Reusable Medical Devices: BI Selection, Overkill Validation Approaches, and First-Time Validation Pass Rates in Common Healthcare Steam Sterilization Cycles

When validating the steam sterilization instructions for a reusable medical device, first-time pass rates are important to manufacturers. Failures in validation testing require resolution, adding to the total validation time, which can result in a delay to a regulatory submission, getting a device to market, or both.