The Vessel Dilator for Central Venous Catheter Placement: Forerunner for Success or Vascular Misadventure?

Author:

Scott Walter Louis1,Collier Paul2

Affiliation:

1. Food and Drug Administration, Center for Devices and Radiological Health, Office of Health and Industry Programs, Division of Device User Programs and Systems Analysis, Rockville, MD  wls@cdrh.fda.gov

2. Department of Surgery and Medical Director, Noninvasive Vascular Laboratory, Sewickley Valley Hospital, Blackburn Rd., Sewickley, PA.

Abstract

During placement of a central venous catheter (CVC), the vessel dilator and/or combination dilator/sheath-introducer are recognized as potential causative agents in numerous traumatic complications that may be erroneously ascribed to the catheter, placement needle, or guidewire. A review of the literature and device-user survey are offered in support of the need for additional training in safe dilator use, as well as the need to address device labeling and device design.

Publisher

SAGE Publications

Subject

Critical Care and Intensive Care Medicine

Reference33 articles.

1. 1.Code of Federal Regulations, Title 21 Section 803.

2. Mosenkis R. Medical devices: international perspectives on health and safety. Van Gruting C, ed. New York: Elsevier; 1994:41-51.

3. 5.Code of Federal Regulations, Title 21 Section 870.1310.

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