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Biomaterials for medical devices: Are current hemo‐ or biocompatibility tests adequate?

Many factors can affect the characterisation of biomaterials during testing. Among them is the type of the testing solution, such as human, animal blood or saline solutions of even different composition. Further influencing factors are drugs that have been administered to the blood donor prior to testing. Experimental details affecting the quality of testing refer to the guidance of blood across the biomaterial leading to different shear stress on blood cells and specific blood donor conditions, such as the age, race and gender. Some of the misconceptions in testing are described here and serve to indicate that a systems approach, and not only individual test parameters, is best when reliably testing for the biocompatibility of biomaterials for further use in medical devices.