On September 1, 2023, the US Food and Drug Administration (FDA) announced a new medical device product classification, thereby establishing FDA regulation of UV robots intended to reduce the number of pathogens on non-critical surfaces of medical devices.
Through the De Novo classification process, the FDA established a new Class II device classification, “whole room microbial reduction devices” for products that claim to reduce microbial load in the presence of non-critical medical device surfaces, such as hospital beds, wheelchairs, IV poles, and many other medical devices common in a healthcare environment.
This is a huge benefit to healthcare facilities across the US because they can now choose a UV device that has successfully completed the rigorous process of FDA authorization and had its microbial reduction claims validated.
There are a large number of UV device products that now fall within the classification of “whole room microbial reduction devices”, including those that make claims for reduction of microbial load in patient rooms and operating rooms. As a result of the new product device classification, and to the extent the product is sold for the use of whole room microbial reduction in patient rooms, operating rooms, and other areas where medical devices may be present, these products may no longer be marketed or sold without authorization from FDA, typically under a 510k clearance.
At this time, the LightStrike+ Microbial Reduction Robot from Xenex is the first and only whole room microbial reduction medical device authorized by the FDA to be marketed and distributed in the United States. As part of the FDA submission, the LightStrike+ robot went through rigorous testing performed on over 10,000 samples of vegetative bacteria and Clostridiodes difficile (C. diff) spores.
It’s not a question of whether pathogens remain on commonly touched surfaces after liquid chemical cleaning, it’s the risk of those pathogens being transmitted from surfaces to the hands of healthcare workers or patients.
The LightStrike+ robot uses a xenon lamp to generate high-intensity pulsed broad-spectrum UV light that reduces the number of pathogens on surfaces and helps break the chain of transmission from one patient or healthcare worker to the next. According to the FDA, we are now authorized to claim a 2-minute microbial reduction cycle for vegetative bacteria.
Xenex founder and Chief Scientific Officer, Dr. Mark Stibich said “This announcement is very important for hospital decision-makers, government agencies, and anyone considering UV technology to understand. Under the De Novo review process, FDA created a new type of classification for the LightStrike+ and similar devices, including other UV devices. Similar to how hospital IPs know how to evaluate something that is FDA authorized, so do government agencies. We’re excited about the ripple effect of FDA authorization, because similar to the hospitals, many government agencies (like CDC) also look to the FDA to validate products”
FDA regulation for UV devices in healthcare settings goes beyond compliance. It sets a higher standard for UV device safety and efficacy, and it reduces the burden on healthcare professionals because they now have the confidence that FDA authorized product claims are accurate and validated.