Putting an Old Belief Out to Pasture: Is a TB Claim Really Required for Healthcare Disinfectants?

Is it true that healthcare disinfectants must have a tuberculocidal (TB) claim? It’s an age-old belief held by many infection preventionists (IP) that healthcare disinfectants must have a TB claim. We did some digging and have published our findings in our latest white paper.

I recall a time when the manufacturer of the disinfectant we used at my hospital had removed the TB claim from the product. The corporate IP informed us that we must find a replacement product that had a TB claim. When I queried as to why, I was told it was a requirement. Knowing how disruptive it can be to switch products and being a very inquisitive and evidence-based IP, I started on a quest to find this “regulation”. I looked at both the local and federal government level and after an exhaustive search, I found no such requirement. After starting in my new role at CloroxPro, I shared this experience with my colleagues which started us on down a discovery path to identify this source of this misinformation. A white paper on this topic is the culmination of our research.

The purpose of a TB claim on surface disinfectants is not for the prevention or control of transmission of tuberculosis, an airborne-spread disease, which is not transmitted via contaminated surfaces or fomites. Rather its purpose is to serve as a benchmark of disinfectant antimicrobial efficacy. This is because Mycobacteria (the genus which TB belongs to) are notoriously difficult to kill with disinfectants. Disinfectants that have a TB claim are considered intermediate-level disinfectants. Yet, according to the Spaulding scheme, no greater than low-level disinfection is necessary for environmental surfaces and non-critical medical equipment (e.g., equipment that only contacts intact skin).

Why is it important to understand that a TB claim is not a requirement? Because two of the leading properties of an ideal disinfectant are a short contact time and good surface compatibility. Harder to kill pathogens, like Mycobacteria (e.g., TB) require tougher disinfectants, which often have longer contact times and less-than-desirable compatibility with surfaces and equipment. Achieving a TB claim also increases the cost of the product. Insisting on a TB claim limits your disinfectant options. Many manufacturers opt not to pursue this unnecessary claim given these downsides as well as the fact that harder-to-kill pathogens like C. difficile are now available for testing.

But where did this misbelief of requiring a TB claim come from? We learned that it came into being in the early years (and fears) of the HIV epidemic, before the causative agent had been identified, and before we knew how easy (or hard) it was to kill with disinfectants. However, the Cleaning Industry has come a long way over the past 40 years. Many, if not most, of today’s EPA-registered healthcare-grade disinfectants have kill claims for the bloodborne pathogens of most concern (e.g., HIV and Hepatitis B and C viruses) negating the need for the TB claim. In fact, these enveloped viruses are among the easiest pathogens to kill. As a result, OSHA revised their definition of an appropriate disinfectant for blood and body fluid clean up to include those with HIV and Hepatitis B kill claims.

Figure 1.

It’s time for this now debunked belief that a TB claim is required to be put out to pasture once and for all. Learn more from our white paper titled “Clearing up the confusion: why a tuberculocidal claim on surface disinfectant is no longer needed.”