Taking Doctors' Orders out of Defibrillators

SF Gate, July 26, 2004

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Mary Kissel, The Wall Street Journal

Should defibrillators be a common piece of safety equipment in homes -- like smoke alarms and fire extinguishers?

A Food and Drug Administration advisory panel will hear arguments Thursday on a petition by Philips Medical Systems to sell the devices, which deliver a powerful electrical shock to restore normal heart rhythms, without a doctor's prescription.

The FDA's decision, expected within a few weeks, could open a potentially huge market and perhaps save the lives of tens of thousands of cardiac-arrest victims each year, Philips contends. But critics claim there is a lack of scientific evidence to support the move. Unless defibrillators are used under a doctor's supervision, they say, consumers might ignore warning signs of heart problems because the device offers a false sense of security. CPR training, doctors add, may save just as many lives as learning how to operate a defibrillator.

Portable defibrillators have been available -- with a prescription -- for many years, but the technology wasn't specifically designed for the general public, and the price tag was high. The vast majority of defibrillators were sold to hospitals and emergency-care services. In 1992, the American Heart Association asked the industry to design a machine for lay users. A decade later, Philips, the U.S. unit of the Netherlands' Royal Philips Electronics NV, became the first company to receive permission to label its product as "for home use." (Most large medical-device product makers offered a similar product for lay people, but with different labeling.) As the technology advanced and public awareness of sudden cardiac disease grew, public-access programs have proliferated. The machines now appear in schools, police stations, health clubs and heavily trafficked facilities such as airports.

Philips, which worked closely with the FDA to create a product that "a naive user" could operate, now says its $1,995 HeartStart Home Defibrillator is safe enough to sell over the counter -- for the same price. The company estimates it has sold 5,000 units so far, and projects 50 percent annual market growth over the next four years if it wins FDA approval.

"Our long term goal is to put them in as many homes in the U.S. as possible," says Deborah DiSanzo, vice president and general manager of cardiac resuscitation at Philips Medical Systems.

Among the facts the FDA will weigh: Death from cardiovascular disease remains one of the nation's biggest killers, striking about 931,000 people annually, according to the American Heart Association. The AHA estimates that out of that number, 340,000 people die from sudden cardiac arrest -- and 70 percent to 80 percent of those attacks happen in the home, often without prior warning.

Most sudden cardiac arrests stem from an electrical malfunction that makes the heart beat abnormally. Symptoms may include dizziness and lightheadedness. Defibrillation can restore a regular rhythm -- if used in time: For every minute that passes, a victim's chance of survival decreases by as much as 10 percent.

All sides seem to agree that today's defibrillators are practically foolproof with little downside. Automatic external defibrillators, or AEDs, are about the size of a hardcover book, and have visual or oral prompts that tell the user how to place electrode pads on the victim's chest. If the machine detects an erratic heartbeat, it automatically delivers a jolt of electricity. If it detects a regular heartbeat, it remains inactive.

"There are occasional malfunctions, but they are very, very rare," says Michael Callaham, a physician and professor of emergency medicine at the University of California, San Francisco.

Doctors want more study of home use of defibrillators before the FDA acts.
"I just don't think that health policy should be made on the basis of anecdotes and marketing," says Arthur Kellermann, who heads the department of emergency medicine at Emory University in Atlanta. "Until, if and when we have data that indicate that putting defibrillators in the homes of patients at moderate to increased risk of sudden cardiac disease actually improves survival, we shouldn't be doing it."

"The 63-year-old gentleman who's had a heart attack -- he's at risk of sudden death," says Mark Mitchell, an emergency physician at St. Joseph Regional Medical Center in Milwaukee. "But the 35-year-old guy who sees this on the television screen and whose Dad died a few weeks ago of a heart attack, he doesn't necessarily need to buy one."

Dr. Kellermann wonders if relatives or friends would rush to the defibrillator and forget to call 911 or to start CPR. Carol Spizzirri, president of Save a Life Foundation, a nonprofit who specializes training school children (K-12) based in Schiller Park, Ill., laments the lack of mandatory maintenance requirements for public and the home devices. "Until a maintenance influstructure and replacement batteries and pads are readably available, I think the monitoring needs to be still in the hands of a physician’s prescription."

At Thursday's meeting, Philips's presentation will focus on the defibrillators' safety, effectiveness and ease of use. The heart of their argument, says Carl Morgan, a Philips scientist, is a company study in which 256 people were tested on their ability to use a defibrillator safely and successfully on a mannequin. The study showed that 89 percent of those who watched a video on the defibrillator's operation used it successfully compared with 87 percent of those who had no training -- a negligible difference, Philips says.