论医疗技术临床应用的伦理审查与监管——由取消医疗技术临床应用准入审批引发的思考

Ethical Review and Surveillance of Medical Technology in Clinical Application:comments on the cancelling of the nonadministrative licensing approval of medical technology in China

在我国取消第三类医疗技术临床应用准入审批的背景下,通过对医疗技术管理新政的解析,从医疗技术伦理审查与监管的视角,提出医疗机构责任主体要切实履行医疗技术临床准入与应用管理责任,务必完善和扩大现有机构伦理委员会在医疗技术伦理评估及监管中的职能与范围,根据不同医疗技术的特点,完善审查流程、提高审查质量,并积极联合卫生行政部门建立有效的第三方定期评估与注重患者反馈的跟踪审查机制,从而有效地防范医疗技术风险,保障医疗技术的安全与合理应用,更好地维护患者健康。

In the background of the cancelling of non-administrative licensing approval of the ClassⅢmedical technology in clinical application in China,an interpretation of the new regulatory policy was made.From the perspective on ethical review and surveillance of medical technology,the authors argued as the responsibility subjects regulated in the new policy,the medical institutions should improve and expand their functions and regulatory scopes of Institutional Review Boards,improve ethical review process and review quality according to the different features of different kinds of medical technologies.Meanwhile,a sound third party assessment and continuing review system focused on patients feedback should be established with the support of government.As a result,it will provide the prevention of medical technology risks and the safeguard of scientific and ethical application of medical technology,as well as better protecting the patient＇s health in the end.