FDA approves first defibrillator especially for at-home use

WASHINGTON -- People can soon plunk down $2,295 for an at-home defibrillator in hopes their loved ones will pull it out and save them if their hearts suddenly stop beating.

Government approval of the first defibrillator specifically for home use is heating up debate over whether broader sale of the heart jump-starters, already common in airports and shopping malls, will save lots more lives -- or waste precious minutes if distraught relatives hunt the machine before dialing 911.

Every year, about 220,000 Americans collapse and die of cardiac arrest. Without warning the heart's electrical system goes haywire and heartbeat abruptly stops. Cardiopulmonary resuscitation -- CPR -- can buy victims some time, but only a defibrillator can restart the heart with a jolt of electricity.

Every minute spent waiting for paramedics to arrive with a defibrillator lowers the chance of survival by 10 percent. So portable versions of the electric shock paddles now are common everywhere from casinos to airplanes to amusement parks. While the machines require no medical expertise, the shocks usually are administered by someone trained to use the machine, such as a security guard.

Food and Drug Administration approval late Friday of the first version designed specifically for at-home use -- Philips Electronics' HeartStart Home Defibrillator -- promises to put more defibrillators into truly untrained hands.

The machine requires a doctor's prescription, comes with advice for potential users to get some training and is not a substitute for paramedics -- people are supposed to call 911 before grabbing the defibrillator.

The HeartStart "talks" users through each step of resuscitation with instructions that were revamped to be simple enough for a sixth-grader to understand. Philips provided the FDA small studies showing that people who had never seen the device could follow the directions.

Don't worry about accidentally zapping someone: The defibrillator doesn't shock if it detects a heartbeat. "These devices are incredibly safe," said Megan Moynahan, FDA biomedical engineer.

The home version also will beep when the battery gets low, much as smoke alarms do.

Philips will begin selling the at-home defibrillator within six weeks, for $2,295 -- about $1,200 cheaper than today's corporate versions.

That's good news, said Dr. W. Douglas Weaver, cardiovascular chief at Detroit's Henry Ford Hospital, who has long pushed for wider public access to the lifesaving heart-starters. "Most people in this country aren't aware ... that almost always people die despite the 911 system."

Some 70 percent of cardiac arrests occur in the home. While they can strike at any age, the average victim is a man in his 60s -- meaning the main users of at-home defibrillators likely will be older women trying to save their husbands, Weaver said.