医疗器械的标识标准化网络监管.pdfVIP

题名：医疗器械的标识标准化与网络监管 作者：周方 周玉风 单位：浙江省丽水市人民医院 地址：浙江省丽水市大众街 15 号 邮编：323000 摘要 目的：通过探讨实施医疗器械的标识（编码）标准化、网络监管平台建设，推动 我国医疗器械信息化监管和物流网络化管理的发展。方法：采取文献检索、现状调查、实 际情况分析、发展前景展望等方法进行分析、研究、探讨，实地调查和询问20家大型（三 甲）医院、30大型家医疗器械生产企业和医疗器械经营企业。结果：由于医疗器械的标识 （编码）不统一、网络信息监管平台的建设滞后，严重阻碍着我国医疗器械管理水平的提 高。结论：加快实施医疗器械的标识（编码）标准化，建立全国范围内的医疗器械网络信 息监管平台和物流网络化管理平台，实现我国医疗器械生产、流通、使用、销毁和回收整 个流程的信息化管理，才能保证追溯的可行性和监管的有效性。 关键词：医疗器械、标识标准化、信息化监管 Title: Medical Device Identification Standardization and Network Monitoring Authors: Zhou Fang Zhou Yufeng Unit: Zhejiang Lishui Peoples Hospital Address: No. 15, Dazhong Street, Lishui, Zhejiang Postal Code: 323000 Abstract Objective: To promote the development of network information management on medical device supervision and logistics through investigating the implementation of the medical device identification(coding) standards and network monitoring platform. Methods: To analyze and study the collected literature and survey results gained by site investigation and inquiry of 20 large (top level) hospitals and 30 major medical device manufacturers and medical device sales companies. Results: The raise of medical device management level are serious obstructed due to the disunion of medical device identification(coding) and the lag in the development of network information monitoring platform. Conclusion: In order to ensure the feasible traceability and effective supervision, it is necessary to accelerate the implementation of medical identification(coding) standards and establish a nationwide monitoring network information platform for medical equipment and logistics network management, and realize the entire process of information management in medical device’s production, distribution, use, destruction and recycling. Keywords: medical device, identification standardization, regulatory information 引言 数字化时代的到来，运用信息化手段管理医疗器械