A new initiative aimed at improving the reliability of external defibrillators has been launched by the Food and Drug Administration, the agency announced Nov. 15.
A new FDA initiative intended to improve the reliability of external defibrillators will address manufacturing and engineering design practices, poor communication to users, and lack of adverse event reporting.
The initiative includes external defibrillators used by medical professionals as well as automated external defibrillators (AEDs) intended for use by members of the public.
According to the FDA, the agency’s Center for Devices and Radiological Health (CDRH) has received more than 28,000 reports of device failures associated with external defibrillators during the past 5 years. Manufacturers have conducted 68 recalls from Jan. 1, 2005 to July 10, 2010.
During a news briefing, Dr. Jeffrey Shuren, director of CDRH, said that 700 deaths had been associated with device failures, but that it’s difficult to determine how many of those resulted directly from malfunctions of the devices. Having suffered cardiac defibrillation, the patients were, of course, very ill, and many would probably have died even if the devices had worked correctly.
The problems the FDA identified range across all manufacturers of the devices. They involve shortcomings in engineering, design practices, and manufacturing practices, poor communication to users, and lack of adverse event reporting.
For example, some manufacturers have used a "fix-on-fail" strategy for dealing with problems. "Fix on fail" refers to the practice of identifying and fixing problems with individual devices on a case-by-case basis instead of informing all users of the problems as part of a recall.
Under the new initiative, the agency will collaborate with manufacturers and others to facilitate the development of the next generation of defibrillators. To further these efforts, the agency will hold a public workshop on Dec. 15-16, intended to bring together government, industry, academia, and clinicians.
The FDA also will work with manufacturers to improve the way they respond to user complaints, conduct recalls, and report adverse events.
Finally, the FDA will propose changes to the classification of AEDs and changes to the premarket regulatory pathway of these devices. The agency plans to announce those proposed changes in 2011.
"I think it’s important to reiterate that we consider these to be lifesaving technologies" Dr. Shuren said during the press briefing. "We’re not taking any of these devices off the market. We’re strongly encouraging people to continue to use them and to use them according to guidelines. And we think that these technologies can improve to reduce the rate of failures that we’ve seen."
A new FDA initiative intended to improve the reliability of external defibrillators will address manufacturing and engineering design practices, poor communication to users, and lack of adverse event reporting.