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Ortho surveillence

This article was originally published in The Gray Sheet

Executive Summary

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)
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