Infection preventionists play an essential role in ensuring healthcare devices, specifically ultraviolet-C (UV-C) disinfection systems, adhere to relevant regulatory standards. As these systems become increasingly commonplace in hospitals as a response to the rise of healthcare-associated infections (HAIs), it’s important for infection prevention and control professionals to have a clear understanding of the regulations that govern these devices. Failing to do so may lead to noncompliance issues, but more significantly, it could compromise patient safety.
Misinformation and mixed messages often originate from UV-C manufacturers, some of whom assert that FDA approval isn’t necessary, while others insist on its importance. This conflicting guidance puts infection preventionists in a difficult position, uncertain of their facility’s compliance status. Gunner Lyslo, CEO of Surfacide, LLC, advises simplicity for gaining clarity: Consult with your in-house legal team or schedule a discussion with your chief compliance officer. Even a short due diligence activity could provide substantial clarity and assurance, confirming your hospital teams are operating within suitable legal limits.
The FDA has released a statement adding clarity to this issue. According to the US Department of Health and Human Services (HHS), products such as Surfacide Manufacturing’s Helios+ UV-C System and Xenex’s LightStrike are considered over-the-counter devices aimed at microbial reduction on noncritical, nonporous medical device surfaces post manual cleaning and disinfection. They are supplemental to standard practices and are used in unoccupied rooms. Such devices require FDA clearance through the Premarket Notification 510(k) process before they can be marketed for microbial reduction of medical device surfaces.
For protocols under the purview of the EPA, like surface disinfectants or air sanitizers, facilities should reach out to the EPA directly. A recent survey in 2023 revealed that a majority of IPC professionals (82%) believe that FDA regulation of UV-C devices would enhance safety and consistency in their use. Lyslo encourages IPC leaders to not merely rely on manufacturer claims, but to actively seek legal counsel. This would prevent significant compliance concerns in the long run. IPC professionals have a unique perspective in advocating for patient safety and regulatory compliance. As UV-C devices are more widely utilized, their correct compliance is crucial both as a legal requirement and a patient safety measure.