国外大型医用设备管理的经验及借鉴意义  

Experience of Major Medical Equipment Management of Foreign Countries and its Significance for China

作　　者：何达[1] 刘佳琦[1] 谷茜[1] 胡献之[1] 梁斐[1] 陈英耀[1] 

机构地区：[1]复旦大学公共卫生学院,上海200032

出　　处：《中国医院管理》2012年第4期61-63,共3页Chinese Hospital Management

摘　　要：目的介绍国外大型医用设备管理的经验,为完善大型医用设备管理办法提供借鉴。方法通过浏览各国卫生部或相关部门的官方网站,并通过Google Scholar搜索引擎检索国外大型医用设备管理的相关信息。结果荷兰和日本等国的市场准入机制、欧盟的上市后监控和警戒系统、加拿大的缺陷设备召回机制、美国的需要许可证制度(CON)都是行之有效的大型医用设备管理经验。结论国外大型医用设备管理的市场准入、上市后监管和缺陷设备召回、政府强制审核和规范配置程序等管理经验,可以为新一轮医改中进一步完善大型医用设备管理提供参考。Objective To introduce experience of major medical equipment management of foreign countries and pro- vide reference for the perfection of major medical equipment management in China. Methods Information related to major medical equipment management were collected by browsing web sites of ministry of health or other in charge depart- ments of several development countries and searching related information through Google Scholar search engine. Results The market access system of the Netherlands and Japan, etc, the monitoring and warning system for marketing equip- ments of EU, the recall mechanism for defective equipments of Canada, and the Certificate of Need System （CON） of the United States are all effective management experience for major medical equipment. Conclusion Management experiencg of market access system, marketing equipment monitoring and warning system, recall mechanism, as well as government＇s mandatory review and regulation of equipment configuration procedures can be the reference for the improvement of major medical equipment management in the new round of health reform in China.

关 键 词：大型医用设备管理经验政府许可机制 

分 类 号：R197.39[医药卫生—卫生事业管理]