Skip to content

Automatic External Defibrillators (#AED) Failures and Malfunctions…F.D.A. Seeks to Toughen AED Regulations #SEM

March 22, 2013

aed

They are so commonplace today that they hardly draw attention…what’s that you say?  AED…Automatic External Defibrillators.  Once a rarity in a public place they now seem to be in most public places: airports, malls, schools, churches and many businesses.  The Food and Drug Administration (FDA) announced that it was moving to toughen regulation of the industry that produces heart defibrillators — devices that are used to jolt a failing heart back into its regular rhythm — after tens of thousands of malfunctions and hundreds of deaths in recent years.

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.

The devices re-establish cardiac rhythms in patients whose hearts have abruptly stopped or lost their regular beats. Such cardiac arrests kill as many as 400,000 people a year in the United States, according to the American Heart Association, more deaths than caused by Alzheimer’s disease, diabetes and accidents combined.

The devices re-establish cardiac rhythms in patients whose hearts have abruptly stopped or lost their regular beats. Such cardiac arrests kill as many as 400,000 people a year in the United States, according to the American Heart Association, more deaths than caused by Alzheimer’s disease, diabetes and accidents combined.

There have been 45,000 reports of the devices failing or malfunctioning since 2005, agency officials said. The vast majority of them were due to manufacturing problems, officials said, but some were because of improper maintenance, such as battery failure. Manufacturers have recalled the devices 88 times in that period.

The problems led the agency to propose a change that would allow it to more closely monitor how the devices — known as automated external defibrillators, or A.E.D.’s — are designed and made. There are about 2.4 million such devices in public places across the country.

Today, the agency issued an order that, if finalized after a public comment period, would require manufacturers to submit details of their designs and the controls they use in buying defibrillator components, many of which are produced abroad. Regulators would also be able to inspect manufacturers’ factories.

Death rates from cardiac arrests have changed little since the 1980s, when defibrillators first became widely available to the public. Experts say those grim statistics could change if more of the devices were accessible to more people. Bystanders use them in just 5 percent of cardiac arrests, according to data from the Emory University School of Medicine, in part because patients usually become ill in private homes where there are no defibrillators.

http://www.nytimes.com/2013/03/23/health/fda-seeks-to-toughen-defibrillator-regulations.html?hp

No comments yet

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: