What Healthcare Facilities Need to Know About ST108

The ANSI/AAMI ST108:2023 standard, “Water for the processing of medical devices,” is an important advancement in ensuring hospital and healthcare facility patient safety and goes beyond just ST108 testing. It addresses the critical need for maintaining high-quality water for medical device processing, a common factor across various stages of device reprocessing, including cleaning, rinsing, disinfection, and sterilization. With the increasing complexity of medical devices and the rise of superbugs, the standard underscores the importance of using water of specified quality to protect patients and extend the device’s life.

Key Highlights of ANSI/AAMI ST108:2023

  • Rigorous Water Quality Requirements: ST108 establishes minimum water quality and steam purity necessary for processing medical devices, aiming to safeguard patient health. It specifies categories of water quality suitable for different stages of sterile processing, risk analysis, and the responsibilities of processing facilities​.
  • Comprehensive Testing Protocols: The standard mandates extensive testing of water used in medical device processing, covering microbial, chemical, and general water quality parameters. This ensures the thorough removal of potential contaminants that could compromise patient safety.
  • Streamlined Compliance and Testing: To manage the broad scope of required testing, ST108 advocates for careful planning and automation where possible. This may include using sensors for real-time monitoring of critical parameters and integrating laboratory testing with documentation software for efficient sample management.
  • Emergency Preparedness: ST108 also outlines procedures for handling emergencies, like service interruptions and boil water advisories, ensuring continuous compliance under various conditions.

Considerations for Healthcare Facilities

To align with the AAMI ST108 standard, healthcare facilities should consider the following actions:

  1. Assess Water Treatment Needs: Evaluate the facility’s current water treatment processes and systems with an independent ST108 risk assessment to identify gaps in compliance with ST108 standards.
  2. Implement Regular Testing: Establish a regular ST108 testing schedule for all required water quality parameters, utilizing both in-house capabilities and external laboratories as needed.
  3. Educate and Train Staff: Ensure that staff responsible for sterile processing are familiar with the ST108 requirements and understand their roles in maintaining water quality.
  4. Engage Expert Partners: Consider partnering with specialized service providers, like Legionella Control Systems, to leverage their expertise in waterborne pathogens, testing, and treatment solutions.

The adoption of ANSI/AAMI ST108:2023 represents a proactive step towards enhancing patient safety and device reliability in healthcare settings. By focusing on water quality, healthcare facilities can address a fundamental aspect of medical device reprocessing, ensuring that all devices are safe for patient use. For expertise in meeting these new standards, Legionella Control Systems offers comprehensive solutions tailored to the unique needs of healthcare facilities, from water treatment to ST108 compliance testing. Their independent expertise in waterborne pathogens and testing capabilities make them an invaluable resource for healthcare facilities aiming to comply with ST108 and improve overall patient safety.

Legionella Control Systems offers ST108 assessments and consultation and ST108 testing and are expert in waterborne pathogen control. Our phones are answered 24 hours per day, so call 888-416-8626 for immediate assistance.