ROSEMONT, Ill. (October 3, 2022)—When a medical device fails to function as originally intended it can jeopardize patient safety and confidence. One important role of the FDA is to continue monitoring devices after approval to mitigate the detrimental effects of these unforeseen problems. Orthopaedics constitute the single largest specialty of medical devices in healthcare, and account for approximately 20% of all recalls issued by the FDA.
Jonathan R. Dubin, MD, FAAOS, orthopaedic trauma surgeon and member of the American Academy of Orthopaedic Surgeons (AAOS) Committee on Devices, Biologics and Technology, is available to speak about the critical role orthopaedic surgeons play in improving patient safety as well as the FDA medical device recall process.
According to Dr. Dubin, it is important that physicians engage in the device safety and recall process. At the most basic level, it is incumbent upon the surgeon to discuss any clinically relevant recalls with the patients in whom they implanted the flawed device once they become aware of the defect. However, AAOS members now have the ability to go a step further by reporting concerns they see in their practice regarding medical devices.
The AAOS Device Recall Dashboard will be a useful surveillance and patient safety tool for physicians and useful for research investigators. The new online database is a collective effort between the AAOS Committee on Device, Biologics, and Technology and the AAOS Patient Safety Committee.
# # #