FDA considers defibrillator sales

WASHINGTON – 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 refuse to prescribe them.

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

Still, the FDA asked its scientific advisers 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, in which the heart’s electrical system goes haywire and the heartbeat abruptly stops. CPR buys some time, but only a defibrillator can restart the heart, with a jolt of electricity.