For Immediate Release

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Defibrillator Recall Raises More Concerns About FDA’s Competency

Statement of Sidney Wolfe, M.D., Director, Health Research Group at Public Citizen*

WASHINGTON - If anyone needed any convincing evidence that there are serious
problems with the Food and Drug Administration's (FDA) regulation and
approval of medical devices, this week should have erased all doubt. Public Citizen sent a letter today
to Acting FDA Commissioner Frank Torti asking why the FDA has not
announced the recall of a Welch Allyn automatic external defibrillator
(AED), a life-saving device typically used by emergency personnel to
resuscitate patients in cardiac arrest. Malfunctions related to this
recall have been linked to two deaths.

On Feb. 26, Welch Allyn initiated a Class 1 recall of 14,000 of its
AEDs. As of this morning, the FDA has not tried to alert the American
public.

Incredibly, this is the eighth - and most serious - recall of a
Welch Allyn AED since 2004. That's alarming enough, but when viewed in
the scope of the FDA's announced recalls this week of two other,
unrelated medical devices, it raises serious concerns about the
competency of the FDA and its ability to keep dangerous medical devices
off the market. 

How many more deaths and near deaths because of delays in
resuscitation will have to occur before the FDA takes more definitive
action to end the use of these all-too-often defective Welch Allyn
devices?

READ the letter about the Welch Allyn recall.  

For background on other issues this week related to medical devices, go to:

http://www.citizen.org/publications/release.cfm?ID=7643

http://www.citizen.org/pressroom/release.cfm?ID=2843

http://www.citizen.org/pressroom/release.cfm?ID=2842

* Dr. Wolfe is also acting president of Public Citizen.

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