Water Testing
for sterile processing professionals
Water quality plays a critical role in patient care, infection control, and regulatory compliance across hospitals, clinics, surgical centers, and dialysis centers. The Affirm line of healthcare focused water testing solutions by Agenics Labs brings precision water analysis to healthcare settings, helping facilities meet the highest standards of safety and quality.
Water Testing Made Easy
The Four Steps to Effective Water Management
1
2
3
4
Assess current water systems and water quality
Implement a water management plan incorporating requirements of the standard
Validate that new systems meet the water quality requirements
Continuously monitor water quality according to the metrics established in the standard
Key Definitions
Utility Water
The initial water coming into a healthcare facility, typically tap water. This water may require additional treatment to meet the quality requirements as outlined in the Standard and can be used for general cleaning tasks such as flushing, washing, and rinsing medical devices.
Water Management Program
A comprehensive written protocol created by a cross-functional team that ensures the quality of all water used throughout medical device processing. A successful water management program is risk based, details roles and responsibilities, specifics verification and validation methods, and documentation expectations.
Critical Water
Water that undergoes extensive filtration and treatment to meet the quality requirements as outlined in the Standard. This water is acceptable for cleaning, final rinse, and sterilization of medical devices and is the input water for steam generation.
Endotoxins
A toxin present inside a bacterial cell. When a cell dies and disintegrates, the toxin is released and can be responsible for inflammation or some diseases. After bacteria is killed by a water treatment system (such as with UV) the endotoxins must be filtered out. Measured by Endotoxin Unit (EU).
Steam Water
Water that is converted into steam whether from a central steam boiler system or local steam generator for use in medical device sterilization. This water must meet requirements as outlined in the Standard and tested as steam condensate.
Bacteria
A single cell living organism that can cause some diseases. Agenics’ bacteria tests looks specifically for aerobic, heterotrophic bacteria that grows in low nutrient environments, such as water.
Water Quality Standards for Routine Monitoring
FAQs
-
The Association for the Advancement of Medical Instrumentation (AAMI) introduced ST108, an evolution of AAMI TIR34, to advance water quality in healthcare settings by establishing clear requirements for the water used in medical device processing. The standard explains proper maintenance of water used in the processing of medical devices, including sterilization, cleaning, rinsing, and disinfecting.
-
PATIENTS: Reduce patient risk of infection or toxicity exposure response caused by microbial or endotoxin contamination on devices.
DEVICES: Improve performance and longevity of equipment by reducing device corrosion, pitting, or scaling of equipment
FACILITIES: Improve water system effectiveness while reducing maintenance costs caused by scaling and build-up
-
Considered a best practice for patient safety, compliance with ST108 is required by accrediting organizations including The Joint Commission and DNV.
-
Head to AAMI.org and search AAMI ST108:2023 - Water for Processing of Medical Devices
Critical Submission Form & IFU
Resources
Utility Submission Form & IFU
Affirm Sell Sheet
ST108 Overview
“The importance of monitoring water quality to prevent problems with microbial proliferation cannot be overemphasized.”
— Provided courtesy of AAMI
Agenics Labs is the leading provider of water testing and analytics for the healthcare industry.
862 Highway 105, Palmer Lake, CO 80133
719.466.5592