3B Medical announced that it received FDA emergency use authorization (EUA) for the use of its Lumin UVC system for N95 mask decontamination.
Lumin is designed for cleaning CPAP accessories but is also used as a multi-purpose sanitizer, 3B Medical said in a news release. The FDA EUA allows for the use of Lumin by healthcare workers in nursing homes, long-term acute care, ambulatory, primary care and clinics to decontaminate N95 respirators for re-use amid the COVID-19 pandemic.
The CDC has previously recognized UVC (ultraviolet) as a potential tool in decontaminating N95 masks, should the proper wavelength and UVC irradiance dose be used. With FDA emergency approval, Lumin is now the only formally recognized N95 decontamination system formally recognized by the administration for killing SARS-CoV-2.
Lumin can be purchased for under $300, too, making it affordable and capable of creating a small enough footprint for use in small offices and clinics, along with nursing homes.
The system’s total output in a five-minute cycle ranges up to 2,400 mJ/cm2, which, according to the company, has been proven sufficient for killing almost any pathogen, including the virus causing COVID-19.
“The COVID-19 global pandemic requires novel approaches and thinking outside the box,” 3B Medical CEO Alex Lucio said in the release. “We were starting to get inundated with calls from hospitals and nursing homes asking if Lumin was strong enough to kill SARS-CoV-2. Lumin is likely the only device designed for home use that is powered high enough to repurpose for this use. We are very excited to have our device authorized by FDA for this application.”
