C.G. Laboratories Validates and develops Manufacturer’s Instructions for Use (IFU) for Reusable Devices
The FDA places responsibility on the device manufacturer for testing and validation of any labeling claims for reuse (that are provided in the IFU-Instructions for Use). This includes the handling, cleaning, disinfection and sterilization of reusable medical devices in a health care facility.
C.G. Laboratories will guide you through the process, ensuring that your product goals are met. We will point out any potential issues before validation begins to give the best possibility for success. This emulates one of our Core Values which is to help our Customers succeed.
Applicable Standards: AAMI TIR 12 and AAMI TIR 30
FDA guidance document: Reprocessing Medical Devices In Health Care Settings: Validation Methods and Labeling
C.G. Laboratories validates the following aspects of Reusable devices:
- Steam Sterilization
- Sterrad Sterilization
- Manual Cleaning (protein and hemoglobin)
- Automated Cleaning (ISO 15883 compliant) – protein and hemoglobin
- Disinfection (low, intermediate or high level) Validation
- Simulated Use (Functionality) Validation
- Thermal Disinfection Validation
- Life Cycle (continuous-cycle programming capabilities)