Jove Graham, PhDGeisinger Health System (PA, USA)2016 CADTH Symposium

Real-World Evidence for Medical Devices: Unique Device Identifiers

Plenary 2: Better Evidence For Everyone: Adaptive Pathways and Real-World Evidence

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.

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• 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

Standards!

Almost every retail commercial product has a unique identifier

• Unique, 10-digit number• Appears in clinical records, required on insurance claims

Drugs have NDC numbers…

drugs.com

Devices ≠ unique identifiers!

UDI = Device Identifier (DI) + Production Identifier (PI)

What is a UDI?

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)

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•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?

But what good is UDI unless…

Medical Device Epidemiology Network (MDEpiNet)

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

BUILD Pilot – Coronary Stents

The BUILD Distributed Data Network

• 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

Getting UDI into Claims

Thank you!

jhgraham1@geisinger.edu