Journal Published Online: 22 October 2009
Volume 6, Issue 10

Active Surveillance Systems for Early Detection and Improved Recall Decision Making

CODEN: JAIOAD

Abstract

Medical device recalls have received significant publicity regarding the timeliness and breadth of the response by the manufacturer. It has been suggested that third party oversight and enhanced public disclosure would improve the recall process. This paper discusses the limitations of passive surveillance systems and proposes new active surveillance systems to support early detection and improved recall decision making. This paper also describes additional benefits of obtaining surveillance information to support iterative design changes and product enhancements.

Author Information

Tolomeo, Deborah
RAC, King & Spalding, LLC, Redwood Shores, CA
Pages: 7
Price: $25.00
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Details
Stock #: JAI102204
ISSN: 1546-962X
DOI: 10.1520/JAI102204