Tougher Review Strategy of Devices adopted by FDA

Agency officials of the U.S Food and Drug Administration said on Thursday that they are taking into account enhanced methods to scrutinize possible security problems with medical devices.

FDA reported that according to the new proposal, devices like stents, implanted defibrillators and artificial joints will have to be reported to the agency electronically and would also have to include special identifying codes to help track their use.

"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.

The FDA also cleared that the proposal has nothing to do with the election outcome.

"The entire FDA post-marketing surveillance system is weak both for drugs and devices," said Dr. Steve Nissen, a Cleveland Clinic Foundation cardiologist scheduled to testify at a congressional hearing this month about the FDA. "Unfortunately, adverse event reporting is voluntary and, generally, only 1 to 10 percent of events are reported," Nissen said.

A Democratic-led Congress is agreeable with FDA to make the changes, starting by shuffling a few committee chairmen.

Democrats Edward M. Kennedy of Massachusetts, Henry A. Waxman of California, and Bart Stupak and John D. Dingell both of Michigan are on the brink to head key congressional panels with investigatory powers and inadvertence by FDA.

"With congressional oversight, [the FDA is] going to face a much tougher, much tougher environment," said John Manthei, a partner in the Washington, D.C., office of Latham and Watkins LLP . "Mr. Waxman and Mr. Dingell and Mr. Stupak have made it very clear that FDA is squarely within their crosshairs," said Manthei, FDA counsel for the Medical Device Manufacturers Association.

The FDA has started subjecting devices to scrutiny in the United States in the recent years and its plan will help it better detect and take action on risks related to thousands of medical devices. The decision comes because of a series of recalled heart defibrillators and concerns about probable side effects with drug-coated stents that treat clogged arteries.

The FDA has been under fire since long and is taking all necessary steps to progress its handling of drug safety, although critics say that more needs to be done.

The plan is a part of FDA’s attempt to refurbish its management of device safety procedures.

Initiating the plan, the FDA has already set up a network of 350 hospitals, reporting problems with devices. This step will help shortening the time it takes for the agency to learn about problems.

As a part of the plan, they said that they will provide time to time information to public regarding device problems and collaborate better with staff in various device offices.