Push to drop the term "recall"

Eddie Farah

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The Heart Rhythm Society has requested the Food and Drug Administration not to use the word "recall" but use "safety advisory" or "safety alert" when referring to defective pacemakers and defibrillators.

According the Heart Rhythm Society's president Dwight Reynolds, "The anxiety created among patients and physicians by this term is the number one cause for replacement of devices." He went on to state whenever a patient leans they have a faulty device the assume it needs to removed immediately. However, such a procedure of removal typically involves more risk than leaving it in

This request has stemmed heated views from both the FDA and physicians and manufactures. The FDS states eliminating the term "recall" requires chances in federal law. Physicians and manufacturers believe non-legislations solutions can be negotiated.

FDA's head of cardiovascular device division has stated the term "recall' is by many different kinds of products.

Since 1990 the FDA has issued safety alerts and recalls on more than 337,000 defibrillators. This has resulted in 5 in 1,000 pacemakers and 21 in 1,000 defibrillators malfunctions resulting in replacement.

Guidant Corporations' Prizm defibrillator is the most controversial case. Since Boston Scientific acquired Guidant the state the problems were fixed in 2002, however patients and physicians were not informed until 2005, after a death of a patient.

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