Review and Summary of Hemodialysis System Investigative Reports from California, the District of Columbia, Massachusetts and Ohio

摘要

This is a summary report by the District of Columbia Department of Consumer and Regulatory Affairs, Service Facility Regulation Administration (DCRA/SFRA) on the results of studies undertaken by four (4) jurisdictions between October 1984 and August 1986. The investigative studies on hemodialysis systems were conducted by California, the District of Columbia, Massachusetts and Ohio under contracts with the U.S. Food and Drug Administration (FDA). The principal aim of the studies was to provide assistance to FDA in gathering specific information on dialysis equipment usage and on problems experienced at dialysis facilities and by home dialysis patients. The report summarizes the findings of these four (4) studies and provides conclusions and recommendations based on these findings. Information was collected from a total of 82 hemodialysis facilities (both hospital-based and freestanding) in urban and rural locations. Interviews were also conducted with 18 home hemodialysis patients. The studies generated important information which was generally known to people who were interested in the well-being of hemodialysis patients, but which had not been previously collected in any systematic way. In addition, the findings served to highlight potential problematic areas that deserve further investigation.