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.
3
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
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
• JAMA (2009): Premarket cardiovascular stent trials follow, on
average, 308 patients for a median of 180 days
FDA Postmarket Surveillance Methods
1.
2.
3.
4.
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
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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What is a UDI?
UDI = Device Identifier (DI) +
Production Identifier (PI)
Benefits of Implementing UDI in Healthcare IT
Provider
•
•
•
•
•
•
•
Manage inventory,
reordering
Locate expired product
Reduce excess inventory
Better inpatient/ outpatient
care coordination
Better clinical decision
support
Manage recalls
Comparative effectiveness
evaluation
Insurer
•
•
•
•
Improved
transparency
on pricing
Find members
with recalled
devices
Better cost
modeling
Patient
•
•
Better
patientcentered care
Allow
patients to
look up own
device (EHR
portal)
Costeffectiveness
evaluation
Everyone: Technology Assessment!
Manufacturer
•
Better info
on utilization
•
Better info
on outcomes
•
Support new
designs,
innovation
•
Recalls
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!
[email protected]