The majority of medical devices recalled from 2005 to 2009 for risk of serious health hazard or death were approved by the less strict 510(k) process intended for devices considered low or morderate risk, according to a study published online Feb. 14 in the Archives of Internal Medicine.
TUESDAY, Feb. 15 (HealthDay News) -- The majority of medical devices recalled from 2005 to 2009 for risk of serious health hazard or death were approved by the less strict 510(k) process intended for devices considered low or moderate risk, according to a study published online Feb. 14 in the Archives of Internal Medicine.
Diana M. Zuckerman, Ph.D., from the National Research Center for Women & Families in Washington, D.C., and colleagues analyzed the U.S. Food and Drug Administration high-risk device recalls from 2005 to 2009. The devices were approved by the FDA under the premarket approval (PMA) process (which requires testing and assessments), the less stringent 510(k) process (for items similar to those already being sold), or were exempt from FDA review.
The investigators identified 113 devices recalled by the FDA after it determined the devices could cause serious health problems or death. Of these, 21 devices were approved through the PMA process, 80 were approved through the 510(k) process, and eight were exempt from approval. The largest recall category was cardiovascular devices, with 35 recalls, 23 of which were approved by the 510(k) process. Of the remaining recalls, 51 percent were in the general hospital, anesthesiology, clinical chemistry, neurology, or ophthalmology categories.
"The standards used to determine whether a medical device is a high-risk or life-sustaining product prior to approval are clearly very different from the standards used to recall a medical device as life-threatening. Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy," the authors write.
One author disclosed a financial relationship with Johnson & Johnson, and one author disclosed financial ties to a research center that receives funding from various pharmaceutical companies.