3B Lumin Authorized for Emergency Use By FDA
As of Dec 3, 2020, the FDA has approved an Emergency Use Authorization for 3B Medical, the makers of the Lumin multi-purpose sanitizer.
Why Is This Important?
This Emergency Use Authorization allows healthcare workers in long-term acute care, primary, ambulatory, and nursing homes to use the Lumin Sanitizer. It disinfects N95 respirators for single-user reuse to prevent the spread of COVID-19.
The use of ultraviolet UVC light for N95 decontamination was first reported by the University of Nebraska Medical Center. Afterward, the CDC officially recognized ultraviolet light as an effective way to kill the coronavirus and decontaminate N95 respirators.
What Is the Lumin Sanitizer?
The Lumin was developed by 3B Medical as a CPAP equipment sanitizer, though it is also used as a multi-purpose device. It uses ultraviolet light and a reflective drawer to eradicate germs on surfaces. When activated, the Lumin runs for 5 minutes.
The Lumin is an affordable, simple-to-use product with single button operation – available from The CPAP Shop for $269.
FDA Requirements for Using the Lumin
As mentioned, the Emergency Use Authorization by the FDA is for the disinfection and repurposing of N95 respirators. No other respirators or face masks are available yet for this emergency use.
In order to meet the FDA authorization, healthcare workers must run the N95 respirator through two cycles on the Lumin. Use one cycle per side. Based on the UVC output and run-time of the device, two cycles meet the requirement for proper wavelength and irradiation, as established by the FDA.
For additional questions regarding the Lumin, contact our knowledgeable customer care team at 866-414-9700 or email firstname.lastname@example.org.