Erroneous defibrillators: FDA new initiative to check safety

By Dr. Ananya Mandal, MDNov 15 2010

More problems are being reported in external defibrillators, the life-saving medical devices located in emergency rooms, airports and other public places. These Automated external defibrillators, or AEDs are generally used in patients who have suffered sudden cardiac arrest if used in the first few minutes after their collapse. They deliver electrical energy to the heart to restore its normal rhythm.

However in the past few years there have been numerous recalls affecting hundreds of thousands of devices, the U.S. Food and Drug Administration said. From January 1, 2005, to July, 10, 2010, there were 68 recalls. The FDA conducted multiple inspections of all external defibrillator manufacturers throughout this period. There are too many reports of malfunctions with some occurring during rescue leading to harm or death of the patient they say.

Some of the leading manufacturers of these devices include Cardiac Science Corp, Philips Medical Systems, Defibtech, Welch Allyn, HeartSine Technologies Inc, Zoll Medical Corp and Physio-Control. About 200,000 automatic AEDs are sold per year in the United States and an estimated 1 million devices are in public and private places available for use.

The agency released a report this Monday saying, “While the FDA continues to advocate use of these important life-saving devices and is not recommending any change to current clinical practices, we believe the devices can be improved in ways that materially improve patient safety.”

Until now the FDA has addressed this problem case-by-case basis. As part of this new initiative the FDA would promote innovation to improve safety and effectiveness, help the industry identify and resolve problems more quickly and designate an appropriate premarket regulatory pathway for automated external defibrillators that promotes best practices for design and testing. Infusion pumps and other devices are also being looked into.

The FDA is collaborating with the University of Colorado’s Department of Emergency Medicine to develop a multi-city AED registry.