A Regulatory Blind Spot Hiding in Plain Sight

By JUSTIN MCKAY

When I’m brought back into the diagnostic area, one of the first things I see is a lead apron, well-worn and folded into itself, about ready to slide off the table where it was absentmindedly placed. For many people, this sight would not be startling, but I know firsthand the life-threatening dangers associated with garments that are not cleaned, stored, and maintained properly.

It is time that patients and staff understand this danger, and regulators take action.

My co-founder and I contracted ringworm in two different hospital networks from wearing unclean garments just like these, handled by hardworking, decent individuals in the imaging and surgery departments we routinely visited.

Healthcare professionals should be more mindful of the cleanliness and the condition of these garments, but those efforts alone are not enough to prevent hospital acquired infections. What my experience and the experiences of so many others indicate is that what is not measured, is not managed. To protect patients and medical professionals alike, there needs to be a clear regulatory protocol for cleaning and maintaining high utilization equipment and garments.

Study after study shows the need for this structure. Research shows that when regimented cleaning and maintenance protocols don’t exist, bacteria grows. In fact, Association of periOperative Registered Nurses (AORN) 2025 guidelines spell out this danger pretty clearly: aprons, vests, skirts, and thyroid shields have contamination rates between 62.5% and 100%. This finding is especially worrisome since, as the National Institutes of Health has found, 80% of chronic infections and 65% of microbial infections are associated with biofilms (thin, sticky layers of microorganisms that form on surfaces).

The question I keep coming back to is: why don’t the standards reflect what we already know? And, trust me, on this issue we know a lot about the danger.

A 2014 study found 84% of tested interventional radiology aprons were colonized with S. aureus and Tinea, and 12% with MRSA while a 2019 report detected bacteria on 80% of operating room apron swabs, with an 80% recurrence rate within six hours of disinfectant wipe-down (wipes alone are ineffective). The dearth of effective cleaning practices are also well-documented. A study released in 2025 found 51.7% positivity across 120 swabs from 20 aprons, only dropping to 41.7% after cleaning while another report issued the same year documented 80.7% contamination across 88 garments. Despite these threats, only two-thirds of departments had any cleaning protocol, or internal compliance records, none had a defined frequency for cleaning.

Clearly these garments are pathogen reservoirs.

When facilities only use wipes and don’t completely remove the bioburden, they’re fostering conditions for surviving bacteria. When I ask imaging departments and hospital administrators who is responsible for making sure these garments are clean, after a delay, a sigh, or a confused look, the answer generally is, everybody.

There is a name for this phenomenon: diffusion of responsibility, a principle that explains that individuals are less likely to feel personal accountability in a group setting because they assume others will act.

Some organizations have tried to outline care for garments like lead aprons.

Let’s start with Spaulding, the classification system from 1968 on which the entire infection prevention field still relies. This classification system was built for a different era, when no one was thinking about a garment that gets passed around all day and never sees a washing machine. Which is why, under Spaulding, lead aprons fall into the “non-critical” category. Current evidence shows these garments routinely come into contact with patients during each shift (Honigsberg, 2017; AORN, 2017), directly challenging the assumptions underlying their “non-critical” classification.

Next there is The Joint Commission, which requires facilities to inspect protective garments and document those inspections. Those rules sound great until you realize there’s no mandate for cleaning protocols or inspections. No required frequency. No validation that decontamination ever happened. Checking a box that says “apron accounted for” tells you nothing about what is living on it.

AORN has done the hard work of documenting the problem and it recommends cleaning, but the guidelines are voluntary. There is no enforcement mechanism, no audit trail, no accreditation consequence for ignoring them. The evidence is right there in the guidelines. The same organization that admits that garments are contaminated, and come into contact with patients each shift, only directs that you should consider wiping them down after use. What is missing is informed regulation.

Finally, the U.S. Food and Drug Administration (FDA) regulates lead aprons as medical devices, but its authority ends at the point of sale. How a facility cleans, stores, or reprocesses those devices after purchase is not on their radar. That is almost completely unregulated. Instructions for use (IFUs) exist on paper, but compliance is unaudited. The Occupational Safety and Health Administration (OSHA) covers the radiation hazard, but is completely silent on the infection hazard the garment itself may create. The bottom line: while 62-100% of these garments are contaminated, not one regulatory body requires anyone to properly clean them.

We must close this deep gap in oversight.

The defense that “nobody told us we had to clean it” is not going to hold up when the published evidence clearly outlines the threat. These risks are not theoretical. Candida auris cases have risen over tenfold from 2019–2024. Facilities that treat contaminated garments as somebody else’s problem are sitting on real, growing liability exposure. And the longer the literature piles up, the harder it gets to argue ignorance.

Hospitals are already being penalized for infections they can track. The Centers for Medicare and Medicaid Services withholds 2% under value-based purchasing and hits the bottom quartile with an additional 1% penalty through the Hospital-Acquired Condition Reduction Program (HACRP). Studies show a single surgical site infection can have a median absolute cost increase of $24,230. What happens when one of those infections traces back to something nobody thought to look at?

What Should Happen Next

Thousands of perioperative professionals were in the same room in New Orleans for AORN 2026. Attendees should demand action. They demanded action a few years prior regarding surgical smoke concerns, and their voices were heard.

AORN’s recommendations are a start, but they are not forceful enough to change behavior. It is time to tie compliance to accreditation, and make contamination data part of the audit. The Joint Commission still stops at visual inspection; the FDA still classifies these garments alongside items that don’t sit against open surgical fields for hours. Both bodies, and other state and federal regulators, must do more.

I encountered this threat in a very personal way 13 years ago, and now scientists have documented the threat in a way that should be impossible to ignore. It’s time regulators listen and take action.

Justin McKay co-founded RadCare Services after personally contracting ringworm from contaminated hospital-issued lead garments in two separate healthcare networks.