FDA Seeks International Joint Replacement Data; Is A U.S. Registry In Sight?
This article was originally published in The Gray Sheet
Executive Summary
FDA is looking to tap into international joint replacement device registry data to study the long-term safety and effectiveness of artificial hips, knees, ankles and other joints
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Next Steps For U.S. Ortho Registry Include Defining Data Elements – Report
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Next Steps For U.S. Ortho Registry Include Defining Data Elements – Report
A recent report on developing a national orthopedic implant surveillance registry recommends FDA begin by defining the necessary data elements
Ortho surveillence
FDA is seeking organizations to participate in linking registries of orthopedic implant procedures to create a national network of safety information on the products. FDA issued a solicitation in July for "entities that are collecting extensive information on artificial joint replacements and have at least 300 participants included in their registry that have been followed for at least one year." The objectives are to evaluate long-term safety and effectiveness of artificial joints; develop a de-identified dataset that includes demographics and device and outcome information; and eventually perform data analysis and generate manuscripts about performance issues. Hip and knee replacements, hip resurfacing products, spinal disc implants and ankle devices are among the implants of interest. The project will be funded under FDA's Sentinel initiative (1"The Gray Sheet" May 26, 2008, p. 9)