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Danica Marinac – Dabic, M.D., Ph.D. Chief, Epidemiology Branch
Office of Surveillance and Biometrics Center for Devices and Radiological Health
Postmarket Transformation at CDRH: The Role of
Statistician
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OutlineOutline
CDRH postmarket responsibilities and challenges
Established roles of the CDRH statisticians
Culture of transformation Postmarket opportunities Vision for the future
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Medical Devices Medical Devices
Critical to the delivery of health care Vary in complexity Rapidly changing
Rapidly expanding
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CDRH Postmarket ResponsibilitiesCDRH Postmarket Responsibilities
Monitoring medical devices and radiological products for continued safety after they are in use
Helping the public get accurate, science-based information needed to improve health
Provide remedial action as needed
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CDRH Postmarket Safety InventoryCDRH Postmarket Safety Inventory
Assessing the impact of our postmarket safety program and pinpoint areas that are in need of improvement
Report Recommendations
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CDRH Sources of Device Information
Sources of CDRH postmarket information
CDRH Sources of Device Information
Sources of CDRH postmarket information
Internal MAUDE (passive reporting)MedSun (enhanced reporting)Inspections (risk based)Recall notificationsPostmarket studies
External Various public health partners
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Postmarket Challenges Postmarket Challenges
Devices – Rapid technology development
Accelerated Approvals Device Use Issues
– Implanted devices are being used for longer time– “Off- label” use– Shift to home use
Data Gathering – Internal (MAUDE, MedSun)– External (NEISS, NIS, CMS, ECRI, ACC, VA)
Data Analysis and Interpretation– Capabilities of current Infrastructure
Risk/Benefit Communication– Multiple audiences
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CDRH Postmarket Transformation GoalsCDRH Postmarket Transformation Goals
Develop a “Culture of Collaboration” on Postmarket Safety within the Center
Develop World Class Data Sources and Systems
Enhance Risk/Benefit Communication Efforts
Improve Enforcement Strategies for Postmarket Issues
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Established Roles of Statisticians Established Roles of Statisticians
Premarket review Advancement of statistical
methods Applied research Outreach/education
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CDRH’s Postmarket Program CDRH’s Postmarket Program
Postmarket ProblemIdentification
Postmarket ProblemIdentification
Postmarket PublicHealth Response
Postmarket PublicHealth Response
Postmarket ProblemAssessment
Postmarket ProblemAssessment
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Postmarket Transformation OpportunitiesPostmarket Transformation Opportunities
Postmarket review
(multi-disciplinary postmarket review approach)
Data mining Strengthening internal and external
collaborations
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Postmarket Problem IdentificationPostmarket Problem Identification
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Example : Post-approval studies Example : Post-approval studies Communicate premarket data
limitations
Essential postmarket questions Study methods Postmarket Plan (PMP)
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Example : Data MiningExample : Data Mining
Initial mapping of the MAUDE database Statistics/epidemiology team CDER/CBER/CDRH Explorations of various techniques are
underway Preliminary analysis using drug eluting stents
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Postmarket Problem AssessmentPostmarket Problem Assessment
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Example : Strengthening collaborations
Example : Strengthening collaborations
Expanding internal collaborations
Exoloring new ways to gain access to richer data
Partner with external groups and organizations
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Example: Ensuring Access to External DataExample: Ensuring Access to External Data
CMS (Medicare, CMS Mandated National Registries) AHRQ
HCUP: Nationwide Inpatient Sample (NIS) Documentation of Device Use and Device Related
Problems Professional societies (ACC, STS) NIH ECRI CPSC
National Electronic Injury Surveillance System (NEISS) Academia (University of Utah, Duke University)
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Postmarket Benefits Postmarket Benefits
TPLC Postmarket studies are founded
on good science Improved use of surveillance
data
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Vision for the Future Vision for the Future
Statistics/Epidemiology Partnership
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Statistics/Epidemiology PartnershipStatistics/Epidemiology Partnership
Backbone of the public health practice
Collective voice of biometric sciences
Premaket/postmarket bridges Lead collaborative efforts Lead outreach and transparency
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