What: Free Webinar – “Improved Access to Device Information: What a UDI System can do for Patients and Consumers”
When: Tuesday, February 26, 2013, 12:00-1:30 PM EST
Topic: Successful Unique Device Identification (UDI) implementation offers a number of potential benefits for patients and consumers, including faster detection of safety concerns associated with specific devices, more efficient communication between providers and patients regarding important medical device information, and independent patient access to information regarding their devices. 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 (CDRH) and Chickasaw Nation Industries, Inc., will host a webinar to discuss the value of UDI implementation for patients and consumers and opportunities for patients and consumers to become involved in the UDI implementation effort.
- Mark McClellan, Director, Engelberg Center for Health Care Reform, Brookings Institution,
- Gregory Daniel, Fellow and Managing Director, Engelberg Center for Health Care Reform, Brookings Institution
- Jay Crowley, Senior Advisor for Patient Safety, FDA/CDRH
- Kate Ryan, Senior Program Coordinator, National Women’s Health Network
- Lisa McGiffert, Project Director, Consumers Union
Link to webinar details: http://www.cvent.com/d/pcqrtp
Link to webinar registration: http://www.cvent.com/d/pcqrtp/4W
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 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; a Final Rule is expected from FDA in the coming months. These regulations will ensure that UDIs will be developed and included on labels for relevant medical devices and that accompanying device information will be available to the public through the global UDI database
For more information about UDI Implementation, visit www.fda.gov/udi.