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Premier healthcare alliance endorses supply chain standards to enhance patient safety, reduce costs
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Lawmakers urge FDA to move forward on Unique Device Identification
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.”