The U.S. Food and Drug Administration (FDA) has announced a new medical device product classification, “whole room microbial reduction device”, which establishes FDA regulation of UV robots intended to reduce the number of pathogens in unoccupied patient rooms, operating rooms and other areas in healthcare facilities where non-critical medical devices are present.
Through the De Novo classification process, the FDA established a new Class II device classification and clarified that UV products intended to reduce microbial load on non-porous, non-critical medical device surfaces (such as hospital beds, wheelchairs, IV poles and other medical devices common in patient rooms and operating rooms) now require FDA authorization before they can be marketed and distributed in the United States.
This new classification includes UV devices marketed to disinfect patient rooms, operating rooms and other areas where non-critical medical devices are present. The new FDA device classification does not specify the level of microbial reduction, rather it applies to the use described regardless of the level of microbial reduction achieved or claimed.
FDA authorization is designed to give hospital decision-makers confidence that the claims for whole room microbial reduction devices (which includes UV robots used to destroy pathogens in healthcare facilities) are accurate and validated.
The FDA has determined premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of this device type. As a result of the FDA’s classification action, prior FDA authorization is now required to market or distribute UV microbial reduction devices intended for use in patient rooms, operating rooms, and other areas where non-critical medical devices are present. Such devices would be considered adulterated and misbranded, and subject to FDA enforcement action. These devices, and their manufacturers and distributors, are potentially subject to a range of compliance and enforcement actions from the agency, some of which are severe, such as requiring product recalls, injunctions and seizure actions.
Xenex Disinfection Services’ LightStrike+ UV robot is so far the only whole room microbial reduction medical device authorized by the FDA to be marketed and distributed in the United States, according to the company. The LightStrike+ robot uses a xenon lamp to create high-intensity, pulsed broad-spectrum UV light that reduces the number of pathogens on surfaces and helps break the chain of transmission from surfaces to patients and healthcare workers.
“This announcement is very important for hospital decision-makers, government agencies, and anyone considering UV technology to understand,” said Mark Stibich, PhD, founder and chief scientific officer of Xenex. “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 the government agencies. We’re excited about the ripple effect of FDA authorization, because similar to hospitals, many of the government agencies (like the CDC) also look to the FDA to validate products.”
Photo courtesy of Xenex