植入性医用耗材溯源规范化管理的探讨  

Discussion of standardized management of the traceability of implanted medical consumables

作　　者：仇保跃[1] 蒋勇[1] 闫伟[1] 

机构地区：[1]第二炮兵总医院医学工程科,北京100088

出　　处：《中国医学装备》2015年第1期123-125,共3页China Medical Equipment

摘　　要：目的:探讨如何在生产和运输环节,医院内部物流及使用环节中规范植入性医用耗材的管理。方法:针对植入性医用耗材的特殊性和高风险性特点,依照国家的相关法规,依托信息化条件,规范植入性医用耗材原材料、产品加工、销售、仓储运输以及患者使用环节的追踪溯源,并对植入性医用耗材溯源规范化管理进行探讨。结果:建立植入性医用耗材各个环节的溯源管理流程,形成植入性医用耗材规范化管理模式,通过不完整信息快速检索实现双向溯源,从而有效控制植入性医用耗材的不良事件发生,降低医疗风险。结论:通过探讨为植入性医用耗材溯源制定相关的规范化管理标准提供参考。Objective：Discuss how the management of implantable medical consumables can be standard during the links of production, transportation, internal logistics of the hospital and the sector of using. Methods： In accordance with the relevant national laws and regulations, and long-term management practice and experience, and aiming at the specialty and high risk characteristics of implanting medical consumables, we apply information technique to regulate the standard operation of the whole medical supplies links （raw materials, processing of products, marketing, warehousing transportation, and the usage of the patients）, therefore the roots can be traced back. The implanted medical supplies traceability standardized management needs to be explored. Results： Through the establishment of the traceability management process system of implanting medical supplies, the standard management mode of the medical supply technique will be attained. Even when the information is incomplete, we can retrieve and trace back quickly. Therefore, the goal of controlling the adverse events of medical implants, reducing medical risks can be achieved. Conclusion：the discussion above can be taken as a reference to the standardization of the management of implantable medical consumables.

关 键 词：植入性医用耗材 质量控制 溯源数据管理 

分 类 号：R197.39[医药卫生—卫生事业管理]