A risk assessment and control model for the failing Björk-Shiley convexo-concave heart valve.
For risk assessment and control of the failing Björk-Shiley convexo-concave heart valve, we present a life cycle-based complex system model and a risk intensity assessment model, allowing consistent analysis of this complex medical problem and identification of all pertinent aspects of product-related risks to patients.
Koornneef
F
F
Delft University of Technology, University of Amsterdam.
van Gaalen
G L
GL
de Mol
B A
BA
D004867:Equipment Design; D004868:Equipment Failure; D004869:Equipment Safety; D006350:Heart Valve Prosthesis / Q000592:standards*; D006801:Humans; D008962:Models, Theoretical; D018570:Risk Assessment; D013673:Technology Assessment, Biomedical / Q000379:methods*