1 / 7

Unique Device Identification (UDI): Implementation and Adoption

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. Basics of the UDI Rule. 21 CFR 801.20

mckenzie-pearson
Download Presentation

Unique Device Identification (UDI): Implementation and Adoption

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 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

  2. 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)…

  3. 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SPL IG r1.2 • September 2014 • Class III Compliance Date • September 2013 • 78 FR 58786 (UDI Rule) published • GUDID Draft Guidance published • GUDID production goes live • UDI Helpdesk goes live • November 2013 • HL7 SPL Implementation Guide published

  4. Where are we… • Helpdesk • >1400 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• Answered: • 711 Regulatory • 599 Technical • 15 Data Quality • www.fda.gov/udi • GUDID • 80 records submitted (unpublished state) • Dozens of draft records • Accounts • 71 production • 32 pre-production (SPL testing) • 10 Third-party

  5. 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.

  6. 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 PostmarketSurveillance -http://www.fda.gov/downloads/MedicalDevices/Safety/CDRHPostmarketSurveillance/UCM348845.pdf HL7 UDI Task Force http://hl7tsc.org/wiki/index.php?title=2013-11-21_TSC_UDI_Task_Force

More Related