FDA's New Sentinal Initiative for Monitoring Device (and Drug) Safety

In a Press release issued 22 May 08, HHS Secretary Mike Leavitt announced new efforts to help FDA improve the safety and quality of medical products. By 2014 FDA will proactively access Medicare Part D (drug reimbursement) information and private-payer information to determine what, if any, adverse events have occurred. The report is available at: http://www.fda.gov/oc/initiatives/advance/reports/report0508.html.

I have more reactions to this as a consumer than as a professional. I know first hand that delayed-type hypersensitivity reactions are underreported. My own allergic reactions were reported and were, frankly, boring to my doctors once they determined that I would live. Furthermore, it wasn't clear what caused the problem, I was exposed to half-a-dozen medical devices during a procedure, any of which could have been the sensitizer. Since there was no way to know, no one knew what to report, including me.

Accessing masses of data and looking for patterns may be the best way to identify what's causing what--both for drugs and devices. It's a little 1990-ish to have the FDA looking at my private medical information, yet a practical necessity for the safety of all. 

The CMS final rule and a related fact sheet may be viewed at www.cms.hhs.gov/PrescriptionDrugCovGenIn/08_PartDData.asp