Postmarket Assessment in the U.S. and Unique Device Identifiers (UDI)

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Presentation transcript:

Postmarket Assessment in the U.S. and Unique Device Identifiers (UDI) Session C7: Evolving Practices in the Assessment of Medical Devices 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.

Geisinger Health System (GHS) GHS serves 44 county region in central and NE PA Integrated Health System: Provider Facilities (7 hospital campuses, 41 community practice sites, etc.) Physician Practice Group (700 physicians) Geisinger Health Plan (insurance company) 4

U.S. FDA Regulation of Devices Class I Class II Class III Listing & registration Always Labeling requirements Good Manufacturing Practices Sometimes “510(k)” premarket notification w/o human data Rarely PMA premarket application w/ human data Never Almost Always Adverse event reporting JAMA (2009): Premarket cardiovascular stent trials follow, on average, 308 patients for a median of 180 days

FDA Postmarket Surveillance Methods Mandatory Reporting (manufacturers) 1984-now Voluntary Reporting (anyone) 1973-now MedSun (active surveying) 1997-now FDA Postmarket (“522”) studies or COA studies 1990-now Publicly accessible database (“MAUDE”)

Limitations of MAUDE / MDRs No denominators Severe under-reporting (numerators) Limited/vague information within reports

Data and scientific partners FDA Sentinel Network (2008-) Lead – HPHC Institute Data and scientific partners Scientific partners Institute for Health

FDA Sentinel = Distributed Data Network 2012 FDA Safety and Innovation Act required FDA to add device information to Sentinel But there was a problem….

National Drug Code (NDC) Number drugs.com Drug Listing Act of 1972 Unique, 10-digit number Universal product identifier for all human drugs in the U.S. Appears in clinical records, required on insurance claims

Almost every regular commercial product has a unique identifier!

Devices do not (*yet) have unique identifiers!

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

Benefits of Implementing UDI in Healthcare IT Provider Insurer Patient Manufacturer Manage inventory, reordering Locate expired product Reduce excess inventory Better inpatient/ outpatient care coordination Better clinical decision support Manage recalls Comparative effectiveness evaluation Improved transparency on pricing Find members with recalled devices Better cost modeling Cost-effectiveness evaluation Better patient-centered care Allow patients to look up own device (EHR portal) Better info on utilization Better info on outcomes Support new designs, innovation Recalls Everyone: Technology Assessment!

But none of that happens 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

PLENARY 2 Better Evidence For Everyone: Adaptive Pathways and Real-World Evidence Tuesday, April 12, 0830 – 0945 LVL3 Canada Hall 1

Thank you! jhgraham1@geisinger.edu