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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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