FDA's UDI Marching Orders: Don't Wait For The Regulation
This article was originally published in The Gray Sheet
The hoped-for regulation on FDA's unique device identification framework will not come out until the first part of 2011, but companies should start taking steps to implement UDI now, an agency official says.
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The long-anticipated proposal maps out a unique device identifier system that FDA says will be crucial to the future of post-market safety surveillance, recall management and safety alerts. The effort also will help reduce medical errors and bring an array of other benefits, stakeholders say.
The FDA-funded effort out of the Mercy health care system, consisting of 31 hospitals and 200 outpatient facilities in Missouri, Arkansas, Oklahoma and Kansas*, is intended as a demonstration project to help troubleshoot UDIs before a mandatory nationwide system is launched. It is one of two UDI demos in the works in advance of FDA regulations.
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.