Fogarasi Magdalene, Snodderly Kirstie, Herman Alexander, Guha Suvajyoti, Porter Daniel
Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, United States Food and Drug Administration, Silver Spring, MD 20993, USA.
Addit Manuf. 2023 Apr 5;67:103468. doi: 10.1016/j.addma.2023.103468. Epub 2023 Mar 1.
The onset of the 2019 novel coronavirus disease (COVID-19) led to a shortage of personal protective equipment (PPE), medical devices, and other medical supplies causing many stakeholders and the general public alike to turn to additive manufacturing (AM) as a stopgap when normally accessible devices were not available. However, without a method to test these AM constructs, there continued to be a disconnect between AM suppliers and the community's needs. The objective of this study was to characterize the pressure drop and leakage of four different publicly available AM face mask models with two filter material combinations, as well as to investigate the impact of frame modification techniques including the use of foam strips and hot-water face forming to improve fit when the masks are donned on manikin head forms. AM face mask frame designs were downloaded from public repositories during the early stages of the COVID-19 pandemic. AM face masks were fabricated and tested on manikin head forms within a custom chamber containing dry aerosolized NaCl. Pressure drops, particle penetration, and leakage were evaluated for various flow rates and NaCl concentrations. Results indicated that filter material combination and frame modification played a major role in the overall performance of the AM face masks studied. Filter material combinations showed improved performance when high filtration fabric was used, and the cross-sectional area of the fabric was increased. AM frame modifications appeared to improve AM face mask leakage performance by as much as 69.6%.
2019年新型冠状病毒病（COVID-19）的爆发导致个人防护装备（PPE）、医疗设备及其他医疗用品短缺，使得许多利益相关者和普通公众在无法获得常规可用设备时，将增材制造（AM）作为权宜之计。然而，由于缺乏测试这些增材制造产品的方法，增材制造供应商与社区需求之间仍然存在脱节。本研究的目的是表征四种不同的公开可用增材制造口罩模型与两种过滤材料组合的压降和泄漏情况，并研究框架修改技术的影响，包括使用泡沫条和热水面部塑形，以改善在人体模型头部佩戴口罩时的贴合度。在COVID-19大流行的早期阶段，从公共存储库下载了增材制造口罩框架设计。增材制造口罩在装有干燥雾化氯化钠的定制腔室内的人体模型头部上制造并进行测试。评估了各种流速和氯化钠浓度下的压降、颗粒穿透率和泄漏情况。结果表明，过滤材料组合和框架修改在所研究的增材制造口罩的整体性能中起主要作用。当使用高过滤织物且织物横截面积增加时，过滤材料组合表现出更好的性能。增材制造框架修改似乎使增材制造口罩的泄漏性能提高了多达69.6%。
