Members Fast Facts News & Media What Others Say Legislative Activity

 

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Premier healthcare alliance endorses supply chain standards to enhance patient safety, reduce costs

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Initiative offers better tracking of medical products and devices to improve patient safety and healthcare efficiency

Lawmakers urge FDA to move forward on Unique Device Identification

Congress Passes Unique Device Identification Language

 

 

Lawmakers urge FDA to move forward on unique device identification

Representatives Mike Doyle (D-PA) and Pete Sessions (R-TX) last week urged the Food and Drug Administration (FDA) to move forward on releasing a proposed rule to develop a mandatory unique identification system for medical devices.  The broad-based Advancing Patient Safety Coalition, of which Premier and several Premier hospitals and health systems are members, has been advocating for the implementation of a unique device identification (UDI) system to improve patient safety, facilitate device recalls and improve device adverse event reporting. Last year, Congress required FDA to create such a system in the Food and Drug Administration Amendments Act of 2007 (PL 110-85).

“A national UDI standard has great potential for our entire healthcare system,” said Reps. Doyle and Sessions in a February 6 letter. “We look forward to hearing about the FDA’s timeline for publishing a proposed rule on a UDI system for medical devices as we all continue to work to enhance patient safety and improve health care efficiency.”