WASHINGTON – People worried about sudden cardiac arrest no longer need a doctor’s prescription to buy devices that jump-start the heart.
The Food and Drug Administration for the first time agreed Thursday to let consumers go online and purchase the $2,000 devices for home use. Some 80 percent of the instances of sudden cardiac arrest, which is best treated by a shock from a defibrillator, happen at home.
Until now, people needed a prescription if they wanted to have a HeartStart home defibrillator to use in those crucial minutes after calling 911 and before an ambulance arrived.
The FDA endorsed a July recommendation from its advisory panel to remove the prescription requirement after federal advisers were satisfied that people could use the machines safely at home.
The agency approved HeartStart for use without prescription for adults and children at least 8 years old and weighing at least 55 pounds. A device used on younger children still requires a prescription. HeartStart can only be used when the individual does not respond to shaking and is not breathing normally.
In addition, the agency will help the manufacturer, Philips Medical Systems, design a study to track the devices’ use to ensure that no unexpected problems arise once the machines are more widely used.
Sudden cardiac arrest is an electrical malfunction of the heart that triggers fatally abnormal heart rhythm. Often, it is the first hint of heart disease and accounts for roughly 340,000 deaths outside of health care settings each year.
HeartStart delivers a jolt of energy equivalent to what it takes to illuminate a 150-watt light bulb for one second.
When the shock is delivered within five minutes of the sudden cardiac arrest, 50 percent of individuals survive, said Deborah DiSanzo, vice president and general manager of cardiac resuscitation at Philips Medical Systems.
Ambulances typically arrive within nine minutes of a 911 call. Once 10 minutes have elapsed since sudden cardiac arrest, the patient has a 1 percent chance of survival, DiSanzo said.
Dr. Graham Nichol, chairman of the American Heart Association’s automated external defibrillator task force, surveyed scientific journals published since 1966 and found no reports to suggest these devices were unsafe.
“Furthermore, there is no evidence the prescription requirement increases safety,” Nichol said.
If other people have experiences similar to Jim Baum’s, the device will prove a lifesaver. Last November, Baum went into cardiac arrest shortly after he purchased defibrillators for each of his three homes. A friend used one of the devices to bring Baum back from the dead, he said.
Opponents argue that families could reduce survival chances by wasting precious time looking for a defibrillator rather than calling 911.
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