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On March 12, 2015, the US Food and Drug Administration released a final guidance for medical device reprocessing entitled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” This guidance was issued after cases of contaminated duodenoscopes which are specialized endoscopy devices behind the recent outbreak of a drug-resistant “superbug” at two Los Angeles hospitals.
This new FDA guidance was released to increase the safety of reusable medical devices and address the possible spread of infectious agents between uses. To ensure the safety reprocessing should be considered as part of the medical device design. These reprocessing instructions are reviewed as part of its regulatory review for reusable medical devices to determine whether they are appropriate and able to be understood and followed by end users. The new guidance lists criteria that should be addressed in the instructions for use with every reusable device to ensure users understand and correctly follow the reprocessing instructions.
Does your medical device manufacturer need a microbiology laboratory for validation testing of it’s medical device sterilization or reprocessing procedures ? Submit a Laboratory Test Request