Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Dr. Knoell Consult GmbH, Mannheim, Germany.
ALTEX. 2017;34(4):479-500. doi: 10.14573/altex.1608081. Epub 2017 May 25.
Amid growing efforts to advance the replacement, reduction, and refinement of the use of animals in research, there is a growing recognition that in vitro testing of medical devices can be more effective, both in terms of cost and time, and also more reliable than in vivo testing. Although the technological landscape has evolved rapidly in support of these concepts, regulatory acceptance of alternative testing methods has not kept pace. Despite the acceptance by regulators of some in vitro tests (cytotoxicity, gene toxicity, and some hemocompatibility assays), many toxicity tests still rely on animals (irritation, sensitization, acute toxicity, reproductive/developmental toxicity), even where other industrial sectors have already abandoned them. Bringing about change will require a paradigm shift in current approaches to testing - and a concerted effort to generate better data on risks to human health from exposure to leachable chemicals from medical devices, and to boost confidence in the use of alternative methods to test devices. To help advance these ideas, stir debate about best practices, and coalesce around a roadmap forward, the JHU-Center for Alternatives to Animal Testing (CAAT) hosted a symposium believed to be the first gathering dedicated to the topic of in vitro testing of medical devices. Industry representatives, academics, and regulators in attendance presented evidence to support the unique strengths and challenges associated with the approaches currently in use as well as new methods under development, and drew next steps to push the field forward from their presentations and discussion.
在努力推进替代、减少和优化动物在研究中的应用的过程中，人们越来越认识到，医疗器械的体外测试在成本和时间方面都更有效，而且比体内测试更可靠。尽管支持这些概念的技术格局迅速发展，但替代测试方法的监管接受程度并没有跟上。尽管监管机构已经接受了一些体外测试（细胞毒性、基因毒性和一些血液相容性测试），但许多毒性测试仍然依赖于动物（刺激性、致敏性、急性毒性、生殖/发育毒性），即使在其他工业部门已经放弃这些测试的情况下也是如此。要实现这一转变，需要对当前的测试方法进行范式转变，并努力生成关于医疗器械可浸出化学物质暴露对人类健康风险的更好数据，并增强对替代方法测试设备的信心。为了推动这些想法，引发关于最佳实践的辩论，并围绕前进的路线图凝聚力量，约翰霍普金斯大学替代动物测试中心（CAAT）举办了一次研讨会，据信这是首次专门讨论医疗器械体外测试主题的研讨会。出席会议的行业代表、学者和监管机构展示了证据，以支持当前使用的方法以及正在开发的新方法所具有的独特优势和挑战，并根据他们的演讲和讨论提出了推动该领域前进的下一步措施。
