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Capitol Health Call
May 9, 2012

Safer Devices Bill

JAMA. 2012;307(18):1904. doi:10.1001/jama.2012.3896

Three senators introduced legislation March 15 intended to give the Food and Drug Administration (FDA) the tools it needs for better oversight of medical devices. Ensuring Safe Medical Devices for Patients (S 2193 [http://thomas.loc.gov]) is cosponsored by Sen Jeff Merkley (D, Ore), Sen Herb Kohl (D, Wis), and Sen Chuck Grassley (R, Iowa).

The bill would direct the FDA to issue a final Unique Device Identifier rule by the end of 2012, requiring every implantable device to carry a unique numerical identifier so products used in patients could be tracked through the distribution chain. The bill would also add medical devices to the Sentinel postmarketing surveillance initiative, which was launched in 2008 and monitors prescription drug safety after FDA approval.