医疗器械临床试验的伦理审查现状及解决思路

Current Situation of Ethical Review and Solving Ideas of Medical Equipment Clinical Trails

医院医疗器械伦理审查项目不断增多,但存在医疗器械临床试验管理不够规范,医院内部对医疗器械临床试验的伦理审查意识不强,医疗器械临床试验伦理审查相关法律法规不健全,医学工程人员伦理学素养不足等问题,影响了审查质量。对此应该制定明确的医疗器械伦理审查范围,提高医院各类人员在医疗器械使用方面的伦理意识,通过医学工程人员在实践中的探索,制定和不断完善医疗器械伦理审查的标准操作规程。

The number of ethical review projects of medical equipment has been increasing. While there are some problems affecting the quality of review ： the management of clinical trials is not standardized ; the consciousness to ethical review of medical equipment in hospitals is not strong; the related laws and regulations are not sound ; the ethical cultivation of medical engineers is not enough, and etc. This paper put forward some solving ideas such as drawing up the ethical review scope of medical equipment, raising the ethical consciousness of all medical staffs in using medical equipment, and formulating and continuously improving the standard operating procedure through the exploration and practice of medical engineers.