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

Abstract

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.

Strategy for the hemocompatibility testing of microparticles

“…While thrombogenic particles are applied to induce regeneration in a defined area of the body (e.g. calcium phosphate loaded blood based hydrogels for bone defect filling), hemocompatible microparticles are required for a variety of applications including ultrasound microbubbles, cancer immunotherapy, drug carrier systems and extracorporeal adsorption matrices for the separation or purification of various molecules [1,13,30,35] [20,43]. Such approaches allow studying the interactions between certain cell types and the material properties in a fundamental way and might improve our knowledge about the underlying molecular mechanisms [38].…”