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SCOTT JAGOW: Asking people to return computer batteries is one thing. Telling somebody their pacemaker is faulty is quite another. In fact, the FDA thinks using the word “recall” in those cases might be a bad idea. Helen Palmer reports from the Health Desk at WGBH.
HELEN PALMER: The FDA’s issued recalls for over a third of a million faulty heart devices in the last 15 years. Doctors say calling these actions recalls upsets patients.
DWIGHT REYNOLDS: Patients were anxious about their recalled device, couldn’t sleep at night even after counseling.
Dwight Reynolds represents doctors who implant these devices. He says the FDA should use the term “class 1 advisory notice” or “class 1 safety alert” for really serious product flaws, those that might kill or seriously harm a patient if the device malfunctioned.
But Arthur Levin of the Center for Medical Consumers says it’s nothing but smoke and mirrors to use a different term than recall for a device with a serious problem.
ARTHUR LEVIN: Patients should be worried about safety issues. The only way we’re goingto create pressure to make devices and drugs safer is because there’ll be pressure from patients to have that happen.
The FDA is holding focus groups to find out just how alarmed patients are by the word recall.
In Boston, I’m Helen Palmer for Marketplace.
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