What is ANSI/AAMI ST108?
Water has often been referred to as the world’s original solvent. Each day, a typical sterile processing department will use thousands of gallons of water to reprocess medical instruments. For years, many healthcare facilities have relied upon the AAMI TIR34 guideline, “Water for reprocessing of medical devices,” as the governing document to establish and manage water quality in their department. This changed with the August 2023 release of ANSI/AAMI ST108, “Water for the processing of medical devices.” This is some of the feedback we have received from healthcare facilities; “we aren’t sure we understood AAMI TIR34,” “I have my doubts we ever fully implemented it correctly,” “ I haven’t read ST108, and I have questions on what will be required for compliance.” Many departments are concerned about the scope and frequency of testing required, and when they will be required to comply. This is causing anxiety throughout the industry.
“ANSI/AAMI ST108 was released as a standard in August of 2023.”
AAMI standards versus Technical Informational Reports (“TIR”)
AAMI standards are subject to a formal process of committee approval, public review, and resolution of all comments. This process of consensus is supervised by the AAMI Standards Board, and with regards to ST108, the American National Standards Institute. Technical Informational Reports aren’t subject to the same formal approval process.
An AAMI standard codifies recommendations and best practices into requirements. A standard will use the verb “shall” and “shall not” to express explicit requirements for compliance, a TIR doesn’t. Instead, a TIR will only use verbs like “should” and “may” to express a recommendation or permission.
Lastly, the normative, or prescriptive, part of the AAMI standard is consistent with the requirements and recommendations provided. A TIR, however, may contain different viewpoints on technical issues. Finally, Annexes for both standards and TIR’s are intended to be informational and might contain conflicting recommendations.
“AAMI ST108 standard expresses explicit consensus requirements for compliance, AAMI TIR34 expressed recommendations and different viewpoints.”
Why is ANSI/AAMI ST108 important?
Healthcare facilities receiving reimbursement from the Center for Medicare and Medicaid Services (“CMS”) and/or are accredited by The Joint Commission are already required to have a water management program. In 2017 the Center for Medicare and Medicaid Services (CMS) released a policy memorandum (Ref: S&C 17- 30-Hospitals/CAHs/NHs) that mandated hospitals adopt a Water Quality Management Program to examine all sources of water and their potential risks to patients; a risk assessment. In 2022 The Joint Commission released an Environment of Care Document (EC.02.05.02 Eps 1-4) that similarly recommended hospitals establish a Water Quality Management Program, administered by a multi disciplinary team, and informed by routine water related risk assessments.
ST108 states similar management and risk assessment requirements for managing the use of SPS (Sterile Processing Services) water. Because the water for reprocessing of medical devices undergoes additional water treatment before it can be used for the washing, cleaning, disinfecting, and sterilization of medical devices, the facility’s current water management program should also include the water in Sterile Processing Department. Also, some SPS water quality parameters are unique to medical device reprocessing and may not be currently monitored in the facility’s Water Quality Management Program.
“…the facility’s current water management program should also include the water in Sterile Processing Department. “
How is ANSI/AAMI ST108 different from AAMI TIR34?
First, ST108 updates and codifies critical disparate recommendations into consensus requirements. The new standard avoids specifying a specific type of technology or treatment to produce the necessary water quality unless that technology has been deemed a requirement. For example, while TIR34 recommends water softening as a pre-treatment for generating Critical Water, it isn’t in ST108, as there can be other methods to address or reduce hard water.
“…there’s a new section on the roles and responsibilities of the multidisciplinary team that will be responsible for water quality and the water management program in health care facilities.”
If you are already familiar with TIR34, you will recognize a great deal in ST108, but there are several significant changes. For instance, there is a requirement in ST108 for a multidisciplinary team responsible for a facility’s water quality with their own unique roles and responsibilities in maintaining the SPS’s water quality. This team is responsible for developing, implementing, and documenting all requirements of a SPS water management program, which should include a risk analysis for new systems and an evaluation plan, reviewed periodically.
The new standard introduces the strategy of alert and action levels on monitoring water quality and defining the appropriate response for each.
“Regular endotoxin testing is required…”
There is an increase in the number of water quality parameters that define Utility and Critical Water (i.e., from 12 to 18) performance qualification, although the number of those parameters with a defined frequency of monitoring has been reduced slightly (i.e., from 9 to 7). Daily testing for pH, water hardness, and temperature at each piece of SPS equipment has been eliminated, replaced with either monthly or quarterly testing. Perhaps the most significant change in water testing is the addition of monthly endotoxin testing at the water generation system and each location of point-of-use in the department. Previously, TIR34 only recommended endotoxin testing after system modifications, repairs, or when persistent, increased microbial levels are detected.
“Regular testing of steam condensate will be required…house steam may not be of sufficient quality for SPS steam in regions with high conductivity water sources.”
A new category of water quality, steam condensate, has been developed, with quarterly monitoring frequency. The quality requirement on the steam condensate is stringent enough that facilities with high conductivity or chlorides in their boiler feedwater may have difficulties obtaining the new standard unless additional treatment steps are enacted. Steam is defined as either house (i.e., plant), process, or clean with the realization that some facility’s current house steam may not be of sufficient quality to ensure the necessary SPS steam quality and purity as defined in AAMI ST79, “Comprehensive guide to steam sterilization and sterility assurance in health care facilities.” Steam quality and feedwater monitoring continues to be defined by the requirements in AAMI ST79, although in ST108, the frequency for boiler feedwater monitoring is no longer specified (daily monitoring had been recommended in TIR34).
“Utility Water is often the hidden root cause of corrosion, staining, and insufficient cleaning.”
AAMI TIR34/ST108 Utility Water
If your current water quality plan fully implements AAMI TIR34, the adjustment to the new ST108 standard, while not trivial, is manageable. You will have to make some changes, but it won’t require you to start over. However, many facilities have misconstrued AAMI water as only applying to Critical Water (i.e., water primarily used for final rinsing operations). The water used for washing and cleaning, defined by AAMI as “Utility Water,” must also be maintained by the water management program. Departments often don’t monitor Utility Water quality or do so infrequently. Consequently, they are unaware when their SPS water falls out of compliance.
“Hospitals using Utility Water that exceeds the AAMI guidelines for conductivity are at risk for higher rates of SSI’s.”
Utility Water is just as important as Critical Water to your SPS success in reprocessing medical devices. High conductivity, chlorides, or pH levels in Utility Water are often the hidden root cause of corrosion, staining, and insufficient cleaning issues in the SPS. This can lead to more reprocessing steps, increase detergent usage, more maintenance and repairs of medical devices, ineffective performance, and failure of devices during procedures, and premature disposal of these devices. It can also result in the buildup of bacteria and endotoxin on medical devices, and ultimately surgical sight infections.
“…nearly 50% of inpatient care facilities with 100 or more beds are in areas where water sources exceed AAMI TIR34/ST108 conductivity guidelines.”
Hospitals using water outside AAMI guidelines for washing and cleaning of their medical devices are at risk for higher rates of SSI’s. Nearly 50% of inpatient care facilities with 100 or more beds are in areas where water sources exceed AAMI ST108 guidelines. It is a very pervasive problem that is going unaddressed in water quality management programs. It is the “elephant in the room” for sterile processing.
The release of ANSI/AAMI ST108 later this year as the new standard for SPS water quality only highlights what has always been true: every drop of water that touches medical instruments at any time during any process must be managed and maintained.
“…every drop of water that touches medical devices at any time during any process will be governed by ANSI/AAMI ST108.”
How to get ST108 compliant?
Current state assessment
The best way is to begin an assessment of your current water quality management program. Identify your team to perform the assessment. Facilities engineering should be able to explain how your current SPS water system was installed, validated, and currently maintained. Infection control will have the policies, procedures, and protocols surrounding SPS water quality. SPS personnel can explain how they monitor processing equipment and how they identify medical devices damaged likely due to water quality. Biomedical engineering, surgical suite personnel, and water treatment specialists also contribute to assessing the current state of your SPS water management program. Some of questions to ask your team:
- Does your facility’s current facility-wide water quality management program manage and monitor the water for processing medical devices?
- What water quality parameters are you currently monitoring, the monitoring frequency, and the historical range in values?
- What are the protocols if there are issues with SPS water quality? • What water treatment equipment, if any, are you using to generate SPS water and steam, and what strategies does the system use to minimize microbial growth?
- How are you monitoring and maintaining your SPS water treatment systems, and how are you documenting this information?
“The best way to get ready is to begin an assessment of your current water quality management program.”
Educate yourself and build your team
One of the central problems with complying with AAMI is that the people leading the effort need to fully comprehend AAMI ST108. The stakeholders in the healthcare facility who will be expected to spearhead the SPS water management program often won’t have in-depth knowledge of AAMI ST108 and understand the rationale for the wording in the standard. Likewise, water treatment OEM’s and integrators may have limited exposure to AAMI, the existing guidelines, and new standards regarding SPS water. Their expertise may be in hemodialysis or laboratory use water and only tangentially in the water used for processing medical devices. They may know what their equipment can do, but they may not understand SPS water quality needs, how the reprocessing equipment operates and uses water, or how upstream or downstream processes of their equipment might affect water quality. Unfortunately, many of these providers are not going to take the time to understand your needs and become part of your team.
“The individuals the department will be traditionally speaking with usually don’t have an expert working knowledge of the AAMI standard…”
Expand your ecosystem
Find AAMI knowledgeable people, possibly outside your current facility and ecosystem. Inquiring with AAMI itself or to access other organizations that focus on sterile processing like HSPA (Hospital Sterile Processing Association). These organizations will be able to point you in the direction of individuals and companies that they consider to be experts. Your current water equipment or lab services provider may not possess the information you need. It will take time for the front-line equipment providers to have a working understanding of the requirements. When they do, their knowledge will typically begin and end with their equipment.
“The key to being ready for the new ST108 standard in the future is to be following the current AAMI TIR34 guidelines today.”
You can also look for companies that specialize in water quality management for sterile processing specifically. Water quality management is a lot more than just supplying the correct equipment. Select a partner that focuses on the management piece; risk assessment, water sampling and testing, sanitization services, and providing water quality assurance plans and ongoing compliance reporting. If the company you are evaluating wants to only sell you water purification equipment and a maintenance service contract, they may not be the best choice for your department. They should be speaking with you predominantly about risk, plans, and compliance.
“Select a partner that focuses on the management piece; water sampling and testing, sanitization services, and providing compliance reporting.”
Identify your future state and perform a gap analysis
While AAMI ST108 does list requirements and is prescriptive, there is latitude for individuality in implementing the new standard. A 24/7 Level 1 trauma center with over 400 beds will have a different ST108 future state implementation than an Ambulatory Surgery Center operating an SPS with single shifts on weekdays. Once you feel confident you have the right people on board, your current and future states identified, you can perform a gap analysis to determine what you must do, or do differently, to be compliant to AAMI ST108.
“…you should perform a Gap Analysis to determine where you are relative to complying with AAMI TIR34 or ST108.”
Future state roadmap and implement your plan
Once you have identified your gap, evaluate the potential solutions, and determine your priorities. You will then be able to put together a future state roadmap. This will include a schedule and a budget. It will identify all the key people, departments, and partners that will be involved in moving toward the future state and then maintaining it. Once these elements are in place you can begin to move forward to your future state.
“A department can ease their transition to ST108 by starting now.”
ST108 will bring changes, but a department that has a solid water quality management program that already complies with all aspects of the current AAMI TIR34 guidelines and complies with the existing CMS Policy Memorandum and Joint Commission Environment of Care Document that concern the use of water in your facility will have a smoother transition into the new ST108 standard. Assess your current set-up, testing, monitoring, and maintenance for your existing Utility Water, Critical Water, and sterilizer steam condensate. Educate yourself and your team on ST108, while expanding your ecosystem with industry experts in the new standard. Identify your future state and perform a gap analysis, prioritizing your implementation work by addressing the highest risk items for your facility first.
“A department can ease their transition to ST108 by starting now.”
About the Authors
Len Sparks is the Director of Operations of VERDA Water Quality Systems and serves on the WG95 working group that authored ST108 Water for the processing of medical devices.
Jeffrey T. Paquet is the CEO of VERDA Water Quality Systems and serves as the Water Quality Expert for the sterile processing advocacy group, Beyond Clean.
VERDA provides turnkey water quality management systems and are experts in providing equipment and services to sterile processing departments to ensure full compliance with AAMI ST108. VERDA is a member of AAMI, and VERDA employees are voting members of the working groups that author and maintain the standards and TIR’s that govern processes and practices in Sterile Processing. VERDA has developed its water quality management services and products specialties while working alongside sterile processing professionals to address significant problems to effectively manage water quality on an ongoing basis.