If anyone needed further evidence that there are serious problems with the Food and Drug Administration’s regulation and approval of medical devices, I believe all doubts have now been erased. A few weeks ago, Public Citizen sent a letter 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 February 26th, Welch Allyn initiated a Class 1 recall of 14,000 of its AEDs. So far, the FDA has made no effort to alert the American public. Dr. Sidney Wolfe of Public Citizen says:
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 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?
The FDA has done a poor job of regulation generally and unfortunately it’s not confined to medical devices. For background on other issues related to medical devices, go to www.citizen.org.
Source: Public Citizen
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