The proposed bill, penned by Senators Jeff Merkley (D-Ore.), Chuck Grassley (R-Iowa), Michael Bennet (D-Colo.) and Herb Kohl (D-Wis.), would ensure all implantable devices have a unique numerical identifier so products can be tracked through the distribution chain and once they are being used with patients. This tracking system would allow rapid and efficient recalls and mitigate the risk of patient harm. The UDI program was created nearly five years ago but the FDA has not implemented it.
This bill would also add medical devices to the sentinel post-marketing surveillance initiative, which was launched in 2008. This surveillance is a national, integrated electronic system that monitors the safety of FDA-approved prescription drugs marketed to patients.
Related Articles on Device Safety:
FDA Publishes Guidance for Pre-Market Approvals
Safe in Common Launches Needlestick Safety Advocacy Tour
FDA Taking Steps to Reduce Risk of Alarm Fatigue
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