Over the past five years, the FDA's Center for Devices and Radiological Health has received more than 28,000 medical device reports associated with the failures of external defibrillators. In addition, manufacturers have conducted dozens of recalls involving hundreds of thousands of the devices. And, as the FDA notes, many of the types of problems are preventable, correctable, and can impact patient safety.
This week, the FDA announced an initiative through which it will take steps to work with manufacturers, users and experts in the field to improve the engineering design and manufacturing practices of these devices, as well as facilitate the development of their next generation.
The FDA is sending a letter to all manufacturers of external defibrillators encouraging them to meet with the agency early in the device development process to discuss ways in which they can avoid common problems in the design and manufacturing of these devices. And to promote innovation and better understand patient outcomes, the FDA is collaborating with the University of Colorado's Department of Emergency Medicine to develop a multi-city AED registry. The registry 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.
Top manufacturers of AEDs include Cardiac Science Corp, Philips Medical Systems, Defibtech, Welch Allyn, HeartSine Technologies Inc, Zoll Medical Corp and Physio-Control, Reuters notes.
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