WAMIII Virtual Series – Session 6
16 April 2020 12PM - 1PM ET
Unique Device Identification (UDI) Across The Device Landscape
Terrie Reed, Principal, Reed McCullough LLC
Ken Fuchs, Sr., Standards Consultant, Draeger Medical Systems, Inc
This session will discuss the current status of the US and Global UDI System, how UDI continues to be integrated into public policy, software applications, data and device communication standards to enhance data used for supply chain, clinical and regulatory decision making. In 2013 the FDA published the UDI regulation requiring device manufacturers to apply a unique device identifier to the label of most medical devices and to submit data to the FDA’s Global Unique Device Identification Database. AccessGUDID, the public portal for GUDID, contains over 2.5 million device model records. Vendors are beginning to take advantage of this global identifier, scanning the UDI to reduce patient exposure to expired and recalled product and to monitor long term outcomes. While there is no specific requirement that UDI be integrated into personal health or point of care devices, it is clear that in order to better track use of these devices, UDI data must flow smoothly from these devices to consuming applications this needs to be accomplished. Fortunately, standards from ISO/IEEE 11073 and IHE PCD are already well positioned for this eventuality and will be discussed.
+ Read Terrie Reed's Bio
Terrie Reed, the former FDA Associate Director of Informatics and Senior Advisor for UDI adoption, has over 20 years of healthcare information management and systems engineering experience. As FDA Associate Director of Informatics Ms. Reed led the cross-disciplinary UDI team that established the initial UDI regulatory policy, designed and rolled out resources now used by software developers, supply chain professionals, clinicians, researchers, manufacturers and regulators as a means to transform the tracking of device-related patient procedure information. Later, as FDA Senior Advisor for UDI adoption, Ms. Reed collaborated across stakeholder groups advocating for UDI to be included in health IT standards to support the scanning of UDI and use of data in AccessGUDID by both manufacturers and healthcare workers. Ms. Reed has also used feedback from innovative pilots and first adopters to inform regulatory strategies impacting the overall UDI system. Now, in her role as an independent consultant, Terrie is excited to advise organizations that seek to achieve the original vision of the UDI system including preventing harm and empowering patients to make more informed care choices by giving them access to timely and accurate UDI-based device information.
+ Read Ken Fuchs' Bio
Ken is currently the Sr. Standards Consultant at Draeger Medical Systems, Inc. a manufacturer of electronic medical devices including patient monitoring, ventilation, anesthesia and warming therapy systems.
Ken is currently responsible for coordination of Drager Medical Systems’ participation in US and International standards development activities. He is also personally active in medical device clinical as well as interoperability related standards. He currently serves as the chair of the IEEE 11073 Standards Committee (SC) for medical device communication, he co-chairs the AAMI MP working group for multi-parameter patient monitors, is Secretary for the IEEE P2733 SC and is involved in a number of other standards development efforts in ISO, IHE, HL7 and AAMI.
Ken’s background has focused on networking, connectivity and system architectures at various point of care medical devices companies including Draeger Medical Systems, Siemens Medical Solutions, Mindray Medical and the non-profit Center for Medical Interoperability.