Comprehensive Review of Hemodialysis Equipment and Related Peripheral Support Equipment: Efficacy, Efficiency and Safety. Volumes 1 and 2

摘要

The report is a study to identify potential and/or existing problems related to design, operation and maintenance of hemodialysis equipment and to make recommendations to CDRH, FDA, for preventive measures for safe operation of the equipment. FDA asked for collection and analysis of hemodialysis equipment information. The Department of Consumer and Regulatory Affairs participated in the study because the District of Columbia has the highest mortality rate of end stage renal disease patients in the nation. The study consisted of on-site inspections of equipment, interviewing hemodialysis facility staff and former home hemodialysis patients, and reviewing manufacturers' literature. The findings are based on data collected from fifteen hospital-based and freestanding hemodialysis facilities now operating in the District of Columbia. The study generated new research data and highlighted potential problem areas that needed further study. The study collected evidence but the data was not sufficient to draw definite conclusions.