or defective devices were associated with the death of almost 5,000 Americans in 2009 alone.
The legislation builds on two important, bipartisan initiatives to improve the oversight of medical devices:
Requires FDA to issue a final Unique Device Identifier (UDI) rule by the end of 2012, requiring implantable devices to carry a unique numerical identifier so products can be tracked through the distribution chain and once they are being used with patients. The UDI program was created nearly five years ago but FDA has not implemented it.
Adds medical devices to the Sentinel post-marketing surveillance initiative, launched in 2008. Sentinel is a national, integrated, electronic system which currently monitors prescription drug safety after FDA approval, once the drugs are being marketed to patients.
The bill has been endorsed by Consumers Union, National Women’s Health Network, National Research Center for Women and Families, Health Care Supply Chain Association, the Premier Healthcare Alliance, Association of American Medical Colleges, Alliance for Advancing Nonprofit Health Care, National Association For Continence, MedicAlert Foundation, Public Citizen, and Union of Concerned Scientists.