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FDA to Tighten Regulations on Defibrillators

Automated External Defibrillator

After 45,000 malfunctions and 88 recalls since 2005, the Food and Drug Administration is seeking tougher regulations on the heart defibrillator industry. There have been “hundreds of deaths in recent years” associated with defibrillators, according to an article in The New York Times.

In one case, a nurse was trying to hook up a defibrillator to a patient in cardiac arrest when its electronic screen read “memory full” and then shut down, according to one example provided by the F.D.A. The patient soon died. In another case, a software defect caused the device to show an “equipment disabled” message. That patient also died.

Regulators are seeking more information about defibrillator designs and the components of the devices. New rules would also allow regulators to inspect factories that make the devices.

From the article:

Such a change would typically require defibrillator makers to conduct costly and time-consuming clinical trials, but Dr. Maisel said that many of the nine manufacturers in the country had already collected the data that such trials would produce, and that only a couple would need to carry out such studies.

Read more at The New York Times.

Image from Flickr user Hawaii County.

By: Andre Francisco
Former Online Producer, POGO

andre francisco At the time of publication, Andre Francisco was the Online Producer for the Project On Government Oversight.

Topics: Public Health and Science

Related Content: Public Health

Authors: Andre Francisco

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