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U.S. Department of Health and Human Services

Medical Devices

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Webinar: The Value of UDI Implementation for Healthcare Systems and Providers, November 5, 2012

What: Free Webinar: “The Value of UDI Implementation for Healthcare Systems and Providers”

When: Monday, November 5, from 2:00 PM to 3:30 PM EST

Topic:  With the enhanced capabilities that could arise from UDI adoption and implementation, there are a number of opportunities that exist specifically for health care systems and providers, including streamlining internal supply chains, more effective recall management, and increased access to device information to inform point of care decisions. Successful unique device identification (UDI) implementation has the potential to enable a host of benefits for healthcare systems and providers in their operational, financial and clinical activities. To explore this promise of successful UDI implementation, the Engelberg Center for Health Care Reform at the Brookings Institution, in cooperation with FDA’s Center for Devices and Radiological Health.

Speakers:  Laurel Junk, Vice President of Supply Chain at Kaiser Permanente, and Natalia Wilson, Co-Director of the Health Sector Supply Chain Research Consortium at the W.P. Carey School of Business at Arizona State University

Link to Agenda:  http://www.cvent.com/events/unique-device-identification-udi-implementation-webinar/agenda-08d4b3880add4d43bb12dcce122f39c1.aspx
Link to Registration:  http://www.cvent.com/events/unique-device-identification-udi-implementation-webinar/event-summary-08d4b3880add4d43bb12dcce122f39c1.aspx
 
Background:  In response to growing calls for the development of a standardized medical device identification system, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA mandated the U.S. Food and Drug Administration (FDA) to create a unique device identification (UDI) system that would enable tracking and identification of medical devices across the medical device lifecycle (i.e., from production through use in clinical practice). In response to this mandate, on July 10, 2012, the FDA published its Proposed Rule for a Unique Device Identification System in the Federal Register. Although this mandate requires that manufacturers label devices on a pre-determined timeline, the mandate does not extend to the use of the UDI in EHRs, Payment Systems, or Incident Reporting Systems.
 
For more information about UDI Implementation or the webinar, please contact: Madris Tomes, UDI External Program Manager at 301-796-5993, or visit www.fda.gov/udi.