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Hospital groups push unique device identifier rule

This article was originally published in The Gray Sheet

Executive Summary

The Advancing Patient Safety Coalition, a group made up of 45 hospital, medical and physician groups including the American Hospital Association, American Heart Association and Premier Inc., signs a petition to Congress Jan. 14 asking House and Senate leaders to be certain to include a House-passed provision on unique device identifiers in final health care reform legislation. The provision calls for FDA to approve a UDI system for medical devices within six months of passage of a reform bill. But FDA and the device industry, represented by AdvaMed's Jeff Secunda, said last summer that hospitals may not be quite ready to implement such a device tracking rule, and would first have to change their infrastructure and IT hardware systems (1"The Gray Sheet" June 22, 2009)

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