Postmarket Surveillance of Medical Device Adverse Events

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.htmlRea
ch me hcj_at_cdrh.fda.gov