FDA's Fast-Track Medical Device Approval Process Under Fire

April 14, 2011— -- WASHINGTON — The FDA is falling short in how it handles recalls of risky medical devices, a new report from the Government Accountability Office concluded, adding to the ever-mounting criticisms of the agency's fast-track, 510(k) approval process.

The FDA doesn't keep track of the reasons devices such as hip implants are recalled, and it doesn't always follow up to make sure the recall was complete, a GAO investigator told the Senate Special Committee on Aging, which held a hearing Wednesday on FDA's 510(k) process.

"Concerns persist about the effectiveness of the 510(k) process in general, including its ability to provide adequate assurance that devices are safe and effective," Marcia Crosse, director of the GAO's healthcare team, told the committee. "Gaps in FDA's postmarket surveillance show that unsafe and ineffective devices may continue to be used, despite being recalled."

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The traditional route of device approval — the premarket approval (PMA) process— requires companies to provide clinical data to support their contention that their medical device is safe and effective. The less-stringent 510(k) process does not require clinical trial data; rather, device companies must prove their device is substantially similar to another device already on the market.

The FDA divides medical devices into three categories of risk: class I devices -- such as reading glasses and tongue depressors -- are very unlikely to harm anyone; class II devices are medium-risk, including bone drills and mercury thermometers; and class III includes high-risk devices like pacemakers and heart valves.

Although a federal law requires that all class III devices must eventually go through the pre-market approval process, that is not happening at the FDA.

From 2003-2007, the FDA approved 228 class III devices through the 510(k) process, the GAO report found. The report builds off an earlier report in which the GAO recommended that the 510(k) process not be available for class III devices.

Such devices, the GAO said, should either be reclassified into a less-risky category or else their manufacturers should have to go through the PMA process.

Speed Versus Safety?

The FDA has begun to take steps to address GAO's concerns, but "progress has been limited," the GAO said. As of this month, there are 26 types of class III devices that can currently enter the market through the 510(k) process, and the FDA has approved 67 devices that fall into those categories since 2009.

Until the FDA issues final decisions on those 26 types of devices, the agency's work is incomplete, Crosse said. That list of 26 types of devices -- all of which came onto the market decades ago -- includes automated external defibrillators and electroconvulsive therapy devices.

Decisions on what should happen to those device types will be made by the end of 2012, said William Maisel, chief scientist at the FDA's Center for Devices and Radiological Health. Maisel testified before the committee and told them his department has devoted a considerable amount of manpower and money to considering how the agency approves medical devices.

As evidenced at Wednesday's hearing, there's little agreement on what sort of additional danger, if any, is posed by fast-tracking devices.

According to figures from the Institute of Medicine (IOM), 1.5 percent of all devices approved through the 510(k) process are recalled.

Ralph Hall, a professor at the University of Minnesota Law School, shared results from an analysis he performed that found the number of 510(k) devices that resulted in the FDA's most dangerous class of recall is even smaller — closer to 0.5%.

But a recent review by Dr. Steven Nissen of the Cleveland Clinic suggests recalls often involve devices approved through the 510(k) process. In Nissen's review of 113 urgent recalls from 2005 to 2009, more than 70 percent of the recalled devices were found to have been cleared via the 510(k) program — compared with 19 percent approved through the FDA's more rigorous premarket approval (PMA) system.

Diana Zuckerman, PhD, president of the National Research Center for Women and Families and one of the co-authors of Nissen's study, said the figures vary so much because the IOM figure doesn't include recalls for devices whose malfunction poses just a "moderate" risk of injury.

What Do You Do When Your Hip Is Recalled?

The panel heard from Katie Korgaokar, a Denver woman who was born with a disease that caused her extreme hip pain once she hit her 30s. She received a DePuy ASR prosthetic hip in 2006, but the hip was recalled in 2010 after it was found to malfunction at a much higher rate than expected. In Korgaokar's case, the metal implant's excessive wear and tear released levels of cobalt and chromium in her body that were 1000% higher than normal.

That recall was judged by the FDA to be just "moderate risk." But Korgaokar had to undergo additional painful surgeries to remove the hip, have a new one implanted, and she said the device malfunction may have caused her to miss her window to have children.

"It still blows me away that something that can go into someone's body doesn't have to be tested," Korgaokar said.

In January, the FDA released a list of 25 actions it is taking to improve the safety of the 510(k) process, but stopped short of weighing in on some of the more controversial recommendations made by the IOM, including giving the FDA authority to order postmarketing studies as part of the 510(k) process.

The agency receives upwards of 3,000 510(k) device applications annually, most of which are approved.

"FDA evaluates thousands of medical devices annually and the vast majority of these devices perform well and improve patients' health," Maisel said.