Sentinel post-market initiative may have trouble tracking products

Tracking the use of specific medical devices using health care claims databases may be difficult, according to a government contractor report on data sources that could support FDA's Sentinel post-market surveillance initiative. Sentinel is intended to create a national, integrated electronic system for monitoring the safety of devices and drugs. Through public-private partnerships, the initiative will eventually allow FDA to access multiple, existing data systems, such as electronic health records and medical claims databases ("The Silver Sheet" June 2008). The contractor, IMS Government Solutions, evaluated the IMS Health Plan Claims Databases and the Military Healthcare Data Database. When using claims data, "it would not be possible to distinguish (and thus, evaluate) the pacemakers made by different manufacturers," the contractor's report says. "Similarly, a researcher would know that a radiological procedure was done with contrast (using a dye), but not which dye was used." The contractor identified other limitations to using claims databases for post-market safety surveillance, including lack of data on race and ethnicity, non-reimbursed treatments, lab results and other clinical data, and patient deaths. The lag time inherent in claims data also hinders early post-market surveillance, the report adds