基于Python的医疗器械报告/原始记录自动生成编辑器设计  

Design of Automatic Editor for Generating Medical Devices Test Reports/Original Records Based on Python

作　　者：汤智[1] 党玺芸 袁秦[1] 何晓帆[1] 柯军[1] 冯珊[1] TANG Zhi;DANG Xiyun;YUAN Qin;HE Xiaofan;KE Jun;FENG Shan(Guangdong Medical Devices Quality Surveillance and Test Insitiute,Guangzhou Guangdong 510663,China)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663

出　　处：《中国医疗设备》2023年第12期106-112,共7页China Medical Devices

基　　金：广东省药品监督管理局2022年科技创新项目(2022TDB48)。

摘　　要：目的 探究医疗器械检测报告/原始记录自动生成的可能性,以突破检测机构长期面临的繁复文字处理的工作瓶颈。方法 基于Python语言,通过Python下的win32com模块、shutil模块、Python-docx库、openpyxl库等的综合使用,设计医疗器械报告/原始记录的自动编辑器,实现批量一键从技术要求生成报告/原始记录。结果 自动编辑器实现了送检信息的链接和检测结果的条件预填充,创新性地攻克了技术要求中引用国家/行业标准嵌套的问题。相较于编辑器上线前,检测人员的工作效率有大幅度提升,且差异有统计学意义(P<0.001);检测周期平均缩短63.8%,报告的文本差错率平均降低80.0%。结论 编辑器的应用为检测人员的日常工作提供了强有力的支撑,提升了检测机构的核心竞争力,同时对相关领域的实验室信息化管理系统编制有很好的启发作用。Objective To explore the possibility of automatic generation of medical device testing reports/original records,in order to break through the bottleneck of complex text processing faced by testing institutions for a long time.Methods The automatic editor for medical device reports/original records based on Python language has been designed through the comprehensive use of win32com module,shutil module,Python-docx library and openpyxl library,and the batch generation of reports/original records from technical requirements by the one-click was realized.Results The automatic editor achieved the linking of testing information and pre-filling of testing results,innovatively overcame the problem of referencing national/industry standards nested in technical requirements.Compared with the editor before on-line,the work efficiency of inspection personnel has been greatly improved and the differences was statistically significant(P<0.001).The testing cycle was shortened by an average of 63.8%,and the error rate of the report text was reduced by an average of 80.0%.Conclusion The application of the editor provides strong support for the daily work of inspection personnel,enhances the core competitiveness of testing institutions,and provides good inspiration for the preparation of laboratory information management system in related fields.

关 键 词：医疗器械报告 原始记录 PYTHON 自动生成 标准嵌套 

分 类 号：R197.324[医药卫生—卫生事业管理]