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

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

3. 3 Postmarket Transformation

4. 4 Adverse event reports are increasing…

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

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

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

8. 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. 9 CDRH Postmarket Reports: Transformation Groundwork Ensuring the Safety of Medical Devices : inventory and assessment of our current postmarket toolsEnsuring the Safety of Medical Devices : inventory and assessment of our current postmarket tools Strengthening FDA’s Postmarket Program for Medical Devices: recommendations for improvementsStrengthening FDA’s Postmarket Program for Medical Devices: recommendations for improvements

10. 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 constituenciesPlace 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”Create at culture of collaboration within CDRH: formalize horizontal communication …..”connect the dots”

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

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

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

14. 14 Medical Device Reporting (MDR) Basic Facts 200,000 reports per year200,000 reports per year Database: over 1.25 millionDatabase: over 1.25 million Individual reports: redacted for WebIndividual reports: redacted for Web Over half the reports are SummaryOver half the reports are Summary Over 90% are from industry (mandatory)Over 90% are from industry (mandatory) 3% are voluntary (MedWatch)3% are voluntary (MedWatch) 2% user facilities2% user facilities > 1% international> 1% international

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

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

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

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

19. 19 Post- approval Studies Post- approval Studies Condition of Approval Postmarket StudiesCondition 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. 20 Section 522 Studies Discretionary postmarket studies for Class ll and Class ll productsDiscretionary postmarket studies for Class ll and Class ll products - Intended to be implanted for more than one year,or - Intended to be implanted for more than one year,or - Life sustaining/life supporting and use outside user facility,or- Life sustaining/life supporting and use outside user facility,or - Failure would likely cause serious health consequences- Failure would likely cause serious health consequences

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

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

23. 23 Also coming….. eMDReMDR New device coding systemNew device coding system

24. 24