Recently the FDA has been in the news with their new and upcoming Sentinel surveillance software to derive additional information about drug reactions and other pertinent data and now it looks as though the process will be extended to to the use of orthopedic devices, knees and hips at the top of the list. Hopefully there will be some information regarding the "squeaking knees" we have read about.
Nobody wants a device recall once it has been implanted, knee, hip or other medical device. BD
The Food and Drug Administration has proposed a program that would query public and private databases to help study the efficacy of orthopedic implants. FDA will issue a request for quotations next month in an effort to identify companies that could evaluate orthopedic implant registries for participation in the program. The program is part of the broader Sentinel Initiative FDA launched earlier this year. The broader effort is intended to monitor and provide early warnings of potential problems with FDA-approved medical products.
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