Abstract #300901

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JSM 2003 Abstract #300901
Activity Number: 289
Type: Contributed
Date/Time: Tuesday, August 5, 2003 : 2:00 PM to 3:50 PM
Sponsor: Section on Health Policy Statistics
Abstract - #300901
Title: Estimating Survival Function in Medical Device Postmarket Surveillance Study
Author(s): Chi-hong Tseng*+ and Yong Wang and Chunlei Ke
Companies: St. Jude Medical and St. Jude Medical and St. Jude Medical
Address: 1848 Purdue, #5, Los Angeles, CA, 90025-5593,
Keywords: postmarket surveillance ; double sampling ; survival analysis
Abstract:

We present a nonparametric approach to estimate the medical device survival function in a retrospective postmarket surveillance (PMS) study. A PMS study is intended to discover device safety data that could not have been obtained through clinical trials and hence serves as an early warning for problems with marketed devices. A typical setting involves a primary sample of all implanted devices from a company database and a validation simple random subsample from the PMS study.The primary sample usually contains rough and incorrect information because of the patients' failure to follow up and device failure underreporting, while the validation subsample consists of up-to-date and correct information. Our proposed method combines both data sets to correct the biased information from the company data set and achieve higher asymptotic efficiency than estimations based only on the validation sample. A simulation study is presented to illustrate the effectiveness of this method.

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