- 72,000 defibrillators failed in the past decade
- February 20, 2015
- Law Firm: Burg Simpson Eldredge Hersh Jardine P.C. - Englewood Office
After overwhelming reports of malfunctioning defibrillators, the U.S. Food and Drug Administration announced it would take steps to improve the dependability of the equipment. The announcement is in response to about 72,000 reports the FDA received between January 2005 and September 2014 regarding failed automated external defibrillators, or AEDs.
Additionally, there were 111 recalls on defibrillators in the same time frame.
These faulty defibrillators were not in hospital settings, but in public vicinities for emergencies, HealthDay News reported. These devices were portable and when a person is hooked up to one, it can automatically detect an irregular heartbeat.
Defibrillators send an electric shock to the heart to help correct dangerous or failing heart rhythms, according to the American Heart Association.
The FDA noted design flaws are the most common cause of malfunctions, such as one instance where an improper design caused the voltage to drop before it should have, making it useless for the patient in need, according to The Washington Post.
The changes proposed by the FDA will introduce new design standards. For instance, the administration will conduct inspections of manufacturers' facilities before approving the defibrillators. Manufacturers will also be required to file annual reports with the FDA detailing the performance and functionality of each device.
"Automated external defibrillator save lives," said William Maisel, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health. "These changes to the way these devices are reviewed will allow us to more closely monitor how they are designed and manufactured. This will go a long way towards correcting long-standing problems and ultimately improving the reliability of these devices."
The FDA does not intend to enforce the new manufacturing standards until July 29, 2016.