PETA International Science Consortium Ltd., London, United Kingdom.
Vedere Solutions LLC, Erie, USA.
ALTEX. 2021;38(1):151-156. doi: 10.14573/altex.2012021.
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.
单核细胞激活试验（MAT）广泛可用，但很少用于替代动物热原试验来评估医疗器械的安全性。为了解决这个问题，国家毒理学计划机构间替代毒理学方法评估中心和善待动物组织国际科学协会有限公司于 2018 年 9 月 18 日至 19 日在国立卫生研究院举行了一次研讨会。与会者包括来自 MAT 测试实验室、医疗器械制造商、美国食品和药物管理局的设备和放射健康中心（CDRH）、美国药典、国际标准化组织以及 MAT 协议开发专家的代表。讨论涵盖了行业对 MAT 的经验、尚存的挑战，以及 CDRH 的医疗器械开发工具（MDDT）计划如何成为一种途径，使 MAT 有资格替代兔热原试验和鲎阿米巴样细胞溶解物试验用于医疗器械测试。讨论了研讨会的结果和后续活动。
