1. Real-World Evidence for Medical Devices: Unique Device Identifiers
Plenary 2: Better Evidence For Everyone: Adaptive Pathways and Real-World Evidence
Jove Graham, PhD Geisinger Health System (PA, USA) 2016 CADTH Symposium

2. Acknowledgments Kevin Capatch (Geisinger) Deb Templeton (Geisinger)
Dr. Joseph Drozda (Mercy Health)
Dr. Brent Muhlenstein (Intermountain Healthcare)
Ben Moscovitch (Pew Charitable Trusts Foundation)
Terrie Reed (US-FDA)
Behnaz Minaei (US-FDA)
Any opinions expressed are my own.
Nothing to disclose.

4. Over $50B in combined operating revenue
Over 100 hospitals
Over 300K employees
Over 18K licensed beds
Over 800K surgical procedures per year
Geisinger Health System, Kaiser Permanente,
Mayo Clinic, Intermountain Healthcare, Mercy Health

5. Standards!

6. Almost every retail commercial product has a unique identifier

7. Drugs have NDC numbers…
drugs.com
Unique, 10-digit number
Appears in clinical records, required on insurance claims

8. Devices ≠ unique identifiers!

9. UDI = Device Identifier (DI) + Production Identifier (PI)
What is a UDI?
UDI = Device Identifier (DI) + Production Identifier (PI)

10. UDI Compliance Dates
September 24, 2015
Class III / Implant/Life Supporting/Life Sustaining (LS/LS)
September 24, 2016
Class II (other than I/LS/LS)
September 24, 2018
Class I & Unclassified (other than I/LS/LS)

11. But what good is UDI unless…
Providers are committed to capturing & tracking UDI?
Healthcare software vendors work w/ providers to store & retrieve UDI?
Standards Development Organizations (SDOs) develop tools to communicate UDI between systems?

13. Medical Device Epidemiology Network (MDEpiNet)

14. Pilot Projects from MDEpiNet
BUILD - Building UDI Into Longitudinal Data for Surveillance & Research – Cardiovascular Devices
VANGUARD - Venous Access: National Guidelines and Registry Development – Central Venous Devices
RAPID – Registry Assessment of Peripheral Interventional Devices

15. BUILD Pilot – Coronary Stents

16. The BUILD Distributed Data Network

17. Getting UDI into Claims
Efforts underway (since June 2014) within ASCX12 standards organization to exchange UDI between provider and insurer as part of administrative transactions
Other standards activities
NCPDP examining standards revisions to support UDI in pharmacy-based administrative transactions
HL7 examining standards revisions to support UDI transmission in HL7 transactions
X12M (supply chain) can support UDI elements; examining standards revisions if needed

19. Thank you!