Management Requirements for ANSI/AAMI ST108 Water Quality

by Ben Frieders

Management requirements plays an essential role in ANSI/AAMI ST108 water quality. Various types of water are used throughout the process, each serving a specific purpose and adhering to strict quality standards to maintain the integrity of medical devices and ensure patient safety. In this guide, we’ll explore Step 2 in implementing the ANSI/AAMI ST108 standard for water quality management.

ANSI/AAMI ST108 Water Quality in Medical Device Processing

There are three key categories of water used in medical device processing: Utility Water, Critical Water, and Steam. Each type of water serves a unique function in ensuring that devices are properly cleaned, sterilized, and safe for use.

1. Utility Water: This is essentially tap water used for flushing, washing, and intermediate rinsing of medical devices. While it plays an essential role in removing debris and initial cleaning, utility water can contain contaminants. This makes it unsuitable for final processing steps. Under the new ANSI/AAMI ST108 standard, pre-treatment of utility water may be required to meet the necessary water quality levels for compliance.
2. Critical Water: Critical water undergoes extensive treatment to remove microorganisms, particles, and other impurities. It is primarily used in the final rinse of critical devices, ensuring that all harmful residues are eliminated. Additionally, critical water is essential for generating steam used during the sterilization process. High-purity water in this stage ensures that no contaminants remain on medical devices before they are used in patient care.
3. Steam: Produced by a boiler or heat exchanger, steam is vital to the sterilization process. Controlling the quality of the steam ensures that it does not introduce contaminants during device sterilization. Maintaining high steam quality is crucial for ensuring that medical devices remain free from harmful substances during the final stages of preparation.

Key ANSI/AAMI ST108 Water Quality Parameters to Monitor

Ensuring proper water quality involves more than just keeping water clean. It’s about meeting measurable standards that protect both device integrity and patient safety. Monitoring specific water quality parameters is critical for maintaining compliance with the ANSI/AAMI ST108 standard. Here’s a closer look at these important parameters:

• pH: Maintaining a neutral to slightly acidic pH ensures that the water is gentle enough for devices while still being effective for cleaning and rinsing. If pH levels are too high or too low, devices may be damaged, and the cleaning process may be less effective.
• Hardness: Hard water causes deposits, or scale, on medical devices, leading to reduced performance and shorter lifespan. Removing hardness from water helps prevent buildup on devices, ensuring optimal function.
• Conductivity: This measures the ability of water to conduct electricity, which is a sign of ionic contamination. High conductivity levels can cause corrosion and staining, reducing device lifespan and effectiveness.
• Alkalinity: Water’s ability to neutralize acids is critical in preventing corrosion and scale formation. High alkalinity can lead to scale buildup, while low alkalinity can cause acidic water to corrode equipment and devices.
• Total Organic Carbon (TOC): TOC measures the amount of organic compounds in water. High levels of TOC can shield harmful microorganisms from effective sterilization, so maintaining low TOC is vital.
• Color and Turbidity: Clear water free from suspended particles ensures that no sediment contaminates devices during the cleaning process. Turbid water indicates the presence of particulate matter, which may cause damage or contamination.
• Bacteria: Waterborne bacteria pose serious risks in healthcare environments. Even trace amounts of bacteria can adhere to device surfaces, compromising sterility and risking patient infection. Maintaining bacterial levels below established limits is crucial for device safety.
• Endotoxins: Released from certain bacteria, endotoxins can cause severe inflammatory reactions in patients. These toxins are resistant to standard sterilization, making it essential to keep endotoxin levels as low as possible in processing water.
• Ionic Contaminants: Ions such as calcium, magnesium, and iron can lead to corrosion and staining, which compromise the integrity and safety of medical devices.

Maintaining Compliance and Patient Safety

Understanding these water quality parameters and implementing proper treatment methods are key to meeting the stringent requirements of ANSI/AAMI ST108. By partnering with a trusted water treatment company, you can design and implement a robust water quality management program that ensures compliance with the standard.

Maintaining proper water quality helps minimize risks, extend the lifespan of medical devices, and protect patients from infections and other complications. Through ongoing monitoring and consistent attention to these critical parameters, your facility can uphold the highest standards of safety and reliability in medical device processing.

Water quality management is a cornerstone of successful medical device processing. By understanding and adhering to the standards set forth in ANSI/AAMI ST108, healthcare facilities can ensure that medical devices are safe, effective, and ready for patient use. Implementing the right water treatment program is essential in maintaining compliance, safeguarding patient outcomes, and ensuring that your devices are prepared to meet the highest quality standards.

For more information and assistance with your ST108 compliance, visit our page on ST108 Testing.

About The Author

Ben Frieders is the Business Development and Marketing Manager at ChemREADY, an industrial water treatment company, where he focuses on driving growth through strategic marketing, business development, and acquisitions. A former U.S. Navy Chief Petty Officer with a background in nuclear operations, Ben brings a unique blend of technical expertise and leadership to the water treatment industry. Certified in ASSE 12080 Legionella Water Safety and Management, he is a recognized expert in water quality standards, regulatory compliance, and Legionella risk management. Passionate about scaling businesses and optimizing systems, Ben combines data-driven strategies with a hands-on approach to help organizations achieve sustainable growth.

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