与Hemospray相关的报道不良事件的分析:FDA的MAUDE数据库研究
Khalid Ahmed1, Mohamed Abdallah2, Daniyal Abbas3
1Department of Internal Medicine, The Wright Center for Graduate Medical Education, Scranton, PA.
Journal of clinical gastroenterology
|June 2, 2023
概括
用于消化道出血的局部静血粉末Hemospray具有与设备相关的问题,如激活失败和患者的不良事件,如组织损伤. 内镜医生在使用该设备时应意识到这些风险.
科学领域:
- 胃肠病学 胃肠病学
- 医疗器械 医疗器械
- 患者安全 患者安全
背景情况:
- 局部静血粉末,如Hemospray,通过形成屏障和帮助凝血来控制胃肠道 (GI) 出血.
- 黑梅斯普雷是美国第一个FDA批准的静血粉,其用于肠道出血的使用正在增加.
- 关于与静血粉相关的不良事件的数据有限,需要进一步调查.
研究的目的:
- 分析和报告与Hemospray (TC-325) 使用相关的不良事件.
- 识别与设备相关的技术问题,与患者相关的不良事件和与医疗保健人员相关的不良事件.
主要方法:
- 分析了来自FDA制造商和用户设施设备体验数据库的营销后监测数据.
- 数据涵盖2018年6月至2022年4月的时间.
- 报告的事件被分为与设备相关的,与患者相关的和与工作人员相关的不良事件.
主要成果:
- 总共有502个医疗器械报告索赔被确定,导致558个与医疗器械相关的问题,28个患者不良事件和2个工作人员不良事件.
- 最常见的设备问题是激活故障 (70.0%) 和CO2流障碍 (21.7%).
- 患者的不良事件主要包括组织损伤/出血 (n=21) 和穿孔 (n=5).
结论:
- 海莫斯喷剂是治疗胃肠道出血的宝贵工具.
- 内镜医生必须意识到与设备相关的潜在问题和患者不良事件.
- 仔细考虑这些风险对于安全有效地使用Hemospray至关重要.
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