国际医疗器械安全性信息分析及建议

根据国际医疗器械监测数据统计,按照中华人民共和国医疗器械分类目录的分类标准、中华人民共和国医疗器械管理办法对医疗器械进行分类,并对不良事件产生原因进行探讨,重点分析了设计因素和临床应用因素。针对存在的问题提出加强人才培养,建立对医疗器械不良事件进行评定的第三方机构,加强政府监管及做好宣传工作等建议。

Security Analysis and Recommendations of the International Medical Equipment

The paper is based on the international medical device monitoring data and in accordance with the classification criteria of medical devices of the People＇s Republic of China as well as measures for the Administration of medical devices. The paper analyzed and focused on the design factors and the clinical application factors, it suggested that more attention for training should be paid; the third party organization to evaluate the adverse events should be established; government supervision needs to be emphasized and propaganda work needs to be performed.