Active Surveillance Systems for Early Detection and Improved Recall Decision Making

Volume 6, Issue 10 (November 2009)

Click here to download this paper now for $25 PDF (92K)

View License Agreement

ISSN: 1546-962X
CODEN: JAIOAD
Published Online: 22 October 2009
Page Count: 7

Active Surveillance Systems for Early Detection and Improved Recall Decision Making

Tolomeo, Deborah
Attorney, RAC, King & Spalding, LLC, Redwood Shores, CA

(Received 30 October 2008; accepted 8 September 2009)

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.

Keywords:
recall, surveillance, medical device, implants

Paper ID: JAI102204
DOI: 10.1520/JAI102204
ASTM International is a member of CrossRef.

Author Title Active Surveillance Systems for Early Detection and Improved Recall Decision Making Symposium Presented at the ASTM Second Symposium on Fatigue and Fracture of Medical Metallic Materials and Devices, 2008-05-07 Committee E08

		SEDL / Journals / Journal of ASTM International (JAI) / Citation Page Volume 6, Issue 10 (November 2009) Click here to download this paper now for $25 PDF (92K) View License Agreement ISSN: 1546-962X CODEN: JAIOAD Published Online: 22 October 2009 Page Count: 7 Active Surveillance Systems for Early Detection and Improved Recall Decision Making Tolomeo, Deborah Attorney, RAC, King & Spalding, LLC, Redwood Shores, CA (Received 30 October 2008; accepted 8 September 2009) 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. Keywords: recall, surveillance, medical device, implants Paper ID: JAI102204 DOI: 10.1520/JAI102204 ASTM International is a member of CrossRef. Author Title Active Surveillance Systems for Early Detection and Improved Recall Decision Making Symposium Presented at the ASTM Second Symposium on Fatigue and Fracture of Medical Metallic Materials and Devices, 2008-05-07 Committee E08