What healthcare teams are still trying to understand about water quality compliance
ANSI/AAMI ST108:2023 has changed the conversation around water quality in Sterile Processing Departments.
For years, water quality was often treated as a background utility issue. If water came out of the faucet, fed the washer, or supplied the sterilizer, many teams assumed the system was doing what it needed to do.
ST108 challenges that assumption.
The standard gives hospitals a more defined framework for understanding, monitoring, and managing water used for medical device processing. But as many healthcare teams are discovering, understanding ST108 and implementing ST108 are two very different things.
That became clear during the recent Healthmark Education webinar, “ST108: So What’s Next?” featuring Len Sparks, COO of MMIC and a contributing member of the ANSI/AAMI ST108 committee, and Renee Vander Weele, Director of Clinical Services for VERDA Water Quality Systems.
The audience reflected the cross-functional nature of the issue. Nearly half of poll respondents came from Sterile Processing, while nearly a quarter came from Infection Prevention. Others represented Endoscopy, OR nursing, surgical technology, vendors, manufacturers, and related healthcare roles.
When attendees were asked whether their facilities had implemented changes because of ST108, 50% said yes, 17% said no, and 33% said they were not sure. That uncertainty says a lot.
Hospitals are aware of ST108. Many are starting to act. But a significant number are still trying to determine whether meaningful implementation has actually occurred.
Why is ST108 implementation challenging?
When attendees were asked about the hardest part of water quality compliance, the top answer was not equipment. It was not testing. It was not even budget.
The top challenge was getting Facilities, Sterile Processing, Infection Prevention, and leadership aligned.
That response confirms what many hospitals are experiencing in real time: ST108 is not just a technical water standard. It is an organizational challenge.
Water quality touches equipment, instruments, patient safety, compliance, capital planning, maintenance, documentation, and corrective action. That means no single department can manage it effectively in isolation.
As Len Sparks explained during the webinar, water quality is not simply a Facilities or Engineering issue. It is tied to patient safety and operational continuity.
That is the key shift.
ST108 is not only asking hospitals to produce better water. It is asking them to build a better water quality program.
When will AAMI TIR119 be released?
One of the most common questions from attendees was about AAMI TIR119.
TIR119 is being developed as guidance to help healthcare facilities implement ST108 in practical, real-world settings. While ST108 defines requirements and expectations, TIR119 is intended to help explain how organizations can begin applying those expectations.
During the webinar, Len explained that TIR119 is designed to help fill the gap between what ST108 requires and how hospitals can actually put those requirements into practice.
At the time of the webinar, the committee had reviewed the latest draft and was working through revisions, with the hope of moving toward publication in the summer timeframe.
But hospitals do not need to wait for TIR119 to begin organizing their water quality program.
ST108 is already published. Facilities can begin now by identifying water use points, reviewing current testing practices, clarifying departmental responsibilities, assessing risk, and documenting how results are reviewed and acted upon.
Is ST108 mandatory?
This is another common question.
ST108 is a published ANSI/AAMI standard. Whether it is treated as “mandatory” can depend on how the standard is adopted, referenced, or interpreted by regulatory bodies, accreditation organizations, internal policies, and facility risk management programs.
But the more practical question is this:
If a water quality issue affects cleaning, sterilization, instrument condition, or patient safety, can your facility show that it has a defined process for managing the issue?
That includes knowing:
- Who reviews water quality results?
- Who maintains the water treatment system?
- Who responds when results are out of range?
- Who determines corrective action?
- Who documents the response?
- Who communicates with SPD, Facilities, IP, leadership, vendors, and OEMs?
ST108 matters because it creates a framework for answering those questions before a problem occurs.
What are hospitals still trying to figure out?
The webinar questions showed that hospitals are asking practical implementation questions, including:
- Where should steam condensate be tested?
- What does steam treatment look like?
- Are steam filters necessary?
- Would cleaning a sterilizer chamber help with staining?
- Does Critical Water affect surgical site infection rates?
- Does Critical Water apply to endoscope processing?
- Are test strips enough?
- Would adding RO solve the problem?
- Who should be responsible for water quality in SPD?
These questions are important because they move the conversation from awareness to action.
The challenge is no longer simply, “Have you heard of ST108?”
The better question is, “Do you have a working program that turns ST108 into daily practice?”
ST108 requires more than equipment
One misconception in the market is that ST108 compliance can be solved by simply installing a water treatment system.
A properly designed water system matters. But equipment alone is not a program.
Hospitals also need monitoring, maintenance, testing, documentation, trend review, staff education, corrective action, risk assessment, and defined responsibilities.
For example, adding reverse osmosis may help reduce dissolved solids. But if the issue is poor steam quality, improper washer loading, detergent overuse, old steam piping, insufficient rinsing, or unclear responsibility, RO alone may not solve the problem.
ST108 implementation requires both technical understanding and operational coordination.
The takeaway
The questions asked during the webinar show that healthcare teams are thinking in the right direction.
They are asking where to test. They are asking who owns the process. They are asking how to interpret results. They are asking how water quality affects steam, instruments, washers, endoscopes, and patient safety.
That is progress.
The next step is turning those questions into a structured water quality program. ST108 has made water quality more visible. TIR119 is expected to provide additional implementation guidance. But hospitals can begin now by forming the right team, defining responsibilities, reviewing current practices, testing appropriately, and using data to guide action.
Water quality is no longer a background issue. It is part of the process. It is part of compliance. And it is part of patient safety.