By Toni Clarke
March 22 The U.S. Food and Drug Administration
is proposing new rules aimed at improving the reliability of
emergency defibrillators following some 45,000 reports of device
failures over the past seven years.
The defibrillators, found in hundreds of airports, shopping
malls and restaurants across the country, are designed to
jump-start the heart after it has suddenly stopped.
The FDA said its proposal would require manufacturers to
provide clinical data or other evidence proving their devices
are safe and effective in order to be approved or remain on the
The proposals would also require manufacturers to provide
inspection reports and submit to the FDA details of any changes
made to the device. Companies will have 15 months to submit the
information to the FDA once the proposals are final.
Dr. William Maisel, deputy director of the FDA's center for
devices and radiological health, said there were 88 recalls of
automated emergency defibrillators in the seven years from 2005
to 2012 as well as thousands of malfunctions.
He said it was not possible to estimate how many deaths
occurred due to the malfunctions since death may have occurred
anyway, but there have been enough cases of device malfunctions
to warrant concern.
Most problems involved the design or manufacture of the
device, or inadequate control of components purchased from other
suppliers, Maisel said, adding that the agency would focus on
these areas when reviewing the new marketing applications.
Makers of emergency defibrillators include Physio-Control
Inc, Zoll Medical Corp and Royal Philips Electronics NV
Rachel Bloom-Baglin of Philips said the company has not yet
seen the written version of the proposal. However, based on
previous discussions with the FDA, the company believes that
more scrutiny would not result in an interruption of supply of
the defibrillators or accessories.
Physio-Control's chief executive, Brian Webster, said the
increase in device failures can partly be attributed to the fact
that they are more prevalent.
"While it is the FDA's position that defibrillator failures
have risen over the past several years, the number of devices in
the market has grown dramatically over that same time period,"
he said. "An evaluation of the number of defibrillator
malfunctions must include the number of devices deployed to
accurately assess whether the failure rate is increasing or
Maisel said it was not possible to give a precise number of
times emergency defibrillators were used and therefore what the
failure rate is, but he said "our perception is that the failure
rate is quite small."
Officials at Zoll were not immediately reachable for
Maisel said the cost of the marketing application for each
company would be $248,000 but that one application would cover
all its models. And he said he does not expect most companies
which have products on the market to have to conduct additional
clinical studies. Most, he said, would already have collected