Unique Device Identification (UDI) Updates on US Activities

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Pierce Cox
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1 1 Unique Device Identification (UDI) Updates on US Activities U.S. - China Healthcare Cooperation Series China FDA Medical Device Executive Development Delegation Visit Symposium and Reception Dennis Black, Director, e-business

2 Agenda: UDI Overview UDI Serves Multiple Purposes Significant UDI Updates: UDI Adoption Activity UDI Collaboration between all participants FDA Implementation Date Extensions and Revised Guidance Summary

3 UDI Overview: How to Establish a UDI System 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 Classification Implementation Verification Legacy Process/Label Review Planning/Process Redesign Analysis of Global Impact and Regulatory Implications GUDID Data Customer Implementation

UDI: Serves Multiple Purposes Our product

healthcare industry is incapable of efficiently

systems It is our hope that the pending CFDA UDI

are harmonized with existing UDI regulations and

4 UDI: Serves Multiple Purposes 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 Supply Chain Healthcare Provider Scanning UDI Requirements

5 Significant UDI Updates: 1) UDI Adoption Activity 2) UDI Collaboration between all participants 3) FDA Implementation Date Extensions and Revised Guidance

UDI Adoption: Future State The goal of the 2007 FDA UDI rule was to ensure all

recalls/adverse events) However the healthcare industry is moving beyond

continuum FDA UDI Rule is Accelerating this Future State Improve Supply Chain

6 UDI Adoption: Future State The goal of the 2007 FDA UDI rule was to ensure all medical devices could be tracked for safety purposes (compliance for recalls/adverse events) However the healthcare industry is moving beyond compliance to scanning and tracking medical devices throughout the healthcare continuum FDA UDI Rule is Accelerating this Future State Improve Supply Chain Track Products Point of Care Scanning Outcomes Analysis Healthcare provider adoption of UDI is causing some rework.

7 UDI Adoption: EHR Integration FDA GUDID Unique Device Identifier Device Identifier (DI) = BD SAP Material Master Patient s Electronic Health Record

UDI Adoption: FDA Strategic Priorities To make that vision a reality, we must develop systems to ensure that data quality is appropriate and sufficient for

8 UDI Adoption: FDA Strategic Priorities 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.

UDI Collaboration: Device Manufacturers are working with Healthcare Providers Examples: Sharing product master data Seeking input on barcode

9 UDI Collaboration: Device Manufacturers are working with Healthcare Providers Examples: Sharing product master data Seeking input on barcode formats Barcode placement Supply Chain Processes Point-of-Care Scanning Some UDI adoption activity has led to rework with labels and UDI master data.

10 UDI Collaboration: Industry Groups 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 Evaluation (BUILD) MDIC Case for Quality (CFQ)

11 AHRMM Learning UDI Community (LUC) 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 Members at Large Clinical Groups Vendors and Distributors Consumer Groups Learning UDI Community Regulatory Agencies Industry Groups Issuing Agencies Supply Chain Groups Device Manufacturers, Distributors, Healthcare Providers, Clinicians, and FDA working together to solve specific UDI related challenges.

12 Medical Device Innovation Consortium (MDIC) This is a public-private partnership to advance medical device regulatory science for patient benefit National Evaluation System for health Technology (NEST) is focused on real-word evidence MDIC and the NEST initiative are aligned with FDA and the goal of using real-world evidence for patient care.

13 Implementation Date Extensions Certain Class II Products ( ) Collections of two or more products Repackaged single-use devices Soft Contact Lens Extension ( ) Class I Product Extension ( ) Several Guidance Documents have been issued.

Extension: Certain Class II Products Applies to: Collections of two or more products Repackaged single-use devices Distributors often remove products from UDI Compliant

14 Extension: Certain Class II Products Applies to: Collections of two or more products Repackaged single-use devices Distributors often remove products from UDI Compliant packages Date extended from until Device Manufacturers, Distributors, Healthcare Providers, and FDA are working on low unit-of-measure challenges.

Extension: Soft Contact Lens Current industry

15 Extension: Soft Contact Lens Current industry practices is to assign a different device identifier (DI) for each prescription Would have created and exceptionally large number of GUDID records Some manufacturers have already implemented UDI Device Manufacturers and FDA working towards a solution.

Extension: Class I Products Class I Products extended for two years 2017-09-20 Time to resolve complex

16 Extension: Class I Products Class I Products extended for two years Time to resolve complex technical issues (trays w/implants, etc.) Renewed focus on GUDID data quality GUDID data quality is an area of focus.

17 Summary 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.

HMMC Webinar, August 9, 2016 Learn How To Get Started with UDI and Why All Channel Players Have A Market Stake

HMMC Webinar, August 9, 2016 Learn How To Get Started with UDI and Why All Channel Players Have A Market Stake Presenters Karen Wolfe, Mayo Clinic Ellenmary Martin, Dukal Amy Kohl, HIDA Dennis Black, BD