Study on Blood Compatibility of a Central Venous Catheter and its Pyrogen Test

Abstract:

Objective:To evaluate the blood compatibility of a central venous catheter in order to provide evidence for the safety of medical devices. Methods:The indexes of coagulation including thrombin time(TT), prothrombin time(PT), activated partial thromboplastin time (APTT) and fibrinogen (Fg) concentration, as well as the indexes of platelet function parameters including TXB2 and platelet count were measured, hemolysis test was conducted as well to detect the hemolysis rate of the sample. Results:There was no significant difference between the samples and negative controls on indexes of coagulation and platelet function (p>0.05), hemolysis test showed that the hemolysis rate of the sample was 1.35% (less than 5%), which was coincident with the criteria of the medical devices. Conclusion:The test sample of central venous catheter has good blood compatibility.

• Periodical: Advanced Materials Research (Volume 630)
• Pages: 409-413
• DOI: https://doi.org/10.4028/www.scientific.net/AMR.630.409
• Online since: December 2012
• Authors: Feng Guo, Yang Yang, Fen Ju Liu, Qing Fang Liu
• Keywords: Blood Compatibility, Central Venous Catheter, Hemolysis Test, Platelet Function

References

[1] Clemence MA, Walker D, Farr BM (1995) Central venous catheter practices: results of a survey. Am J Infect Control 23: 5-12.

DOI: 10.1016/0196-6553(95)90002-0

[2] Feron VJ, Groten JP, van Bladeren PJ (1998) Exposure of humans to complex chemical mixtures: hazard identification and risk assessment. Arch Toxicol Suppl 20: 363-373.

DOI: 10.1007/978-3-642-46856-8_32

[3] ISO10993-4 (2002) Evaluation of medical devices-part 4: selection of tests for interactions with blood. J 2-10.

[4] Haycox CL, Ratner BD (1993) In vitro platelet interactions in whole human blood exposed to biomaterial surfaces: insights on blood compatibility. J Biomed Mater Res 27: 1181-1193.

DOI: 10.1002/jbm.820270909

[5] Siskin GP, Reiner E, Stainken BF, Dowling K, Dolen EG, et al. (2001) Activated clotting time as a screening test prior to catheter-based cardiovascular procedures. Catheter Cardiovasc Interv 54: 191-195.

DOI: 10.1002/ccd.1265

[6] Lippi G, Musa R, Avanzini P, Aloe R, Pipitone S, et al. (2012) Influence of in vitro hemolysis on hematological testing on Advia 2120. Int J Lab Hematol 34: 179-184.

DOI: 10.1111/j.1751-553x.2011.01378.x

[7] Daneshian M, Guenther A, Wendel A, Hartung T, von Aulock S (2006) In vitro pyrogen test for toxic or immunomodulatory drugs. J Immunol Methods 313: 169-175.

DOI: 10.1016/j.jim.2006.04.009

[8] Mazzotti F, Beuttler J, Zeller R, Fink U, Schindler S, et al. (2007) In vitro pyrogen test-A new test method for solid medical devices. J Biomed Mater Res A 80: 276-282.

DOI: 10.1002/jbm.a.30922