UV Device Confusion: Why Hospitals Must Ask the Right Regulatory Questions

As hospitals increasingly invest in ultraviolet-C (UV-C) disinfection systems to combat health care-associated infections (HAIs), many infection prevention and control (IPC) professionals may be unaware of the complex regulatory landscape governing these devices. Without clarity, facilities risk noncompliance—and more importantly, could undermine patient safety.

Mixed Messages Fuel Uncertainty

In this installment of an exclusive interview with Infection Control Today^®, Gunner Lyslo, CEO of Surfacide, LLC, underscored a growing issue in health care disinfection: Hospitals often do not know whether their UV-C systems require FDA clearance. “That’s a fair assessment,” Lyslo said. “Hospitals simply don’t have all the information. Not knowing the law or the rules can be problematic. It doesn’t exactly give you a 'get out of jail free card.’”

Confusion often stems from conflicting claims by different UVC manufacturers. Some claim FDA authorization is unnecessary, while others insist it is. This conflicting guidance puts infection preventionists in a problematic position, unsure of whether their facility is fully compliant.

A Call for Legal Review

Lyslo offered a straightforward path to clarity: “Talk to your in-house legal team or schedule a meeting with your chief compliance officer,” he advised. “Ask them, ‘Are we regulated by the FDA? Do we need to comply with FDA regulations for this product or category, such as QX or J?’”

He emphasized that even 10 to 20 minutes of due diligence could provide clarity and confidence, ensuring hospital teams are operating within appropriate legal boundaries.

The FDA’s Position

To clear up the confusion, ICT contacted the US Food and Drug Administration (FDA) for guidance. According to a statement from Emily G. Hilliard, press secretary for the US Department of Health and Human Services (HHS), UV-C devices like Surfacide Manufacturing’s Helios+ UV-C System and Xenex’ LightStrike are considered over-the-counter devices. They are intended for microbial reduction on noncritical, nonporous medical device surfaces, after manual cleaning and disinfection.

These devices are not replacements for manual cleaning but are to be used in unoccupied rooms as a supplement to standard practices. And yes, FDA clearance through the Premarket Notification 510(k) process is required prior to marketing such devices if they are intended for microbial reduction of medical device surfaces.

“FDA clearance through the Premarket Notification 510(k) process is required prior to marketing a device intended for microbial reduction of medical device surfaces. More information about this device type can found in our Product Classification database,” according to the statement from HHS.

Additionally, the FDA considers a product subject to regulation if it meets the definition of a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act. For EPA oversight (eg, for surface disinfectants or air sanitizers), facilities are encouraged to consult the EPA directly.

More information on UV-C standards and regulations is available at: Regency Supply UV Light Standards Guide.

IPC Professionals Want Clarity

In a 2023 survey, 82% of surveyed IPC professionals believe that FDA regulation of UV-C devices would help improve safety and consistency in their implementation. Lyslo agrees, urging IPC leaders not to rely solely on manufacturer claims.

“Seek counsel.” he said. It’s a small step that could prevent significant compliance issues down the road.

Conclusion

Infection preventionists are uniquely positioned to advocate for patient safety and regulatory compliance. As the use of UV-C devices expands, so does the responsibility to ensure their proper use. Clarifying FDA requirements is both a legal and a patient safety concern.

The first installment is here. The second installment is here.