FDA task force: Use network of registries to track med devices

A new report calls for the creation of a national coordinated registries network (CRN) to monitor medical devices after they become commercially available.

The U.S. Food and Drug Administration asked an independent group of experts for recommendations to improve its approach to designing and evaluating medical devices. The recommendations call for a master network of data in each clinical area where devices are used.

summary of the task force's recommendations was published Monday in the Journal of the American Medical Association (JAMA).

Information on medical devices can be found in registries, electronic health records and claims data, but the recommendations call for aggregating it in a central location to make it easier for regulators, doctors and patients use it.

"Conceptually, this is the best way for us to make sure that physicians and patients get up-to-date, near real-time information about the performance of medical devices to be able to make informed choices about what works best for individual patients." Art Sedrakyan, M.D., director of the Medical Device Epidemiology Network's Science and Infrastructure Center and a professor at Weill Cornell Medical College, said in an announcement.

The CRN also will provide device manufacturers with information from more diverse groups of patients exposed to devices in more diverse treatment settings, the report says.

The JAMA summary includes eight foundational characteristics for a national medical device evaluation system, including providing continuously updated data; identifying lessons learned; leveraging international medical device data efforts; and promoting pilot programs that create momentum for a centralized database.

The recommendations will be open for feedback for 60 days.

A report from the Pew Charitable Trusts last fall called for a national system of registries to track medical devices.

In addition, registries can go further than the premarket trials necessary for FDA approval by allowing for the evaluation of devices in wider populations over longer periods of time, according to the report.

The FDA's Premarket Approval pathway allows high-risk medical devices on the market with too little research to prove their safety and effectiveness, according to research recently published in JAMA.

To learn more:
- read the report (.pdf)
- here's the summary
- check out the announcement