Unique Device Identification (UDI): Implementation and its real world use cases

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SDRAN Monthly Program


Unique Device Identification (UDI): Implementation and its real world use cases


Program Speaker:

Terrie Reed

Director Partner Relationships, Symmetric Health Solutions



FLYER

Event Agenda:

Date: Wednesday, 20 Oct 2021

Time:


6:00 – 6:05 PM Welcome and Announcements

6:05 – 7:05 PM Program Presentation

7:05 – 7:30 PM Q & A

Program Topic:


Unique Device Identification (UDI): Implementation and its real world use cases


The UDI system was created by the International Medical Device Regulators Forum (IMDRF) providing guidelines to establish UDI as a standard for device identification that manufacturers would be required to apply to a device label and submit information about the model/version of the device to a publicly available database in each participating jurisdiction. While participation in the UDI System is voluntary, the FDA, followed by Europe and many other jurisdictions have chosen to implement UDI.


The goals in the US and Europe include using UDI to improve regulatory processes as well as have a positive impact on clinical care, patient safety and clinical evaluation of devices. This session will include a review of the history of the global UDI system, current state of UDI in the US and a personal view of the opportunities and challenges of implementing the US UDI System by panelists who are experts in US regulation, health IT software development, and hospital supply chain operations.


Speaker Biography:

Terrie Reed – Director Partner Relationships, Symmetric Health Solutions. Former Associate Director of Informatics at the Food and Drug Administration (FDA)


Terrie has spent the past 15 years advocating for a safer, better functioning medical device ecosystem. As Associate Director of Informatics, she led the FDA’s development of the Global Unique Device Identification Database (GUDID), the foundation of recent efforts to introduce data standards and transparency to stakeholders ranging from health systems to manufacturers, distributors, researchers, and patients. In her role as Director, Partner Relationships at Symmetric Health Solution, Ms. Reed has seen first-hand the power of UDI to improve the efficiency of the healthcare supply chain and clinical data in hundreds of hospitals that are choosing to replace custom product identifiers with a scannable globally unique identifier tied to standard information stored in FDA’s AccessGUDID. As UDI adoption increases, further improvements in patient safety, post-market surveillance of medical devices, and device innovation are becoming possible, not only in the US but globally as the European Union, Korea, and other jurisdictions are creating their own UDI databases based upon internationally harmonized principles of a global UDI System.


Ms. Reed continues to influence global efforts through consultancies with the WHO, participation in public private partnerships and cross-stakeholder communities where she contributes to efforts to document and share best practices on the use of UDI to promote interoperability in health IT standards.


Location:

Not applicable - This is an online event

Online registration (ends 19Oct2021): $10 SDRAN Member

$15 Non-Member

For Questions Email: programs.committee@sdran.org

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