报告医疗器械事故的挑战和动态:一种定性研究
Meital Mishali1, Nadav Sheffer2, Maya Negev1
1The Health and Climate Resilience Lab, School of Public Health, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.
Frontiers in health services
|December 26, 2025
概括
改善医疗器械不良事件报告需要解决监管缺口和沟通问题. 更明确的角色和反机制对于提高全球患者安全和设备警至关重要.
科学领域:
- 医疗器械安全 医疗器械安全
- 公共卫生监督是对公共卫生的监督.
- 监管科学是一种监管科学.
背景情况:
- 对医疗器械的不良事件报告对于市场后监测和预防患者伤害至关重要.
- 维护,制造,用户错误和临床问题等因素使根源原因分析和问责制复杂化.
- 现有的法规塑造了政策,执法和不良事件报告中的责任.
研究的目的:
- 检查医疗器械事故报告中的感知,行为和挑战.
- 专注于以色列公共和私营部门的关键利益相关者.
- 一个国家正在等待有效的医疗器械法律的案例研究.
主要方法:
- 31个深度采访的定性主题分析.
- 利益相关者包括卫生部,医疗机构 (医生,护士,管理人员) 和医疗器械公司 (首席执行官,监管事务经理).
- 采访被转录和编码使用诱导主题分析.
主要成果:
- 因果关系的复杂性转移了责任,阻碍了根源原因的识别和问责制.
- 利益相关者之间的沟通是复杂的,不清楚的,有时受到利益冲突的影响.
- 报告行为受到组织文化的影响;护士报告的比医生更多;缺乏反减少了动机.
结论:
- 障碍包括监管漏洞,不清楚的程序,沟通问题和法律问题.
- 积极的组织间合作得到了注意到.
- 更强有力的监管,反,更明确的角色和支持性管理可以促进响应式报告文化,以改善医疗器械警和全球患者安全.
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