Cardiopulmonary Bypass Systems: A Study of Safety and Performance

摘要

This study of safety and performance of cardiopulmonary bypass (CPB) systems fulfills the requirements of FDA Contract 223-80-5081. The report includes a comprehensive review of the literature, identification of risks and hazards associated with CPB systems, a study of components and systems currently on the market, a study of nine users of CPB systems, and comments from an open review of the interim report. The study also addresses the feasibility of using the systems approach as well as the components approach to any standards effort for cardiopulmonary bypass systems.