IEEE Spectrum March, 2012 - 57

A Shocking Truth

The FDA's Shein agrees that the vast
majority of today's AEDs are effective.
"There is room for improvement, but it
Continued from page 34
would be a poor choice to leave an AED
AED on the market. The 510(k) system hanging on the wall rather than applying
was originally intended as a temporary the therapy to a patient," he says. Rare failmeasure to grandfather in devices already ures, like that of the unit used on Eugene
on the market in 1976. More than 30 years Malofiy, are of course distressing. But a
later, the process is still being used to clear much bigger factor in the poor survival
AEDs, as well as 25 other high-risk prod- rate from sudden cardiac arrest is the diffiucts, including implantable pacemakers, culty of getting access to an AED in the first
ventricular bypass devices, and systems place. In the United States, AEDs are used
for electroconvulsive therapy. Meanwhile, in just 4 percent of sudden cardiac arrests
external defibrillators have graduated
from manual operation that requires some
degree of skill to complete automation.
They have also been upgraded to administer a biphasic shock, use rechargeable batteries, and incorporate LCD screens, CPR
pacing systems, voice prompts, and selftesting circuits. These features add to the
things that can go wrong-and as they were
introduced, they were grandfathered in.
In a recent report, the Institute of
Medicine of the National Academies noted
that "Prior 510(k) clearances are legally
binding on the FDA when making clearance decisions. Thus, any unsafe or ineffective devices are embedded in the system."
Dr. Michael Carome, a physician with the
consumer advocacy group Public Citizen,
goes further: "The entire category of AEDs
has been insufficiently regulated by the
FDA. The status quo essentially represents
ongoing, uncontrolled human experimentation with no ethical oversight," he says.
The FDA is now considering whether
to remove the 510(k) loophole for AEDs
and classify them as full Class III products. Despite claims from manufacturers
that reclassification will double or triple
the development time for new devices,
the change seems likely to proceed.

that occur in public places. One reason is
that AEDs are not always easily located;
more on this later. Another deterrent is
that many AEDs are labeled "For use by
trained personnel only." These labels arose
because virtually all AEDs are prescription-only devices, bought under the authority-and responsibility-of a medical officer
at the airport, mall, or school. If an AED
were somehow misused-or even correctly
used by someone not explicitly authorized
by the prescribing physician-that doctor
could be held legally liable and theoretically

Not everyone favors reclassification.
"AEDs are fine, technologically," says Gust
Bardy, a physician who helped to found
the Seattle Institute for Cardiac Research
(and is a consultant for Cardiac Science).
"You can always find engineering problems, but patients in cardiac arrest are
predominantly going to die. There seems
to be an unrealistically high expectation
that these machines can reverse the process of death. The more restrictions one
puts on AEDs and the more demands for
AED perfection, the fewer lives will actually be saved. Innovation will be pushed
overseas, and we'll be stuck with AEDs
that are older and more expensive."
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Table of Contents for the Digital Edition of IEEE Spectrum March, 2012