Vascular Catheter Devices: A Study of Safety and Performance, Volume 2

摘要

Volume 2 includes lists and charts of supplemental information of the study which describes the risks and hazards of vascular catheter devices and presents recommended minimum labeling and performance requirements which address the cited problems. The Franklin Research Center gathered information by reviewing medical literature, USP problem report files, manufacturers' product literature, and interviewing prominent clinical users. The researchers analyzed the data to define device problems and develop their recommendations, then submitted the interim study findings for open review at the 1981 annual meeting of the American Heart Association. The study should be of interest to standards writers, clinical users, and catheter designers, researchers, and manufacturers.