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

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Presentation on theme: "Postmarket Assessment in the U.S. and Unique Device Identifiers (UDI)"— Presentation transcript:

1 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

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.

3

4 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

5 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

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7 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”)

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

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

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

11 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

12 Almost every regular commercial product has a unique identifier!

13 Devices do not (*yet) have unique identifiers!

14 | 14

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

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17 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!

18 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

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

21 Thank you!

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