Following on the heels of the New York Times' call for a national joint registry, the FDA has announced plans to expand its Sentinel Initiative to encompass medical devices.
The Sentinel program, launched in May, strives to be "a national, integrated, electronic system for monitoring medical product safety." The FDA is now in the process of initiating the orthopedic device arm of the program, which seeks to evaluate the performance of total hip, total knee, hip resurfacing, intervertebral disc implants and ankle devices of through the collection of registry data. This data collection process, per the FDA, should require minimal data transfer and protect patient privacy.
The industry publication Government Health IT reports that the FDA will issue a call for quotes this month to identify companies to review implant registries for inclusion in the program. Among the data sources the FDA is looking at are government databases (e.g., the CMS database), private and public medical claims databases and electronic health record systems.
The Sentinel System represents a major shift in how the FDA will compile and review patient outcomes. The agency currently has databases such as MAUD, which require healthcare professionals to link an adverse effect to a device and then report it, and these reporting rates are low. The Sentinel program would attempt to gather outcomes from all procedures, enabling a broad view of device performance over large populations and over time. This can be beneficial for companies seeking to demonstrate the efficacy of their devices, creating a data pool less encumbered by concerns of bias than company-funded studies and also of little cost to the manufacturers.
