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FDA implements new device monitoring strategies

The U.S Food and Drug Administration said that they are going to evaluate and monitor problems with medical devices more strictly. The agency reported that, according to a new proposal, devices such as: 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.

The FDA has started subjecting devices to scrutiny in recent years. The plan will help better detect and take action against risks related to thousands of medical devices. The crackdown comes as the result 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 from loose handling of drug safety. The plan is part of the FDA’s attempt to refurbish its management of device safety procedures.

The FDA has already set up a network of 350 hospitals designed to report problems with devices. This hospital network will help shorten the time it takes for the agency to learn about problems. As part of the plan, the FDA said that they will provide periodic information to the public regarding device problems and collaborate more closely with the manufacturers of the devices.