High-Risk Medical Devices Fail to Get Full Review, GAO Says

High-risk medical devices are approved for sale without sufficient proof of safety by U.S. regulators who don’t monitor recalls when concerns arise during marketing, the Government Accountability Office found.

The Food and Drug Administration gave expedited reviews to at least 67 devices such as pacemakers and hip joints since the GAO called in January 2009 for “immediate steps” to increase standards or reclassify potential risks, Marcia Crosse, GAO’s director of health care, told lawmakers in Washington today. While the FDA has enhanced its oversight, she said, it continues to review 26 of 27 types of high-risk devices cited in 2009.

“It remains to be seen whether these actions will help ensure that medical devices marketed in the United States receive appropriate premarket review,” Crosse told the Senate Special Committee on Aging. “Gaps in FDA’s post-market surveillance show that unsafe and ineffective devices may continue to be used, despite being recalled.”

A series of device recalls led by Johnson & Johnson (JNJ)’s decision last year to pull 93,000 artificial hips from the market has heightened scrutiny of the agency’s approval process. The FDA has been slow to implement a 1976 law requiring that all high-risk devices undergo a strict review. Many are still cleared with minimal tests under the so-called 510(k) program if companies prove they’re similar to existing products, said the GAO, the investigative arm of Congress.

High-Risk Devices

The FDA requires extensive testing for less than one-tenth of devices. The GAO study focuses on high-risk devices, including those that are implantable or life sustaining.

William Maisel, deputy director for science in the FDA’s Center for Devices and Radiological Health, said the agency is reviewing data on the 26 device categories cited by the GAO and is “committed to completing this evaluation” by the end of 2012.

After that process, the FDA may reclassify the devices as “medium risk” or order companies to go through a premarket approval process that typically requires clinical trials, he said.

The 510(k) program, which clears about 3,800 to 4,000 products a year, is “critical to a vibrant and successful device industry,” testified David Nexon, senior executive vice president for the Advanced Medical Technology Association, a trade group. The process “has an exemplary record of protecting the public from unsafe devices,” he said.

‘Delicate Balance’

Senator Herb Kohl, a Democrat from Wisconsin and the committee chairman, said the FDA has an “extremely difficult assignment” in striking a “delicate balance between safety and innovation.”

The ranking Republican on the committee, Senator Bob Corker of Tennessee, said: “Candidly, I don’t know of anybody who’s really happy with the FDA.”

Nexon said while companies support the existing 510(k) program, they have complained of “a very severe deterioration in FDA performance over the past five years,” including slower reviews of applications and inconsistent application of standards.

“I’ve never seen the degree of angst and upset that we have now,” Nexon said. “It really does need to be fixed.”

Maisel said the agency has undertaken a series of steps to enhance its review process and tracking of approved devices.

“We would like to deliver more consistency and transparency in our decision making,” he told the senators.

Regulators also don’t routinely analyze trends in device recalls or ensure that companies make promised fixes in the prescribed time frame, increasing the risk that unsafe products linger on the market, the GAO found.

Previous Recalls

Eighty-one percent of the 113 withdrawn devices deemed high-risk recalls by the FDA from 2005 to 2009 were approved under the less-stringent pathway, researchers said Feb. 14 in the journal Archives of Internal Medicine.

Cardiovascular devices accounted for a third of the recalls, among them automated external defibrillators made by Minneapolis-based Medtronic Inc. (MDT), Zoll Medical Corp. (ZOLL) of Chelmsford, Massachusetts, and closely held Welch Allyn Inc., of Skaneateles Falls, New York, the researchers said. Defibrillators are devices that shock irregular or stopped hearts back into normal rhythms.

Senate Democrats say the FDA may need new authority, including mandatory device registration and recall power, to more quickly identify potential safety issues.

Internal Review

The FDA is conducting an internal audit of the 510(k) program and has sought the advice of the Institute of Medicine, an independent arm of the National Academy of Sciences. The agency in January announced 25 steps to improve consistency and transparency in the review process. More changes were referred to the institute, which plans to issue a report this year.

Jeffrey Shuren, director of the FDA’s devices center, is scheduled to testify tomorrow at a separate hearing on medical device approvals with the House Oversight & Government Reform committee.

Among the devices recalled were 93,000 hip implants made by the DePuy Orthopaedics unit of New Brunswick, New Jersey-based J&J, including 37,000 in the U.S. In announcing the recall, J&J cited unpublished U.K. data showing that within five years as many as 13 percent of the hips failed and needed to be replaced.

Katherine Korgaokar, a J&J hip recipient, had her implant replaced after her doctor said excessive wear had released high levels of cobalt and chromium into her body, testified. She said recovering from the second operation has been “substantially more difficult than the first,” and she may require more surgeries.

Before her implant, she thought devices were extensively tested by regulators.

“It still blows me away that something that goes into somebody’s body can be approved without proper testing,” Korgaoker, 41, of Denver, said at the hearing.

To contact the reporters on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net; David Voreacos in Washington at dvoreacos@bloomberg.net

To contact the editors responsible for this story: Reg Gale at rgale5@bloomberg.net; Michael Hytha at mhytha@bloomberg.net

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