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

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

Session C7: Evolving Practices in the Assessment of Medical Devices

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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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)

• JAMA (2009): Premarket cardiovascular stent trials follow, on average, 308 patients for a median of 180 days

U.S. FDA Regulation of DevicesClass I Class II Class III

Listing & registration Always Always Always

Labeling requirements Always Always Always

Good Manufacturing Practices Sometimes Always Always

“510(k)” premarket notification w/o human data

Sometimes Sometimes Rarely

PMA premarket application w/ human data

Never Sometimes Almost Always

Adverse event reporting Always Always Always

http://www.drjohnm.org/2012/08/trials-and-fibrillations-post-up-st-jude-riata-lead-update/

FDA Postmarket Surveillance Methods

1. Mandatory Reporting (manufacturers) 1984-now2. Voluntary Reporting (anyone) 1973-now3. MedSun (active surveying) 1997-now4. 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

Institute for Health

Lead – HPHC Institute

Data andscientific partners

Scientific partners

FDA Sentinel Network (2008-)

• 2012 FDA Safety and Innovation Act required FDA to add device information to Sentinel

• But there was a problem….

FDA Sentinel = Distributed Data Network

• 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

National Drug Code (NDC) Number

drugs.com

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?

Benefits of Implementing UDI in Healthcare ITProvider 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!

•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 none of that happens unless…

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

Tuesday, April 12, 0830 – 0945LVL3 Canada Hall 1

Thank you!

jhgraham1@geisinger.edu