Clinical Reprocessing Sterilization Validations and Functionality Studies

The sterilization validation test confirms the appropriate Sterility Assurance Level (SAL) of the medical device. Theclinical reprocessing sterilization validations and functionality testing establishes the pertinent sterilization parameters for health care reprocessing instructions. Based on the data obtained through testing, the manufacturer will be able to provide health care facilities with validated sterilization parameters. Ingenes can validate using steam (gravity or prevacuum), ethylene oxide (EO), radiation, or dry heat. For reusable instruments, liquid chemical or thermal disinfection may be acceptable alternatives.

In addition, the manufacturers should validate end of life cycles for reusable or reprocessed medical devices to demonstrate functionality with repeated exposures and clinical simulations. Ingenescan assist you with study design and execution of functionality and repeated use studies.

The applicable guidelines for testing reusable medical devices are ANSI/ASMI ST79, ANSI/AAMI ST77 and AAMI TIR12. Ingenespartnering lab got the required infrastructure, equipment, and qualified personnel to help guide you through this process. Our FDA Consultant and sterilization experts will provide individualized consultation and are here to help simplify the complex regulatory and standard recommended for clinical reprocessing sterilization validation and functionality studies.

Please contact us for further information about our clinical reprocessing sterilization validation services.

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