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作 者:苏辅芸 袁博 李艺芳 SU Fu-yun;YUAN Bo;LI Yi-fang(NMPA Institute of Medical Economics;Guangzhou Pharmaceutical Economic Press Co.,Ltd.)
机构地区:[1]国家药品监督管理局南方医药经济研究所 [2]广州医药经济报出版有限公司
出 处:《中国食品药品监管》2024年第9期182-193,共12页China Food & Drug Administration Magazine
基 金:2023年中国药品监督管理研究会课题(2023-Y-Q-003)。
摘 要:目的:开展2023年度医疗器械安全公众满意度的调查研究,了解公众对医疗器械安全的满意程度和变化情况,为医疗器械监管提供参考依据。方法:通过医疗器械安全公众满意度指标评价体系(MSI模型)开展分析研究。对2023年度江苏、广东、湖南、四川、辽宁等地区的消费者开展调查,发放问卷共计1200份,回收有效问卷1090份。对公众对医疗器械安全及监管的态度、信任、期望和满意程度开展分析。结果:MSI模型信度与效度良好;2023年公众对医疗器械安全总体满意度为80.41分,与2022年基本持平;不同地区公众满意度存在明显差别,呈现“中西高、东部低”的趋势;公众对医疗器械监管认知存在一定的偏差;公众购械用械存在风险。结论:根据满意度各项指标对比结果,建议有针对性地加强科普宣传力度,并持续加强监管,确保公众购械用械安全。Objective:This empirical study aims to conduct 2023 annual survey on public satisfaction regarding medical device safety to gauge the public’s satisfaction levels and track changes in attitudes,providing references for medical device regulation.Methodology:Using the Medical Device Safety Public Satisfaction Index(MSI)model,this study conducted a survey of consumers from Jiangsu,Guangdong,Hunan,Sichuan,and Liaoning.A total of 1200 questionnaires were distributed,with 1090 valid responses collected.Analyze public attitudes,trust,expectations,and satisfaction towards medical device safety and regulation.Results:The MSI model demonstrated good reliability and validity.The overall public satisfaction with medical device safety in 2023 was 80.41 points,remaining consistent with 2022.Significant regional differences in public satisfaction were observed,showing a trend of"higher in the central and western regions,lower in the eastern region."Public understanding of medical device regulation displayed some discrepancies,and risks were noted in the public's use and purchase of devices.Conclusion:Based on a comparison of satisfaction indexes,it is recommended to strengthen targeted public science outreach.Continued regulatory oversight is essential to ensure the safety of medical device usage and purchases.
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