March 22 The U.S. Food and Drug Administration
is proposing new rules aimed at improving the reliability of
emergency defibrillators after receiving roughly 45,000 reports
of device failures over the past seven years.
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
Emergency defibrillators are used by paramedics and others
to deliver electrical shocks to people in sudden cardiac arrest.
The proposals would also require manufacturers to provide
inspection reports and submit to the FDA details of any changes
made to the device.
Most problems reported with the devices are "preventable and
correctable," the FDA said in a statement. "The most common
issues involve the design and manufacture of the devices and
inadequate control of components purchased from other
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.
She said she believes there have been more reports of device
failures in part because there are more of them in public places
and many more people using them.
Officials at Physio-Control and Zoll were not immediately
reachable for comment.