Tuesday, February 15, 2011

Recalled medical devices mostly untested

Recalled medical devices mostly untested, report says.


Two of the major television networks and a number of newspapers and consumer medical sites discussed a study published online Feb. 14 in the Archives of Internal Medicine about a possible link between fast approval of some medical devices and their subsequent recall. ABC World News (2/14, story 7, 2:55, Sawyer) reported "a new warning about some of the medical devices so many Americans have implanted," including "replacement hips and knees, heart valves," and "pacemakers."

The CBS Evening News (2/14, story 6, 2:25, Couric) reported, "The FDA approves new medical devices in the hopes of saving lives, but in 2006, some devices were linked to more than 2,800 deaths and close to 120 injuries. Today," a paper in "the Archives of Internal Medicine urged the FDA to improve the way devices are tested before they reach the public."

On the front of its Business Day section, the New York Times (2/15, B1, Meier) reports, "Most medical devices recalled in recent years by the Food and Drug Administration because they posed a high risk to patients were not rigorously studied before being cleared for sale." Researchers Diana M. Zuckerman, PhD, and Paul Brown, of the National Research Center for Women & Families, along with Steven E. Nissen, MD, of the Cleveland Clinic, "found that most medical devices that were the subject of high-risk recalls from 2005 to 2009 had been cleared through a regulatory pathway that requires little, if any, testing."

"Researchers examined the 113 devices that the FDA recalled between 2005 and 2009 for posing serious health risks, including endangering patients' lives," the Washington Post (2/15, Stein) reports. "Most of the devices -- 71 percent -- had been approved without undergoing testing in people."

On its front page, the Los Angeles Times (2/15, A1, Zajac) reports, "Cardiovascular devices, chiefly external defibrillators, made up nearly a third of the recalled medical products from 2005 through 2009, the time covered by the review," and "only 21 of the recalls in the new study involved products approved after clinical trials."

"The study found that most medical devices that were recalled over serious risks to patients were cleared through the Food and Drug Administration's 510(k) approval process or were exempt from regulatory scrutiny entirely," the Minneapolis Star Tribune (2/15, Moore) reports, explaining that "the 510(k) process requires device manufacturers to prove a new product is 'substantially equivalent' to one currently on the market -- usually without clinical data to prove the product is safe and effective." Because of previous criticism of this pathway to approval from both Congressional officials and consumer advocacy groups, "Dr. Jeffrey Shuren, the FDA's new device chief, has announced changes to strengthen the 510(k) process, and the Institute of Medicine will weigh in with the findings of its own review this summer."

Millions "may be at risk." According to the AP (2/15, Tanner), an invited commentary accompanying the study "says the analysis shows that 'millions of Americans may be at risk for device-related injuries and recalls from high-risk devices that were cleared by FDA without any supporting clinical trial data.'"

Modern Healthcare (2/15, McKinney) quotes the study authors' conclusion: "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."

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