STANDARD PRACTICES
Making UDIs meaningful: It’s more than just talk
by Karen Conway, Executive Director, Industry Relations, GHX A
s manufacturers are busy preparing to comply with the U.S. FDA UDI rule, the federal government is equally hard at work trying to ensure that the unique device identifi ers (UDIs)
deliver the value intended. But it’s not just the FDA. The Offi ce of the National Coordinator for Health IT is also involved. One of the individuals at the FDA who has been most involved in UDI is now on temporary assignment (or what the federal government calls a detail) at the ONC. In this month’s column, we hear from Terrie Reed, known to most of us as the Associate Director, Informatics at the FDA Center for Devices and Radiological Health (CDRH). But through March, she holds the title of Medical Device Safety Consultant to the Chief Medical Offi cer at ONC.
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The original intent of the UDI rule was to improve adverse event reporting and product recalls, by requiring manufacturers to assign and label their products with UDIs and provide additional informa- tion about those products to an FDA Global UDI database (GUDID). When you consider UDIs within the context of the ONC’s mission to promote development of a nationwide health information technology infrastructure and more specifi cally the meaningful use of electronic health records (EHRs), the question arises, how to integrate UDIs in EHRs and the broader healthcare IT network. That’s where Reed’s work comes in. Until recently, the discussions around including UDI documentation in EHRs as part of meaningful use has been mostly talk, as part of exploratory discussions between the FDA and ONC. But now there is a specifi c proposal related to implantable devices on the table. As currently drafted, it would require eligible physicians and hospitals to record the FDA UDI when patients have devices implanted for each newly implanted device. To meet meaningful use criteria, under the proposal, they would have to do so for “80% of patients seen within the EHR reporting period.”
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Speaking recently at a quarterly meeting of the GHX Implantable Device Supply Chain Special Interest Group (IDSC SIG), Reed ex- plained why the two government organizations are focused primarily on implantables. Under FDA’s risk-based approach to UDI, manufac- turers of Class III devices, which include ma ny implantables, will be the fi rst that must comply with the regulation, by September 24 of this year. All implantables regardless of class must comply by the following September. But Reed said it’s more than that. She explained that, unlike other medical and surgical products, implanted devices are not visible to the human eye, making it diffi cult to determine which specifi c devices have been implanted into a patient. That presents considerable challenges in the event of a product recall, challenges that could be overcome if the clinician could look up the information in the patient’s EHR. Implanted devices also remain with the patient long after the actual episode of care, and the ability to securely share that data
58 March 2014 • HEALTHCARE PURCHASING NEWS •
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STANDARD PRACTICES
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