By now, most of us in the manufacturing world are familiar with the steady stream of news describing organizations, large and small, providing medical equipment using 3D printers. Face masks, face shields, swabs, and parts for ventilators are the most common—and needed—as the frontline medical community struggles to heal patients while protecting themselves. What could be simpler than to create a design, prep the data, ship it to a printer and send the finished part to a happy user or manufacturer?
It is not as simple as it sounds.
“There are literally hundreds of 3D printing designs to support the current COVID-19 response. Some work, others don’t. Some look great but do not work,” explained Dr. Jenny Chen, M.D., founder and CEO of 3DHEALS, a company focusing on education and industrial research in bioprinting, regenerative medicine, and healthcare applications using 3D printing. She was a moderator for a webinar panel titled “3D Printing Design for COVID-19,” presented April 22.
Some of the most relevant highlights from the 90-minute webinar were discussions about liability, best choice of materials, and dealing with material shortages as demand spikes for the raw materials needed to make the products that are in such high demand.
Volunteers and Liability
“In March, four people started a non-profit group called MAKE4COVID and [as of April 22] we are over 2,000 people” making needed personal protective equipment (PPE) for the greater Colorado area, said Nicholas Jacobson in the webinar. He is an architect and designer focused on biomedical 3D printing. MAKE4COVID is a coalition formed by the maker community, with small providers as well as larger companies.
Jacobson stressed the need to work directly with surgeons using PPE to develop the best designs possible. “We had a trauma surgeon who literally flipped our design [for a face shield] upside down to make it work better for her,” he said. “We had high hopes when we started, but we would come up with a design and [the sources for] materials dried up,” he said, a caution echoed by others in the webinar. He explained how they made do with substitutes, constantly shifting designs to accommodate the materials they could actually get.
He also shared concerns about liability. “Face shields were easy because there was no liability attached, at least in Colorado,” he said. “But, as we get into producing medical devices, the territory gets a lot trickier.” He noticed that there was much initial skepticism of taking equipment from such a coalition, until the pandemic progressed and the need became greater. “Still, liability is a real concern for the future.”
Respirator Mask Designs
Beyond face shields, MAKE4COVID also went through a process of designing face masks, which as of April 22 were in production. Again, as in face shields, Jacobson stressed it was a process that required input from end users to create an acceptable face mask design.
Dr. Kevin Yoder, D.D.S., is a practicing dentist who also provides software for dentists to employ 3D printers in their practices. He stressed the need to use biocompatible resins from 3D printers. “If you are using 3D printing for face masks and other PPE, one should ask if there is any harm in doing that, such as allergic reactions,” he said. Using biocompatible resins would reduce that, among other considerations. He also stressed that when using FDM for PPE, avoid using ABS since it produces a harmful off-gas. The FDM materials he recommended were TPU, PLA and PETG.
Yoder also noted that even among the 3D-printed masks they were one-size-fits-all designs. “Adapting designs to the unique anatomy [of patients] and creating one-off designs is what dentists do all the time,” he said. In response, he adapted his dental software to create MeshMask, a free and semi-automated software tool to create a custom-fitted mask based on 3D face scans.
Designs, Laboratories, and Liability
As expected, it is not just in the U.S. that people are finding source materials difficult to get. “If you are looking for straight plastic PETG right now, you will have to wait at least 15 weeks,” said Dr. Stephanie Willerth. She has been working with a group in British Columbia using an open-source approach to 3D printing for PPE. She has the technical credentials, holding a Canada Research Chair in Biomedical Engineering at the University of Victoria, Canada with dual appointments in the Department of Mechanical Engineering and the Division of Medical Sciences as a Full Professor.
By converting what had been her biomedical laboratory into a temporary facility for inspecting and sterilizing the parts, the lab has been able to ship out 100 to 200 face shields per day for use in B.C. “We did consult with the Health Canada authorities to ensure our designs were suitable and we did have some disclaimers on our packaging,” she said.
She expressed a sentiment most ad hoc providers can relate to. “A month ago we weren’t doing this and now we are making large quantities and shipping them every day,” she said.
As Dr. Chen noted in the conversation afterwards, “there is a possibility that liability can be an issue after all of this is over; the risk is not zero. However, if you have gone through various processes to vet your design, vet your final manufactured product, you have tried your best, and demonstrated a process or obtained your design from an official website, the risk may be decreased.”
To listen and watch the entire webinar go to: https://3dheals.com/3d-printing-design-for-covid-19-show-notes-and-recordings
To learn more about 3DHEALS, go to https://3dheals.com/