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FDA Grants De Novo Authorization for LightStrike+ UV Robot in Healthcare Facilities

The U.S. Food and Drug Administration (FDA) has granted De Novo authorization to Xenex Disinfection Services, Inc. (Xenex) for their innovative LightStrikeTM+ device. This device utilizes high-intensity, broad-spectrum ultraviolet (UV) light, marking a significant advancement in pathogen-reduction technology. It stands as the first of its kind to be regulated by the FDA for the purpose of reducing pathogens on non-porous, high-touch surfaces within healthcare environments.

The primary objective of LightStrike+ devices is to perform microbial reduction on non-critical medical device surfaces in healthcare settings where visible contamination is absent. These devices have received authorization for use in various healthcare settings, including unoccupied operating rooms, hospital rooms, and other clinical areas where non-critical medical devices may be present.

The development of the LightStrike+ device draws from over a decade of accumulated knowledge derived from best practices implemented in various healthcare facilities. Esteemed institutions like HonorHealth, Mayo Clinic, MD Anderson Cancer Center, Ochsner Health System, Stanford Health Care, and Texas Health Resources have already incorporated LightStrike robots into their comprehensive disinfection strategies.

Despite thorough manual cleaning efforts, dangerous pathogens can persist on surfaces within healthcare facilities. The LightStrike+ robot utilizes a xenon lamp to emit high-intensity pulsed UV light, effectively reducing the presence of these pathogens on surfaces. This groundbreaking technology plays a crucial role in interrupting the chain of pathogen transmission, thereby preventing their transfer from one patient or healthcare worker to another.

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