Pediatric Intensive Care and Intermediate Care Department, Sant Joan de Déu University Hospital, Universitat de Barcelona, Esplugues de Llobregat, Spain; Immune and Respiratory Dysfunction Research Group, Institut de Recerca Sant Joan de Déu, Santa Rosa 39-57, 08950 Esplugues de Llobregat, Spain.
Innovation Department. Sant Joan de Déu University Hospital, Universitat de Barcelona, Esplugues de Llobregat, Spain.
Paediatr Respir Rev. 2020 Sep;35:61-63. doi: 10.1016/j.prrv.2020.06.015. Epub 2020 Jun 20.
There are significant logistical challenges to providing respiratory support devices, beyond simple oxygen flow, when centres run out of supplies or do not have these devices at all, such as in low resource settings. At the peak of the COVID-19 crisis, it was extremely difficult to import medical equipment and supplies, because most countries prohibited the medical industry from selling outside of their own countries. As a consequence, engineering teams worldwide volunteered to develop emergency devices, and medical experts in mechanical ventilation helped to guide the design and evaluation of prototypes. Although regulations vary among countries, given the emergency situation, some Regulatory Agencies facilitated expedited procedures. However, laboratory and animal model testing are crucial to minimize the potential risk for patients when treated with a device that may worsen clinical outcome if poorly designed or misused.
在中心耗尽供应品或根本没有这些设备(例如在资源匮乏的环境中)时,提供除简单氧气流量以外的呼吸支持设备存在重大后勤挑战。在 COVID-19 危机的高峰期,进口医疗设备和用品极其困难,因为大多数国家禁止医疗行业向其本国以外的地区销售。因此,全球的工程团队自愿开发紧急设备,机械通气方面的医学专家也帮助指导了原型的设计和评估。尽管各国的规定不同,但鉴于紧急情况,一些监管机构为加快程序提供了便利。然而,实验室和动物模型测试对于降低患者在使用设计不当或使用不当可能导致临床结果恶化的设备时的潜在风险至关重要。