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Defibrillator Sales

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U.S. health officials on Thursday approved over-the-counter sales for an at-home heart defibrillator that proponents hope will save more people from sudden cardiac death.

The manufacturer, Philips Medical Systems, wants to make the $2,000 devices as common in homes as fire extinguishers and smoke alarms. But skeptics note the vast majority of people will never need defibrillators and question if having the devices at home actually helps. Philips Medical Systems is a unit of Dutch group Philips Electronics NV . Known as automated external defibrillators, or AEDs, the devices can deliver a life-saving shock to patients in cardiac arrest, a condition in which the heart suddenly stops pumping. Cardiac arrest accounts for more than 340,000 U.S. deaths each year, according to American Heart Association estimates. Eighty percent of cases occur in homes. About 95 percent of cardiac arrest victims die, but patients can be saved if they are defibrillated quickly. “It’s a matter of time. We have to get the shock there within five minutes,” said Deborah DiSanzo, vice president and general manager of Philips’ cardiac resuscitation unit. Doctors had been reluctant to prescribe the devices, particularly to people who look healthy, DiSanzo said. Others said physicians were concerned about the risk of shocking someone who does not need it, something the company said would not happen thanks to built-in safeguards. With the prescription requirement now lifted by the Food and Drug Administration, the company expects to sell about 20,000 of the AEDs next year, DiSanzo said. To date, the company has sold about 5,000. Studies show having defibrillators in airports and other public places saves lives, but no data yet exists on the experience in homes. Some physicians worry frantic relatives might fumble with the device or delay calling emergency services. “We’re making this decision with no studies to support it,” said Dr. Arthur Kellermann, chair of emergency medicine at Emory University. He called the device “an expensive lottery ticket” that people may feel compelled to buy after seeing emotional advertisements.People would be better off spending their money on a health club membership or a blood-pressure checkup to keep their hearts healthy, he added. Dr. Chris White, chairman of the department of cardiology at the Ochsner Clinic Foundation in New Orleans, said most people who could benefit from defibrillators should probably have them implanted in their chest. The Philips device, called the HeartStart Home Defibrillator, gives step-by-step audio instructions for placing the pads on a victim’s chest and delivering an electronic jolt. The device is designed to analyze the victim’s heart rate and deliver a shock only if necessary. In a study of 124 people, 87 percent who had no training used the device properly on a mannequin, as did 89 percent of those who watched video instructions prior to using the defibrillator. None of the users was harmed. The FDA said it approved the defibrillator for use on adults or children who are at least eight years old or who weigh at least 55 pounds. Small pads are available by prescription for use on infants and young children. Consumers can buy the devices now through Philips, and the company hopes to have them available in electronics stores and through catalogs later this year, DiSanzo said. The company plans television and print ads, she said.(Source: Reuters Health News: Lisa Richwine: September 2004.)


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Posted On: 17 September, 2004
Modified On: 3 December, 2013

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