Title: Postmarket Surveillance of Medical Device Adverse Events
1Postmarket Surveillance of Medical Device Adverse
Events
Hesha Jani Duggirala, PhDEpidemiology Branch
Division of Postmarket SurveillanceOffice of
Surveillance and BiometricsCenter for Devices
and Radiological Health
2CDRH Background
Center for Devices and Radiological
HealthEnsuring the safety and effectiveness of
medical devices
3Postmarket SurveillanceActivities
Medical Device Reporting(MDR) systemData
miningMedical Product Surveillance Network
(MedSun)
4MDR 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)
5MDR Reporting
Device informationPatient informationProcedure
information
6MDR Reporting
Review of dataIndividual reportsAggregate data
7Limitations of MDR
UnderreportingIncomplete, non-validated data
No incidence dataUncertain causality Biased
reporting
8Data Mining at CDRH
Working with Lincoln Technologies webVDME
programDrug-eluting stents test case
9MedSun
Medical Product Surveillance NetworkReport
deaths, serious injuries, near misses
10Additional Information
MDR www.fda.gov/cdrh/mdrSearch MDR online
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMDR/
Search.cfmMedSun www.medsun.net/about.htmlRea
ch me hcj_at_cdrh.fda.gov