What is Included in The New AAMI st108 Standard?
- Identifies the categories of water quality that should be used during each stage of sterile processing.
- Provides a risk analysis and establishes roles and responsibilities for processing facilities.
- Assesses water quality based on factors such as pH, microbial level, conductivity, and other properties.
- Establishes maintenance, monitoring, and quality improvement procedures for water treatment systems.
- Addresses emergency circumstances such as service interruptions and boil water advisories.
What Facilities are Affected by ST108?
The upcoming standard, expected to be implemented in 2024, 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.
Legionella and Other Waterborne Pathogens
Facilities providing Medicaid and Medicare services must implement a water management plan to address Legionella and other waterborne pathogens. This plan encompasses verification and validation procedures, with Legionella testing being the sole method for validation.
At IWC Innovations, our water management plans address Legionella and other waterborne pathogens and are also tailored to meet the specific requirements for facilities that must follow ST108 standards. Through stringent verification and validation, including Legionella testing, we ensure the safety of healthcare environments while complying with industry standards.
Streamlining Compliance: Trust IWC Innovations for Your ST108 Journey
Choose IWC Innovations as your consultant to navigate the new ST108 standard seamlessly from start to finish. Our expertise lies in comprehensive water management solutions tailored to meet the specific requirements of healthcare facilities. With a deep understanding of the ST108 standard and its implications, we guide you through every step of compliance, from initial assessment to implementation and ongoing maintenance. Our dedicated team ensures that your facility meets all regulatory requirements while prioritizing patient safety and operational efficiency. Trust IWC Innovations to be your partner in achieving compliance with the ST108 standard, providing peace of mind and exceptional service every step of the way.
