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Quicker FDA review results in harmful devices

Most medical devices recalled for serious health risks were cleared after a quicker type of U.S. government review that usually requires no testing in people, researchers find.
/ Source: Reuters

Most medical devices recalled for serious health risks were cleared after a quicker type of U.S. government review that usually requires no testing in people, U.S. researchers said Monday.

The team -- led by consumer advocates and Cleveland Clinic cardiologist Steven Nissen, an outspoken critic of government oversight of product safety -- said the findings showed the need for more testing of risky products.

An industry group and the Food and Drug Administration defended the quicker review method, saying thousands of patients had benefited and only a tiny fraction of the products were recalled.

The study, published in the peer-reviewed Archives of Internal Medicine, was released as the FDA reviews the way it handles medical devices, which range from simple bandages and tongue depressors to implants such as pacemakers and artificial hips. Makers include Medtronic Inc, Johnson & Johnson and Boston Scientific Corp.

In the study, researchers at the National Research Center for Women & Families looked at medical devices recalled from 2005 to 2009 for defects with the potential for life-threatening or serious, permanent harm.

They found 80 out of 113 recalled products, or 71 percent, were cleared through a shorter FDA review process known as 510(K) that was designed for low- and moderate-risk devices.

The faster review allows approval if a device is similar to another on the market. The FDA usually does not require human testing or manufacturing plant inspections. Most new devices are cleared through that process.

"These findings demonstrate systematic problems in the implementation of existing medical device regulations that have exposed patients to serious harm," the researchers wrote.

Tens of millions of people were exposed to the faulty products, the authors said. It is difficult to tell how much harm resulted as problems with drugs and devices often go unreported to regulators. Even when problems are disclosed, it can be tough to tell if the device was the cause.

About 31 percent of the recalled products were heart devices, including automated external defibrillators used in public places such as airports to revive cardiac arrest victims. The FDA has reported hundreds of cases where AEDs failed and might have contributed to deaths and is looking for ways to avoid future problems with AEDs.

The authors said the FDA should require clinical trials in people for more devices rather than letting them through the abbreviated review process.

FDA spokeswoman Karen Riley said "even one recall is too many" but stressed most of the 19,000 devices in the study cleared through 510(K) review had no problems. The recalls "don't reflect the thousands of people who have benefited from these devices," she said.

She said it was "not surprising" most recalled devices were 510(K)s as most products are cleared through that process.

Diana Zuckerman, the study's lead author, said no 510(K) products should be subject to a high-risk recall because the quicker review is meant for low- or moderate-risk devices.

The FDA's Riley also pointed to changes the FDA unveiled last month as steps to improve the process. Those steps were denounced by safety advocates and cheered by the industry as the agency deferred the most contentious issues.

The FDA also is reviewing whether certain devices need to be reclassified to require more data, Riley said.

The Advanced Medical Technology Association, an industry group known as AdvaMed, said looking simply at recalls was a flawed way to evaluate the 510(K) program. Adopting the major changes in light of "remarkably low recall rates" would "harm patient access to medical technology," AdvaMed President Stephen Ubl said in a statement.

"The last thing patients need is more red tape and bureaucracy that do not contribute to safety," Ubl said.