Biocompatibility of Tissue Engineered Implants

Publisher Summary The term “biocompatibility” is defined as the ability of a material, prosthesis, artificial organ, or biomedical device to perform with an appropriate host response in a specific application. The terms “biocompatibility assessment” and “safety assessment” are generally considered to be synonymous. The safety assessment of biomaterials, prostheses, artificial organs, and other medical devices is generally considered to be the determinant of the biological interactions of the medical device in an in vivo environment. The goal of safety testing is to evaluate if a medical device presents potential harm to the patient or user under conditions simulating use. In considering tissue engineering, a tissue engineered implant may be defined as a biologic–biomaterial combination in which some component of tissue has been combined with a biomaterial to create a device for the restoration or modification of tissue or organ function. Biocompatibility assessment may be considered to be a measure of the degree (magnitude) and extent (duration) of adverse alteration in homeostatic mechanisms. The physiological and other biomedical parameters, i.e., homeostatic mechanisms, that are important in a specific application determine the host response.