FDA Grants Lumin Emergency Authorization for Use on N95 Respirators

Using UVC to kill COVID-19, the mask offers a lower-cost alternative to help healthcare workers decontaminate N95 masks for reuse.

• By David Kopf
• Dec 10, 2020

The FDA granted an Emergency Use Authorization to use 3B Medical Inc.’s Lumin UVC system on N95 respirators during the COVID-19 pandemic.

3B Medical designed Lumin to clean CPAP accessories but is also used as a multi-purpose sanitizer that kills bacteria and viruses, including human coronavirus and influenza, in only 5 minutes with no chemicals. The FDA announcement allows healthcare workers employed in nursing homes, long term acute care, ambulatory, primary care, and clinics to use Lumin for N95 reuse to stop the spread of COVID-19.

N95 mask reuse became an important issue when shortages of the masks became an issue early into the COVID-19 public health emergency. The University of Nebraska Medical Center first reported the viability of UVC for N95 decontamination, and then the CDC then recognized UVC as a potential means of decontaminating N95 respirators if the proper wavelength and UVC irradiance dose were used. 

“Being able to reuse an N95 mask quickly and effortlessly is a game-changer for allowing healthcare workers to remain safe,” 3B Medical CEO Alex Lucio said. “Front line healthcare workers are in dire need of an immediate solution to reuse their masks. Lumin is fast and easy to use and we are glad the device could be re-purposed to meet that need in this crisis.”

Now recognized by FDA for killing SARS-CoV-2 on N95 masks, the Lumin can be purchased for under $300, offering a competitive price alternative to more expensive and complex solutions. Also, it is small enough for safe use in small offices and clinics, as well as in nursing homes.