Unique Device Identification (UDI) Updates on US Activities · Some UDI adoption activity has led to rework with labels and UDI master data. ... MDIC and the NEST initiative are aligned
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• Develop a standardized system to create the UDI• Place UDI on label and (sometimes) the device• Create and maintain the Global UDI Database• Adoption and Implementation
Product Analysis Verification
Legacy Process/Label Review
Classification
Planning/Process Redesign
Implementation
Analysis of Global Impact and Regulatory Implications GUDID Data Customer
• Our product identification system serves many requirements
• The healthcare industry is incapable of efficiently implementing multiple product identification systems
• It is our hope that the pending CFDA UDI Regulation (and other emerging UDI regulations) are harmonized with existing UDI regulations and market needs
“To make that vision a reality, we must develop systems to ensure that data quality is appropriate and sufficient for regulatory decision making, that data flows seamlessly between systems, and that unique device identifiers (UDI)are routinely incorporated into electronic health information.”
• Advanced Medical Technology Association (AdvaMed)
• Association for Healthcare Resources and Materials Management (AHRMM) Learning UDI Community (LUC)
• Medical Device Innovation Consortium (MDIC) National Evaluation System for health Technology (NEST)
• Medical Device Epidemiology Network (MDEpiNET)– Registry Assessment of Peripheral Artery Devices (RAPID)– Building UDI into Longitudinal Date for Medical Device
• Level Below Each• Bar Code Logistics • Business Case for UDI• Catalog Number Field• Clinically Relevant Size• Device Categorization• HCT/P • High Risk Implants• Low Unit-of-Measure• Multiple DI Work Group
Learning UDI Community
Consumer Groups
Industry Groups
Supply Chain
Groups
Issuing Agencies
RegulatoryAgencies
Vendorsand
Distributors
Members at Large
Clinical Groups
Device Manufacturers, Distributors, Healthcare Providers, Clinicians, and FDA working together to solve specific UDI related challenges.
• True UDI adoption is starting to occur in the US• Much industry collaboration on UDI• FDA is an active industry participant• Some UDI requirements have evolved• We are optimistic that UDI will achieve the desired
benefits in the U.S.
Global Harmonization of UDI requirements is essential.