Monday, April 18, 2011

DePuy hip recall: Senate to probe safety of medical devices

April 12, 2011 by MassDevice staff (excerpts )

The U.S. Senate's Special Committee on Aging will hear testimony on Johnson & Johnson subsidiary DePuy's hip recall as it focuses on patient safety in the approval process for medical devices.
The U.S. Senate's Special Committee on Aging announced that the Warsaw, Ind.-based company's massive hip replacement system recall will be front and center during its examination of the FDA and its role in "protecting patient safety as part of the medical device approval process," according to a prepared release.

"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," the committee wrote. "The results of these investigations caused procedural and management changes to be implemented at the Center for Devices and Radiological Health in recent months."

The Senate committee hearing will be followed by a hearing in the House Thursday, which has a much more industry-friendly tone. The House Oversight & Government Reform Subcommittee on Health Care  is scheduled to hold its "Pathway to FDA Medical Device Approval: Is there a Better Way?" hearing April 14, to "study the FDA's inconsistent application of reasonable standards for safety and effectiveness in approving medical devices, and the impact it has on American job creators."

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