Pyrogens and Safety of Medical Devices

Pyrogens are fever-inducing substances derived from pathogens or even abiotic materials. The presence of pyrogenic contaminants in injectables or on medical devices can lead to severe reactions of the immune system, which can cause the death of patients, particularly in seriously ill patients. 

The research group focusses on the one hand on the testing of injectables and medical devices for their pyrogenic potential in vitro to prevent harmful reactions in vivo (see Figure). On the other hand, we also investigate the performance of medical devices in terms of their bio- and haemocompatibility. Our research focusses in particular on the early activation of the plasma contact phase system and the adsorption of plasma proteins. We firstly aim to understand the mechanism behind the unwanted activation and then establish methods to prevent or at least reduce the reaction leading to the activation of plasma proteins and cells, which ultimately cause the failure of the device. 

Coagulation activation Inflammation DIC, SIRS

Contact{element.contextual_1.children.icon}: Dr. Sandra Stoppelkamp Group leader{element.contextual_1.children.icon}: 07071 29-83340{element.contextual_1.children.icon}: 07071 29-5369


External Scientific Consultant{element.contextual_1.children.icon}: Dr. med. Stefan R. M. Fennrich

Dr. Fennrich was involved in the development of the monocyte activation test (MAT) at the University of Konstanz. The test method was introduced in 2010 into the European Pharmacopoeia as an alternative to animal pyrogen testing. As an external consultant, he brings his longstanding expertise in the field of pyrogen testing to our lab.

selected publications:

Selected publications:

  • Inflammatory potential of cotton-based surgically invasive devices: Implications for cardiac surgery. Trunk S, Müllerbader P, Hennig U, Abel M, Koggel A, Stang K, Altreuter Y, Steger V, Schlensak C, Wendel HP, Stoppelkamp S. J Biomed Mater Res B Appl Biomater. 2019,107(6):1877-1888. doi: 10.1002/jbm.b.34280. 
  • Speeding up pyrogenicity testing: Identification of suitable cell components and readout parameters for an accelerated monocyte activation test (MAT). Stoppelkamp S, Würschum N, Stang K, Löder J, Avci-Adali M, Toliashvili L, Schlensak C, Wendel HP, Fennrich S. Drug Test Anal. 2017, 9(2):260-273. doi: 10.1002/dta.1973. 
  • Identification of Predictive Early Biomarkers for Sterile-SIRS after Cardiovascular Surgery. Stoppelkamp S, Veseli K, Stang K, Schlensak C, Wendel HP, Walker T. PLoS One. 2015,10(8):e0135527. doi: 10.1371/journal.pone.0135527. eCollection 2015.
  • Hemocompatibility testing according to ISO 10993-4: discrimination between pyrogen- and device-induced hemostatic activation. Stang K, Krajewski S, Neumann B, Kurz J, Post M, Stoppelkamp S, Fennrich S, Avci-Adali M, Armbruster D, Schlensak C, Burgener IA, Wendel HP, Walker T. Mater Sci Eng C Mater Biol Appl. 2014,42:422-8. doi: 10.1016/j.msec.2014.05.070. 
  • Highly sensitive pyrogen detection on medical devices by the monocyte activation test. Stang K, Fennrich S, Krajewski S, Stoppelkamp S, Burgener IA, Wendel HP, Post M. J Mater Sci Mater Med. 2014, 25(4):1065-75. doi: 10.1007/s10856-013-5136-6.

Zertifikate und Verbände

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