1. 1 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

2. 2 Outline nCDRH postmarket responsibilities and challenges nEstablished roles of the CDRH statisticians nCulture of transformation nPostmarket opportunities nVision for the future

3. 3

4. 4 Medical Devices Critical to the delivery of health care Vary in complexity Rapidly changing Rapidly expanding

5. 5 CDRH Postmarket Responsibilities M onitoring medical devices and radiological products for continued safety after they are in use H elping the public get accurate, science-based information needed to improve health P rovide remedial action as needed

6. 6 CDRH Postmarket Safety Inventory nAssessing the impact of our postmarket safety program and pinpoint areas that are in need of improvement nReport nRecommendations

7. 7 CDRH Sources of Device Information Sources of CDRH postmarket information Internal MAUDE (passive reporting) MedSun (enhanced reporting) Inspections (risk based) Recall notifications Postmarket studies External Various public health partners

8. 8 Postmarket Challenges nDevices –Rapid technology development nAccelerated Approvals nDevice Use Issues –Implanted devices are being used for longer time –Off- label use –Shift to home use nData Gathering –Internal (MAUDE, MedSun) –External (NEISS, NIS, CMS, ECRI, ACC, VA) nData Analysis and Interpretation –Capabilities of current Infrastructure nRisk/Benefit Communication –Multiple audiences

9. 9 CDRH 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

10. 10 Established Roles of Statisticians nPremarket review nAdvancement of statistical methods nApplied research nOutreach/education

11. 11 CDRHs Postmarket Program Postmarket Problem Identification Postmarket Public Health Response Postmarket Problem Assessment

12. 12 Postmarket Transformation Opportunities nPostmarket review (multi-disciplinary postmarket review approach) nData mining nStrengthening internal and external collaborations

13. 13 Postmarket Problem Identification

14. 14 Example : Post-approval studies Communicate premarket data limitations Essential postmarket questions Study methods Postmarket Plan (PMP)

15. 15 Example : Data Mining nInitial mapping of the MAUDE database nStatistics/epidemiology team nCDER/CBER/CDRH nExplorations of various techniques are underway nPreliminary analysis using drug eluting stents

16. 16 Postmarket Problem Assessment

17. 17 Example : Strengthening collaborations Expanding internal collaborations Exoloring new ways to gain access to richer data Partner with external groups and organizations

18. 18 Example: 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)

19. 19 Postmarket Benefits TPLC Postmarket studies are founded on good science Improved use of surveillance data

20. 20 Vision for the Future Statistics/Epidemiology Partnership

21. 21 Statistics/Epidemiology Partnership nBackbone of the public health practice nCollective voice of biometric sciences nPremaket/postmarket bridges nLead collaborative efforts nLead outreach and transparency

22. 22

23. 23