A Lifesaving Machine Over the Counter?
FDA Panel OKs No-Prescription Sales of Home Defibrillator
Aug. 6, 2004 -- Is a heart-shock machine a medical device or a home-safety need?
The FDA is soon likely to approve over-the-counter sales of a home defibrillator, HeartStart, made by Philips, a WebMD sponsor. Last week, an FDA advisory panel recommended that consumers should be able to purchase the device without a prescription.
The decision pleases Lance B. Becker, MD, director of the emergency resuscitation center at the University of Chicago. Becker, serving as a consultant to Philips, testified before the panel in favor of approving over-the-counter sales of the home defibrillator. Becker also consults with other defibrillator makers.
"I think the device is more like a smoke detector or a fire extinguisher than a medical device," Becker tells WebMD. "You have an airbag and seat belt not because you are going to have an accident, but because you can't predict when you will have an accident. You can't put an airbag in your car after you've had an accident -- yet that's been our policy for these defibrillators."
A Zap in Time
They're called automated external defibrillators, or AEDs. They are machines that can be used to jump-start a heart that has stopped beating, almost always due to a heart attack. The machines are automated so that they won't give a shock unless they detect that a person's heart has stopped beating and is just fluttering -- ventricular fibrillation, in medical lingo.
The HeartStart home defibrillator was the only AED presented to the FDA advisory panel. Once activated, this device gives verbal instructions to the user.
"It talks you through everything you have to do," Becker says. "After a pull of the handle, the pads come out. You look at the picture and place the pads as shown. The device knows when electrical contact is made. It knows when you have put the pads on a person's skin. It then says, 'Analyzing, stand back, do not touch the patient.' If it detects fibrillation, it will say, 'Charging, stand back, stand back,' and tell you to press the orange flashing light. That is how easy it is to save someone's life."
And that's not all. The machine then instructs the user on how to give CPR.
Why not just call 911? That's what's controversial.
Those who favor home defibrillators point out how little time there is to waste. According to a recent study, a person who collapses from a heart attack has only a 12% chance of survival if not defibrillated in five minutes. Family members might be able to deploy an AED before emergency help could arrive.
On the other hand, home defibrillators might make real families in a real emergencies waste precious time, says Arthur Kellermann, MD, MPH, chairman of the department of emergency medicine at Atlanta's Emory University.
"Having an AED in the home might make a person less likely to call 911 or go to the ER, because of embarrassment they might be wrong about the signs of a heart attack," Kellerman says. "It might make a family focus their efforts on frantically looking for the thing -- 'Is it under the bed? In the closet?' -- rather than calling 911. We don't know. That's why more studies are needed."