医疗器械标准数据库用户体验测评及提升建议

Performance Evaluation on User Experience of Medical Device Standard Databases and Suggestions for Improvement

目的提升我国医疗器械标准数据库的检索效果,助推我国医疗器械数字化标准研究。方法采用数据库体验泛用性得分和平均站点索引量等多种计算方法,对国际标准化组织(ISO)、美国食品和药物管理局(FDA)、国际电工委员会(IEC)、欧洲标准化委员会(CEN)、日本独立行政法人药品和医疗器械综合机构(PMDA)、英国标准协会(BSI)、中国食品药品检定研究院(NIFDC)7个医疗器械标准数据库的各项功能的使用体验、检索效果进行评价性研究。结果7个医疗器械数据库具有各自的优势、特色与不足,从综合测评结果而言,ISO数据库在使用体验和检索效果2个方面具有综合优势。结论建议借鉴国外医疗器械数据库及其检索网站的界面友好性、检索效率、数据库界面的泛用性等先进经验,以提升我国医疗器械标准数据库的相关性能。

Objective To improve the retrieval effect of the Chinese medical device standard database,and to promote the research of digital standards for medical devices in China.Methods Several calculation methods such as the database experience generality score and the average site index were used to study the user experience and retrieval effect of the various functions of seven medical device standard databases,including the databases of the International Organization for Standardization(ISO),Food and Drug Administration(FDA),International Electrotechnical Commission(IEC),European Commission for Standardization(CEN),Pharmaceuticals and Medical Devices Agency(PMDA),British Standards Institute(BSI),and National Institute for Food and Drug Control(NIFDC).Results The seven medical device databases have their advantages,characteristics,and limitations.In terms of comprehensive evaluation results,the ISO database has comprehensive advantages in user experience and retrieval effect.Conclusion It is recommended to learn from the advanced experience of foreign medical device standard databases and their retrieval websites,such as friendly interface,retrieval efficiency,and universality of database interface,to improve the performance of Chinese medical device standard database.