FDA OKs Defibrillator Without Prescription

By DIEDTRA HENDERSON

AP Science Write

September 17, 2004, 8:29 PM EDT

WASHINGTON -- People worried about sudden cardiac arrest no longer need a doctor's prescription to buy devices that jump-start the heart. The Food and Drug Administration for the first time agreed Thursday to let consumers go online and purchase the $2,000 devices for home use. Some 80 percent of the instances of sudden cardiac arrest, which is best treated by a shock from a defibrillator, happen at home.

Until now, people needed a prescription if they wanted to have a HeartStart home defibrillator to use in those crucial minutes after calling 911 and before an ambulance arrived.

The FDA endorsed a July recommendation from its advisory panel to remove the prescription requirement after federal advisers were satisfied that people could use the machines safely at home.

The agency approved HeartStart for use without prescription for adults and children at least 8 years old and weighing at least 55 pounds. A device used on younger children still requires a prescription. HeartStart can only be used when the individual does not respond to shaking and is not breathing normally.

In addition, the agency will help the manufacturer, Philips Medical Systems, design a study to track the devices' use to ensure that no unexpected problems arise once the machines are more widely used.

Sudden cardiac arrest is an electrical malfunction of the heart that triggers fatally abnormal heart rhythm. Often, it is the first hint of heart disease and accounts for roughly 340,000 deaths outside of health care settings each year.

HeartStart delivers a jolt of energy equivalent to what it takes to illuminate a 150-watt light bulb for one second.

When the shock is delivered within five minutes of the sudden cardiac arrest, 50 percent of individuals survive, said Deborah DiSanzo, vice president and general manager of cardiac resuscitation at Philips Medical Systems.

Ambulances typically arrive within nine minutes of a 911 call. Once 10 minutes have elapsed since sudden cardiac arrest, the patient has a 1 percent chance of survival, DiSanzo said.

The division, part of Andover, Mass.-based Philips Electronics North America, said it has sold more than 6,000 devices from November 2002, when the FDA first approved their use, through this past Wednesday.

Waiving prescriptions could raise sales beyond 20,000 per year and perhaps cut a few hundred dollars from the $1,995 price, DiSanzo said. By Christmas, consumers should be able to purchase the devices at electronic stores and elsewhere.

Dr. Graham Nichol, chairman of the American Heart Association's automated external defibrillator task force, surveyed scientific journals published since 1966 and found no reports to suggest these devices were unsafe.

"Furthermore, there is no evidence the prescription requirement increases safety," Nichol said.

Still, because of the lack of "sufficient scientific data," the organization said it could not endorse or caution against use of the devices in homes.

The FDA's mandated study may help fill that data gap.

If other people have experiences similar to Jim Baum's, the device will prove a lifesaver. Last November, Baum went into cardiac arrest shortly after he purchased defibrillators for each of his three homes. A friend used one of the devices to bring Baum back from the dead, he said.

"Without that defibrillator, I would not be here," said the 65-year-old, who lives most of the year in California.

But Dr. Arthur Kellermann, chairman of the department of emergency medicine at Emory School of Medicine in Atlanta, said he had "substantial reservations" about the FDA's actions.

"We have no scientific evidence to support the decision and I don't think that's a good way to make health policy," Kellermann said.

Kellermann said the devices were "very expensive lottery tickets" because there is "a remote possibility" a family may save a life by owning one.

Opponents argue that families could reduce survival chances by wasting precious time looking for a defibrillator rather than calling an ambulance.

Dr. Mickey S. Eisenberg, a professor of medicine at the University of Washington Medical Center, disagreed.

"I just don't buy that argument. It's the same argument as saying 'Does a smoke detector impede people from calling the fire department?'" Eisenberg said.

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On the Net:

Food and Drug Administration: http://www.fda.gov

Philips Medical Systems: http://www.medical.philips.com/index.html

Copyright © 2004, The Associated Press

FDA Gives The OK For Home Defibrillators

BY DELTHIA RICKS

STAFF WRITER

September 17, 2004

FDA tosses out prescription requirement for consumer purchase of the portable machines used in shocking a heart stricken by arrest

Consumers can now buy without prescription a portable device that is capable of shocking a failing heart into a life-sustaining lub-dub, the Food and Drug Administration announced yesterday.

About 80 percent of cardiac arrests occur at home and the FDA's decision largely was in response to consumers who wanted over-the-counter equipment to use in the critical moments before assistance arrives. Before yesterday's decision, anyone who wanted an in-home automatic external defibrillator -- an AED -- required a doctor's prescription.

FDA officials approved the device for use on adults and on children who are at least 8 years old and weigh 55 pounds or more. The device, which costs $1,995, is similar to the AEDs increasingly seen in airports, sports arenas, malls and other sites. Medicare will reimburse the cost for people with heart disease, according to the device manufacturer.

About the size of a hefty dictionary, the defibrillator is used when a patient is in fibrillation -- cardiac arrest. Cardiac arrest is not a heart attack, but an electrical malfunction of the heart. Patients in arrest for 10 minutes have only a 1 percent chance of survival. An estimated 340,000 people in the United States die annually of cardiac fibrillation.

The machine can distinguish between a heart attack and cardiac arrest. With a heart attack, caused by blocked arteries, the heart is not in electrical chaos. It is the electrical dysfunction that queues the machine to correct the fibrillation.

A computerized voice in the machine "talks" laypeople through the procedure. When the device's soft pads are placed on the chest it can instantly tell whether a patient is in fibrillation. The machine sends a reviving electrical jolt through the heart. The Louis Acompora Foundation in Northport, established after the cardiac arrest death in 2000 of the 14-year-old lacrosse player, was behind an earlier push in New York to get AEDs installed in public places.

Dr. Graham Nichol, chairman of the American Heart Association's AED task force, examined reams of medical studies and found no indications non-prescription use would be unsafe. A device called HeartStart currently is the only AED made for home use.

"We believe they are safe, which is the primary question the FDA was asked ... ," Nichol said. "There's no evidence the prescription requirement increased safety or the ability to use the device, so we supported removing the prescription requirement."

In November, California resident Jim Baum, 65, went into cardiac arrest shortly after purchasing defibrillators for each of his three homes. A friend used one of the devices to revive Baum, he said. "Without that defibrillator, I would not be here," he said.

HeartStart is manufactured by Philips Medical Systems, in Andover Mass.

Deborah DiSanzo, a vice president, said the device must be purchased directly from the company. "You can buy them directly from us at heartstarthome.com, and we're driving to have them on retail store shelves by Christmas," DiSanzo said.

She said the device comes with a training video and information about more comprehensive training with the American Red Cross, the American Heart Association or Medic First Aid Group International.

This story was supplemented with a wire service report.

Copyright © 2004, Newsday, Inc.