Senators Jeff Merkley (D-Ore.), Chuck Grassley (R-Iowa), Michael Bennet (D-Colo.) and Herb Kohl (D-Wis.) have introduced the bipartisan Ensuring Safe Medical Devices for Patients Act, designed to give the Food and Drug Administration the tools it needs to improve oversight of medical devices.
The bill would require the FDA to issue a unique device identifier rule by the end of 2012. This rule 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 bill has already been endorsed by many organizations, including the Health Care Supply Chain Association, the Premier Healthcare Alliance and Association of American Medical Colleges.
The bill would require the FDA to issue a unique device identifier rule by the end of 2012. This rule 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 bill has already been endorsed by many organizations, including the Health Care Supply Chain Association, the Premier Healthcare Alliance and Association of American Medical Colleges.
Related Articles on Device Safety:
Call to Action Aims to Protect Healthcare Workers From Bloodborne Diseases
Nurses at Risk of Blood Exposure During Catheter Insertion, Removal
Changes to Spinal Catheter Systems Needed to Reduce Risk of Patient Harm