COVID-19对医疗设备报告和调查的影响
Zoe Pruitt1, Christian Boxley1, Seth A Krevat1,2
1MedStar Health National Center for Human Factors in Healthcare.
随着COVID-19的流行,医疗器械制造商在调查故障时面临了重大障碍,这可能会影响患者的安全. 在疫情期间对设备问题的延迟调查可能会导致未来的伤害.
科学领域:
- 医疗器械安全 医疗器械安全
- 公共卫生 公共卫生
- 监管科学 监管科学
背景情况:
- 制造商和用户设施设备体验 (MAUDE) 数据库收集美国食品和药物管理局 (FDA) 的医疗设备报告.
- 美国食品和药物管理局在2020年5月发布了有关COVID-19大流行期间医疗器械报告的指南,预测了潜在的报告和调查延误.
研究的目的:
- 分析COVID-19大流行对医疗器械报告的影响.
- 了解制造商在疫情期间调查设备故障时所面临的挑战.
主要方法:
- 对2020年1月1日至7月31日期间提交到MAUDE数据库的报告进行分析.
- 识别提及COVID-19的报告,以评估与大流行有关的影响.
主要成果:
- 在816,470份报告中,有3,500份提到COVID-19.
- 这些报告中有90.3%详细介绍了制造商在调查因流行病限制而导致故障设备的挑战.
- 4.8%的COVID-19患者描述了不良事件,85.8%的功能障碍具有临床意义.
结论:
- 随着COVID-19大流行,医疗器械报告和调查面临着巨大的挑战.
- 在疫情期间推迟的调查和设备的临床管理引发了对未来患者安全的担忧.
- 未经调查的故障对患者安全的长期影响仍然不清楚.
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