Regulatory and Safety Considerations in Deploying a Locally Fabricated, Reusable Face Shield in a Hospital Responding to the COVID-19 Pandemic
Regulatory and Safety Considerations in Deploying a Locally Fabricated, Reusable Face Shield in a Hospital Responding to the COVID-19 Pandemic
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DOI：
10.1016/j.medj.2020.06.003
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发表时间：
2020-12-18
期刊：
影响因子：
17
通讯作者：
Yu, Sherry H.
中科院分区：
文献类型：
--
作者：
Mostaghimi, Arash;Antonini, Marc-Joseph;Yu, Sherry H.
背景资料：由于供应链中断，COVID-19疫情导致医护专业人员的个人防护设备严重短缺。基于3D打印的本地制造是解决这一挑战的一种方法，特别是在防护面罩等产品的情况下。没有明确的路径存在，但是，引入本地制造的产品到临床setting.Methods：我们描述了一个研究协议下机构审查委员会的监督，允许临床医生参与一个迭代的设计过程，然后在急诊室的真实世界的测试。所有的设计，使用的材料，测试协议，和调查结果的报告，以促进类似的努力在其他临床settings.Findings：临床测试允许事件指挥团队在一个主要的学术医疗中心，介绍当地制造的面罩到一般使用中的快速，但控制良好的方式。与标准的医院面罩不同，当地制造的设计旨在可重复使用。我们讨论了设计和测试过程，并概述了与个人防护设备（如面罩）的制造和测试相关的监管考虑因素。我们的工作是一个案例研究，为当地应对与流行病相关的医疗供应链中断提供了有力的应对措施，对医疗保健专业人员、医院管理人员、监管机构、以及对COVID-19和未来医疗保健紧急情况感到担忧的公民。
Background: Due to supply chain disruption, the COVID-19 pandemic has caused severe shortages in personal protective equipment for health care professionals. Local fabrication based on 3D printing is one way to address this challenge, particularly in the case of products such as protective face shields. No clear path exists, however, for introducing a locally fabricated product into a clinical setting.Methods: We describe a research protocol under Institutional Review Board supervision that allowed clinicians to participate in an iterative design process followed by real-world testing in an emergency department. All designs, materials used, testing protocols, and survey results are reported in full to facilitate similar efforts in other clinical settings.Findings: Clinical testing allowed the incident command team at a major academic medical center to introduce the locally fabricated face shield into general use in a rapid but well-controlled manner. Unlike standard hospital face shields, the locally fabricated design was intended to be reusable. We discuss the design and testing process and provide an overview of regulatory considerations associated with fabrication and testing of personal protective equipment, such as face shields.Conclusions: Our work serves as a case study for robust, local responses to pandemic-related disruption of medical supply chains with implications for health care professionals, hospital administrators, regulatory agencies, and concerned citizens in the COVID-19 and future health care emergencies.