The Food & Drug Administration today announced a program for improving the safety and efficacy of automated external defibrillators.
The federal watchdog agency said it’s received 28,000 reports of AED failures in the last five years, yet 300,000 Americans could benefit from treatment from the devices every year.
AEDs are designed to treat cardiac arrest and both diagnose and treat abnormal heart rhythms. While some external defibrillators and intended for medical professionals, AEDs are turning up in homes and public locations with simpler designs.
The FDA’s Center for Devices and Radiological Health, which is running the External Defibrillator Improvement Initiative, said many of the problems associated with the devices are preventable and include engineering and manufacturing issues related to "adequate control of components bought from other suppliers."
Through the AED program, the CDRH hopes to designate an "appropriate" premarket approval protocol for AEDs that promotes improved design and testing practices, according to the FDA. The agency also hopes to enhance its ability to collaborate with AED manufacturers on identifying problems with devices currently on the market.
In recent months, Zoll Medical Corp. (NSDQ:ZOLL) and Philips Healthcare have both dealt with safety issues related to their external defibrillators, which led to recalls. Other companies that manufacture the devices includ Cardiac Science Corp. (NSDQ:CSCX), Defibtech, Welch Allyn Inc., HeartSine Technologies Inc. and Medtronic Inc. (NYSE:MDT) subsidiary Physio-Control Inc.
The CDRH intends to hold a meeting for the initiative Dec. 15 and 16 at FDA headquarters near Washington, D.C.
