国内外一次性医疗器械重复使用管理政策现状研究

Study on the Management Policy Situation of the Re-use of Single-use Device at Home and Abroad

目的:为我国一次性医疗器械(SUDs)的重复使用管理提供参考。方法:介绍我国SUDs的使用管理现状以及美国、德国SUDs重复使用的管理政策,并对已发表的SUDs重复使用的研究文献进行研究,分析并探讨其安全性和伦理性。结果:我国尚无法规明确定义SUDs重复使用的范围、标准和要求等;美国和德国对SUDs重复使用的管理较为完善但模式各有不同。经文献分析表明,目前对SUDs重复使用存在支持、反对及认为应分类管理3种研究结果。在安全性方面,SUDs重复使用需要依据具体品种和消毒操作而定;在伦理问题方面,应关注患者知情权、对成本的节约以及环境的影响。结论:我国应建立健全SUDs重复使用管理制度,开展重复使用的分类评估,鼓励第三方组织参与SUDs回收,并加强其不良反应监测等。

OBJECTIVE：To provide reference for the management of re-use of single-use devices（SUDs）in China. METHODS：The management situation of SUDs use in China and the management policy of SUDs re-use in America and Germany were introduced,the published literature of SUDs re-use was researched and the safety and ethicality were analyzed and discussed. RESULTS：China had no regulation for the clear definition of the range,standards and requirements of SUDs re-use;America and Germany had well-management for the SUDs re-use with different modes. Literature analysis showed that there were 3 results for the SUDs re-use,including supporting,opposition and classified management. In terms of safety,SUDs re-use needs the base of specific species and disinfection operations;in terms of ethicality,SUDs re-use should focus on the right to know of patients and the effects on cost savings and environment. CONCLUSIONS：China should establish and improve the management policy of SUDs re-use,develop the classification assessment of re-use,encourage third-party organizations participating in the recycling of SUDs and strengthen the monitoring of adverse reactions,etc.