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External defibrillators to get a safety upgrade, FDA says

External defibrillators are lifesavers for thousands of people who keel over annually from sudden cardiac arrest, but they also fail often enough to worry regulators.

In a bid to improve the performance of the devices, the Food and Drug Administration on Monday announced a program to promote safer defibrillators through improved design and manufacturing practices. Nearly 300,000 people in the U.S. collapse each year when their hearts stop pumping. Survival, in many cases,  depends on delivery of an electrical shock from a defibrillator.

Over the last five years, however, the FDA says it has received more than 28,000 reports associated with failures of the devices, and manufacturers have conducted dozens of recalls involving hundred of thousands of units. Some defibrillator malfunctions have been linked to patient harm, including deaths.

Both the reports of device failures and the number of recalls have been trending upward. In examining the reports, the agency says it has identified several areas for improvement. Some of these are quality control problems, like making sure parts meet manufacturers’ specifications. Other shortcomings involve engineering issues, such as allowing a voltage-monitoring circuit to draw power from the same source it’s supposed to be monitoring, which can render the device unable to deliver a shock.

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In other cases, FDA observed a practice of “fix-on-fail” in which manufacturers repair glitches in individual units as they crop up, without notifying all users of a particular model so that all units in service can be examined, and repaired, ahead of a problem.

The FDA is slated to hold a news conference with reporters later Monday to lay out further details about the program.


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