New Water Quality Standards for Medical Device Processing

In 2023, healthcare facilities saw a shift from advisory best practices in water quality for medical device processing to enforceable standards with the release of AAMI ST108:2023. This new standard is more than just a set of recommendations—it’s a comprehensive guide to managing water quality and steam purity, ensuring patient safety through proper water system design, monitoring, and maintenance. Let’s break down what these new standards mean for healthcare organizations.

Building a Multidisciplinary Water Management Team

One of the most significant updates in AAMI ST108 is the requirement for healthcare facilities to establish a multidisciplinary water management team. Why is this important? It ensures that water quality isn’t handled in silos—every aspect of water management benefits from the expertise of individuals from various departments.

This team should include:

• Senior organizational leadership
• Facilities and engineering personnel
• Infection prevention and control specialists
• Medical device processing staff
• Clinical engineering professionals
• Surgical suite and procedure room staff
• Water treatment experts

By pulling together a team with diverse skills, healthcare facilities can create a more thorough and effective approach to managing water quality, with each member playing a role in maintaining a safe environment for patient care.

Expanded Water Quality Categories

AAMI ST108 introduces updated water quality categories that directly impact the medical device reprocessing workflow:

• Utility Water: This is water from the tap, which might need additional treatment. It’s typically used for tasks like flushing, washing, and the initial rinsing of medical devices.
• Critical Water: This water undergoes extensive treatment to remove microorganisms and contaminants. It’s primarily used for final rinsing and generating steam for sterilization.
• Steam: This is water heated into vapor, used for sterilizing medical devices.

Along with these categories, the standard defines specific water quality parameters such as pH levels, bacteria, endotoxin presence, and ionic contaminants. These guidelines ensure water safety throughout different stages of medical device processing.

Designing Effective Water Systems

Effective water system design is crucial under AAMI ST108. Healthcare facilities need to tailor their systems to meet the specific demands of their environment. Key factors to consider include:

• The quality of local feedwater
• Treating municipal water to meet the standard for utility water (e.g., through filtration or softening)
• Employing systems like reverse osmosis (RO), deionization (DI), or distillation to produce critical water

Water treatment isn’t just about meeting the basic requirements—proper system design ensures long-term functionality and compliance. Facilities must also validate their systems with operational protocols, ensuring everything works smoothly from day one.

Ongoing Monitoring and Maintenance

One of the more challenging aspects of AAMI ST108 is the enhanced focus on ongoing monitoring and testing. Regular checks are not just recommended; they are now required to keep the water quality up to standard. The responsibility primarily falls on engineering and water maintenance teams, but sterile processing staff also need to be aware of the implications when water quality falters.

Contaminated water can lead to serious issues such as:

• Corrosion and staining of medical instruments
• Elevated risk of microbial transmission

Regular testing helps prevent these problems, ensuring that water used in medical device reprocessing is always up to par.

What Healthcare Facilities Should Do Next

Implementing AAMI ST108 means more than just updating policies—it requires active engagement from all parts of the healthcare facility. Here are a few next steps:

• Partner with infection preventionists to understand your current water treatment systems.
• Conduct regular laboratory testing to assess water quality for processing.
• Audit and monitor existing water management plans—making adjustments as needed to meet the new standards.
• Educate staff on the updates to ensure compliance.

In some cases, facilities may need to invest in infrastructure upgrades, especially if existing water systems don’t meet the new requirements. Not doing so could lead to serious consequences, including failure to pass sterilization tests, or worse, posing health risks to patients due to improperly sterilized equipment.

Final Thoughts

The new AAMI ST108:2023 standard represents a significant leap forward in healthcare facility management of water quality for medical device processing. By adopting these standards, facilities can ensure a higher level of patient safety and operational efficiency. The key is to start now—build your multidisciplinary team, assess your systems, and take proactive steps to stay compliant.

For further details and resources, visit www.ECRI.org.