Defibrillators are supposed to save lives by shocking a patient’s heart back into a normal rhythm, but they have malfunctioned in about 45,000 cases since 2005, according to the Food and Drug Administration. So on Friday, the FDA proposed new rules aimed at insuring that the potentially life-saving devices work properly when they’re needed.
The FDA’s plan is to require manufacturers of automated external defibrillators, or AEDs, to submit applications for pre-market approval, according to this announcement. That would allow the agency to “more closely monitor how these devices are designed and manufactured,” according to the FDA announcement.
AEDs are portable devices used to treat victims of sudden cardiac arrest, a condition in which “the heart suddenly and unexpectedly stops beating,” depriving the brain and other vital organs of blood, according to this explainer from the National Heart, Lung and Blood Institute. Patients usually die if they’re not treated within a matter of minutes – for each one-minute delay, the patient’s odds of survival drop by 10%, the National Heart, Lung and Blood Institute says.
AEDs help by sending an electric shock to the heart via sensors attached to the patient’s chest. Before the shock is delivered, the sensors send information to a computer in the AED to figure out whether an electric shock would help. If the computer decides that it will, a voice prompt tells the operator what to do, this National Heart, Lung and Blood Institute website says. If all goes according to plan, the patient’s heart will resume beating properly.