A basic overview of hemocompatibility

Hemocompatibility refers to the ability of a device to cause hemolysis (rupture of red blood cells), clotting, formation of a thrombus or activation of the complement system. Hemocompatibility testing is essential for evaluating the interactions of medical devices having contact with blood. Evaluating hemocompatibility is therefore required before patient exposure and is required for 510(k) clearance, premarket approval and CE mark approvals, for example. The scope that hemocompatibility must consider depends on the device's intended use and characteristics determined through a biological evaluation plan.