涉及眼科医疗器械的严重事件报告给AEMPS
L C Ramón-Carreira1, E M Sobas2, J C Pastor2
1Universidad de Valladolid, Valladolid, Spain; Facultad de Enfermería, Universidad de Valladolid, Valladolid, Spain.
Archivos de la Sociedad Espanola de Oftalmologia
|March 9, 2025
概括
新的规定要求向西班牙药品和医疗器械局 (AEMPS) 报告医疗器械严重事故. 眼科设备问题,包括OCT等软件和设备,越来越多地被报告.
科学领域:
- 医疗器械监管和安全 医疗器械监管和安全
- 眼科医疗器械监视监控 眼科医疗器械监控
背景情况:
- 医疗器械条例和192/2023皇家法令对医疗器械实施了新的安全和报告义务.
- 医疗机构和医疗人员必须向西班牙药品和医疗器械机构 (AEMPS) 报告严重事件.
研究的目的:
- 建立涉及眼科医疗器械的严重事故的基线.
- 评估科学协会和组织中监管概念的传播情况.
- 确定自2018年以来报告的严重事件的趋势.
主要方法:
- 与眼科医疗器械相关的严重事件的识别报告给AEMPS.
- 对受到健康警报的事件进行分析.
- 从2018年起对报告的审查.
主要成果:
- 建立了涉及眼科医疗器械的严重事故报告的基线.
- 虽然报告事件的百分比仍然很小,但有关软件和设备故障的报告显著增加.
- 现在在事件报告中已经发现了手术显微镜和光学一致性断层扫描 (OCT) 等特定设备.
结论:
- 监管框架正在推动眼科医疗器械严重事故报告的增加.
- 眼科设备软件和复杂设备的新出现的问题需要持续警和安全协议的潜在更新.
- 持续监测至关重要,以确保患者安全和监管合规在眼科医疗技术的不断变化的景观.
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