Product Liability

FDA to meet with AED makers to discuss problems with devices

AED Sign 100x100 FDA to meet with AED makers to discuss problems with devicesAutomated external defibrillators (AEDs) are life-saving devices that send a jolt of electric current to the heart of people who are unconscious and suffering from cardiac arrest in order to restore a normal heart rhythm. However, the emergency devices have been plagued by defects over the years that have spurred recalls and caused several injuries and deaths. Now Food and Drug Administration (FDA) is asking all manufacturers of AEDs to meet with the government and discuss solutions to the problems with the devices.

AEDs are used by emergency or medical personnel or by others who have completed CPR AED training courses to treat adults in cardiac arrest. In 2009 alone, the FDA issued 17 recalls on the devices for problems ranging from confusion instructions to wiring problems to memory chip defects.

Between January 2005 and May 2010, the FDA received more than 28,000 adverse event reports for external defibrillators, including malfunctions, patient injuries and deaths. Details in the reports varied greatly among manufacturers, which rendered the FDA limited in its ability to identify, track and address device safety problems.

The meeting with AED manufacturers is part of a External Defibrillator Improvement Initiative designed to foster the development of safer and more effective external defibrillators through improved design and manufacturing practices. Industry participants will also be urged to address current practices for identifying, reporting, and acting on the device complaints.

The agency is also teaming up with the University of Colorado’s Department of Emergency Medicine to develop a multi-city AED registry that will collect information about AED usage and provide the infrastructure to allow development of innovative AED features such as automated integration into local 9-1-1 systems.