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FDA Struggles To Create A User-Friendly Device Identification System

This article was originally published in The Gray Sheet

Executive Summary

The hardest part about establishing a mandatory unique identification system for devices is crafting one that all users - from manufacturers to distributors to hospitals - will be able to implement, FDA says

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Challenges Remain In Linking Unique Device Identifiers To Electronic Health Records

Manufacturers and hospitals have high hopes for the benefits of linking unique device identifiers, still about two years from prime time, to patient electronic health records and registries.

Challenges Remain In Linking Unique Device Identifiers To Electronic Health Records

Manufacturers and hospitals have high hopes for the benefits of linking unique device identifiers, still about two years from prime time, to patient electronic health records and registries.

Hospital groups push unique device identifier rule

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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