Unique Device Unique Device Identification (UDI): Identification (UDI):

Implementation Implementation and Adoptionand 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 RuleBasics 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…Where we are…

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• September 2013– 78 FR 58786 (UDI Rule) published– GUDID Draft Guidance published– GUDID production goes live– UDI Helpdesk goes live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

• 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

Where are we…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(unpublished state)– Dozens of draft records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

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Adoption of UDI into Health IT Adoption of UDI into Health IT

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• 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.

UDI website - www.fda.gov/UDI– UDI Help Desk– Sign up for UDI alerts– GUDID Draft Guidance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/CDRHPostmarketSurveillance/UCM348845.pdf

HL7 UDI Task Force http://hl7tsc.org/wiki/index.php?title=2013-11-21_TSC_UDI_Task_Force

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UDI ResourcesUDI Resources