Assessment of in vitro blood compatibility of polymer and metal medical devices

Introduction. As part of the development of a new method for in vitro hemocompatibility testing, it is necessary to study the blood compatibility of various medical devices on an artificial blood flow test model. Material and methods. To study the blood compatibility of 13 polymeric and metallic medical devices, a method based on an in vitro artificial blood flow test model simulating the conditions of human arterial blood flow was used. Morphofunctional blood parameters were studied: levels of platelets, leukocytes, prothrombin fragment F1+2, thrombin-antithrombin complex III, beta-thromboglobulin, thromboxane B2 and complement cleavage proteins C3 after incubation with medical devices, positive and negative control samples. Results. It has been established that the degree of changes in the parameters reflecting the enhancement of platelet activation processes and blood forming elements, complement system and coagulation processes has a dependence on the time of incubation of medical devices with heparinized human blood in the test model of artificial blood flow in vitro. After 20 minutes of incubation of 13 medical devices, blood parameters did not statistically significantly differ from the positive control, but when the incubation time was increased to 60 and 120 minutes, 6 out of 13 devices, both polymeric and metallic, affected cellular and humoral components of blood, indicating their less pronounced hemocompatibility properties. Limitation. The study is limited to evaluating the hemocompatibility of polymeric and metallic medical devices only using a dynamic in vitro artificial blood flow test model. Conclusion. All studied polymeric and metallic medical devices were blood compatible after 20 minutes of incubation on an in vitro artificial blood flow test model using whole heparinized blood.