Affiliations: Safety Science Group, Delft University of Technology, Delft, Netherlands | Department of Cardiopulmonary Surgery, Academic Medical Center, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, Netherlands
Abstract: In the Netherlands, the incidence of fractured Björk-Shiley convexo-concave heart valves led to investigations regarding the extent, impact, and management possibilities of this public health problem. Apart from an epidemiological study, we performed a safety management study. This study led us to conclude that: (1) the Björk-Shiley convexo-concave heart valve is perceived as a safety risk by patients, doctors, and health care administrators alike; (2) doctors and health care administrators rely heavily on the technical information regarding artificial heart valves that is provided by the manufacturer; (3) the professionals best qualified to assess and control the risks of heart valve replacement are cardiac surgeons. Based on these conclusions, this report provides recommendations regarding safety risk assessment and the participation of doctors in preimplantation and clinical research programmes in order to improve the safety of newly designed heart valves.
