A Comparison of Passive and Active Surveillance Approaches for Medical Devices

• Activity Number: 70
• Type: Topic Contributed
• Date/Time: Sunday, July 29, 2012 : 4:00 PM to 5:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Jeremy Strief*+
• Companies: Medtronic
• Keywords: Surveillance ; Medical Device ; Post-Market ; Signal Detection ; Quality Assurance ; Reliability

Abstract

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.