New Healthcare Water Treatment 2023 Requirements: ST108
Understanding the AAMI ST108 Standard: Key Updates for Healthcare Facility Managers
Updated: May 2023
As a healthcare facility manager, ensuring compliance with evolving industry regulations is crucial to patient safety and operational efficiency. One of the most significant updates in healthcare water treatment is the AAMI ST108 standard, which establishes stringent water quality requirements for processing reusable medical devices.
Keeping up with these regulations is essential for maintaining compliance and preventing potential risks to patients and staff. This article provides a detailed overview of AAMI ST108, the key differences from previous standards, and actionable steps for facility managers to implement these requirements effectively.
What Is AAMI ST108?
The AAMI ST108 standard outlines the quality and safety requirements for water used in the cleaning, rinsing, and sterilization of reusable medical devices. It applies to all healthcare facilities that process surgical instruments, endoscopes, and other reusable medical equipment, including hospitals, outpatient surgical centers, and specialty clinics.
This standard ensures that water used in medical device reprocessing meets strict purity levels, minimizing risks of contamination, biofilm formation, and infection transmission.
Key Differences Between AAMI ST108 and Previous Standards
The implementation of AAMI ST108 introduces several critical updates that healthcare facility managers need to address:
- Mandatory Use of Reverse Osmosis (RO): Facilities must now use reverse osmosis (RO) water treatment as the primary purification method to ensure high water quality for medical device reprocessing.
- Enhanced Water Quality Monitoring: Regular testing and documentation of water quality parameters are now required to maintain compliance and prevent microbial contamination.
- Strict Storage & Distribution Standards: Facilities must implement proper storage and distribution protocols to prevent recontamination of purified water.
- Comprehensive System Design & Maintenance: Water treatment systems must adhere to specific installation, operational, and maintenance guidelines to ensure long-term compliance.
How AAMI ST108 Impacts Healthcare Facility Managers
Adapting to the AAMI ST108 standard requires healthcare facility managers to take a proactive approach in upgrading water treatment systems, training personnel, and ensuring continuous compliance.
Actionable steps include:
- Implementing Reverse Osmosis (RO) Systems: Facilities must assess their current water treatment infrastructure and invest in RO technology to meet the new purification requirements.
- Developing a Comprehensive Monitoring Plan: Regular water testing, documentation, and reporting protocols must be established to ensure ongoing compliance with AAMI ST108.
- Training Staff on New Procedures: Healthcare personnel involved in medical device reprocessing need thorough training on water quality management, system maintenance, and proper sterilization protocols.
- Upgrading Storage and Distribution Systems: Facilities must ensure that purified water is properly stored and distributed to prevent contamination before it reaches sterilization equipment.
Compliance Deadline and Enforcement
The current version of AAMI ST108 was published in 2020, with a compliance deadline of December 31, 2022. Failure to comply with these requirements may result in regulatory penalties, legal liability, and potential patient safety risks.
Since AAMI ST108 is a mandatory standard, healthcare facilities must take immediate steps to ensure compliance, minimize risks, and maintain high standards of care.
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New Water Management Requirements for Healthcare Facilities
Beyond AAMI ST108, another critical regulatory change impacting healthcare water treatment is the implementation of new water management program (WMP) requirements, effective January 2022.
The CDC and Joint Commission now mandate comprehensive Legionella water management plans for all hospitals, nursing homes, and healthcare facilities to prevent outbreaks of Legionnaires’ disease and other waterborne pathogens.
Understanding the New EC.02.05.02 Standard
Previously, Standard EC.02.05.01 required healthcare facilities to minimize biological contamination in water systems. However, starting in 2022, it has been replaced by EC.02.05.02, which introduces more stringent requirements, including:
- Comprehensive Water Management & Safety Program: Each facility must establish a water safety team responsible for monitoring, testing, and managing waterborne pathogens.
- Legionella Risk Assessments: Facilities must conduct detailed water system risk analyses to identify and mitigate Legionella growth risks.
- Regular Testing and Corrective Action Plans: Healthcare institutions must establish routine water quality testing procedures and corrective action plans to ensure safe water systems.
Chemstar WATER: Your Partner in Healthcare Water Treatment Compliance
At Chemstar WATER, we specialize in healthcare water treatment solutions and compliance support for AAMI ST108, EC.02.05.02, and other critical water quality standards.
We partner with leading infection control experts to develop custom Water Management & Safety Plans (WMPs) for hospitals, long-term care facilities, and healthcare institutions nationwide. Our comprehensive approach includes:
- On-site water system assessments to identify compliance gaps.
- Custom-designed RO and water treatment systems to meet AAMI ST108 requirements.
- Legionella risk analysis and mitigation strategies aligned with EC.02.05.02.
- Staff training programs on healthcare water management best practices.
With increasing regulatory scrutiny and rising patient safety concerns, ensuring water quality compliance is more critical than ever. Don’t wait until violations or outbreaks occur—proactively safeguard your healthcare facility today.
