March 13, 2009
Defibrillator Recall Raises More Concerns About FDA’s Competency
Statement of Sidney Wolfe, M.D., Director, Health Research Group at Public Citizen*
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:
* Dr. Wolfe is also acting president of Public Citizen.