Unique Device Identification (UDI) Status, Learnings, Next Steps

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1 Unique Device Identification (UDI) Status, Learnings, Next Steps Jeffrey Shuren, M.D., J.D. Center for Devices and Radiological Health (CDRH) US Food and Drug Administration (FDA) IMDRF September 2016

2 What is a UDI? Required on the device label, packages or, in some cases, on the device itself UDI = DI + PI Code in plain text and machine readable format (AIDC) *+X999123ABC0 /$$ A1234/S1234/16D J* 2

3 Benefits of UDI Improve Patient Safety More Accurate Understanding of Device Benefit- Risk Profile Facilitate Device Innovation and Patient Access Collect and analyze more detailed and accurate device information to detect product problems Identify and remove unsafe products Increase likelihood of identifying counterfeit products Better evaluate product performance Improve device selection by providers and patients Understand patient-device characteristics to improve device design Inform regulatory decisions (e.g. expand indications, new device approvals, PAS) 3

UDI Place UDI on label and (sometimes) the device Create

4 Establishing a UDI System UDI Final Rule [78 FR 58786] Sept 24, 2013 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 4

5 Implementation Timeframe Compliance Date Must bear a UDI & submit data to GUDID September 24, 2014 Class III devices, incl. class III stand alone software Devices licensed under the PHS Act September 24, 2015 Implantable, life-supporting and life-sustaining (I/LS/LS) devices, incl. stand alone software September 24, 2016 Class II devices Direct Marking of I/LS/LS for certain intended uses Direct Marking for class III devices and devices licensed under the PHS Act, for certain intended uses September 24, 2018 Class I devices and devices not classified class I, II or III Direct Marking of class II devices for certain intended uses September 24, 2020 Direct Marking of class I devices and devices not classified into class I, II or III, for certain intended uses 5

6 Data Collection Repository of key device identification information Contains ONLY the DI; PIs are not submitted to nor stored in the GUDID Contains only PI flags to indicate which PIs are on the device UDI 6

7 Adoption and Data Use Public Access to GUDID data High quality public search, download and web services (APIs) Provides link to health IT expertise and initiatives 7

8 GUDID Records and Submission Compliance Deadlines Data Current as of September 1, 2016 Class III I/LS/LS Class I & Unclassified Class II

9 Helpdesk Statistics set/13 nov/13 jan/14 mar/14 mai/14 jul/14 set/14 nov/14 jan/15 mar/15 mai/15 jul/15 set/15 nov/15 jan/16 mar/16 mai/16 jul/16 Help Desk Cases Opened Help Desk Cases Closed 9

10 September 2013 to 2016 LESSONS LEARNED 10

11 Subject Matter Expert Resources UDI Team Technical Regulatory Adoption Data Quality Standards UDI Helpdesk Collaborators Internal (Premarket, MDR, Compliance, CBER, CDER, ORA) External (device and healthcare industry) Government (NLM, ONC, CMS, VA) Healthcare Systems Registries 11

12 UDI Program Components Data Adoption Collection Education Policy and Data Use Focus on Data Quality Improvement - Collaborate and Communicate 12

13 Lessons Learned Data Collection Use data standards; focus on downstream data use Set expectation of continuous improvement Provide public access to database in multiple forms Plan for challenging device types (kits, device systems, consigned devices) 13

14 Lessons Learned Education Automate help desk tools; consider chat or phone option Early and often website, webinars, guidances, FAQs Staff for cyclical ups and downs Leverage issuing agencies and other external groups to multiply common messages 14

15 Lessons Learned Policy Leverage available vetted policies/standards IMDRF UDI Guidance Issuing Agency Standards Guidances by other countries Establish firm deadlines and extend as needed Base policy and technical decisions on real world use of UDI data 15

16 Lessons Learned Adoption and Data Use Emphasize value of DI + 5 PI fields DI is key in database and link across data sources. Learning UDI Community framework for shared best practices Integrate in National & International device initiatives NEST, Registries, EHR Certification Demonstrate benefit of UDI adoption through pilots, ROI analysis and early adopters 16

17 Labeler Challenges UDI is New Setting best practices for adding UDI to label Difficult to collect data across Enterprise and submit to GUDID Combining regulatory and healthcare uses Heterogeneity of devices Wide variety of characteristics Implantables, instruments, orthopedic trays, software, etc. UDI rule can t cover it all Variability in UDI use GUDID fields vary by context of use Difficult to coordinate development of consensus-based best practices Best source to improve UDI in practice 17

18 Questions? FDA UDI Website (including Helpdesk): /udi Slide Presentations, Transcripts and Webinar Recordings are available at: /CDRHWebinar Under Heading: Unique Device Identification (UDI) System 18

APACMed Workshop Update on UDI Implementation & ASPAC Regional Trend. Victoria Qu Sept. 22 nd, 2017

APACMed Workshop Update on UDI Implementation & ASPAC Regional Trend Victoria Qu Sept. 22 nd, 2017 1 Disclaimer / 免责声明 The views and opinions expressed in the following PowerPoint slides are those of the