Thursday, April 20, 2006

Shock Docs Help FDA

According to the New York Times, a panel of physicians from the Heart Rhythm Society will help the Food and Drug Administration (FDA) decide proper notification practices during medical device (especially pacemaker and defibrillator) recalls. Defibrillators are used to prevent sudden cardiac arrest in heart patients susceptable to the development of rapid heart rhythms by delivering a powerful shock automatically to the heart to restore normal rhythm. Last fall, despite evidence they were aware of a rare incidence of short-circuiting of one model of their defibrillator, Guidant Corporation (soon to be acquired by Boston Scientific) initially failed to issue a recall until physicians threatened to go public, citing statistics suggesting the defect was rare. The Heart Rhythm Society subsequently convened a panel to study better ways to notify patients and work with physicians when medical issues with these devices surface. Their report is due May 2, 2006. This will mark the first time an outside panel will advise members of the FDA. Recommendations will be made for physicians, too, to assure more timely reporting of device-related complications.


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