Perspectives on In Vivo Testing of Biomaterials, Prostheses, and Artificial Organs

Abstract

The goal of in vivo testing of a medical device is to determine the safety or biocompatibility of the device in a biological environment. Biocompatibility is the ability of a medical device to perform with an appropriate host response in a specific application. Biocompatibility assessment is considered to be a measure of the magnitude and duration of adverse alterations in homeostatic mechanisms that determine the host response. Perspectives are provided on the role of injury, tissue responses to medical devices, and blood responses to medical devices. The concept of the normal foreign body reaction is presented. The potential importance of the macrophage, an important component of the foreign body reaction, in controlling the biocompatibility in the in vivo environment is discussed.