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.

Compliance with ethical standards. A positive opinion was received from the Bioethics Commission of the Research Institute of GT Computer Science of the Russian Center for Ethics and Health Care (Protocol No. 2 dated 03/29/2022). All participants gave informed voluntary written consent to participate in the study.

Authors’ contributions:
Lappo L.G. – data collection and processing, text writing, statistical analysis, editing;
Grynchak V.A. – research concept and design, editing;
Sychik S.I. – material processing, editing.
All co-authors – approval of the final version of the article, responsibility for the integrity of all parts of the article.

Conflict of interest. The authors declare no conflict of interest

Funding. The study was carried out within the framework of the task 04.08. “To develop a method for evaluating the in vitro hemocompatibility of medical devices based on the test model of artificial blood flow” of the State Scientific and Technological Program “Scientific and Technical Support of Quality and Availability of Medical Services” for 2021–2025 of the subprogram “Safety of Human Environment” (State registration number 20220371 dated 03/28/2022).

Received: February 12, 2025 / Revised: February 25, 2025 / Accepted: July 14, 2025 / Published: August 29, 2025

1. ISO 10993-4:2017. Biological evaluation of medical devices. Part 4: Selection of tests for interactions with blood. Geneva: 2017.

2. Blok S.L.J., van Oeveren W., Engels G.E. The optimal incubation time for in vitro hemocompatibility testing: Assessment using polymer reference materials under pulsatile flow with physiological wall shear stress conditions. Journal of Biomedical Materials Research. 2019; 107(7): 2335.

3. Engels G.E., Blok S.L.J., van Oeveren W. In vitro blood flow model with physiological wall shear stress for hemocompatibility testing — An example of coronary stent testing. Biointerphases, 2016; 11(3): 031004.

4. Sevastyanov V.I. Assessment of biological safety of medical devices (analytical review. Perspektivnye. materialy. 2024; 4: 17–30. (in Russian)

5. Bhatt A. et al. Product evaluation: blood compatibility studies. In. Biomedical product and materials evaluation. Еd. P.V. Mohanan. Sawston. 2022; 435–59.

6. Link A. et al. Hemocompatibility testing of blood-contacting implants in a flow loop model mimicking human blood flow. J. of Vis. Exp. 2020; 5; 157. https://doi.org/10.3791/60610 PMID: 32202530

7. Jaffer I.H., Jaffer I.H., Weitz J.I. The blood compatibility challenge. Part 1: blood-contacting medical devices: the scope of the problem. Acta Biomaterialia. 2019; 94: 2–10.

8. Braune S. Lendlein А., Jung F. Developing standard and test protocols for testing the hemocompatibility of biomaterials Hemocompatibility of biomaterials for clinical applications: blood — biomaterials interaction. Еd.: C. Siedlecki.Duxford: United Kingdom Woodhead Publishing, 2018, 51–65.

9. Weber M., et al. Blood-contacting biomaterials: in vitro evaluation of the hemocompatibility. In: Hemocompatibility of Biomaterials for Clinical Applications: Blood-Biomaterials Interactions (51–76). Edition: 1st. Woodhead Publishing, 2018; 6: 99. https://doi.org/10.3389/fbioe.2018.00099

10. Mohan C.C., Chennazhi K.P., Menon D. In vitro hemocompatibility and vascular endothelial cell functionality on titania nanostructures under static and dynamic conditions for improved coronary stenting applications. Front Bioeng Biotechnol. 2013; 9(12): 9568–7. https://10.1016/j.actbio.2013.08.023

11. Munch K. et al. Use of simple and complex in vitro models for multiparameter characterization of human blood-material/device interactions. J. Biomater. Sci. Polym. 2000; 11(11): 1147–63.

12. Lappo L.G., Sychik S.I., Grynchak V.A. Use of whole conserved blood for in vitro evaluation of hemocompatibility of medical devices. V: Sychik SI, red. Health and the environment: collection of scientific papers [Zdorov’e i okruzhayushchaya sreda: sb nauch tr.] Gomel’, RB: Redaktsiya gazety «Gomelskaya praўda»; 2024. 34: 246–53. (In Russian)

13. Lappo L.G., Sychik S., Grynchak V.A. Development of a dynamic in vitro test model of artificial blood flow for assessing the hemocompatibility of medical devices: In book. Health and the environment: collection of scientific papers [Zdorov`e i okruzhayushhaya sreda: sb. nauch. trudov], Gomel’, RB: Redaktsiya gazety «Gomel’skaya praўda»; 2024, 34: 237–45. (In Russian)