The FDA has proposed a program that would ask public and private databases to help study the efficacy of orthopedic implants, such as total hip and knee, hip resurfacing, ankle devices, and intervertebral disc implants. The Agency will soon request quotations to identify companies that could evaluate orthopedic-implant registries for participation in the program. The network generated would let FDA tap several information sources on medical products. The agency says it would make network queries with minimal data transfer and protect patient privacy.

The FDA acknowledges a drawback to existing post-market surveillance programs in that healthcare professionals and patients must first recognize an association between an adverse effect and a medical product before reporting it. Most adverse events, it says, are never reported. And when they are, the information provided is incomplete.

In contrast, the new program would let the FDA search government databases, such as Medicare's along with private and public medical-claims databases, and electronic health record systems. The agency adds that the proposed evaluations of orthopedic-implant registries would lead to recommendations for involvement of the most promising data sources.