FDA Needs Tougher Rules for Medical Devices, Lawmakers Told

A panel of medical industry experts testified before a Congressional hearing today and told lawmakers that the Food and Drug Administration needs to add teeth to its approval process for medical devices in order to better protect patients from injuries.

Medical devices, a broad category which includes everything from artificial hips, heart defibrillators, and pacemakers to tongue depressors and other medical equipment, are subjected to an FDA review and approval process that is, quite simply, “broken,” one legislator said.

“Its standards, its procedures and its rules don’t meet modern needs of getting medical devices to those in need with confidence in their safety,” Representative Frank Pallone (D-N.J.) said of the FDA’s medical device review process.

The FDA’s inabilities to thoroughly review medical devices before they are approved and continue to monitor them for problems once they are put into use “raise concerns” about how safe and effective medical devices are, said Marcia Crosse, health care director for the nonpartisan Government Accountability Office. The GAO is the watchdog investigative arm of Congress.

Medtronic Problems Take Center Stage

While the FDA has been faulted for dropping the ball on a variety of medical devices, the Congressional hearing focused on recent actions involving defective heart defibrillator wires and related devices which have been blamed for scores of patient deaths and injuries.

In June, Medtronic Inc., a leading medical device company, announced the recall of 21,000 of its Kappa and Sigma series implantable pacemakers after the devices were found to contain faulty wiring that could cause the life-saving devices to malfunction. The company estimated there were more than 1.7 million of the devices in patients around the world.

Medtronic’s Sprint Fidelis heart defibrillator leads have been the subject of recalls and safety warnings. In 2007, the tiny wires that connect defibrillators to patients’ hearts were ordered recalled after they were found to fracture, posing a life-threatening problem. The company now says at least 18 patients have died due to complications from its Sprint Fidelis products.

Medical Device Makers Support FDA

Medical device industry officials defended the FDA at the hearing and called the agency’s oversight of their products “rigorous.”

“FDA has comprehensive authority to regulate medical devices through a combination of premarket and postmarket controls,” said Stephen Ubl, president of the Advanced Medical Technology Association. “It is important to remember that millions of Americans benefit from” devices each year, he said in a statement.

Margaret Hamburg, the woman recently appointed as FDA commissioner by President Barack Obama, has vowed to examine the agency’s use of a fast-track medical approval process that critics say is used to hurry through devices that need a more careful review.

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