FDA to strengthen efforts in medical device oversight

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The FDA is considering using a new computer-based safety reporting method to more effectively keep track of problems with approved medical devices, Reuters reports. The change would require that problems with products such as stents, defibrillators implanted in heart patients, and artificial replacement joints be electronically reported via the new system using unique identification codes for each device.

"Postmarket systems that enable constant learning and feedback not only help support best medical practices to ensure safe use of devices with maximum effectiveness, but they also spur continued innovation. This plan is a major step in that direction," said Daniel Schultz, head of the FDA's Center for Devices and Radiological Health, Reuters reports. The agency also is looking to give improve the hospital-based reporting system which is supposed to quickly identify device problems. The FDA also indicated that it has plans to do a better job of informing the public and health professionals about device problems as they become known.