Postmarket Transformation at CDRH: The Role of Statistician

1. Postmarket Transformation at CDRH: The Role of Statistician Danica Marinac – Dabic, M.D., Ph.D. Chief, Epidemiology Branch Office of Surveillance and Biometrics Center for Devices and Radiological Health

2. Outline • CDRH postmarket responsibilities and challenges • Established roles of the CDRH statisticians • Culture of transformation • Postmarket opportunities • Vision for the future

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

5. CDRH 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 • Provideremedial action as needed

6. Assessing the impact of our postmarket safety program and pinpoint areas that are in need of improvement Report Recommendations CDRH Postmarket Safety Inventory

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

8. 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

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. Established Roles of Statisticians • Premarket review • Advancement of statistical methods • Applied research • Outreach/education

11. CDRH’s Postmarket Program Postmarket Problem Identification Postmarket Problem Assessment Postmarket Public Health Response

12. Postmarket Transformation Opportunities • Postmarket review (multi-disciplinary postmarket review approach) • Data mining • Strengthening internal and external collaborations

13. Postmarket Problem Identification

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

15. Example : 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

16. Postmarket Problem Assessment

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

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

20. Vision for the Future Statistics/Epidemiology Partnership

21. Statistics/Epidemiology Partnership • Backbone of the public health practice • Collective voice of biometric sciences • Premaket/postmarket bridges • Lead collaborative efforts • Lead outreach and transparency