Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Part6

Validation of the Final Microbicidal Process to Prepare

the Device for the Next Patient

A.     Disinfection

FDA recommends that you validate your disinfection processes and instructions. FDA

also recommends that you follow the recommendations in device-specific FDA guidance documents or any relevant FDA-recognized standards.

B.      Sterilization

FDA recommends that you validate as well as provide in your labeling, sterilization cycle
specifications that are consistent with the conventional parameters presented in Appendix

C. This is to ensure that your device is compatible with the necessary FDA-cleared
reprocessing equipment, and the reprocessing instructions are technically feasible for implementation by users. For reusable devices that are intended to be used sterile,
labeling should include a sterilization process that you have validated to attain a sterility assurance level (SAL) of 10^-6 (or 10^-3, as appropriate).

Validation data should be generated in FDA-cleared sterilizers and with FDA-cleared

sterilization accessories (e.g., biological indicators, physical/chemical sterilization

process indicators, sterilization wraps). Alternatively, validation data may be generated in sterilizers that can show equivalent or better control of key sterilization parameters than FDA-cleared sterilizers. If you choose this approach, you should address differences that may exist between the test sterilizer and the FDA-cleared sterilizer.