One of the most important decision-making factors for a healthcare facility when purchasing a new device is how long a device will last under its intended use. Fortunately, with access to quality medical device material compatibility testing, you can officially gage the overall shelf life of a device under reprocessing conditions. HIGHPOWER’s test methodology is based on methods outlined in AAMI TIR 12, AAMI TIR 17 and other sterilization specific national and international standards. As such, our team is expertly qualified to provide you with support and knowledge during your product design process.
The material validation process makes sure all of the materials in a medical device are compatible. Reusable medical devices require device design control testing of materials, systems, and finished devices in order to assure that the device and the materials it is comprised of are compatible with the various sterilization & cleaning listed in the devices’ labeling claims. If it isn’t compatible, you risk premature deterioration of the product and, therefore, a significantly shorter lifespan. Here’s what you can expect from chemical compatibility testing.
Materials Compatibility/Repeat Cycle Testing is sometimes referred to as “Functionality or Limits of Reuse Testing.” These terms basically mean the same thing with the objective of medical device material compatibility testing to look for degradation of the device after repeated exposure to cleaning and sterilization processes. The device or material is typically run through one or more sterilization and/or cleaning cycles and then evaluated at defined intervals for degradation. After chemical compatibility testing, devices are often tested for cytotoxicity.
At HIGHPOWER, we’re always adding new tests to our service lineup to meet our customers’ expectations. If you don’t see your required test listed, please contact us at clientservices@highpowervtls.com with your inquiry. We strive to provide manufacturing companies like yours with all the support and resources needed to create a quality product. We’ll create a personalized experience for you based on your particular development needs.
Tests Available by Test Code:
| Test Code | Test Name |
|---|---|
| MC-100NX | Materials Compatibility for STERRAD 100NX Cycles |
| MC-100S | Materials Compatibility for STERRAD 100S Cycles |
| MC-DRY | Materials Compatibility for Dry Heat Cycles |
| MC-ETO | EtO Concentration run @ 446 mg/L, 567 mg/L, 735 mg/L or 759 mg/L |
| MC-NX | Materials Compatibility for STERRAD NX Cycles |
| MC-STEAM | Materials Compatibility for Steam Cycles |
| MC-VPRO | Materials Compatibility for V-PRO Cycles |
| MC-SZ | Materials Compatibility for STERIZONE Cycles |
| MC-COLD | Chemical Immersion Cycle (High Level Disinfectants) |
| RESID-H2O2 | Residual Testing of Hydrogen Peroxide |
| RESID-ETO | Residual Testing of EtO |
| MC-WASH | Materials Compatibility Testing, Mechanical Washer—Repetitive Cleaning |
| MC-MANUAL | Materials Compatibility Testing, Manual Wash—Repetitive Cleaning |