Material-mediated pyrogens in medical devices: Applicability of the in vitro Monocyte Activation Test

Main Article Content

Lindsey K. Borton , Kelly P. Coleman
[show affiliations]


Pyrogenicity presents a challenge to clinicians, medical device manufacturers, and regulators. A febrile response may be caused by endotoxin contamination, microbial components other than endotoxin, or chemical agents that generate a material-mediated pyrogenic response. While test methods for the assessment of endotoxin contamination and some microbial components other than endotoxin are well-established, material-mediated pyrogens remain elusively undefined. This review presents the findings of literature searches conducted to identify material-mediated pyrogens associated with medical devices. The in vivo rabbit pyrogen test (RPT) is considered to be the “gold standard” for medical device pyrogenicity testing, despite the fact that few medical device-derived material-mediated pyrogens are known. In line with global efforts to reduce the use of research animals, an in vitro monocyte activation test (MAT) has the potential to replace the RPT. The MAT is used to detect substances that activate human monocytes to release cytokines. This review will also describe the potential opportunities and challenges associated with MAT adoption for the detection of material-mediated pyrogens in medical device testing.

Article Details

How to Cite
Borton, L. K. and Coleman, K. P. (2018) “Material-mediated pyrogens in medical devices: Applicability of the in vitro Monocyte Activation Test”, ALTEX - Alternatives to animal experimentation, 35(4), pp. 453–463. doi: 10.14573/altex.1709221.

Most read articles by the same author(s)