WINTER HAVEN, FL – 3B Medical has received Emergency Use Authorization from the FDA to permit use of Lumin, a UVC system, on N95 respirators during the COVID-19 pandemic. Lumin was designed to clean CPAP accessories but is also used as a multi-purpose sanitizer.
The announcement by the FDA allows Lumin to be used by healthcare workers employed in nursing homes, long term acute care, ambulatory, primary care, and clinics to allow N95 re-use to stop the spread of COVID-19 and help keep frontline healthcare workers safe.
UVC was first reportedly used for N95 decontamination during the COVID-19 crisis by the University of Nebraska Medical Center. Since then, the CDC recognized UVC as a potential means of decontaminating N95 respirators, if the proper wavelength and UVC irradiance dose were used.
While FDA has approved other systems for hospital use, the approved systems are complicated, limited to large hospitals and/or extremely expensive. Lumin is the only N95 decontamination system formally recognized by FDA for killing SARS-CoV-2 that can be purchased for under $300, and with a small enough footprint to be used safely in small offices and clinics, as well as in nursing homes.
“The COVID-19 global pandemic requires novel approaches and thinking outside the box,” said Alex Lucio, CEO of 3B Medical, Inc. “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’s total output in a single 5 minute cycle ranges up to 2,400 mJ/cm2, which studies show is sufficient to kill almost any pathogen, including SARS-CoV-2.
“A lot of the calls coming into our office are from Fire & Rescue departments, nursing homes and smaller community hospitals, clinics and primary care physician offices trying to keep their workers safe,” Lucio continued. 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.”