This developmental project seeks to facilitate early detection of serious complications associated with new orthopedic devices. Innovative aspects of the project include validation of administratively-derived safety measures, use of FDA-approval data as a benchmark for monitoring safety, and use of readily-available population-based databases to evaluate the safety of emerging surgical devices. The project implements statistical modeling techniques that leverage medical claims data to continually assess the risks of new devices as additional data is accured on repeat surgery, infection, other complications, and death. We will demonstrate the approach by examining the experience with bone morphogenetic protein, a biological agent used as an adjuncent to spinal fusion surgery.
Timely reporting of safety data for new devices could reduce complications, help clinicians and patients make informed decisions about whether to undergo orthopaedic surgery and what types of surgical devices to use.
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