Demand for critical medical supplies continues to rise, as does the number of COVID-19 cases and 3D printers have been seen as a way to help bolster manufacturing capabilities, wherever it is needed.
Now, the FDA will be working with government and public-private partners to distribute and evaluate 3D designs and models, in a bid to provide desperately needed hardware and parts.
Alongside the National Institutes of Health and the Department of Veterans Affairs—as well as America Makes, the national accelerator program for additive manufacturing managed by the Department of Defense—the collective framework will look to help hospitals and others furnish components close to the patient or at the point-of-care.
This could include increasingly scarce ventilator valves and other parts, as well as personal protective equipment such as face masks and rigid plastic shields.
America Makes, the National Additive Manufacturing Innovation Institute, includes member organizations from industry and academia as well as government and non-government agencies. It will act as a matchmaker between the needs of the healthcare industry and the designs and capacity of the 3D printing community.
The resulting models will be provided to the VA for preliminary evaluations, in consultation with the FDA and the NIH’s National Institute of Allergy and Infectious Diseases, before being provided an official emergency use authorization allowing local production nationwide.
Earlier this week, the FDA unlocked the use of 3D-printed, single-part nasopharyngeal swabs for COVID-19 testing, according to HP—which is providing design files for face shields, hands-free door openers and mask adjustment straps. The industrial fabrication company FormLabs also said it is ramping up swab production.
In addition, HP is working on designs for a 3D-printed emergency respirator, to provide ventilation support in hospitals and ICUs, which it expects could be scaled up to produce between 50 and 100 units per day.
Previously, the FDA issued a wider authorization for ventilators, tubing connectors and accessories, which the agency said could also include items such as 3D-printed tube splitters allowing multiple patients to be hooked up to the same ventilator.
Meanwhile, the European organization for additive manufacturing and machine tool production, CECIMO, has been working to coordinate a continent-wide call to action with the European Commission. CECIMO has begun collecting information from companies interested in participating in the collaborative effort.