FDA Rolls Out Plan for Better Postmarket Device Monitoring
The FDA launched its Postmarket Transformation Initiative back in January. The team in charge of that effort now introduces its action plan with the following items:
- “creating a cross-cutting organizational structure within CDRH to better integrate premarket, postmarket and enforcement
- developing internal performance measurements to track the center’s handling of postmarket issues, such as recalls;
- pursuing the development of a unique identifier system to identify a device and the information associated with that device throughout its lifetime;
- proposing mandatory use of electronic reporting for required adverse event reports and revising the current system that records reported adverse events for devices (the Manufacturer and User Facility Device Experience Database or MAUDE system);
- increasing the use of Medical Product Safety Device Network (MedSun) programs–a network comprised of more than 350 hospitals that have been recruited and specifically trained to identify and report device problems, and help provide “real time” data on signals and safety problems;
- enhancing risk/benefit communication efforts so health practitioners, patients and consumers receive clearer and more timely information on public health news;
- increasing the coordination among the agency’s compliance and enforcement programs.”
More details can be found here and in this CDRH report.
November 9, 2006 Related topics: Legal & legislative, Medical Devices & Products, Quality, Safety, Errors