In order to release your medical device among the health-care community, it must be able to be sterilized. You also need a team of qualified and knowledgeable medical device sterility test validation professionals to determine that the method is efficacious. HIGHPOWER’s medical device sterilization validation methodology is based on methods outlined in AAMI TIR 12, ANSI / AAMI / ISO 14937, ANSI / AAMI ST81, and ANSI/AAMI/ISO 17665-1. Reusable medical devices require sterilization efficacy validation in order to assure proper and safe reprocessing by health care personnel. After that method is validated, it can be repeated per the IFU after each use.
Sterilization Efficacy testing is sometimes referred to as “Half Cycle Testing, 100% Overkill Method Testing or Sterilization Validation Testing.” All these terms mean the same thing in order to determine how effectively a sterilization process will sterilize the device(s) being tested. With the proper medical device efficacy testing, there will be no question that your product is safe to use on patients.
Typically, the device being validated is run in an FDA-cleared sterilization cycle using one half of the sterilization exposure time that is normally used in a clinical setting. The test device also includes at least 10^6 spores of a highly resistant organism, placed in locations that would be the most difficult for sterilant penetration. A full cycle then result with at least 10-6 SAL (sterility assurance level). By testing with such stringent guidelines, we can validate that the sterilization process will be successful even in worst-case testing conditions.
HIGHPOWER has every major FDA cleared sterilization process onsite. This includes steam sterilization validation modalities as well as low-temperature sterilization processes.
Sterilization is a crucial aspect of the medical device validation process, and there are a number of ways to test sterilization efficacy. We’re constantly adding new medical device sterilization validation tests to meet our customer’s expectations. If you don’t see your required test listed, please contact us at clientservices@highpowervtls.com with your inquiry.
Tests Available by Test Code:
| Test Code | Test Name |
|---|---|
| SE-100NX-DUO | Sterilization Efficacy Validation for STERRAD 100NX Duo |
| SE-100NX-EXP | Sterilization Efficacy Validation for STERRAD 100NX Express |
| SE-100NX-FLX | Sterilization Efficacy Validation for STERRAD 100NX Flex |
| SE-100NX-STD | Sterilization Efficacy Validation for STERRAD 100 NX Standard |
| SE-100S | Sterilization Efficacy Validation for STERRAD 100S Cycles |
| SE-COLD | Chemistry Immersion Efficacy (High Level Disinfectant/Sterilant) |
| SE-DRY | Sterilization Efficacy Validation for Dry Heat |
| SE-ETO | Sterilization Efficacy Validation for EtO |
| SE-NX-ADV | Sterilization Efficacy Validation for STERRAD NX Advanced |
| SE-NX-STD | Sterilization Efficacy Validation for STERRAD NX Standard |
| SE-STEAM | Sterilization Efficacy Validation for Steam (gravity or dynamic air removal) |
| SE-VPRO | Sterilization Efficacy Validation for VPRO processes |
| TP-STEAM | Steam Thermal Profile Study |
| DT-STEAM | Steam Dry Time Study |
| TP-DRY | Dry Heat Thermal Profile Study |
| TP-WASH | Thermal Disinfection—Ao Study |
| HLD | High Level Disinfection Study |
| ILD | Intermediate Level Disinfection |
| LLD | Low Level Disinfection |
| SIM-USE | Simulated Use Testing |
| IN-USE | In Use Testing |