Study of recalled medical devices faults lax FDA testing methods

February 14, 2011

A new analysis is raising questions about how good a job the Food and Drug Administration is doing at protecting Americans from faulty medical devices.

Researchers examined the 113 devices that the FDA recalled between 2005 and 2009 for posing serious health risks, including endangering patients' lives. Most of the devices - 71 percent - had been approved without undergoing testing in people, the researchers reported Monday in the Archives of Internal Medicine.

That's because under a process designed to get products on the market as soon as possible, they were deemed to be similar to another product already being sold. Only 19 percent underwent more stringent review.

"Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy," wrote Diana M. Zuckerman of the National Research Center for Women & Families in Washington, D.C., and Steven E. Nissen of the Cleveland Clinic in Cleveland.

One-third of the recalled devices were for heart disease, including automatic external defibrillators, or AEDs. Those are the gadgets that have been increasingly showing up in airports, office buildings and other public places that shock the hearts of people who suffer sudden cardiac arrest. Defective AEDs reportedly have resulted in hundreds of patient deaths, the researchers said.

The findings indicate that the agency is allowing too many medical devices onto the market using the less stringent approval process, the researchers said.

"The FDA is now using the . . . process for 98 percent of the medical devices that they review, including heart valves, glucose meters and artificial hips and knees," Zuckerman said in a statement released with the report. "We think patients will be shocked to learn how often new medical products using different materials, made by a different manufacturers, are not scientifically tested in humans to see how well they work."

Nissen said the findings should be a "wake-up call" to the agency and doctors.

Officials at the FDA, however, dismissed the findings, saying that it was not surprising that most of the recalls involved devices approved through the accelerated process since most of the devices on the market were approved that way.

"Even one recall is too many," said FDA spokeswoman Karen Riley in an e-mail. "But, considering that more than 19,000 devices were cleared via the ... process between 2005 and 2009, it's important to keep the 80 recalls in perspective. They represent a small numbers of the devices cleared via this program and don't reflect the thousands of people who have benefited from these devices."

Riley noted that the agency had recently completed a review of the program and was making 25 changes designed to make the approval process even safer.

In an editorial accompanying the study, Rita Redberg, editor-in-chief of the journal, agreed the findings indicate the need to improve safeguards.

"Doing the right thing will require withstanding the pressure of industry lobbyists," she wrote. "Without any data to support their statements, the lobbyists suggest that the proposed FDA changes--which could improve public safety--will 'chill device development.'"

Officials representing the medical device industry also dismissed the findings. The big problem with the FDA's medical device review process is that it is too slow, a trade group officials said. Many products, including those made in the United States, routinely become available in Europe years before they are approved in this country, he said.

"The real problem at FDA is not that they are clearing unsafe devices. They are doing a very good job of making sure devices are safe and are taking steps to make the process even better," said David Nexon, senior vice president at AvaMed, the industry's trade group. "The bigger problem is the efficiency and consistency of the process deteriorated so dramatically in recent years."

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