JSM 2005 Online Program

Abstract #304116

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Activity Number:	444
Type:	Topic Contributed
Date/Time:	Wednesday, August 10, 2005 : 2:00 PM to 3:50 PM
Sponsor:	Biopharmaceutical Section
Abstract - #304116
Title:	Statistical Methods in Signaling and Monitoring Medical Device Adverse Reports
Author(s):	Chang Lao*+
Companies:	U.S. Food and Drug Administration
Address:	1350 Piccard Drive, Rockville, MD, 20850, United States
Keywords:	Adverse Report ; Medical Devices
Abstract:	In 1984, the U.S. Food and Drug Administration (FDA) required manufacturers of medical device and radiation-emitting devices to submit reports of events that reasonably suggested a medical device had caused or may have caused or contributed to the death, serious injury, or serious illness of a patient in addition to device malfunctions whose recurrences would likely result in death, serious injury, or serious illness of a patient. Several statistical methods are discussed in this paper to analyze such medical device reports (MDRs), including MDR spike detection, nonparametric MDR trend test, the exploratory nonparametric regression methods, simple Poisson, mixed binomial/Poisson, zero-truncated Poisson, and the negative binomial (compound Poisson) in monitoring and determining the upper 95% threshold values. Two real MDR datasets are used to illustrate the above statistical applications.

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