The Food and Drug Administration gave the go-ahead last week for the Philips HeartStart, an automated external defibrillator (AED), to be sold over the counter without a prescription.
The device is used to shock a heart back to normal rhythm when a person is experiencing cardiac arrest. Each day in the USA, an estimated 165 people have an electrical short circuit in the heart called ventricular fibrillation -- the most common cause of sudden cardiac arrest. AEDs have been used mainly by trained rescuers, but in recent years they have been placed in airports, malls and other public places.
Now consumers can buy them, at about $2,000 each, for the home, where most cases of sudden cardiac arrest occur. Here are answers, from experts and USA TODAY's research, to common questions:
Q: Why would I consider getting an AED when nobody in my home has heart trouble?
A: Cardiac arrest often strikes without warning. The first sign of any trouble for many victims is when the heart suddenly stops beating, and they fall to the ground either not breathing or not breathing normally. They are, as doctors say, ''clinically dead.'' These are the victims most easily saved with a quick shock from a defibrillator. They are otherwise healthy, so if their heart's electrical system can be reset quickly, they can make it to a hospital alive to be treated for the underlying medical problem.
Q: How quickly do they need to be shocked?
A: Life and death is decided within six minutes. When a heart goes into ventricular fibrillation (or V-fib), it quivers, unable to pump blood, until it dies. Flatline usually comes in about 10 minutes. But when the heart is shocked within the first few minutes, most patients survive.
Q: I live close to a fire station with a rescue unit. Doesn't it have an AED?
A: Most first responders carry AEDs, but emergency medical services can't get to these patients fast enough to save them. In the nation's largest cities, these services are fragmented, inconsistent and slow, USA TODAY found in an investigation published last year. Many cities are improving, but progress is slow. By putting AEDs into the hands of people who can reach the patient before help arrives, cities and companies have saved more lives than even the best emergency medical systems. Scientific studies show some of the results. The percent of V-fib victims saved by various groups: American Airlines workers, 40%; casino guards, 59%; personnel and bystanders in Chicago airports, 61%.
Q: But I read that some people have died when an AED was nearby. What happened?
A: Sometimes panicked people have fumbled with devices they were not trained to use. In other instances, co-workers did not know there was an AED on site. Most of the people who have been saved were saved by people trained in CPR and AED use. Though the FDA said in its decision last week that the device could be used by anyone who followed directions on the packaging, training helps reduce panic.
Q: What if I panic?
A: The HeartStart was designed specifically with panic in mind. The designers know that the device will likely be used by somebody who is home alone and watching a loved one turn shades of blue. In simulated emergencies, designers saw the kinds of mistakes people make, and they built in features that help people avoid those mistakes.
Q: What kinds of errors can the device detect?
A: One common mistake people make is applying the two sticky pads that deliver the shock to the victim's shirt instead of to the bare skin. The machine will never deliver a shock if it does not have a good connection with bare skin. Engineers saw that when the pads were improperly placed, the machine kept repeating the same instructions over and over without really helping the user understand exactly what was wrong. Now the HeartStart slows down and gives instructions in calm but different phrases until each step is completed.
Q: Does everyone think buying an AED over the counter is a good idea?
A: No. Opponents point out that it's expensive, and that the likelihood that you would ever use the device is so low that it would be a waste of money. A nationwide study is underway to see whether putting AEDs in homes would save more lives. But because cardiac arrest is a relatively rare occurrence, and nobody in any one home taking part in the study might ever have a cardiac arrest, results are years away.
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