About STERIS Device Testing
The STERIS Device Testing team is a dedicated group of degreed Scientists with over 70 years of combined experience that provides validations for Medical Device Manufacturers (MDMs). This service has been made available to device manufacturers since the late 1980s and supports STERIS's low temperature modalities.
Since the inception of the program, STERIS Device Testing has performed numerous studies on thousands of medical devices and works with MDMs to provide a service that benefits our mutual Customers, the healthcare organizations. STERIS Device Testing evaluates reusable medical devices for material compatibility and microbial efficacy within selected STERIS low temperature reprocessing solutions, providing Customers and MDMs with assurance that their medical devices can be safely and repeatedly processed.
Currently, STERIS Device Testing conducts testing in the following STERIS products:
- V-PRO™ Low Temperature Sterilization Systems
- SYSTEM 1E™ Liquid Chemical Sterilant Processing System
- SYSTEM 1™ endo Liquid Chemical Sterilant Processing System
- SYSTEM 1™ EXPRESS Sterile Processing System (outside of USA only)
- enspire™ 3000 Cleaning & Liquid Chemical Sterilant Processing System
- enspire™ 300 Automated Endoscope Reprocessor
- ADVANTAGE PLUS™ Automated Endoscope Reprocessor
- ADVANTAGE PLUS™ Pass-Thru Automated Endoscope Reprocessor
- DSD Edge Automated Endoscope Reprocessor
In addition, STERIS also collaborates with sterilization wrap and container manufacturers to perform sterile storage and shelf life testing for packaging materials, such as wrap and containers.
Devices that pass material compatibility and microbial efficacy testing are added to the STERIS Device Compatibility Matrix:
STERIS Low Temperature Reprocessing Device Compatibility Matrix
The Device Matrix tool is an intuitive online platform, free to use and a great resource when searching for up-to-date reprocessing information for devices.
STERIS Device Testing provides assistance in the preparation of the Instructions for Use. Please contact Richard T. Gurley at Richard_Gurley@steris.com.