Real-World Evidence for Medical Devices: Unique Device Identifiers

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Presentation transcript:

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

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.

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

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

Devices ≠ unique identifiers!

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

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)

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?

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

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

Thank you! jhgraham1@geisinger.edu