公立医疗机构医疗器械监管模式新探

目的为提高公立医疗机构医疗器械监管效能提供参考。方法结合上海松江辖区内医疗器械监管的实际情况,总结公立医疗机构医疗器械管理中存在的问题。结果公立医疗机构医疗器械管理有了较大程度的改善,但仍存在人员储备不足、制度执行不到位等问题。结论政府部门应在完善相关法律法规、提高监督执法效能的同时,指导公立医疗机构进一步增强医疗器械风险管理意识,完善管理制度,确保公众医疗器械使用安全。

Exploration on Mode of Medical Device Regulation in Public Medical Institutions

Objective To provide reference for improvement of efficacy in medical device regulation in public medical institutions. Methods Problems existing in medical device management in public medical institutions were summarized in combination with the current local administration situation in Songjiang District in Shanghai. Results Medical device management in public medical institutions was greatly improved. However, there were still such defects as staff shortage and weak execution of regulations. Conclusion The government department should further enhance related laws and regulations, improve administration efficacy, and guide medical institutions to improve their performance in medical device management, and improve management system to ensure the safe public use of medical devices.