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FDA medical device system under scrutiny

WASHINGTON — Government investigators say the Food and Drug Administration is putting patients at risk by approving sensitive medical devices such as hip joints and heart defibrillators under the same streamlined system intended for power wheelchairs, stitches and catheters.

The Government Accountability Office told a Senate committee on Wednesday that the approvals remain a serious issue — more than two years after the watchdog agency first cited the problem to the FDA.

In 2009, the GAO faulted the FDA for not reclassifying more than 26 types of devices so they receive more stringent reviews. Since then, the agency has cleared 67 individual, high-risk devices through the so-called 510(k) system, which is used to clear the majority of devices.

Wednesday's hearing came as the FDA faces complaints from medical device manufacturers that the speed of U.S. device reviews lags behind other countries. The Institute of Medicine is reviewing the device approval process at FDA request.

The industry's chief trade association, AdvaMed, has spent hundreds of thousands of dollars lobbying against new device regulations that they say would slow down innovation.

But Senate Aging Committee chairman Herb Kohl, D-Wis., warned Wednesday that swift approvals must not compromise safety.

"Faulty medical devices, especially those implanted in the body, can have a disastrous impact on the health of those who use them," he said.

The committee heard testimony from Katherine Korgaokar, a patient who had to have her Johnson & Johnson hip implant removed because of a defect that caused it to release metals into her body. Korgaokar told senators that the metals, cobalt and chromium, could damage a fetus and make it difficult for her to have children.

"I had no idea how these metals would affect my body," Korgaokar said.

The FDA's Dr. William Maisel told lawmakers that the FDA will reclassify the 26 types of high-risk devices cited by GAO before the end of 2012.

Medical devices include everything from tongue depressors to silicone breast implants and pacemakers. In 1976, Congress set up a three-tiered classification system for the devices.

Low-risk devices like crutches and hospital beds do not require FDA review. Moderate-risk devices such as mercury thermometers and power wheelchairs could be cleared by the speedy 510(k) method. If the FDA doesn't object to a manufacturer's 510(k) application within 90 days, the device is automatically approved for marketing.

High-risk devices such as pacemakers and heart valves have to go through tighter scrutiny, and their manufacturers are required to provide studies demonstrating their safety and effectiveness. Devices classified as high-risk tend to be ones that are implanted in the body or could spell the difference between life and death.

But an exception was made for new versions of high-risk devices that were already on the market in 1976, such as certain types of defibrillators and orthopedic implants. These devices could go through the faster 510(k) system if manufacturers could show they were "substantially equivalent" to their precursors. In 1990, Congress told the FDA to end the practice, but it has continued.

According to the GAO, the FDA has reclassified only one group of devices since 2009, leaving 26 remaining.

FDA medical device system under scrutiny 04/13/11 [Last modified: Wednesday, April 13, 2011 5:54pm]
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