Whole-Room Microbial Reduction Devices: What FDA Authorization Really Means

Series Introduction

As UV-C and other whole-room microbial reduction technologies become increasingly visible in health care, infection prevention, and environmental services, leaders face questions that extend well beyond whether the technology can kill microorganisms.

In this 3-part series based on a panel discussion at the Exchange26: AHE Education & Solutions Summit in New Orleans, Infection Control Today^® examines the issues health care organizations should consider before and after investing in UV-C, including FDA authorization and manufacturer claims, why the technology must supplement rather than replace manual cleaning, and how facilities can determine whether a device addresses a genuine infection prevention need.

Together, the articles offer a practical framework for moving beyond the appeal of new technology and asking a more important question: Does the evidence, implementation strategy, and intended use support safer patient care?

The rapid expansion of ultraviolet disinfection technology during the COVID-19 pandemic provided health care facilities with additional options to supplement environmental cleaning. It also created a complicated marketplace in which infection preventionists (IPs), environmental services (EVS) leaders, and purchasing teams may encounter devices making similar-sounding claims while operating under very different regulatory circumstances.

During a panel discussion at the Exchange26: AHE Education & Solutions Summit in New Orleans, the speakers focused on UV technology and whole-room microbial reduction devices. Regulatory experts emphasized that health care organizations have a responsibility to understand not only what a manufacturer says its technology can accomplish, but also what claims have actually been authorized.

The speakers included:

• Sadé L. Rolon, MBA, CMIP, CHESP, T-CHEST, T-CSCT, the regional director of operations for Sodexo’s Healthcare Division,
• Julie Mangino, MD, infectious disease specialist at The Ohio State University Medical Center, Columbus, OH,
• James “JJ” Odom, MBA, CHESP, CMIP, T-CHEST, the university director of buildings & grounds at UConn Health, Farmington, Connecticut,
• Christopher Dugard, MS, director for the Division of Infection Control Devices in the Office of Surgical and Infection Control Devices, FDA/Center for Devices and Radiological Health,
• Elizabeth “Liz” Claverie, MS, (retired CAPT, 0-6) vice president, regulatory strategic liaison for Steris.

What Is a Whole-Room Microbial Reduction Device?

Under 21 CFR 880.6510, a whole-room microbial reduction device is a medical device intended to reduce microbial load on medical device surfaces following cleaning and disinfection. Performance testing must demonstrate microbial log reduction against the most resistant microorganism tested, with panelists noting that devices reviewed thus far have demonstrated a minimum 2-log reduction.

Dugard emphasized, “I did want to mention in particular, 2 logs does not mean maximum two logs. So far, we've seen a minimum of 2 logs, but you can certainly go beyond that if your device can do more. Notably, this regulation is not intended for standalone reduction or disinfection.”

For those companies that have a device or are interested in designing one, Dugard explains, “because [the FDA has] established this regulation, you would be supporting substantial equivalence to the existing devices through the 510(k) pathway. And again, substantial equivalence is defined as at least as effective and as safe as the devices currently on the market, so you can't improve on what is currently there.”

Why Was this Regulatory Category Created?

The regulatory category itself is relatively new.

Claverie read the regulation: “According to the United States Food and Drug Administration, it defines a medical device under section 201(h) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321(h)… ‘It is an instrument, apparatus, implant, or related article intended to diagnose, cure, treat, or prevent, [operative word], disease, or affect body structure, function without chemical action inside the body.’”

Dugard explained that it was established on September 1, 2023, following the FDA's granting of the Xenex LightStrike De Novo. Interest in UV technologies, however, had been building well before then and accelerated dramatically during the pandemic as the FDA received requests involving UV technologies for applications ranging from personal protective equipment treatment to environmental decontamination.

“So, again, technically, it was created because we received a premarket submission, and it was reviewed and classified appropriately,” Dugard continues. “But to provide a little bit more context around the situation, we had already, even before prepandemic, we'd been regulating UV devices, like UV air purifiers… In addition, for radiation-emitting products in general, whether you're a medical device or a consumer product, you still have to adhere to what we call the EPRC regulations, the Electronic Product Radiation Control. When it crosses the line into medical device territory, then there start to be premarket requirements.”

Dugard then spoke about the UV devices he had seen himself prepandemic, “I had a feeling that we were going to continue to see more and more, but at the time, it wasn't gaining a lot of traction at the agency. That all changed during the pandemic. We started seeing request after request for emergency use authorizations for UV products, anywhere from sanitizing PPE to whatever else people needed during the pandemic. And then that has basically carried on postpandemic. It's not slowed down. There's a lot of innovation. There's a lot of confusion out there, but we are seeing UV devices used more and more.”

What Is the Difference Between EPA and FDA Oversight?

One source of continuing confusion is the distinction between EPA and FDA oversight.

Dugard explained that the dividing line can depend heavily on a product's intended use and claims. “Generally, EPA will regulate consumer products and pesticide products, and there may be some requirements that you have to consider around that, but I don't want to speak for the EPA, so I'll leave that there. I encourage you to reach out to that agency if you're marketing any sort of UV device at all. FDA is involved when the device starts making medical device claims.”

Claverie said, “A couple of quick points I want to make are that an EPA-registered device will treat or disinfect inanimate objects, surfaces, or environmental elements like air or water, while an FDA-regulated device is intended for the diagnosis, treatment, or prevention of medical conditions in human or animals that's acting on or inside the body.”

Dugard offered an especially straightforward example: A claim that a technology reduces or prevents infections, including health care-associated infections (HAIs), is clearly a medical device claim and requires clinical evidence.

By contrast, Dugard said, “To give you an example of what is not a medical device claim, if you say you are reducing the population of a specific organism by X amount, but there are no additional health claims attached to that, we don't consider that a medical device claim. Again, there's a lot of nuance, and I have to say a lot of our conversations with some of these manufacturers end up going back and forth on specific language or on their claims, so if there is any confusion, please reach out to us [the FDA].”

For IPs and EVS professionals, that distinction makes vendor vetting particularly important.

Rolon described evaluating multiple UV technologies at a previous organization. A vendor indicated that it had a K number and was awaiting an FDA decision. A check of the FDA database, however, showed that the claimed submission had not been made. “I went into the database, and they had not submitted anything. And that's improper. So, we need to make sure, as we are vetting information, [that] we're really making sure when people are telling us something, we're not just taking it necessarily at face value. We need to do some of that education, and there's an onus and responsibility when we're bringing things into the organization.”

Unauthorized claims are not simply a technical regulatory issue. Claverie, a former FDA regulator, warned that marketing medical devices with unauthorized or off-label claims can constitute misbranding and potentially lead to warning letters, seizures, and even criminal prosecution. Health care organizations may also expose themselves to additional legal and regulatory risks when devices are used in ways that differ from their cleared labeling.

Claverie said, “Compliance is managed through statutory frameworks under the Food, Drug, Cosmetic Act, sections 201, 301, and 502. Even in the act, they list under the Code of Federal Regulations, they list and have laws for everything from labeling to how your establishment needs to register the device to the quality management system.”

The Timeline UV-C and Potential UV-C Companies Need to Know

Claverie then explained the timeline for those companies whose products are not yet approved by the FDA. “This year in February, which FDA actually had been announcing for the last couple of years, that they were transitioning over from Title 21 820, their QMR system to transitioning over to international standard ISO 13485, and they gave a 2-year warning so that all of the manufacturers in the United States would know that this is what they were doing, and they put it into practice in February, right, Chris? In February of this year. So, it is very dangerous to have a product out there labeled and marketed as a medical device when it has not gone through the proper regulatory procedures with the FDA.”

However, Dugard offers a practical reason for working with the FDA. “If you're talking to us, we understand there's a lot of confusion in this device space right now. So, if you're confused, please talk to us. And when you're talking to us and working with us, we are less motivated to take some of those more extreme enforcement actions.”

Then he explained the reason and need for the regulation:

“But outside the regulatory risk, I did kind of want to make one more plug for the overall risk. I really, truly believe that this regulation helps level the playing field. Because without this regulation, it really doesn't matter how effective your device is. You could do all the testing, and every claim that you make could be 100% true. But if we don't have enforcement of those claims and truth in what you're saying, and assurance of truth in what you're saying, somebody down the street could see that and go, ‘Oh well, let's just say ours is a little bit better, and start selling that.’”

Dugard continues, “And then what is a health care facility going to buy? They're going to go for the one that sounds better. So, I think, you know, this just really helps ensure that, when you've got a product that actually does what you say it can do, then you've got the power of the agency behind you to help make sure you don't have someone else misbranding, and, potentially, getting this device out there over yours.”

The Key Regulatory and Legal Risk if a Health Care Facility Uses a WRMR Device Off-Label

The next question for the panel was, “What are the key regulatory and legal risks to health care if they were to use one of these medical devices off-label?”

Claverie spoke bluntly, “Using a medical device off-label creates a major legal and regulatory risk for the healthcare provider. So, it's not just you. Now you're placing the health care provider at risk, and there's heightened liability for medical malpractice, regulatory penalties from agencies like my former agency, the FDA, state medical boards, loss of institutional accreditation, etc. And with FDA regulatory enforcement, the agency regulates the commercial distribution and the labeling of the devices. So, promoting off-label uses outside of the approved use of the device can trigger any of these things, and I mentioned in the prior response to the prior question some of the things that it can trigger. So, it's really serious.”

Claverie then described the many times she had been called to testify during her almost 32 years with the FDA: “I actually was called in many times to testify when either the hospital sued the medical device manufacturer because the medical device manufacturer had a label that was not approved by FDA, and they were marketing it, and then the hospital got sued, or the medical device manufacturer had an appropriate label, but guess what? The salesperson went into the hospital and marketed the device for off-label use. So, when FDA inspectors did inspections, we saw what we had cleared, and …the FDA has no way of knowing that a product is being verbally marketed off-label unless the user notifies FDA…. Just be aware.”

The practical lesson for infection prevention is straightforward: verify before you buy.

Infection preventionists, environmental services, clinical leadership, procurement, biomedical engineering, and regulatory personnel should review the FDA database, examine the device's indications for use and instructions for use, and compare those documents with what is being said during the sales process.

A sophisticated-looking robot and an impressive log-reduction claim do not, by themselves, answer the most important questions.

What exactly has this device been authorized to do? What evidence supports that claim? And is that what the hospital is purchasing it to accomplish?