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FDA Placing Heart Defibrillators Industry Under Tighter Laws

Mar 24, 2013 11:45 PM EDT
A photo of an X-ray showing a heart defibrillator implanted in a patient.
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FDA announced Friday that it will be putting the heart defibrillators industry under the microscope, after tens of thousands of malfunctions have been reported which have resulted in hundreds of deaths in recent years.

The Food and Drug Administration cites two examples of malfunction among many. In one, a health professional attempted to insert a defibrillator in a patient who was having a cardiac arrest when its electronic screen read “memory full” and then went off. And the patient in question passed away soon afterwards. A software glitch, in the second case, caused a defibrillator to show an “equipment disabled” message. Again, the patient did not survive.

Defibrillation is a common treatment for life-threatening cardiac dysrhythmias, ventricular fibrillation, and pulse less ventricular tachycardia. Defibrillation consists of delivering a therapeutic dose of electrical energy to the affected heart with a defibrillator.

Defibrillators can be found anywhere: from malls, to airports, casinos and churches, and of course, medical settings.

It is estimated that cardiac arrests kill as many as 400,000 people a year in the United States, according to the American Heart Association – that is more deaths than caused by Alzheimer’s disease, diabetes and accidents combined.

Since 2005, reports of malfunction have been pouring in – 45,000 – agency officials said. While a fraction of that number was caused by improper maintenance, battery failures, the overwhelming majority of them were due to manufacturing problems, officials announced. In that same period, device recall happened 88 times.

“We think tens of thousands of adverse events is too many and 88 recalls is too many,”

Dr. William Maisel, chief scientist at the F.D.A.’s Center for Devices and Radiological Health, said in a conference call with reporters on Friday.

According to the announcement, in the future manufacturers might be required to submit details of their designs and the controls they use in the purchase of defibrillator components, many of which are produced abroad. In the process, FDA officials will also carry out inspections to manufacturers’ factories.

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