The Food and Drug Administration approved the first 3D-printed gas mask respirator to meet its regulatory standards to protect clinical health care professionals against COVID-19. The announcement comes from a tweet issued by the Veterans Health Administration Innovation Ecosystem.
Created by the VHA team, the 3D-printed mask is one of several types of personal protective respirator masks health care workers can use to block the transmission of the novel coronavirus.
The mask works by securely fitting around the mouth and nose, strapping to the ears. Using a special filter designed to remove COVID-19 particulates, the mask is able to pull clean air through. The masks are also easy to disinfect and reuse. Respirators are the most protective masks against particulate transmissions, such as the viral droplets and aerosols spread by those infected with the virus.
The rapid approval of the 3D-printed mask comes amid reports of medical professionals lacking critical personal protective equipment while on the frontlines of the pandemic, in part due to a delay in global supply chains
In response, the FDA had issued a memorandum of understanding between NIH, VHA, and FDA. The public-private partnership is aimed at accelerating information-sharing and production of 3D-printed personal protective equipment and other medical device parts to quickly address the ongoing crisis
The collaboration with additive manufacturer America Makes quickens the process of approval for COVID-19 equipment using NIH’s 3D Print Exchange, an existing open-source tool that allows anyone who has a potential 3D-printing, biomedical prototype to upload and share them to its website. Those with COVID-19-related prototypes can submit them to the site, where they can then be clinically tested and evaluated by the VHA Innovation Ecosystem, in conjunction with the FDA via the VHA 3D Printing Network.
Once the models are tested, reviewed, and approved then the final products are highlighted on the site. The medical equipment will also be matched and distributed to 3D-printing organizations that can produce them effectively and distribute them to health care facilities in need.
For the moment, there have been six COVID-19-related, 3D-printed medical devices that have been “reviewed for clinical use” on NIH’s site — just a week since the effort’s launch on March 27.