January 7 @ 4:00 – 5:00 pm
Speaker: Terrie L. Reed, MSIE
Presented from Duke University
Broadcast Link: Seminar
There are multiple national efforts focused on advancing the science and efficiency of medical product decision making by improving the structure and quality of initial data capture, leveraging electronic infrastructure that overlaps with clinical care, professional society, federal and other data systems and registries. This presentation will provide an overview of those efforts with a particular focus on efforts to adopt Unique Device Identifiers and a standard core set of data elements to allow clear identification of regulated medical devices through distribution and use. The discussion will include an overview of a new FDA Public Private Partnership called MDEpiNet, that has DCRI as its coordinating Center and about an MDEpiNet-sponsored Informatics Think tank to be held in February that will be addressing the need to strike the right balance between making sufficient changes to the quality of data at initial data capture to improve downstream clinical information without requiring such extensive change that costs in money, systems and resources pose too high a barrier to be realistically implemented or sustained.
Terrie Reed, MSIE works as a senior Clinical Research Informatics Project Leader at Duke Clinical Research Institute, where she provides informatics subject matter expertise and support to device-related projects and programs such as the MDEpiNet (Medical Device Epidemiology Network) public-private partnership. Formerly, Terrie was the Associate Director of Informatics at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Surveillance and Biometrics (OSB), where she led the implementation of the UDI Final Rule including the development and population of the Global Unique Device Identification Database (GUDID) as a master source of device information. Over the course of her 12 years at the FDA she led several data-management initiatives, including a joint project between the National Cancer Institute (NCI) and FDA CDRH focused on improving and simplifying the device and patient problem codes used to code medical device adverse event reports. Prior to working in academia and government, she worked for 13 years at a healthcare facility in Indianapolis in various positions as a process engineer, quality analyst, and medical information specialist.