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FDA looks to solve problems with defibrillators
CHICAGO (Reuters) - Health regulators are taking a closer look at ways to solve the many problems found with external defibrillators, the life-saving medical devices located in emergency rooms, airports and other public places.
Automated external defibrillators, or AEDs, can save the lives of patients who have suffered sudden cardiac arrest if used in the first few minutes after their collapse. The devices work by delivering electrical energy to the heart to restore its normal rhythm.
But the industry has conducted dozens of recalls in recent years, affecting hundreds of thousands of devices, the U.S. Food and Drug Administration said.
Health regulators said they had received thousands of reports of malfunctions -- some during rescue attempts -- which may have contributed to patient harm or death.
"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," the agency said in a report released on Monday.
Top manufacturers of AEDs include Cardiac Science Corp, Philips Medical Systems, Defibtech, Welch Allyn, HeartSine Technologies Inc, Zoll Medical Corp and Physio-Control.
The FDA said a variety of problems were identified in all kinds of external defibrillators from all manufacturers.
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.
Many of the types of problems identified are preventable and correctable as well as affect patient safety, the FDA said. One example, FDA officials said, was that a button that activates the electrical charge was covered. That is a design flaw that is easy to fix.
As part of the initiative, the FDA said it 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.
The review is part of a larger move by the agency to look at categories of medical devices thought to have systemic problems. In April, the FDA said it was looking at infusion pumps, saying chronic issues with the widely used devices were preventable.
To date, the FDA has addressed defibrillator problems on a case-by-case basis. But it has conducted an industrywide review and has identified several practices that have contributed to these persistent safety risks, including methods of designing and manufacturing, handling user complaints, conducting recalls and communicating with users.
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 FDA said it is collaborating with the University of Colorado's Department of Emergency Medicine to develop a multi-city AED registry.
(Reporting by Debra Sherman; Editing by Lisa Von Ahn, Dave Zimmerman)
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