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Justifying Family Groupings to Maximize Value for Cleaning and Sterilization

By: Nick Workman and Emily Mitzel
Published: Orthopedic Design Technology

Orthopedic and surgical implant device manufacturers could be spending more time and money on testing than necessary by not considering family grouping when validating the cleaning and sterilization processes that occur at healthcare facilities. Cleaning and sterilization validations help ensure patient safety and minimize healthcare-acquired infections, corrective actions, and recalls. Device manufacturers can use worst case or family grouping for the validations of cleaning and sterilization processes that occur at a healthcare facility unless the device is very unique and specialized. These devices must be individually validated.

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