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.
Justifying Family Groupings to Maximize Value for Cleaning and Sterilization
Published In: Orthopedic Design Technology
May 23, 2016
Reusable Medical Devices Expert
Emily Mitzel is an Expert Advisor and Senior Scientist at Nelson Labs. Her expertise includes reusable device reprocessing validations, newly manufactured device validations, sterilization, and microbiology testing. Emily presents at Nelson Labs’ seminars, tradeshows, ISO, FDA, AAMI, and client facilities across the U.S. and internationally. Emily is an active committee member of many working groups...