在医疗器械不良事件报告中,协调代码的应用研究.
Soo Jeong Choi1,2, Sooin Choi3,4, Songhyeon Park5
1Division of Nephrology, Department of Internal Medicine, Soonchunhyang University College of Medicine, 170, Jomaru-Ro, Bucheon, 14584, Republic of Korea. crystal@schmc.ac.kr.
医疗器械不良事件 (MDAE) 报告显示监管机构之间的代码应用有所不同. 大多数参与者使用了广义代码,表明需要在市场后监督中提高标准化.
科学领域:
- 监管科学 监管科学
- 医疗器械安全 医疗器械安全
- 市场后监督 后市场监督
背景情况:
- 报告不良事件对于医疗器械 (MD) 的市场后监测和安全信号检测至关重要.
- 由于全球事件和公共卫生危机,国际监管机构实施了医疗器械不良事件 (MDAE) 的标准化代码.
- 本研究评估了MDAE术语和编码系统的实际应用.
研究的目的:
- 评估国际医疗器械监管机构论坛 (IMDRF) 的不良事件术语和代码的应用.
- 在医疗器械不良事件报告期间识别代码选择的模式和变化.
主要方法:
- 对监管机构MD培训计划的参与者进行了在线调查.
- 该调查包括六个虚拟医疗设备不良事件 (MDAE) 案例,让参与者编码.
- 对参与者的代码选择进行了分析,以寻找模式和变化.
主要成果:
- 监管机构主要选择广泛的 (一级) 代码,而不是详细的 (二级或三级) 代码,用于MDAE报告.
- 虽然代码的选择有所不同,但超过50%的受访者选择了针对特定案件的预期代码 (案例6).
- 与设备问题,组件和健康影响相关的代码经常被选择用于原因调查.
结论:
- 在医疗器械不良事件 (MDAE) 报告中观察到术语和代码选择的多样化.
- 研究结果表明,在一致应用标准化MDAE编码系统方面,存在潜在的挑战.
- 可能需要进一步改进或培训,以提高MDAE报告的统一性.
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