在MAUDE数据库中报告趋势的评估:1991年至2022年
Meital Mishali1, Nadav Sheffer2, Oren Mishali3
1University of Haifa, School of Public Health, Haifa.
Digital health
|January 24, 2025
概括
2015年和2018年的监管更新影响了医疗器械不良事件报告率. 这些变化改善了报告,但突出了延迟,特别是对于制造商来说,影响了数据库完整性和患者安全.
科学领域:
- 医疗器械安全 医疗器械安全
- 监管科学是一种监管科学.
- 公共卫生监督是对公共卫生的监督.
背景情况:
- 对医疗器械的不良事件报告对于市场后监测和风险减轻至关重要.
- 美国食品和药物管理局 (FDA) 的制造商和用户设施设备体验 (MAUDE) 数据库是收集这些报告的主要工具.
- 确保来自不同报告来源的数据完整性对于有效的监督至关重要.
研究的目的:
- 在MAUDE数据库中分析医疗器械不良事件报告模式.
- 评估2015年和2018年监管更新对不同类型的报告员报告率的影响.
- 通过将平均报告时间与监管要求进行比较来评估报告时间表的合规性.
主要方法:
- 从MAUDE数据库中获取了跨越1991-2022年的数据.
- 过的年度报告按报告员类型和事件类别计算.
- 通过从收到的日期减去意识日期来计算平均报告时间.
主要成果:
- 2018年自愿故障总结报告 (VMSR) 计划与制造商报告的增加相关,在2022年达到顶峰.
- 经销商报告在2018年后激增;自愿报告稳步增加,在2015年随着eMDR更新而升.
- 与分销商和用户设施相比,制造商超过了报告死亡 (80天) 和故障 (89天) 的监管时间表.
结论:
- 2015年和2018年左右的报告趋势可能与监管变化相关.
- 定制的监管更新,包括用户友好的电子表格和程序调整,可以提高报告质量.
- 在报告类型之间平衡报告量对于MAUDE数据库的完整性,透明度和改善健康结果至关重要.
关键词:
美国食品药品监督管理局 FDA FDA马德数据库的数据库是什么医疗器械 医疗器械 医疗器械不良事件是不良事件.市场监督后的市场监督工作监管 监管 监管 监管 监管 监管报告来源报告来源报告报告趋势的情况.更多相关视频
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