Xenex Disinfection Services was granted De Novo authorization for the LightStrike+ device, a high-intensity, broad-spectrum ultraviolet (UV) light robot, by the U.S. Food and Drug Administration (FDA).
The authorization creates a new medical device product classification under which the LightStrike+ robot is the first and only product of its type, setting the precedent for FDA regulation of UV robots intended for use in reducing pathogens on non-porous, high-touch surfaces in the healthcare environment.
“We understand that it can be challenging for hospitals to evaluate UV technologies, especially given the unverified and often exaggerated claims made by some manufacturers,” said Morris Miller, Xenex chief executive officer. “FDA authorization gives hospital decision-makers the confidence that Xenex’s claims for LightStrike+ are accurate and validated.”
LightStrike+ devices are intended to perform microbial reduction on non-critical medical device surfaces free from visual soiling in the healthcare environment following manual cleaning and disinfection practices. They are authorized for use in healthcare facilities, including unoccupied operating rooms, hospital rooms, and other clinical settings where non-critical medical devices may be present.
Dangerous pathogens remain on surfaces in healthcare facilities, even after thorough manual cleaning efforts. The LightStrike+ robot uses a xenon lamp to create high-intensity pulsed UV light that reduces the number of those pathogens on surfaces and helps to break the chain of transmission from one patient or healthcare worker to the next. Xenex’s FDA authorization is supported by rigorous testing performed on over 10,000 samples of vegetative bacteria and Clostridiodes difficile (C.diff) spores.
More than 1,200 healthcare facilities worldwide have run LightStrike robots over 37 million cycles, according to Xenex. Many leading hospitals, including HonorHealth, Mayo Clinic, MD Anderson Cancer Center, Ochsner Health System, Stanford Health Care and Texas Health Resources use LightStrike robots as part of their comprehensive disinfection strategy.
“We have been working with our hospital partners for over a decade to support them in their mission to improve patient safety and public health,” said Dr Mark Stibich, founder and chief scientific officer of Xenex. “As an infectious diseases epidemiologist, I am highly concerned about antibiotic resistance in the hospital environment. I hope that FDA authorization will allow hospitals to more easily use this tool in their fight against pathogens.”
