The American Hospital Association has expressed its support of the proposed bipartisan Ensuring Safe Medical Devices for Patients Act, which would require the FDA to issue a unique device identifier rule by the end of 2012, according to an AHA News Now report.
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.
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.
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