再处理医疗器械监管的研究及思考

Research and Reflection on Reprocessed Medical Devices Supervision

在保证安全、有效的前提下,是否可对医疗器械再处理后进行重复使用,从而降低医疗费用,已成为我国相关监管部门的关注点。该文通过对美国、日本、欧盟等国际主要经济体对再处理后医疗器械的监管政策进行研究,从法规层面、技术层面对监管再处理医疗器械的风险进行思考,分析我国对再处理医疗器械进行监管的思路和风险关注点,为我国对该类器械的监管提供借鉴和参考。

Under the precondition of ensuring safety and effectiveness,whether to reuse reprocessed medical devices to reduce the medical expenses has become the focus of the relevant regulatory authorities in our country.In this paper,we studied the regulatory policy for reprocessed medical devices in major international economies,such as United States,Japan,European Union and so on.From the regulatory and technical level,we thought about the risks of supervising reprocessed medical devices,and analyzed the ideas and risk concerns of supervising reprocessed medical devices to provide reference for regulation of such devices in our country.