Water quality is present in every sterile processing department (SPD). It touches every step of medical device reprocessing — from the initial rinse in decontamination to the final preparation for sterilization. The average value of the instruments being processed is $13 million, yet, until recently, water quality management programs were often fragmented, inconsistent, or entirely absent.
With the release of ANSI/AAMI ST108:2023, the standard for Water for the Processing of Medical Devices, hospitals and surgery centers now have a clear mandate: develop and maintain a documented, multidisciplinary water quality management program that meets specific microbial and chemical limits.
But knowing what needs to be done and knowing how to start are two very different things.
Why ST108 Raises the Bar
The new standard is more than a list of water test results to hit — it’s a living plan that must be monitored, adjusted, and documented over time. This requires:
Collaboration across infection prevention, facilities, sterile processing, and vendors.
Defined specifications for Utility and Critical Water based on the devices being processed.
Routine testing and corrective actions when results fall outside established limits.
In other words, it’s not a “set it and forget it” task — it’s an ongoing quality improvement process. For more on this, check out: Episode 3: Keeping Water Quality in Check with AAMI ST:108
The Implementation Framework
A practical way to approach implementation is to use the PLAN–DO–CHECK–ACT model:
PLAN: Identify needs, conduct a system survey, and define your objectives.
DO: Assemble your team and implement initial improvements.
CHECK: Review water quality data against ST108 limits.
ACT: Make adjustments, correct deficiencies, and continue to refine the program.
This cycle repeats continuously, ensuring your facility stays ready for Joint Commission surveys, CMS audits, and — most importantly — safe patient care. For more on this topic check out: Episode 1: The Journey of Water Quality Implementation in Hospitals
Three Paths to Compliance
Your facility’s starting point will influence your implementation strategy:
Hire a Professional – Best for facilities with no ST108 experience, limited resources, or tight timelines. You’ll get expert guidance, a system assessment, staff training, and a compliance roadmap.
Do It Yourself – Works for facilities with in-house expertise, time, and a dedicated team familiar with water systems and documentation.
Enhance What You Have – Ideal if you already have a Legionella water management plan or partial monitoring in place. Start with a gap analysis against ST108 and prioritize improvements.
For more on this, check out: Episode 2: Get to Know Critical Water Purification Systems
Risk Assessment: The Critical First Step
A risk assessment identifies hazards that could compromise device processing. Examples include:
High chloride levels in critical water leading to pitting and corrosion of surgical instruments.
Municipal water source changes (lakes, rivers, wells) causing sudden shifts in water chemistry.
Distribution system issues such as dead legs, biofilm growth, or pressure fluctuations.
Addressing these risks proactively reduces costly repairs, prevents device damage, and ensures consistent compliance.
Avoiding Common Pitfalls
Based on field experience, common challenges include:
Underestimating the time and documentation needed.
Ignoring seasonal variations in source water quality.
Failing to establish clear responsibilities for monitoring and corrective actions.
The key is to start simple, build a strong team, and view compliance as a journey — not a one-time event.
Final Takeaway
The message from ST108 is clear: water quality is no longer a “background” concern in sterile processing — it’s a core compliance and patient safety issue. Whether you hire an expert, take a DIY approach, or enhance an existing program, the important thing is to start now and keep improving.
Belimed and VERDA Water Quality Systems have helped hospitals across the country navigate ST108 requirements, from initial assessments to full program implementation. If you’re ready to take the first step, we’re here to guide you. Want to speak to a VERDA water quality expert, click here