JSM 2012 Home

JSM 2012 Online Program

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

Online Program Home

Abstract Details

Activity Number: 70
Type: Topic Contributed
Date/Time: Sunday, July 29, 2012 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #305172
Title: A Comparison of Passive and Active Surveillance Approaches for Medical Devices
Author(s): Jeremy Strief*+
Companies: Medtronic
Address: Medtronic Energy and Component Center, Brooklyn Center, MN, 55430, United States
Keywords: Surveillance ; Medical Device ; Post-Market ; Signal Detection ; Quality Assurance ; Reliability

Increasing scrutiny is being applied to the issue of tracking adverse events and product performance for medical devices, particularly in a post approval setting. This presentation will discuss both traditional passive surveillance approaches and more modern active surveillance approaches. Passive surveillance may be defined as any system which relies on a patient or clinician to initiate a medical device complaint. Such systems are prone to underreporting, especially for low severity adverse events. By contrast, active surveillance may be defined as a system in which patients are being prospectively surveyed or monitored by the medical device manufacturer, so as to increase the probability that any existing adverse events will be reported to the manufacturer. This presentation will describe the statistical strengths and weaknesses of the two surveillance approaches. In particular, a variety of quality assurance statistical methods-Statistical Process Control, Survival Curve Trending, Disproportionality Analysis-will be discussed in the context of each surveillance approach.

The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.

Back to the full JSM 2012 program

2012 JSM Online Program Home

For information, contact jsm@amstat.org or phone (888) 231-3473.

If you have questions about the Continuing Education program, please contact the Education Department.