在COVID-19大流行期间,呼吸器的颗粒过效率
Jackson Williams1, Lucan Baillie1, Wayne Clancy1
1Health Products Regulation Group, Therapeutic Goods Administration, 27 Scherger Drive Fairbairn, Australian Capital Territory 2609, Australia.
Journal of infection and public health
|May 13, 2025
概括
治疗用品管理局 (TGA) 测试了400批呼吸器的颗粒过效率 (PFE). 70%符合要求,突出了在释放前需要对PFE标准进行验证的需要.
科学领域:
- 医疗器械规则 医疗器械规则
- 公共卫生 公共卫生
- 呼吸系统保护 呼吸系统保护
背景情况:
- 呼吸器是预防空气传播疾病传播的关键医疗设备.
- 治疗用品管理局 (TGA) 在COVID-19大流行期间调查了呼吸器颗粒过效率 (PFE).
- 测试包括在澳大利亚供应的呼吸器和来自其他司法管辖区的呼吸器,以确保其符合要求.
研究的目的:
- 评估澳大利亚可用的呼吸器的PFE性能.
- 为了评估是否符合声称的PFE标准.
- 为了确定影响呼吸器PFE性能的因素.
主要方法:
- 总共有400个呼吸器批量使用TGA开发的快速选PFE方法进行了测试.
- 使用统计功率分析,根据声称的PFE标准,制造国和在澳大利亚治疗用品登记册 (ARTG) 中的纳入时间来区分性能.
- 还比较了手术与非手术呼吸器的索赔.
主要成果:
- 70%的测试呼吸器批次 (n=400) 符合预先设定的合规标准.
- 在使用某些标准 (例如,42 CFR Part 84,AS 1716:2012) 的呼吸器与其他标准 (例如,GB 2626:2006) 相比,在PFE中观察到具有统计意义的差异.
- 在手术和非手术呼吸器之间没有发现显著的PFE差异.
结论:
- 在上市之前,确保呼吸器符合其声称的PFE,基于既定标准,至关重要.
- 建议进行进一步的研究,以评估临床环境中的呼吸器对气溶颗粒的有效性.
- 调查各种呼吸道保护装置的影响及其在医院声称的效率是有必要的.
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