reprocessing.

Defining Water Quality for Healthcare

• Utility Water:
  Typically sourced from municipal supplies, utility water may require additional treatment to meet healthcare benchmarks. It is mainly used for flushing, cleaning, or rinsing prior to disinfection or sterilization.
• Critical Water:
  Subjected to thorough purification to remove microbial contaminants, inorganic particulates, and organic residues, critical water is used for final rinsing or steam generation. Its heightened purity helps avoid post-disinfection contamination.
• Steam:
  Generated by boilers or steam generators, steam sterilizes medical devices through high-temperature processes. Whether provided by a central utility or localized sterilizer, steam quality is integral to validated sterilization outcomes.

Implementation Steps for AAMI ST108 Compliance

1. Water Quality Assessment:
   An accredited testing provider evaluates incoming water to determine the treatment needed, aligning with specific healthcare standards.
2. Implementation of Water Treatment Plan:
   Once data is established, facilities must adopt targeted water treatment solutions that address identified contaminants and ensure water meets medical device processing requirements.
3. Assurance of Proper Water Quality:
   Periodic audits validate that treated water remains within acceptable ranges. Adjustments are made if operating conditions or source water parameters shift.
4. Ongoing Water Monitoring:
   Routine testing protocols confirm the efficacy of water treatment processes and ensure microbial levels stay within acceptable limits. Collaboration between maintenance and reprocessing teams is vital for quick resolution of any anomalies.

The ANSI/AAMI standard underscores that “The importance of monitoring water quality to prevent problems with microbial proliferation cannot be overemphasized.”

Your Partner in Water Quality: Chemstar WATER

Chemstar WATER is prepared to guide your facility through every stage of
ANSI/AAMI ST108:2023 compliance. Our integrated approach covers initial assessments, system design, validation protocols, and long-term support—ensuring that your healthcare operations consistently benefit from pristine water quality.

Rely on our technical expertise and regulatory insight to uphold patient safety and meet the evolving demands of modern medical device reprocessing. With
Chemstar WATER, you gain confidence that your water treatment systems deliver the purity necessary for safe and effective sterilization.