WASHINGTON (AP) - Federal health officials have approved sale of the first defibrillator specifically for at-home use, a machine that promises to help people jump-start the heart of a collapsed loved one before paramedics ever arrive.
Every year, about 220,000 Americans collapse and die of cardiac arrest - without any warning, their hearts just suddenly stop beating. CPR buys victims crucial time but only a defibrillator can restart a 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 in airports, shopping malls and even amusement parks. They are so easy to use that untrained passers-by have simply picked one up and saved lives.
Doctors also occasionally prescribed those devices for heart disease patients to keep at home, in hopes that a relatives or visitor would revive them if they collapsed.
But now the Food and Drug Administration has approved one manufacturer's version - a smaller and slightly less expensive model - for at-home use, a move that maker Philips Electronics and some heart experts hope will begin to make home defibrillators as common as smoke alarms and fire extinguishers.
Sales of the HeartStart Home Defibrillator will begin within six weeks, a Philips spokesman said Tuesday. A doctor's prescription is required.
The home defibrillator will cost $2,295, compared with about $3,500 for today's portable defibrillators. Philips initially will sell the home version directly to patients who have prescriptions via the Internet or telephone, but says CVS pharmacies also will begin stocking the devices early next year.
It's not yet clear whether insurance companies will pay for at-home defibrillators.
But because most cases of cardiac arrest occur in the home, some heart experts have long called for at-home defibrillators.
Others have cautioned that putting defibrillators in so many untrained hands could be risky, if a distraught spouse spends precious minutes hunting the defibrillator instead of dialing 911.
The FDA spent months working with Philips to rewrite instructions for the at-home defibrillator so that they're even easier to understand than models used in airports and shopping malls, said FDA cardiovascular chief Dan Schulz. The instructions are supposed to be understandable by a sixth-grader.
Turn on the machine and it provides talking instructions, beginning with the reminder to take off the victim's shirt and then directions on how to place the shocking pads in the right spot on the chest.
The device will detect if the person has a heartbeat - and will not shock if the patient doesn't need it, said FDA biomedical engineer Megan Moynahan.
"These devices are incredibly safe," she said.
