AAMI ST108
AAMI ST108 Is Here — Is Your Sterile Processing Department Ready? Stay Compliant, Stay Operational.
Achieve and Maintain AAMI ST108 Compliance with Confidence
As the healthcare industry continues to evolve, compliance with standards like AAMI ST108, which focuses on water quality for medical device processing, is more critical than ever. At IWC Innovations, we provide a full-service approach to help your facilities meet and maintain compliance with the new ST108 requirements. Our solution combines advanced digital compliance tracking with expert consulting support, offering peace of mind and operational clarity.
Introducing CLEAR: Your AAMI ST108 Compliance Companion
Our proprietary CLEAR platform is a cloud-based tool that simplifies AAMI ST108 compliance across your entire facility network. With CLEAR, you can:
Track and manage water sample data with ease
Monitor compliance status across all systems in your network
Quickly identify which facilities are within or out of compliance with ST108
Streamline reporting and auditing processes with real-time dashboards and alerts
CLEAR empowers your team to stay ahead of compliance by streamlining water quality data—no more manual tracking or scattered spreadsheets.
Expert Consulting with 60+ Years of Combined Experience
Beyond digital tools, our team brings unmatched expertise in High-Purity Water Systems and Sterile Processing Environments. With over six decades of combined experience, our consulting services include:
System troubleshooting for any issues affecting water quality or compliance
Custom design and engineering of new water systems aligned with ST108 specifications
On-site and virtual guidance to help your team understand and implement compliance protocols
Staff training and operational support to ensure long-term success
Whether you’re building new processes or optimizing existing systems, our experts are here to partner with you every step of the way.
Ready to Simplify ST108 Compliance?
Get Started with CLEAR and Expert Support from IWC Innovations.
What is AAMI ST108?
The American National Standards Institute (ANSI) and The Association for the Advancement of Medical Instrumentation (AAMI) have introduced this standard as a replacement for the TIR34:2014 guideline. It outlines the requisite water quality for the thorough cleansing and disinfection of medical devices and instruments. This standard aims to establish consistent industry regulations governing the processing and sanitation of medical equipment. It includes specifications for water sampling and designates essential water system components.
What is Included in The New AAMI ST108 Standard?
Defines water quality levels for each stage of sterile processing
Outlines risk analysis and facility responsibilities
Evaluates water quality by pH, microbes, conductivity, and more
Sets maintenance, monitoring, and improvement procedures
Covers emergencies like service outages and boil advisories
What Facilities are Affected by ST108?
The upcoming standard, expected to be implemented in 2025, outlines protocols for water system design, monitoring, testing, and maintenance. It will affect all medical facilities conducting surgical procedures with sterilizable instruments, including hospitals, ambulatory surgical centers (ASCs), and doctors’ offices offering outpatient or same-day surgeries.
Categories of Medical Devices
| Device Category | Definition | Examples | Minimum Disinfection Level |
|---|---|---|---|
| Critical | A medical instrument designed to access sterile tissues or the vascular system | Surgical instruments, transfer forceps, cardiac catheters, biopsy forceps, etc. | Sterilization |
| Semi-critical | A medical instrument intended for use with non-intact skin or mucous membranes | Non-invasive, flexible fiber optic endoscopes, endotracheal and aspirator tubes, respiratory therapy equipment, etc. | High-Level Disinfection |
| Non-critical | A medical instrument designed for contact with intact skin but not mucous membranes | Bedpans, reusable anesthesia masks, blood pressure cuffs | Low-level or Intermediate Level Disinfection |
Categories of Water Quality for Medical Device Processing
| Type | Definition | Usage |
|---|---|---|
| Utility Water | Water sourced from the tap that might necessitate additional treatment | Flushing, washing, and intermediate rinsing of medical devices |
| Critical Water | Water that is treated to ensure microorganisms, inorganic & organic materials have been removed | Final rinse or steam generation |
| Steam | Water undergoes a transformation from liquid to vapor phase when heated using a boiler or steam generator. Steam can originate from a central facility within the hospital, such as a boiler plant, or it can be produced locally within a sterilizer using a steam generator. | Sterilization of medical devices |
What Can Happen if the System is Not in Compliance with ST108?
Inadequate sterilization of surgical instruments poses immediate risks, prompting the suspension of surgical operations until the sterilization system meets mandated water quality standards. In addition to the immediate risks posed by inadequate sterilization of surgical instruments, this downtime can prove costly for surgical centers. The suspension of surgical operations not only disrupts patient care but also results in significant financial losses due to halted procedures and potential reputational damage to the facility.
Partnering with IWC Innovations can help ensure that your surgical center remains compliant with the new ST108 standard. Our proactive approach allows us to discern any potential faults or issues that might jeopardize the sterilization process under the new ST108 standard. By gaining a deep understanding of your unique water infrastructure, we can effectively identify and rectify any shortcomings, ensuring seamless compliance and optimal performance in sterilization procedures.
Streamlining Compliance: Trust IWC Innovations for Your ST108 Journey
Partner with IWC Innovations to confidently navigate the new ST108 standard from start to finish. Our team specializes in water management solutions tailored for healthcare, guiding you through assessment, implementation, and ongoing compliance. With deep expertise and a focus on patient safety and efficiency, we help ensure your facility meets every requirement—delivering peace of mind and reliable support every step of the way.
Need the Highest Standards of Purity for Your System?
Contact us today for a consultation and elevate your quality and performance!
