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

By: Robert Mueller, Chemistry Project Coordinator; Blake Northrup, Study Director; and Jason Pope, Senior Scientist

Published: Medical Design Briefs

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. Read the full article on the MDB website.