Medical Device Safety

1. Medical Device Safety Susan Gardner, Ph.D. Director, Office of Surveillance and Biometrics Center for Devices and Radiological Health

2. Agenda • Overview of the CDRH Postmarket Transformation Effort • Status of targeted postmarket initiatives

3. Postmarket Transformation

4. Adverse event reports are increasing…

5. Recalls remain a source of concern… FY 06 as of 7-31-06

6. FDA and the medical device industry are under scrutiny… FDA To Improve Guidelines for Medical Devices Recall of Hemodialysis Device Points to Kink in Blood Tubes F.D.A. Puts Restrictions On Guidant Medical Devices Are Hot, Which Is Why Guidant Is FDA Issues Alert for Abbott Glucose Meters Check the Meters' Setting, Says FDA and Abbott Diabetes Care

7. Institute of Medicine Report: Save Medical Devices for Children - Monitoring postmarket study commitments - Public access to information about postmarket studies - Adverse event reporting - Organizational attention to pediatric issues

8. CDRH Post-market Safety Framework A network programs and tools focused towards minimizing harm and maximizing benefit associated with the use of marketed medical devices. It is linked to CDRH pre-market programs and supported by CDRH’s external public health partners.

9. CDRH Postmarket Reports: Transformation Groundwork • Ensuring the Safety of Medical Devices : inventory and assessment of our current postmarket tools • Strengthening FDA’s Postmarket Program for Medical Devices:recommendations for improvements

10. 1. Develop a Culture of Collaboration • Place more emphasis on collaboration in identifying, analyzing and solving postmarket problems, both within the Center and with outside constituencies • Create at culture of collaboration within CDRH: formalize horizontal communication …..”connect the dots”

11. 2. Develop World Class Data Sources and Systems • Improve data systems, enhance data quality, improve data analysis What we will do • Champion unique device identification • Implement an electronic reporting system • Evaluate MDR program to optimize • Optimize our surveillance program with a balance of passive and active reporting, and access to external data sources

12. 3. Enhance Risk/Benefit Communication • Maximize our ability to communicate information clearly and quickly to practitioners, patients and consumers What we will do • Develop and implement a risk communication strategy • Partner with outside professional groups • Create easier access to Center information

13. 4. Improve Enforcement Strategies for Postmarket Issues • Improve the coordination, consistency, quality and timeliness of inspections, reporting and enforcement actions What we will do • Improve interactions and collaboration between ORA and CDRH • Assess the effectiveness of current enforcement strategies and revise accordingly • Update data systems; use metrics to monitor and improve performance • Integrate postmarket information in CDRH to improve signal detection and decision making

14. Medical Device Reporting (MDR)Basic Facts • 200,000 reports per year • Database: over 1.25 million • Individual reports: redacted for Web • Over half the reports are Summary • Over 90% are from industry (mandatory) • 3% are voluntary (MedWatch) • 2% user facilities • > 1% international

15. Value of MDR • Detection of rare, unexpected events • Following high profile devices • Signals for emerging issues • Trends for familiar, mature products (summary) • Adjunct analysis for investigations • Available for public use • High value of voluntary reports (MedWatch)

16. Challenges of MDR • Passive reporting system – depends on recognition of a problem - no validation • Poor reporting; not timely; not complete • Lack of context for incident • Inadequate analysis of event • More quantity than quality

17. Medical Product Safety Network: MedSun • Network of 350 health care facilities • Specifically trained to report device related adverse events • Barriers to reporting reduced through education, extensive feedback of safety information

18. How MedSun Enhances Surveillance:Direct Access to Device Users • Better reports: real-time contact with reporter • Emphasis on use error • Emphasis is on prevention: close calls • Laboratory for research ( rapid response/evaluation surveys) • Targeted surveillance: LabNet, HeartNet, KidNet

19. Post- approval Studies • Condition of Approval Postmarket Studies • Automated tracking system for all PAS • Involvement of epidemiologists for study design • Guidance document • Website for status of studies • Feedback to Advisory Panels

20. Section 522 Studies • Discretionary postmarket studies for Class ll and Class ll products • - Intended to be implanted for more than one year,or • - Life sustaining/life supporting and use outside user facility ,or • - Failure would likely cause serious health consequences

21. Improve and Expand Data sources • Increase use of registries for postmarket surveillance and postmarket studies • Support applied epi program • Collaborations with other agencies • Increase collaborations with professional organizations (HRS)

22. Unique Device Identifiers • Federal Register notice for comment in August 2006 • Public meeting in October 2006 • Standardized ID would facilitate tracking for recalls • Increase ability to identify products associated with AE • Assist hospitals in tracking and managing devices • Enhance value of electronic health records – allow improved surveillance

23. Also coming….. • eMDR • New device coding system