Regulatory and Safety Considerations in Deploying a Locally Fabricated, Reusable Face Shield in a Hospital Responding to the COVID-19 Pandemic
© 2020 Elsevier Inc..
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.
FUNDING: : This work was supported by the Harvard MIT Center for Regulatory Sciences, NIH/NCI grants U54-CA225088 and T32-GM007753, and the Harvard Ludwig Center. M.-J.A. is a Friends of McGovern Graduate Fellow.
| Errataetall: | |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:1 |
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| Enthalten in: |
Med (New York, N.Y.) - 1(2020), 1 vom: 18. Dez., Seite 139-151.e4 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Mostaghimi, Arash [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 02.05.2022 Date Revised 21.11.2022 published: Print-Electronic UpdateOf: medRxiv. 2020 Apr 15;:. - PMID 32511612 Citation Status MEDLINE |
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| doi: |
10.1016/j.medj.2020.06.003 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM314118055 |
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| 100 | 1 | |a Mostaghimi, Arash |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Regulatory and Safety Considerations in Deploying a Locally Fabricated, Reusable Face Shield in a Hospital Responding to the COVID-19 Pandemic |
| 264 | 1 | |c 2020 | |
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| 500 | |a Date Completed 02.05.2022 | ||
| 500 | |a Date Revised 21.11.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a UpdateOf: medRxiv. 2020 Apr 15;:. - PMID 32511612 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2020 Elsevier Inc. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a FUNDING: : This work was supported by the Harvard MIT Center for Regulatory Sciences, NIH/NCI grants U54-CA225088 and T32-GM007753, and the Harvard Ludwig Center. M.-J.A. is a Friends of McGovern Graduate Fellow | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a 3D printing | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a FDA regulations | |
| 650 | 4 | |a PPE | |
| 650 | 4 | |a additive manufacturing | |
| 650 | 4 | |a face shield | |
| 650 | 4 | |a local fabrication | |
| 650 | 4 | |a maker communities | |
| 650 | 4 | |a personal protective equipment | |
| 650 | 4 | |a regulatory science | |
| 700 | 1 | |a Antonini, Marc-Joseph |e verfasserin |4 aut | |
| 700 | 1 | |a Plana, Deborah |e verfasserin |4 aut | |
| 700 | 1 | |a Anderson, Philip D |e verfasserin |4 aut | |
| 700 | 1 | |a Beller, Brandon |e verfasserin |4 aut | |
| 700 | 1 | |a Boyer, Edward W |e verfasserin |4 aut | |
| 700 | 1 | |a Fannin, Amber |e verfasserin |4 aut | |
| 700 | 1 | |a Freake, Jacob |e verfasserin |4 aut | |
| 700 | 1 | |a Oakley, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Sinha, Michael S |e verfasserin |4 aut | |
| 700 | 1 | |a Smith, Leanne |e verfasserin |4 aut | |
| 700 | 1 | |a Van, Christopher |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Helen |e verfasserin |4 aut | |
| 700 | 1 | |a Sorger, Peter K |e verfasserin |4 aut | |
| 700 | 1 | |a LeBoeuf, Nicole R |e verfasserin |4 aut | |
| 700 | 1 | |a Yu, Sherry H |e verfasserin |4 aut | |
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