DePuy Hip Recall Spurs Senate Hearing on Device Approval Process
News about defective hip implants continued to roll in this week as it now appears that a U.S. Senate Special Committee on Aging will hear testimony today about the dangerous devices. Mass Device indicates that the hearing is connected to a large scale Senate investigation around the approval process currently available for medical devices and the effect of that process of patient safety. As the DePuy hip recall clearly showed, questions abound about the way in which devices are often rushed to market and harm unsuspecting medical patients.
The testimony in front of the subcommittee puts Johnson & Johnson—the conglomerate that owns DePuy—right in the middle of the federal investigation evaluating that medical device approval process. After the testimony of the Johnson & Johnson executives, the committee will hear from one of the victims of the recall—many Illinois nursing home residents have found themselves in circumstances just like the victim representative.
Following that personal appeal, a national researcher will touch on the broader issue and explain new data that reveals that devices that are approved through the 510(k) pre-market notification program usually include many more recalls than normal. This alternative approval process allows devices to reach consumers sooner, bypassing the Food and Drug Administration’s more comprehensive PMA protocol. This “short-cut” often has the effect of glossing over problems with involved devices.
“Internal reviews by FDA officials and other outside sources have found troubling lapses in the procedures by which a number of medical devices were approved," said the Senate subcommittee, adding that "the results of these investigations caused procedural and management changes to be implemented at the Center for Devices and Radiological Health in recent months.”
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