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SUMMARY:Ensuring Medical Device Safety on the U.S. Market: Building a Bett
 er Surveillance System - Sean Cheng - Engineering Design Centre
DTSTART:20090520T153000Z
DTEND:20090520T163000Z
UID:TALK18477@talks.cam.ac.uk
CONTACT:Thomas Jun
DESCRIPTION:The U.S. Food and Drug Administration’s Center for Devices a
 nd Radiological Health (CDRH) is responsible for ensuring patient safety a
 nd continued surveillance of more than 500\,000 medical device models on t
 he U.S. market. Currently\, the CDRH Office of Surveillance and Biometrics
  (OSB) does not have standardized procedures in place for monitoring devic
 e problems\, but rather rely on individual analysts’ experience and obse
 rvations for problem detection. Furthermore\, the increase of medical devi
 ce reporting (MDR) makes timely review by analysts evermore difficult. The
 se difficulties may lead to delayed awareness of potentially harmful and l
 ife-threatening design flaws\, and hinder timely enforcement actions. An o
 ngoing project aims to build a framework for an effective detection system
  by focusing on existing patterns in the MDR database and from analyst exp
 eriences\, as well as on previous Class I device recall (the most serious)
  cases. This presentation will provide a snapshot of U.S. FDA's current po
 stmarket surveillance process for medical devices and use past device reca
 lls to demonstrate both quantitative and qualitative methods that will hel
 p improve the system of ensuring patient safety.
LOCATION:Marshall's meeting room (next to EDC loft)\, Inglis Building\, En
 gineering Department
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