Medical Device Recalls
Medical device recalls, according to an article in the Archives of Internal Medicine, overwhelmingly involve products that have not been tested on a human being. In the report published on February 14, 2011, researchers examined 113 devices that the Food and Drug Administration had recalled between 2005 and 2009. These devices were all ones that posed serious health risks. Seventy-one percent of those recalled devices had been approved without undergoing any testing on human beings. The reason that these products were able to skirt around the rigorous testing is because they were deemed to be similar to other products already being sold. Only 19% of those products that were recalled had actually undergone the more stringent review process of being tested on human beings.
One-third of the recalled devices were for heart disease, including the automatic external defibrillators which are seen frequently in airports, office buildings and other public places to revive people who have undergone sudden cardiac arrest. In fact, defective automatic external defibrillators have reportedly resulted in hundreds of patient deaths.
Although the report in question is critical of the FDA, the FDA responds that this only constitutes 80 recalls which constitute a very small number of the total devices that are cleared through this program.
At this point, the FDA is contemplating more stringent review procedures for so-called similar products.
For more information on medical device injuries see http://www.brienrochelaw.com/attorney-practice/product-liability/medical-device-injuries/.
