A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic
A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic
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DOI：
10.3389/fdgth.2021.617106
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发表时间：
2021-03-22
影响因子：
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通讯作者：
Sorger, Peter K.
中科院分区：
文献类型：
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作者：
Antonini, Marc-Joseph;Plana, Deborah;Sorger, Peter K.
2019冠状病毒病疫情期间，传统制造、供应及分销渠道中断，导致个人防护装备及其他医疗用品普遍短缺。这些短缺促使当地努力使用非传统的快速制造来满足紧急的医疗需求。在这里，我们提出了一个危机响应设计框架，旨在协助产品开发在流行病的条件下。该框架强调利益相关者的参与、全面但高效的需求评估、快速制造和改进的产品测试，以加速医疗保健产品的开发。我们将这一框架与以更谨慎的速度进行的传统医疗器械制造进行了对比，讨论了应对流行病的制造的优势和劣势，并考虑了相关的监管政策。我们强调使用的危机响应框架的面罩设计和生产的一个大型美国学术医院的案例研究。最后，我们提出了旨在提高未来对流行病和医疗紧急情况的抵御能力的建议。这些措施包括继续开发适合快速制造的开源设计，对制造商社区和医院管理人员进行快速制造医疗器械的教育，以及帮助在质量和创新之间取得平衡的监管政策的变化。
The disruption of conventional manufacturing, supply, and distribution channels during the COVID-19 pandemic caused widespread shortages in personal protective equipment (PPE) and other medical supplies. These shortages catalyzed local efforts to use nontraditional, rapid manufacturing to meet urgent healthcare needs. Here we present a crisis-responsive design framework designed to assist with product development under pandemic conditions. The framework emphasizes stakeholder engagement, comprehensive but efficient needs assessment, rapid manufacturing, and modified product testing to enable accelerated development of healthcare products. We contrast this framework with traditional medical device manufacturing that proceeds at a more deliberate pace, discuss strengths and weakness of pandemic-responsive fabrication, and consider relevant regulatory policies. We highlight the use of the crisis-responsive framework in a case study of face shield design and production for a large US academic hospital. Finally, we make recommendations aimed at improving future resilience to pandemics and healthcare emergencies. These include continued development of open source designs suitable for rapid manufacturing, education of maker communities and hospital administrators about rapidly-manufactured medical devices, and changes in regulatory policy that help strike a balance between quality and innovation.