FDA aims to change the way it monitors safety of defibrillators

March 26, 2013 by Karen Kaplan

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 ensuring that the potentially life-saving devices work properly when they're needed.

The FDA's plan is to require manufacturers of , 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 , a condition in which "the heart suddenly and unexpectedly stops beating," depriving the brain and other of blood, according to 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 percent, the institute says.

AEDs help by sending an 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, the institute's website says. If all goes according to plan, the patient's heart will resume beating properly.

The problems with AEDs are varied. In one case, a made by Defibtech was recalled to fix a that could cancel the shock. In another case, Philips Healthcare recalled thousands of its HeartStart units because a faulty memory chip was rendering the devices inoperable. In yet another case, a faulty component prompted a recall of AEDs made by Cardiac Science.

These problems are "preventable and correctable," according to the FDA announcement.

"Automated external defibrillators save lives," Dr. William Maisel, chief scientist at the FDA's Center for Devices and Radiological Health, said in a statement. "However, the agency is concerned about the number of recalls and manufacturing problems that have been associated with these devices and we're committed to working with manufacturers to address these issues."

Though the problem with defibrillators is serious, the FDA has judged that the public is better off keeping them in use while the issues are resolved rather than taking them off the market altogether.

The proposed rules came from the agency's Circulatory System Devices Panel. If approved after a 90-day public comment period, the FDA plans to "exercise enforcement discretion" for 18 months, it said.

Explore further: FDA proposes new rules for heart defibrillators

Related Stories

FDA proposes new rules for heart defibrillators

March 22, 2013
(AP)—The Food and Drug Administration will require makers of heart-zapping defibrillators to submit more data on their safety and effectiveness following years of recalls of the emergency devices.

Recommended for you

Genetic analysis links obesity with diabetes, coronary artery disease

November 16, 2018
A Cleveland Clinic genetic analysis has found that obesity itself, not just the adverse health effects associated with it, significantly increases the risk of Type 2 diabetes and coronary artery disease. The paper was published ...

Non-coding genetic variant could improve key vascular functions

November 15, 2018
Atherosclerotic disease, the slow and silent hardening and narrowing of the arteries, is a leading cause of mortality worldwide. It is responsible for more than 15 million deaths each year, including an estimated 610,000 ...

Study of two tribes sheds light on role of Western-influenced diet in blood pressure

November 14, 2018
A South American tribe living in near-total isolation with no Western dietary influences showed no increase in average blood pressure from age one to age 60, according to a study led by researchers at Johns Hopkins Bloomberg ...

Heart failure patients shouldn't stop meds even if condition improves: study

November 13, 2018
(HealthDay)—There's bad news for heart failure patients with dilated cardiomyopathy who'd like to stop taking their meds.

Bypass beats stents for diabetics with heart trouble: study

November 13, 2018
(HealthDay)—People with both diabetes and multiple clogged heart arteries live longer if they undergo bypass surgery rather than have their blood vessels reopened with stents, according to follow-up results from a landmark ...

New treatment significantly reduces cardiovascular events when combined with statins

November 12, 2018
Statins are the most commonly used treatment for cardiovascular disease. Despite reducing certain risk factors, if triglyceride levels remain high with use of statins, there is still a significant risk for heart attack, stroke ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.