FDA Lays Out Plan to Regulate Heart Defibrillators Following 45,000 Faulty Reports in 7 Years

Following 45,000 reports of over the past seven years in lifesaving devices called automated external defibrillators, the U.S. Food and Drug Administration proposed on Friday to require all manufacturers to get agency approval.

These automated external defibrillators (AEDs) are portable devices that deliver an electrical shock to the heart to try to restore the heart during cardiac arrest.

Dr. William Maisel, chief scientist at the FDA's Center for Devices and Radiological Health, said in a statement that the agency was "concerned about the number of recalls and manufacturing problems that have been associated with these devices."

"These devices are critically important and serve a very important public health need. The importance of early defibrillation for patients who are suffering from cardiac arrest is well-established," he said.

The FDA says the heart defibrillators been inundated by design and manufacturing flaws for years. The FDA says that it would focus on those areas when it reviewed new marketing applications. The agency added  it has received 45,000 reports of problems with defibrillators between 2005 and 2012.  

The actual number of AED failures is not known, but, "it's quite small," Maisel said. The most common problems are random power shutdowns, erroneous error messages and failure of the components of the machine, he noted.

Maisel also noted that there were 88 recalls of automated emergency defibrillators in the seven years from 2005 to 2012 as well as thousands of malfunctions, according to Reuters.

There are about 2.4 million such devices in public places throughout the United States, according to The New York Times.

"Today's action does not require the removal or replacement of AEDs that are in distribution. Patients and the public should have confidence in these devices, and we encourage people to use them under the appropriate circumstances," Maisel said.