Firm asks FDA to OK Home Defibrillators (about time)

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Firm Asks FDA to OK Home Defibrillators

Associated Press

WASHINGTON (AP) -- Defibrillators, those machines that jump-start a stopped heart, may not need to be sold with a doctor's prescription, government advisers said Thursday.

Philips Medical Systems has asked the Food and Drug Administration to allow over-the-counter sales of its HeartStart home defibrillator, arguing that more people would keep the devices at home in case of collapse but physicians often won't prescribe them.

There's no proof yet that in-home use of the machines actually save lives - or if distraught relatives waste precious minutes by hunting the defibrillator instead of dialing 911 first when someone collapses. A major National Institutes of Health study is trying to determine that, but won't be completed for years.

Still, the FDA asked its scientific advisers Thursday to debate the issue.

The panel didn't vote on whether to grant Philips' request for over-the-counter sales.

But, the advisers' general consensus was that getting a prescription for the easy-to-use devices didn't add much value, said FDA cardiovascular devices chief Dr. Bram Zuckerman.

The FDA isn't bound by the panel's advice, but generally follows it.

Every year, about 220,000 Americans die of cardiac arrest, where the heart's electrical system goes haywire and heartbeat abruptly stops. CPR buys some time, but only a defibrillator can restart the heart, with a jolt of electricity. Every minute spent waiting lowers the chance of survival by 10 percent, and 95 percent of victims die.

Last fall, a major study showed that having portable defibrillators in airports and other public places can double the chances of surviving cardiac arrest.

Yet roughly 80 percent of cardiac arrests occur in the home, and that's where many cardiologists question the usefulness of the $2,000 machines. There's less chance of a collapse being witnessed at home than in a public place, and loved ones may be more likely to panic.

Philips argues it's a question of consumer choice. It has sold 5,000 home defibrillators with a prescription since 2002, but expects sales to significantly increase if the FDA lifts the prescription requirement.