Biocompatibility

Biocompatibility is the evaluation of how therapeutic non-drug materials (implanted, inhaled or surface contacting) interact with the human body, most often when in use as a medical device. Many factors determine biocompatibility of a material, including but not limited to its shape, surface porosity, material, sterilization, intended use, and elution of chemical entities from the device into the body. New materials and blends of existing materials are constantly being introduced to the market and new modes of utilization are regularly being invented. This, combined with prolonged use of devices, novel applications and constantly evolving regulations are further complicating the methods for assessing their biocompatibility and acceptability for use. Further, risk based on chemical analysis of substances being extracted from a device serves as a separate basis for assessing potential risk to patients.