FRIDAY, March 22 (HealthDay News) -- To improve the quality of
lifesaving devices called automated external defibrillators, the
U.S. Food and Drug Administration proposed Friday that the seven
manufacturers of these devices be required to get agency approval
for their products.
Automated external defibrillators (AEDs) are portable devices
that deliver an electrical shock to the heart to try to restore
normal heart rhythms during cardiac arrest. Although the FDA is not
recalling AEDs, the agency said that it is concerned with the
number of recalls and quality problems associated with them.
"[The] FDA is not questioning the clinical utility of AEDs," Dr. William Maisel, chief scientist in FDA's Center for Devices and Radiological Health, said during a press conference on Friday announcing the proposal.
"These devices are critically important and serve a very important public health need. The importance of early defibrillation for patients who are suffering from cardiac arrest is well-established," he said.
Maisel added the FDA is not calling into question the safety or
quality of AEDs currently in place around the country.
There are about 2.4 million such devices in public places
throughout the United States, according to
The New York Times.
"Today's action does not require the removal or replacement of AEDs that are in distribution. Patients and the public should have confidence in these devices, and we encourage people to use them under the appropriate circumstances," Maisel said.
Although there have been problems with AEDs, their lifesaving
benefits outweigh the risk of making them unavailable, Maisel
Dr. Moshe Gunsburg, director of cardiac arrhythmia service and
co-chief of the division of cardiology at Brookdale University
Hospital and Medical Center in Brooklyn, N.Y., supports the FDA
"Cardiac arrest is the leading cause of death in the United States. It claims over 250,000 lives a year," he said.
Early defibrillation is the key to helping patients survive,
Gunsburg said. Timing, however, is critical. If a patient is not
defibrillated within four to six minutes, brain damage starts and
the odds of survival diminish with each passing minute, which is
why 90 percent of these patients don't survive, he explained.
The best chance a patient has is an automated external
defibrillator used quickly, which is why Gunsburg and others want
AEDs to be as common as fire extinguishers so laypeople can use
them when they see someone go into cardiac arrest. The FDA's action
will help ensure that these devices are in top shape when they are
needed, he said.
But, there have been problems and failures with AEDs. Between
2005 and 2012 the FDA received about 45,000 reports of failure of
these devices. In addition, there have been 88 recalls, Maisel
According to Maisel, it isn't known whether failures of AEDs
cause any deaths. That's because when these devices are used,
patients are in cardiac arrest and most die even when an AED is
used and works well, he said.
However, machine defects may have contributed to patient deaths,
Timesreported. For example, in one case, a nurse was
attempting to attach a patient in cardiac arrest to a defibrillator
when the device's screen read "memory full." In another case, a
problem with a defibrillator's software caused the device to read
"equipment disabled" as it was being used on a patient. In both
cases, the patient died, the newspaper said.
The actual number of AED failures is also not known, but, "it's
quite small," Maisel said. The most common problems are random
power shutdowns, erroneous error messages and failure of the
components of the machine, he noted.
"Tens of thousands of adverse events is too many. We think 88 recalls are too many," Maisel said.
"So, by calling for pre-market approval we can focus our attention on the types of problems that have been observed and our expectation is that we will observe an improvement in the reliability over time with these devices," he said.
This action is being taken based on the recommendation of the
FDA's Circulatory System Devices Panel, which wants AEDs to be a
Class III medical device requiring pre-market approval.
AEDs were on the market before the current approval process for
Class III medical devices was updated, so they didn't need
pre-market approval. But given their problems they should now
require approval, Maisel said.
In addition to the safety and effectiveness data, the
application must include a review of a manufacturer's quality
systems and an inspection of its plant.
According to the FDA, after the device is approved, the
manufacturer must submit any significant changes made to the
device, as well as a yearly report on the device's performance.
The public will have 90 days to comment on the FDA proposal.
When the proposal becomes final, the process of getting all AEDs
approved will take about two years, Maisel said.
For more information on automated external defibrillators, visit
U.S. National Heart, Lung, and Blood
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