The Food and Drug Administration plans to require makers of high-risk medical devices to put a unique identifying number on all such products, in an effort to create an early-warning system for devices that may break down and pose safety dangers for patients.
The new FDA final rule is part of the agency’s heightened emphasis on the safety of devices such as heart defibrillators that can malfunction. The “unique device identifier” will give the FDA a means to quickly sift through databases such as those at hospitals and insurance companies and determine if a malfunction is something rare or part of a pattern.
For the FDA, it is an attempt to overcome a historic lapse in which defibrillator wires malfunctioned but it took many months before the agency and the industry knew the scope of the problem. In 2007, defibrillator wires, or “leads,” made by Medtronic Inc. and called Sprint Fidelis began occasionally fracturing in patients, a pattern noticed by doctors at the Minneapolis Heart Institute early that year. It took months for the company and the federal agency to put in place a recall of the thousands of such leads implanted in patients world-wide.