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A plague of worry over medical-device recalls
Minneapolis-St. Paul Star Tribune


May 17, 2006

Webster's defines a recall as asking "purchasers to return an imperfect or dangerous product so that a manufacturing defect can be corrected."

It seems simple enough, but this two-syllable word packs a powerful punch - especially when attached to a medical device, such as a pacemaker or a defibrillator, that is surgically implanted. The prospects might seem downright scary to patients who have the recalled device inside their bodies.



Now medical device manufacturers and a group representing doctors who implant pacemakers and defibrillators have advocated eliminating using the word "recall" when advising the public about a product malfunction. Their request comes after a year of pacemaker and defibrillator recalls that shook the industry and spooked patients.

They said it conjures an image of a faulty brake line in a car or latch in a child safety seat, or even spoiled meat. And it doesn't accurately reflect the different ways, many of which are not life-threatening, that a device could fail. The terms "advisory notice" and "safety alert" are much more accurate, they said.

The Food and Drug Administration (FDA), which regulates medical devices, said Friday that it is "considering" the recommendation by the Heart Rhythm Society.

The issue has come to the fore after a yearlong controversy surrounding pacemaker and defibrillator recalls, particularly those by Guidant Corp. The company was widely criticized for not disclosing a potential flaw in a popular model of defibrillator. Medtronic Inc. and St. Jude Medical Inc. issued smaller safety advisories.

While manufacturers left it up to doctors to decide whether to take out the recalled device, many patients grew panicked that their device would not work when they needed it most. (Implantable cardioverter defibrillators, or ICDs, are stopwatch-sized devices that shock an erratically beating heart back into rhythm.)

"A lot of time the (devices) don't need to be taken out," said Jan David Wald, an analyst with A.G. Edwards. "They need to be monitored more carefully or (doctors) may be able to fix it through a programming change."

Steve Ubl, president and CEO of the industry group AdvaMed, agreed. The group supports the term "recall" only for situations in which a device must be removed from the market because of safety concerns.

"The term 'recall' was developed for foods and drugs and is not always appropriately applied in the context of medical devices," Ubl said. "If a food or drug is contaminated or unsafe, you throw it out. You can easily pick up a replacement at the grocery store or the pharmacy. This is not the case with a life-sustaining medical device."

It is rare for the FDA to launch a recall on its own; most are initiated by the manufacturers of the faulty product. There are different classifications, with a Class I alert the most serious, indicating a reasonable chance that the product could cause serious health problems or death.

Whether the FDA dubs a recall serious or not, there's a certain emotional charge to the word for patients, said Dr. Robert Hauser, a senior consulting cardiologist with the Minneapolis Heart Institute, who served on the heart society's panel.

"It would be better for patients if we called it an advisory," Hauser said. "A recall implies that something needs to be taken out and returned, like taking your car in for an oil change."


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