GAO renews critique of FDA medical device system

WASHINGTON (AP) — 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 Congress Wednesday that the approvals remain a serious issue for the government — more than two years after the watchdog agency first cited the problem to the FDA.

The GAO previously faulted the FDA in a 2009 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 vast majority of devices.

Devices classified as high-risk tended to be ones that are implanted in the body or could spell the difference between life and death.

Wednesday's hearing comes as the FDA faces complaints from medical device manufacturers that the speed of U.S. device reviews lag behind other countries. At the same time, public safety advocates point to reports by GAO and others that suggest the agency is being too lenient in clearing critical, life-sustaining devices.

The Senate committee heard testimony from representatives of both groups.

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.

"The drive toward getting new technologies to market shouldn't be done at the risk of patient safety," Kohl said. "Faulty medical devices, especially those implanted in the body, can have a disastrous impact on the health of those who use them."

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 metal 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, and more importantly, I didn't know if they would impact my ability to have children," Korgaokar said.

For its part, the FDA pointed to its ongoing effort to overhaul the medical device approval system, which is more than 35 years old. The agency announced some minor changes to the program in January and is still weighing broader reforms.

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

"FDA evaluates thousands of medical devices annually and the vast majority of these devices perform well and improve patient health," stated Maisel's prepared testimony. He is deputy director for science in FDA's device center.

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 wheel chairs 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.

An exception was carved out 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 ordered the FDA to end the practice, but it has continued even as generations of technology have come and gone.

The report urged the FDA to promptly resolve the problem, either by carrying out full reviews or reclassifying the devices as lower risk, if appropriate.

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

Democratic lawmakers and public safety advocates have been pressing for additional FDA powers to regulate devices, such as mandatory recall authority and an extra device classification. Device companies and Republican lawmakers have stressed the need to streamline device reviews to keep the industry competitive.

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