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Compliance In Focus
Posted by John Lehmann on Mon, Mar 26, 2012

The Ensuring Safe Medical Devices for Patients Act

This month a new bipartisan bill was presented to the Senate which aims to make medicalCapital Building devices safer. The bill, “The Ensuring Safe Medical Devices for Patients Act” was introduced by four Senators: Jeff Merkley (D-OR), Chuck Grassley (R-IA), Michael Bennet (D-CO) and Herb Kohl (D-WI).

According to the press-release, the bill builds on two initiatives to improve the oversight of medical devices, by:

This would “require implantable devices to carry a unique numerical identifier so products can  be tracked through the distribution and when being used with patients.  The UDI program was created nearly five years ago but FDA has not implemented it.”

“Sentinel is a national, integrated, electronic system which currently monitors prescription drug safety after FDA approval, once the drugs are being marketed to patients.” 

Senator Grassley believes that “the post-market surveillance work of the FDA needs to be empowered to be able to use the important and valuable information about drugs and devices that becomes available when millions of people start using them, compared to what can be known before a drug or device goes on the market.  This legislation would deliver some of the necessary tools to the FDA to make it more effective in looking out for patients.”

Do you agree that the FDA should have the additional authority to conduct post marketing surveillance? Would this bill “implement long overdue reforms and help save patient lives”? Share your opinion below!

Photo Credit:  Glyn Lowe

Topics: Medical Device Oversight, Senators


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