FDA calls in expertise on heart device safety: report

NEW YORK (Reuters) – The U.S. Food and Drug Administration
plans to turn to outside medical experts to help it review the
safety of heart devices, such as defibrillators, that are
already on the market, the New York Times said on Friday.

Daniel Schultz, director of the agency’s Center for Devices
and Radiological Health, told the Times the move would mark the
first time that the FDA would have outside experts regularly
advising it about the safety of medical devices being sold.

The move comes after a rash of recalls of life-saving heart
rhythm management devices made by Guidant Corp. and other
manufacturers and follows criticism over Guidant’s failure to
notify physicians and the public about life-threatening defects
in some of its defibrillators.

The FDA also came under fire for its lack of supervision of
the Guidant matter. The agency usually relies on manufacturers
to alert it to problems with medical devices.

Defibrillators are devices used to jolt a dangerously
racing heartbeat back to its normal rhythm.

The agency’s decision also comes as a medical group that
represents doctors who implant such devices is preparing to
release a report recommending changes in how data about heart
units is collected and disclosed.

Schultz said in a telephone interview with the newspaper
that the agency plans to expand an existing advisory panel that
reviews and approves new heart devices for sale, adding members
who will help the FDA oversee the safety of marketed products.

Those experts will be asked to help the FDA interpret data
from device manufacturers and will also be available to advise
on how best to respond to immediate problems such as recalls,
he told the newspaper.

“We recognize that we need to do a better job and that we
need to do a better job in leveraging outside expertise,” he
told the newspaper. “This seemed like a logical first step in
doing that.”