On Dec. 3 the U.S. Food and Drug Administration authorized the emergency use of the Lumin LM3000 device for bioburden reduction of compatible N95 respirators that are contaminated or potentially contaminated with SARS-CoV-2 or other pathogenic microorganisms. The Lumin LM3000 utilizes ultraviolet germicidal irradiation (UVGI) to reduce the bioburden on one compatible N95 respirator at a time by exposing the outer surface of the respirator for 5 minutes, followed by the exposing the inside surface of the respirator for 5 minutes.
The Lumin LM3000 is currently only authorized for use with 3M Model 1860 N95 respirators, previously referenced as “compatible N95 respirators.” The Lumin LM3000 is not authorized for use with any other respirator model.
The authorization is for a maximum of 4 bioburden reduction cycles per respirator or 5 donnings, whichever comes first, for single-user reuse by health care personnel to supplement CDC reuse recommendations to prevent exposure to pathogenic biological airborne particulates during the COVID-19 pandemic. Prior to bioburden reduction, the compatible N95 respirator must be placed in a breathable paper bag and held for a minimum of 5 days, in accordance with the CDC reuse recommendations. The authorization includes additional instructions for health care facilities. Learn more from the FDA about UVC lamps and COVID-19.
3B Medical indicates in a press release that Lumin was designed to clean CPAP accessories. However, the FDA authorization notes that Lumin has not been previously cleared or approved by FDA for any indication. Furthermore, in February the FDA issued a safety communication and consumer update about concerns related to CPAP cleaning devices that use ozone or ultraviolet light.