Prototype submitted for emergency FDA approval; could help ease shortage of life-saving PPE
By the University at Buffalo
There are plenty of online tutorials for using 3-D printing to create N95-like respirators.
Yet to work properly, and reduce the spread of COVID-19, these improvised respirators must meet stringent requirements.
For example, a respirator’s effectiveness is “highly dependent upon proper fit and use,” according to the Centers for Disease Control and Prevention. Otherwise, virus-laden respiratory droplets can sneak past tiny gaps between the respirator and user’s face.
With that and other critical details in mind, a University at Buffalo-led research team is developing plans to 3-D-print safe, effective and reusable N95-like respirators. The team, which includes local manufacturers and 3-D-printing enthusiasts, has submitted its work to the U.S. Food and Drug Administration for emergency approval.
The submission was led by team member Peter Elkin, M.D., professor and chair of the department of biomedical informatics in the Jacobs School of Medicine and Biomedical Sciences at UB and professor in the department of medicine. If authorized, the device could help regional and national manufacturers produce respirators and help alleviate the worldwide shortage of personal protective equipment.
“This is a coordinated effort that cuts across UB’s research enterprise and involves Buffalo’s entrepreneurial digital manufacturers. Very quickly, a team of scientists, engineers and doctors coalesced, with each member offering their support and expertise to address what’s become a severe need to fight the spread of COVID-19,” says project coordinator Albert Titus, Ph.D., professor and chair of the department of biomedical engineering in the UB School of Engineering and Applied Sciences and Jacobs School of Medicine and Biomedical Sciences at UB.
One Size Doesn’t Fit All
Most 3-D-printed respirators are made of hard plastic that’s sturdy, but lacks the sealing capability of traditional respirators, which are flexible and designed to form a protective barrier around the face.
To address the limitation, the team is using a more malleable plastic that requires more expertise to print.
The team also designed plans for at least five different respirator sizes that take into consideration typical female and male facial features. This approach is believed to be unique, as many 3-D-printed respirators are based on a one-size-fits-all approach.
The respirator would be reusable, because it could be sanitized after each use.
Each respirator has an opening to insert a filter cut from MERV 15 air filters (common to hospitals, clean room and other uses). The team is also exploring using human-safe HEPA filters in a turn-and-click mechanism, which may improve the respirator’s breathability.
Another idea is to custom print respirators for a user’s face. The user’s face would be scanned using a 3-D face scanner, or they could submit phone or tablet-camera-generated 3-D models of their face, which could be used as blueprints for a customized respirator.
“These are just a few of the ideas we’re working on,” Titus says. “With the need more urgent than ever, this team is really pushing itself to come up with effective yet practical designs.”
How the Team Formed
The team began to assemble in earnest in March at the Jacobs School.
Noting the dwindling supplies of respirators, researchers inquired about UB’s 3-D-printing capabilities. The conversation spread to several departments in the Jacobs School, as well as the School of Public Health and Health Professions.
It eventually led to a small group of UB researchers who, working with templates shared by the Billings Clinic in Montana, quickly 3-D-printed a few prototype respirators.
Encouraged by the results, the informal team began to contact fellow researchers in the biomedical engineering department, which is a joint program of the Jacobs School and the School of Engineering and Applied Sciences. Team members also reached out to leaders in Buffalo’s startup community, especially leaders working in additive manufacturing.
Within days, the informal group became a working group directed by Titus. Subgroups formed to tackle areas such as design of the respirator, testing perspectives and production logistics.
The effort widened to include the School of Dental Medicine; faculty from the department of pathology and anatomical sciences; faculty and clinical informatics fellows in the department of biomedical informatics in the Jacobs School; the Sustainable Manufacturing and Advanced Robotic Technologies (SMART) Community of Excellence; E-NABLE, an online community that works on 3-D-printed prosthetics and other devices; as well private partners such as UBMD Orthopaedics and Sports Medicine.