城乡统筹发展下的医疗器械在线监管系统研究

【作者】 张建国；

【导师】 叶茂； 张本强；

【作者基本信息】 电子科技大学 ， 软件工程， 2010， 硕士

【摘要】 随着重庆市城乡统筹发展建设任务的推进,对于传统的医疗器械监管模式带来了新的挑战。借助互联网基础设施和信息化手段,改变基层委托监管方式,使其最大层度地发挥医疗器械监管信息共享的优势,已成为一个重要课题。利用已经成熟的网络技术,运用先进的管理信息系统和软件开发平台,对医疗器械在线监管进行科学化管理,实现跨地域界限的监管信息共享系统,建成公开、透明的医疗器械监管信息系统,已成为医疗器械监管业务发展的最好模式。针对城乡统筹发展下医疗器械在线监管业务的特点,提出基于Internet的医疗器械在线监管系统的开发,目的在于为区县委托监管人员、乡镇医疗器械监督人员、提供一个网络化的信息交互平台,通过整个系统的实现,架构医疗器械生产企业、经营企业、医疗机构、使用人员和医疗器械行业管理部门之间的交互桥梁,推进医疗器械安全的可持续发展。本文首先研究了医疗器械监管的现状和发展趋势,在线监管的目的和意义,分析了城乡统筹发展环境下的医疗器械在线监管系统建设的可行性,指出了利用网络化的信息技术支撑工具,解决区县分局委托乡镇街道部门的监管过程中存在的问题,同时利用互联网络为医疗器械生产厂家、经营单位、医疗机构提供重点监管器械的设备流向信息的及时申报,采用不良事件信息的网上管理,提高了监管效率;通过分局之间的信息互动和快速交流利用加强监管活动安排与协助排查。然后对系统进行需求分析,论证了系统开发中的技术路线和关键技术选型,确定了系统总体架构设计,包括系统的逻辑结构、功能结构、物理结构和用户结构,概要描述了各层设计思想和设计原则。对系统的四个子系统及各模块的功能要求进行了详细描述,确定了系统的设计原则,开发环境,研究方法等,并对设计中的主要问题进行了探讨;最后,通过系统试点和试运行,证明达到了项目提出的建设目标和要求,并且满足未来的扩展性要求,同时保护了医疗器械生产经营单位的信息安全。系统采用将j2ee架构,数据库采用了ORACLE,采用JDBC作为B端的数据访问技术。系统实现了医疗器械生产经营和使用单位、监管机构等多方互动的网络平台,为医疗器械监管人员、委托监管人员和生产经营使用单位提供了高效快捷、方便的信息服务。更多还原

【Abstract】 With the overall development of urban and rural construction tasks of the advance, the traditional regulatory model for medical devices brings new challenges. With Internet infrastructure and information technology tools to change the way primary regulatory commission, to the maximum level degree of regulation of medical devices to play the advantages of information sharing has become an important issue. Use of network technology has matured, the use of advanced management information systems and software development platform, on-line monitoring for medical devices and scientific management, and supervision of cross-regional information sharing system boundaries to build an open, transparent regulatory information systems for medical devices, has been supervision of a medical device the best business model.For urban and rural development operations under the supervision of medical equipment online the characteristics of the Internet-based online monitoring system for medical devices development, aimed at regulators for the county commission, township supervisors, medical devices, providing a network-based information exchange platform, implementation of the system, structure of medical device manufacturers, enterprises, medical institutions, the use of personnel and medical equipment industry management of interaction between the bridge, promoting the sustainable development of medical device safety.This thesis studies the medical device regulatory status and trends, on-line monitoring of the purpose and significance of the urban and rural environment for the development of medical devices under the feasibility of building online monitoring system, pointing out that the use of networked information technology support tools to solve District Branch of the Department’s monitoring commissioned by the process of township street problems, while using the Internet for medical equipment manufacturers, business units, medical device regulatory agencies focus on the flow of information in a timely manner the device reporting, adverse event information using the online management improve the efficiency of supervision; through the interaction of information between branches and the rapid exchange of regulatory activities by strengthening the arrangements and to assist the investigation.Then the system requirements analysis, systems development demonstrates the technical route and key technology selection, determine the overall system architecture, including the system’s logical structure, functional structure, physical structure and user structure, the outline design description of each layer and design principles. The four subsystems of the system functional requirements and the modules described in detail to determine the system design principles, development environment, research methods, and the design of the main issues discussed.Finally, the pilot and test run through the system proved to propose the construction of the project objectives and requirements and meet future expansion requirements, while protecting the medical equipment production and business units of information security. System uses the j2ee architecture, database using ORACLE, used as a B-side JDBC data access technology. System realizes the operation and use of medical equipment production units, regulators and other interactive multi-network platform for the medical device regulators, entrusted with supervisory staff and production units to provide a quick and efficient and convenient information services.更多还原