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FDA Aims to Make External Defibrillators Safer

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External defibrillators, medical devices used to deliver a high-energy shock to the heart in people who have suffered sudden cardiac arrest, are often defective, according to a new Food & Drug Administration (FDA) analysis. The agency has decided to launch a new initiative to make external defibrillators safer.

Automated external defibrillators (AEDs) are found in public settings and increasingly in homes, airports and office buildings. More complex external defibrillators are used in hospitals by trained health care professionals. During the past five years, the FDA’s Center for Devices and Radiological Health (CDRH) has received more than 28,000 medical device reports associated with the failures of external defibrillators. In that same period, there have been 68 recalls of the devices.

Many of the types of problems the FDA identified in its analysis are preventable, correctable, and impact patient safety. As a part of a broad initiative, CDRH is taking steps to work with manufacturers, users and experts in the field to improve the engineering design and manufacturing practices of external defibrillators, and facilitate the development of their next generation.

The program will start with a public meeting December 15th and 16th at the FDA’s headquarters in Silver Spring, Md., to bring together representatives from companies and others to discuss ways to improve the devices. The agency also is working with the University of Colorado’s Department of Emergency Medicine to develop improvements that will make it easier to use the devices more effectively.

The FDA is also is sending a letter to the 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.

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