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Postmarket Surveillance of Medical Device Adverse Events

Postmarket Surveillance of Medical Device Adverse Events. Hesha Jani Duggirala, PhD Epidemiology Branch Division of Postmarket Surveillance Office of Surveillance and Biometrics Center for Devices and Radiological Health. CDRH Background.

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Postmarket Surveillance of Medical Device Adverse Events

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  1. Postmarket Surveillance of Medical Device Adverse Events Hesha Jani Duggirala, PhDEpidemiology Branch Division of Postmarket SurveillanceOffice of Surveillance and BiometricsCenter for Devices and Radiological Health

  2. CDRH Background Center for Devices and Radiological HealthEnsuring the safety and effectiveness of medical devices

  3. Postmarket SurveillanceActivities Medical Device Reporting(MDR) systemData miningMedical Product Surveillance Network (MedSun)

  4. MDR Reporting ▪ Nationwide passive surveillance system▪ Device death, serious injuries, and malfunctions▪ Reports submitted by manufacturers,user facilities, and voluntary reporters (including patients, healthcare providers, and consumers)

  5. MDR Reporting Device informationPatient informationProcedure information

  6. MDR Reporting Review of dataIndividual reportsAggregate data

  7. Limitations of MDR UnderreportingIncomplete, non-validated data No incidence dataUncertain causality Biased reporting

  8. Data Mining at CDRH Working with Lincoln Technologies’ webVDME programDrug-eluting stents test case

  9. MedSun Medical Product Surveillance NetworkReport deaths, serious injuries, near misses

  10. Additional Information MDR: www.fda.gov/cdrh/mdrSearch MDR online: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMDR/Search.cfmMedSun: www.medsun.net/about.htmlReach me: hcj@cdrh.fda.gov

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