FDA to revamp medical device safety procedures

From the Associated Press

The Food and Drug Administration plans to revamp how it handles safety issues with the stents, pacemakers, implantable defibrillators and other medical devices it regulates, the agency said Thursday.

As it does so, the FDA plans to use data-mining techniques that could give the agency early warning of potential problems.

The FDA effort parallels similar efforts underway to improve the agency’s response to drug safety concerns.


How the FDA handles safety issues with the products it regulates already is under scrutiny and is expected to receive even more attention from Democrats now that they will be the majority party in Congress.

With medical devices in particular, concern grew after last year’s slew of high-profile recalls or safety warnings affecting more than 200,000 defibrillators.

The new plan calls for reorganizing the FDA’s Center for Devices and Radiological Health to allow better sharing of safety information.

It also calls for streamlining the now-disjointed way the agency collects reports of possible problems from multiple sources, including manufacturers and doctors.

Proposals include expansion of a pilot program that collects safety reports in real time from hospitals, as well as tapping into medical device data amassed by the Veterans Affairs Department, the Defense Department and the Centers for Medicare and Medicaid Services.

The FDA also wants all medical devices marked with a unique number, which would allow them to be better tracked in a recall. AdvaMed, an association that represents about 1,300 medical device companies, has said it doesn’t oppose the idea but believes it should be optional.