C7 graham session c7 mon1530_v6[2]
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Transcript of C7 graham session c7 mon1530_v6[2]
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
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!