Unique Device Identification (UDI): Implementation and Adoption

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Unique Device Identification (UDI)
Implementation and Adoption

• Leslie M Tompkins, PhD
• FDA, Center for Devices and Radiological Health
• UDI Lead, Standards and Vocabularies
• HL7 Working Group Meeting, Phoenix
• May 2014

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Basics of the UDI Rule

• 21 CFR 801.20
• the label of every medical device shall bear a
  unique device identifier (UDI)

• 21 CFR 830.300
• the labeler of a device must provide the
  information required for each model or version
  required to bear a unique device identifier (UDI)

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Where we are

• January 2014
• GUDID release 1.1
• March 2014
• GUDID release 1.2
• April 2014
• HL7 SPL IG r1.2
• September 2014
• Class III Compliance Date

• September 2013
• 78 FR 58786 (UDI Rule) published
• GUDID Draft Guidance published
• GUDID production goes live
• UDI Helpdesk goes live
• November 2013
• HL7 SPL Implementation Guide published

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Where are we

• Helpdesk
• gt1400 questions received
• Answered
• 711 Regulatory
• 599 Technical
• 15 Data Quality
• www.fda.gov/udi

• GUDID
• 80 records submitted (unpublished state)
• Dozens of draft records
• Accounts
• 71 production
• 32 pre-production (SPL testing)
• 10 Third-party

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Adoption of UDI into Health IT

• Harmonization of UDI representation across HL7
  documents and messages
• NPRM 2015 Certification Criteria for EHRs
• PROPOSED Meaningful Use, Stage 3
• should record the FDA Unique Device Identifier
  (UDI) when patients have devices implanted for
  each newly implanted device.

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UDI Resources

• UDI website - www.fda.gov/UDI
• UDI Help Desk
• Sign up for UDI alerts
• GUDID Draft Guidance
• Appendix B Vocabulary
• Appendix C - UDI Specifications by Issuing
  Agency
• Strengthening our National System for Medical
  Device Postmarket Surveillance -http//www.fda.gov
  /downloads/MedicalDevices/Safety/CDRHPostmarketSur
  veillance/UCM348845.pdf
• HL7 UDI Task Force
• http//hl7tsc.org/wiki/index.php?title2013-11-21_
  TSC_UDI_Task_Force