植入性医疗器械唯一标识溯源管理的探讨.pdfVIP

植入性医疗器械唯一标识溯源管理的探讨 吴静炯 唐苏红 华茵 罗晓晨 复旦大学附属上海市第五人民医院 设备科(上海 200240) 摘要：本文探索植入性医疗器械唯一标识的追溯管理。植入性医疗器械管理是保 障临床医疗安全的一项重要工作。在植入性医疗器械使用过程中，加强植 入性医疗器械使用前管理，通过植入性医疗器械唯一标识全程追溯监管软 件，使用条码扫描枪、条码复原打印机、数据服务器等网络安全通讯设备， 对植入性医疗器械标识进行手术前初次扫描确认，在手术中由使用者核 对，当手术结束后，对植入性医疗器械标识进行再次扫描确认并登记。遵 循国家相关的法律法规和各类条例，选择合法的生产企业和供应商，选择 合格、合适、合理价格的医疗产品，符合流程规范严格执行并持续改进， 从而保证了植入性医疗器械的安全有效，保证使用过程中的医疗安全。 关键词：植入性医疗器械 唯一标识 追溯管理 The discussion of the implantable medical device unique identifier traceability management Wu Jing-jiong Tang Su-hong Hua Yin Luo Xiao-chen The Fifth People’s Hospital of Shanghai Affiliated to Fudan University (Shanghai 200240) Abstract ：This article explores the implantable medical device unique identifier traceability management. Implantable medical devices management is an important work for protect the safety of treat. We should strengthen the management of implantable medical devices before using them. Before surgery done the first scan to implantable medical devices by barcode scanner, barcode printers, data server, network security equipment and so on. The user should proofread identifier during the surgery. Done the second scan to implantable medical devices and register them after surgery. Follow the relevant state laws and regulations and various regulations, select the legitimate manufacturers and suppliers, reasonable price of medical products. Strictly according to process standard and continuously improve it, thus keep implantable medical devices safe and effective. To ensure safety during use of surgery. . Keywords ：implantable medical device,unique identifier,trac