区块链在医疗器械全生命周期质量管理中的应用探讨  

Effect of blockchain on the whole life cycle quality management of medical devices

作　　者：陆阳 杨林[1] 戴剑峰[1] 胡海洋 吴涵旭 王菁菁 钱雪峰[1] LU Yang;YANG Lin;DAI Jianfeng;HU Haiyang;WU Hanxu;WANG Jingjing;QIAN Xuefeng(The First Affiliated Hospital,Soochow University,Suzhou 215000,China)

机构地区：[1]苏州大学附属第一医院,江苏苏州215000

出　　处：《现代医院》2022年第8期1248-1249,1253,共3页Modern Hospitals

基　　金：国家重点研发计划(2017YFC0114300);江苏省高校哲学社会科学研究一般项目(2019SJA1245);苏州市科技发展计划重点项目(SS201847)。

摘　　要：区块链作为一种去中心化基础性架构和分布式计算范式,已经受到包括政府部门、科研单位、创新企业和金融机构等的高度重视与广泛关注,将为新一代的信息技术带来全新的发展变革际遇。作为临床诊疗的重要物质保障和技术支撑,医疗器械具有技术含量高、风险管控严、更新升级快、经济成本大等特点。区块链的数据去中心化管理、安全性保障和不可篡改等特点恰好与医疗器械管理的安全性、溯源性和全流程管控等高度吻合。因此,本研究尝试将区块链技术应用到医疗器械全生命周期质量管理当中,持续发掘区块链的应用价值,助力公立医院医疗器械管理提质增效。As a decentralized basic architecture and distributed computing paradigm,blockchain has been highly valued and widely concerned by government departments,scientific research institutions,innovative enterprises and financial institutions.It will bring a new opportunity of development and reforms for the new generation of information technology.As an important material and technical support for clinical diagnosis and treatment,medical devices have such characteristics as high technical content,strict risk management and control,fast updating and upgrading,and high economic cost.Characteristics like data decentralization management,security guarantee and non-tampering of blockchain are highly consistent with the requirements of medical devices for security,traceability and whole-process control.Therefore,this study attempts to apply blockchain technology to quality management of medical devices throughout their life cycle,continuously explore the application value of blockchain,and help public hospitals improve the quality and efficiency of medical device management.

关 键 词：区块链 医疗器械 全生命周期管理 医疗安全 

分 类 号：R197.39[医药卫生—卫生事业管理] TP311.13[医药卫生—公共卫生与预防医学] R319[自动化与计算机技术—计算机软件与理论]