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Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic
Personal protective equipment (PPE) includes protective clothing, gowns, gloves, face shields, goggles, face masks, and respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness. While it is possible to use 3D printing to make certain PPE, there are technical challenges that have to be overcome to be effective enough. 3D-printed PPE can be used to provide a physical barrier to the environment. However, 3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators.
For additional information, please see the FDA guidance document and FAQ.
3D Printing for COVID-19 Response at MIT - This document outlines associated risks with using 3D printing for COVID-related medical devices and PPE.
Safety and 3D-Printed COVID-19 Medical Devices — An Interview with Veterans Affairs from 3Dprint.com.
3D Printing of Medical Equipment Can Help in the Pandemic - but Is Only a Stopgap from The Pew Charitable Trust
Public-Private Partnership to Coordinate on Open-source Medical Products for the COVID-19 Response
The Food and Drug Administration (FDA), the Veterans Health Administration (VA), the National Institutes of Health (NIH), and America Makes are partnering to coordinate the additive manufacturing response to Coronavirus.
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The FDA is striving to facilitate the use of 3D printing and other advanced manufacturing technology to bring PPE and other needed medical device parts to healthcare organizations through emergency use authorization.
- The NIH 3D Print Exchange is providing access to a collection of design files for sharing with the community.
- The Veterans Health Administration is leading a process to review protective equipment and other devices in demand for the COVID-19 crisis. Prototypes that meet applicable standards will be designated as "Clinically Reviewed."
- America Makes is a large public-private partnership with members that span many different 3D printing industries. They have created an online repository to connect the capabilities of the additive manufacturing industry with specific needs of health care providers.
Members of the collaboration will work continuously to evaluate 3D printable parts and other improvised designs for their effectiveness and identify several designs that are likely to be the most useful for healthcare providers and patients in shortage situations. For more information, view COVID-19 Supply Chain Response: Frequently Asked Questions.
Printing Materials and Sterilization
ASTM International is providing no-cost public access to important ASTM standards used in the production and testing of personal protective equipment.
Things to Consider to Produce Safe and Effective Medical Devices from Formlabs
Which Materials should I use to 3D print PPE or Medical Components? by Javelin Tech
Prusa Face Shield disinfection
Current Initiatives
The Biomedical Library at the University of Pennsylvania is working with the Penn Health Tech Rapid Response Team to create face shields, masks, and ventilators.
Stony Brook University is producing face shields with partners on Long Island.
Do-It-Yourself Medical Devices and Protective Gear Fuel Battle Against COVID-19 at Georgia Tech
MatterHackers COVID-19 Maker Response Hub
COVID-19 Response Projects from the Stanford BioEngineering Prakash Lab
Formlabs 3D Printed Test Swabs for COVID-19 Testing and COVID-19 Community Part Library
How Academic Medical Centers and the 3D Printing Industry Teamed Up to Respond to COVID-19
Additional References
Jones, R. M., Bleasdale, S. C., Maita, D., Brosseau, L. M., & CDC Prevention Epicenters Program. (2020). A systematic risk-based strategy to select personal protective equipment for infectious diseases. American Journal of Infection Control, 48(1), 46-51.
Perez, M., Block, M., Espalin, D., Winker, R., Hoppe, T., Medina, F., & Wicker, R. (2012, August). Sterilization of FDM-manufactured parts. In 23rd Annual International Solid Freeform Fabrication Symposium–An Additive Manufacturing Conference (pp. 285-296).
Phan, L. T., Sweeney, D., Maita, D., Moritz, D. C., Bleasdale, S. C., Jones, R. M., & CDC Prevention Epicenters Program (2019). Respiratory viruses on personal protective equipment and bodies of healthcare workers. Infection Control and Hospital Epidemiology, 40(12), 1356–1360. https://doi.org/10.1017/ice.2019.298
Provenzano, D.; Rao, Y.J.; Mitic, K.; Obaid, S.N.; Pierce, D.; Huckenpahler, J.; Berger, J.; Goyal, S.; Loew, M.H. Rapid Prototyping of Reusable 3D-Printed N95 Equivalent Respirators at the George Washington University. Preprints 2020, 2020030444 (doi: 10.20944/preprints202003.0444.v1). https://www.preprints.org/manuscript/202003.0444/v1
Ricles, L. M., Coburn, J. C., Di Prima, M., & Oh, S. S. (2018). Regulating 3D-printed medical products. Science Translational Medicine, 10(461), eaan6521.
Tarfaoui, M.; Nachtane, M.; Goda, I.; Qureshi, Y.; Benyahia, H. 3D Printing to Support the Shortage in Personal Protective Equipment Caused by COVID-19 Pandemic. Materials 2020, 13, 3339.
Tino, R., Moore, R., Antoline, S. et al. COVID-19 and the role of 3D printing in medicine. 3D Print Med 6, 11 (2020). https://doi.org/10.1186/s41205-020-00064-7
Verbeek, J. H., Ijaz, S., Mischke, C., Ruotsalainen, J. H., Mäkelä, E., Neuvonen, K., Edmond, M. B., Sauni, R., Kilinc Balci, F. S., & Mihalache, R. C. (2016). Personal protective equipment for preventing highly infectious diseases due to exposure to contaminated body fluids in healthcare staff. The Cochrane Database of Systematic Reviews, 4, CD011621. https://doi.org/10.1002/14651858.CD011621.pub2
Vordos, N., D. A. Gkika, et al. (2020). "How 3D printing and social media tackles the PPE shortage during Covid – 19 pandemic." Safety Science 130: 104870. http://www.sciencedirect.com/science/article/pii/S0925753520302678
Last modified date: Fri, 08/07/2020 - 8:54am