Using the monocyte activation test as a stand-alone release test for medical devices

Main Article Content

Jeffrey Brown
Amy J. Clippinger
Claire Fritz Briglia
Warren Casey
Kelly Coleman
Anja Fritsch
Thomas Hartung
Djik Maouyo
Thierry Muller
Johannes Reich
Laure Robert
Ruth Roeder
Guillermo Sanchez
Anita Y. Sawyer
Shabnam Solati
Radhakrishna Tirumalai
Walter Zwisler
David Allen

Abstract

Monocyte activation tests (MAT) are widely available but rarely used in place of animal-based pyrogen tests for safety assessment of medical devices. To address this issue, the National Toxicology Program Interagency Center for the Eval­uation of Alternative Toxicological Methods and the PETA International Science Consortium Ltd. convened a workshop at the National Institutes of Health on September 18-19, 2018. Participants included representatives from MAT testing laboratories, medical device manufacturers, the U.S. Food and Drug Administration’s Center for Devices and Radio­logic Health (CDRH), the U.S. Pharmacopeia, the International Organization for Standardization, and experts in the development of MAT protocols. Discussions covered industry experiences with the MAT, remaining challenges, and how CDRH’s Medical Device Development Tools (MDDT) Program, which qualifies tools for use in evaluating medical devices to streamline device development and regulatory evaluation, could be a pathway to qualify the use of MAT in place of the rabbit pyrogen test and the limulus amebocyte lysate test for medical device testing. Workshop outcomes and fol­low-up activities are discussed.

Article Details

How to Cite
Brown, J., Clippinger, A. J., Fritz Briglia, C. ., Casey, W., Coleman, K., Fritsch, A., Hartung, T., Maouyo, D., Muller, T., Reich, J., Robert, L., Roeder, R., Sanchez, G., Sawyer, A. Y., Solati, S., Tirumalai, R., Zwisler, W. and Allen, D. (2021) “Using the monocyte activation test as a stand-alone release test for medical devices”, ALTEX - Alternatives to animal experimentation, 38(1), pp. 151-156. doi: 10.14573/altex.2012021.
Section
Meeting Reports

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