Doctors Say FDA Must Do Better to Protect Public from Dangerous Medical Devices

Doctors Say FDA Must Do Better to Protect Public from Dangerous Medical DevicesPhysicians across the country are calling for the Food and Drug Administration to enhance its safety reporting requirements for medical devices after a batch of defective heart-defibrillator wires led to injuries and deaths, The Wall Street Journal reports.

According to the news source, the FDA has responded by pledging to unveil a more intense monitoring program in April that will reportedly remove defective medical devices from the market faster. The agency says it plans to give each medical device a unique number, making for easy tracking in the event of a recall. The renewed zeal among doctors comes after a defibrillator wire, produced by St. Jude Medical, has been associated with 20 deaths.

Physicians say the current system does not appropriately assess the risks of such medical devices, and say they want the FDA to better manage reports of medical device malfunctions. The current system mandates that hospitals report devices when they are seen to fail, however the reporting is not performed in a uniform manner. Much of the time, the FDA relies on voluntary reports from a select number of healthcare centers.

"We don't know the numerator of device failures at all," said Edward J. Schloss, medical director of cardiac electrophysiology at Christ Hospital in Cincinnati. "There are times a lead fails, and no one knows it failed."

Robert G. Hauser, a cardiologist at the Minneapolis Heart Institute, added that the St. Jude wires story is "another example of our flawed regulatory system."

William Maisel, deputy director for science with the FDA's center for medical devices, conceded that the process could be improved.

"We would concur that the current efforts are not constructed to identify underperforming products in the marketplace," he said. "We need a robust data-collection methodology."

According to Bloomberg, St. Jude announced on Wednesday, April 4, that it planned to stop selling two types of wires used in its heart devices, as an investigation showed that in certain cases, parts of the wires protruded from their insulations.

The St. Paul, Minnesota-based company has ceased selling QuickSite and QuickFlex wires due to the problem, however Citi Investment Research analyst Matthew Dodds says the company may have to recall more products in the future.

The company also announced its newer wires were designed with an additional insulation coating, and should not have the same problem.