At Senate hearing, critics slam FDA's device safety record

by Brendon Nafziger, DOTmed News Associate Editor | April 14, 2011

Dr. Frederic Resnic, an interventional cardiologist with Harvard Medical School and Brigham and Women's Hospital in Boston, criticized the current surveillance system as a "patchwork of voluntary reporting mechanisms."

"Despite efforts to encourage reporting, GAO says less than one in 200 device failures is reported to the FDA," he said.

But he also thought electronic tracking and the creation of device registries would help improve the monitoring of device failures. He recommended setting up an automated system that would monitor hundreds or thousands of devices: it would work like a smoke alarm, triggering an alert to the FDA once a specific metric rose above a certain threshold.

Electronic tracking was also favored by the Advanced Medical Technology Association, a device lobby.

"A more practical approach is registries based on unique device identifiers and electronic records, where data is collected as part of the normal course of doing business," said David Nexon, senior executive vice president with AdvaMed.

Numbers game

Patient safety advocates and device representatives also disputed the number of recalls, with patient advocates saying it was around 40 percent of the devices cleared or approved, and the industry less than 1 percent. The GAO said it was around 18 percent.

Zuckerman, who found the higher rate of recalls, said it was because she also looked at moderate-risk recalls, as these still have serious consequences. "Over 170 knees and hips and joint components [were] recalled in the last five years, all moderate risk, all require surgery and rehab," she said.

Ralph Hall a professor with the University of Minnesota Law School in Minneapolis, whose study found a lower rate of recall, countered that most serious, high-risk, Class I recalls stemmed from manufacturing and quality control issues (55 percent), not lack of clinical data. Also he said, based on his data, he did not find a significant difference in the number of devices subject to Class I recalls between PMA and 510(k) systems, indicating the problem was not a dearth of clinical evidence.

"I can say, from data I've seen, quality system regulation is the key way to have the greatest positive impact on device safety," he said. "Ninety percent of all recalls were because of the quality system."

Sunshine policies

Intriguingly, during the question and answer session, Sen. Ron Wyden (D-Ore.) veered somewhat off-topic and said he would take up group purchasing organization concerns about the lack of price transparency for medical devices, as companies often impose "gag orders" on hospitals purchasing equipment. "It's a very vexing problem," he said.

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