Healthcare Standards Update: AAMI ST108 Standards
Updated: May, 2023
As a facility manager, you are tasked with ensuring that your facility complies with the latest regulations and standards in order to provide safe and efficient services to your patients. That can be challenging as the standards are ever-evolving. Our goal is to keep you abreast of the ones related to water treatment and provide any additional resources you need to ensure your water plan meets the highest standards. Recently, the
AAMI Standards Board approved three new work item proposals, including two in the sterilization area and one in the medical equipment management area. In this blog, we will focus on one of these proposals, AAMI ST108, which is related to water for the processing of reusable medical devices.
AAMI ST108
AAMI ST108 is a standard that sets out the requirements for the quality of water used in the processing of reusable medical devices. The standard covers the entire water treatment process, from the initial source of water to the final product used in the processing of medical devices. The standard applies to all facilities that process reusable medical devices, including hospitals, clinics, and other healthcare facilities.
So, what are the differences between AAMI ST108 and the old standard?
One of the most significant changes is the requirement for facilities to use reverse osmosis (RO) as the primary method for producing purified water. The standard also requires that facilities monitor the quality of their water on a regular basis and maintain records of their water quality data. Additionally, the standard includes specific requirements for the design, installation, and operation of water treatment systems.
Another key difference is the inclusion of specific requirements for the storage and distribution of purified water. The standard requires that facilities use appropriate storage and distribution systems that prevent contamination and ensure the quality of the water. The standard also requires that facilities develop and implement procedures for the cleaning and maintenance of their water storage and distribution systems.
How will this new standard affect facility managers?
For starters, facility managers will need to ensure that their facilities are using RO as the primary method for producing purified water. This may require an investment in new equipment and training for staff on the use of RO systems. Facility managers will also need to develop and implement procedures for monitoring the quality of their water and maintaining records of their water quality data. Additionally, facility managers will need to ensure that their facilities have appropriate storage and distribution systems in place and that staff are trained in the proper cleaning and maintenance of these systems.
It is also important to note that AAMI ST108 is not just a suggestion or guideline – it is a mandatory standard that must be followed by all facilities that process reusable medical devices. Facilities that do not comply with the standard may face penalties or fines and may also be putting their patients at risk.
When did this new standard go into effect?
The current version of AAMI ST108 was published in 2020, and facilities had until December 31, 2022, to comply with the standard.
In conclusion, AAMI ST108 is a new standard that sets out the requirements for the quality of water used in the processing of reusable medical devices. This standard includes several significant changes from the old standard, including the requirement for facilities to use RO as the primary method for producing purified water. Facility managers need to ensure that their facilities are in compliance with the new standard by December 31, 2022. Failure to comply with the standard may result in penalties or fines, and may also put patients at risk. As such, it is important for facility managers to take action now to ensure that their facilities are in compliance by the deadline.
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Effective January 2022: New water management requirements
By now most hospitals, senior care, and health services are aware of the upcoming mandates from the CDC and Joint Commission to implement Legionella water management programs. The new healthcare water treatment 2022 requirements and revised standards (ANSI/ASHRAE STANDARD 188-2018, LEGIONELLOSIS: RISK MANAGEMENT FOR BUILDING WATER SYSTEMS) cover virtually any large building, especially healthcare facilities in the United States, and go a long way into itemizing all that companies can do to protect the quality of water and therefore the quality of life for the people and pets they serve.
For the past 20 years, the Joint Commission has required that accredited health care facilities should “minimize pathogenic biological agents in cooling towers, domestic hot-and cold-water systems, and other aerosolizing water systems” according to the Standard EC.02.05.01.
Effective January 1, 2022, this standard will be replaced with EC.02.05.02, which was approved by the Centers for Medicare and Medicaid Services (CMS) and issued early this year.
This new, EC.02.05.02 standard requires hospitals and nursing care centers to have a water management and safety program (WMP) that “addresses Legionella and other waterborne pathogens.” A designated individual or team must oversee the entire WMP – development, management, maintenance – to ensure it meets applicable laws and regulations and includes a flow diagram of water systems, risk analysis, control measures, corrective actions to maintain control measures and WMP reviews. The Joint Commission refers its accredited hospitals and nursing care centers to ASHRAE 188, the CDC Toolkit, “Developing a Water Management Program to Reduce Legionella Growth and Spread in Buildings,” and ASHRAE Guideline 12-2020.
Chemstar WATER has been partnering with world-renowned experts and providing WMPs for its Healthcare Customers
In 2021 we let customers know of our formalized services to offer guidance in co-creating the Water Management and Safety Plans (WMP) along with an additional in-depth Risk Analysis. As a result, many of our existing customers as well as new clients have worked with Chemstar WATER to develop new WMPs or revise their existing ones. Chemstar WATER also partners with national infection disease and pathogen control consultants and experts in order to provide our healthcare customers with the most up-to-date information. By teaming up with external experts, you get the added credibility of world-renowned specialists alongside Chemstar WATER’s industry expertise.
This year especially has been incredibly busy and we have been doing our best to meet the demand in developing the WMPs. Contact us if you still need help with the upcoming changes.
