Considerations in Post Market Surveillance: The Medical Device Epidemiology Network (Mdepinet) Methodology Center
Laura Hatfield, Harvard Medical School Lauren Kunz, Harvard School of Public Health *Sharon-Lise T. Normand, Harvard Medical School and Harvard School of Public Health Fred Resnic, Lahey Clinic Medical Center Aartik Sarma, Harvard Medical School Keywords: bayesian, comparative effectiveness, variaiblity Clinical outcomes associated with medical devices depend on interactions among (1) device hardware and software, (2) patient anatomy and physiology, (3) concurrent medical therapies, and (4) operator experience. The MDEpiNet Methodology Center is focused on developing methodology for combining information across data sources for inferring post market device safety and effectiveness accounting for these sources of variations. The comparative safety of artificial hips (data across registries and claims data), vascular closure devices (data across operators), and the effectiveness of cardiac resynchronization therapy (CRT) devices (data across published studies) illustrate our approaches. Using fully Bayesian hierarchical models, estimators are developed and the validity of assumptions and limitations of various approaches are discussed.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC