Report on Device Recalls Criticizes Current FDA Approval Process

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Over a recent 5-year period, the majority of medical devices recalled for life-threatening or serious hazards were cardiovascular devices. But most of these products were initially approved by the US Food and Drug Administration (FDA) through the less burdensome 510(k) process or were exempt from regulatory review altogether because they were considered low risk. That disconnect raises questions about whether current standards for approval are adequate, asserts a study published online February 14, 2011, ahead of print in Archives of Internal Medicine.

Diana M. Zuckerman, PhD, and Paul Brown, BS, both of the National Research Center for Women and Families (Washington, DC), and Steven E. Nissen, MD, of the Cleveland Clinic (Cleveland, OH), analyzed the FDA's list of high-risk device recalls from 2005 through 2009.

Overall, the FDA issued 113 recalls during the study period. Of these, 21 devices (19%) were approved through the premarket approval process (PMA), 80 devices (71%) were approved through the 510(k) pathway, and 8 devices (7%) were exempt from regulatory review. In addition, 4 (4%) were counterfeit devices or categorized as “other” and thus did not go through any of the 3 processes for approval, clearance, or registration.

The 510(k) process requires that a device demonstrate “substantial equivalence” to an existing, approved product, while the PMA process requires more extensive testing.

Breaking Down the Breakdowns

The dominant category of recalled products was cardiovascular devices, which accounted for 35 separate recalls, or 31% of the devices on the FDA’s high-risk recall list. Most were automated external defibrillators. Of these, 66% previously had been cleared as 510(k) and 34% approved as PMA.

“Despite the FDA law that requires almost all Class III devices to be approved through the more stringent PMA process, 13 of the 510(k) high-risk recalled [cardiovascular] devices were designated as Class III devices (12%),” the researchers write.

Second on the list were general hospital devices, including insulin pumps, intravenous infusion devices, and patient lifts, which amounted to 27 recalls. Of these, 74% originally had been approved through 510(k) review and 22% through the PMA process. Anesthesiology devices, including mechanical ventilators, came in third; ten were cleared by the 510(k) process, and 1 was exempt from review. The remaining recalls were either clinical chemical analysis devices, such as glucose meters and other diagnostic testing equipment, or neurologic devices, such as shunts and devices for the face, jaw, and cranium. Of these, 70% and 83%, respectively, were cleared by the 510(k) process. None went through PMA.

Who’s Watching the Watchers?

According to Dr. Zuckerman and colleagues, the findings indicate “systematic problems” in how new medical devices are introduced. They state that the 510(k) process was specifically intended for devices with less of a need for scientific scrutiny, such as surgical gloves and hearing aids. But over time as new devices became more complex, “the FDA did not have the resources to develop performance standards for new moderate-risk devices or to shift more devices to the much more stringent and time-consuming PMA process,” the study authors write.

The FDA’s implementation of the 510(k) process also has received considerable criticism from public health advocates and from other federal agencies in reports, medical journal articles, and testimony before Congress. Currently, the Institute of Medicine is conducting an independent outside review of the process. Its report is due by summer 2011.

One reason the FDA relies heavily on the 510(k) process is because it is significantly less expensive and enables the relatively small Center for Devices and Radiological Health to review thousands of devices each year, the investigators say. As an example, in 2005, the average cost for the FDA to review a 510(k) submission was about $18,200, compared with $870,000 for a PMA submission.

In August 2010, the FDA itself released an internal report proposing changes intended to strengthen and clarify the 510(k) process. Suggestions were that clinical trials should be required in more 510(k) reviews and that safety would be enhanced if the FDA had expanded authority to require premarket inspections and postmarket studies as a condition of clearance.

However, in an editorial accompanying the study, Rita F. Redberg, MD, MSc, and Sanket S. Dhruva, MD, of the University of California, San Francisco (San Francisco, CA), counter that the FDA has since “backed down from several essential safeguards” in its implementation plan, which was released in January 2011.

Part of the problem for the FDA, say Drs. Redberg and Dhruva, is that the agency must withstand pressure from industry lobbyists.

“Without any data to support their statements, the lobbyists suggest that the proposed FDA changes—which could improve public safety—will ‘chill device innovation,’” the editorialists write. They state that a report commissioned by AdvaMed, the largest medical device industry trade association, found a similar number of total 510(k) recalls, but “has spun their report to say that the findings argue against improvements.”

But Drs. Redberg and Dhruva argue for the need “to immediately strengthen device safety regulations to protect Americans from avoidable injuries and death. This process must begin by appropriately classifying high-risk devices according to their risk for adverse events and by requiring high-quality clinical trial data of safety and effectiveness so that the FDA will get it right the first time.”

Keep Recalls in Context

In a telephone interview with TCTMD, David E. Kandzari, MD, of Piedmont Heart Institute (Atlanta, GA), said the study authors failed to put the recalls into the context of the sheer number of devices approved from 2005 to 2009, which totaled about 19,000 to 20,000.

“We should be very careful not to throw out what has overall been a very successful process at the cost of 80 cases, representing far less than 1% of the totality of approved devices in the United States,” Dr. Kandzari stressed.

Another issue, he added, is that the study does not speak to whether actual harm was caused to patients by the devices. Recalls also may have been triggered by post-marketing surveillance as part of an FDA mandate. Although not always required, the FDA does sometimes ask for such efforts as part of a 510(k) approval, Dr. Kandzari said.

“The other big issue is that there is nothing in this study to suggest that a PMA process, as the editorialists suggest, would identify an issue that would then lead to a recall,” he added. “My suspicion, in fact, is most of these recalls are not recognized until the devices are put into clinical practice or clinical situations like off-label use that are way beyond the context of PMA studies.”

Finally, Dr. Kandzari said, while constructive criticism and suggestions for improving the approvals process are welcome, it is important to remember that no system is perfect and never will be.

“The opportunity to improve upon it is there, but we must be realists,” he said. “The FDA is in the process of revising their 510(k) process. There is a consideration for reclassifying some devices and implementing a new class (Class IIb) that could be required to provide some clinical data for their approval through the 510(k) process.”

 

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Sources:
1. Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med. 2011;Epub ahead of print.

2. Redberg RF. Medical device recalls: Get it right the first time. Arch Intern Med. 2011;Epub ahead of print.

 

 

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