Be mindful of FDA ban on triclosan, 23 other antiseptic chemicals
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March 1, 2018
The FDA in December issued a final rule on the safety and effectiveness of active ingredients in over-the-counter healthcare antiseptic hand washes and rubs that could potentially be used in a medical setting. The final rule, which led to the ban of 24 chemicals, might not have been all that surprising. But it is still significant.
“I think most large healthcare facilities that have been following this FDA ruling have already investigated their use of these chemicals,” says Peggy Luebbert, MS, CIC, CHSP, CBSPD, an infection preventionist at OrthoNebraska in Omaha, Nebraska. “I’m concerned more about the smaller facilities, including clinics, that may not have been aware of this potential ruling and therefore haven’t evaluated their antiseptics.”
Luebbert believes most manufacturers did “a pretty good job of making us aware of” the potential for their products to be banned. But she says that if facilities have not already responded to the FDA’s final rule, they must do an assessment of their antiseptics to see if triclosan or any of the 23 other banned chemicals are present in their current products. If they are, they need to be replaced with an approved alternative.
“CDC's latest guideline on hand hygiene notes that it is not always necessary to use chemicals that kill germs in our soaps for routine hand hygiene in a hospital setting,” Luebbert says. “Part of the concern is the potential for development of antimicrobial resistance over multiple usages. The other part of it is that we don’t care if the germs go down the drain 'dead or alive' — we just want them off our hands. So it’s not necessary to expose yourself to those chemicals if you don’t need to.”
Per the FDA, triclosan is the only active ingredient currently being used in marketed healthcare antiseptic products that must be removed from the market. “Therefore,” an FDA spokesperson said, “this rule will remove only a small number of products from the market and consequently will have little impact on the industry.”
The FDA began mulling a final rule on triclosan in 2013, after the Natural Resources Defense Council in 2010 filed a lawsuit against the FDA for failing to issue a final rule regulating triclosan (and triclocarban), and Avon, Johnson & Johnson, and other corporations started to phase triclosan out of any products using the chemical.
Recent research has shown that triclosan alters hormone regulation in animals and might be harmful to the immune system, according to Mayo Clinic. It was also found that it might contribute to antimicrobial resistance. And, as Luebbert reminds us, many healthcare workers must disinfect their hands dozens of times a day.
Additionally, the FDA says there is no evidence that products containing triclosan are more effective than plain soap and water in preventing the spread of illness.
“Ensuring the safety and effectiveness of over-the-counter healthcare antiseptics has been a priority for the FDA, not only because these products are an important component of infection control strategies in healthcare settings, but also because of the role these products may play in contributing to antimicrobial resistance if they’re not manufactured or used appropriately,” FDA Commissioner Scott Gottlieb stated. “Healthcare providers are on the front lines of care. They need and deserve to have safe and effective means for preventing the spread of infection.”
Manufacturers have been given one year to comply by reformulating their products to remove the active ingredients or by removing their products from the market.
Luebbert says there are places in the medical environment where an antimicrobial soap is still needed, such as an operating room or a lab with a “high bioburden of organisms and/or large amounts of body fluid.” She recommends that each facility do a department-by-department assessment to determine where antimicrobial hand hygiene agents are needed. One WHO-approved antiseptic she now often sees in use is chlorhexidine gluconate (CHG) agents.
Additionally, the FDA has deferred final rulemaking for one year on six other active ingredients that are most commonly used in marketed over-the-counter antiseptics to give manufacturers more time “to complete the scientific studies necessary to fill the data gaps identified so that the agency can make a safety and efficacy determination about these ingredients.” They are ethanol, chloroxylenol, isopropyl alcohol, povidone-iodine, benzalkonium chloride, and benzethonium chloride.
According to the FDA spokesperson, the FDA “anticipates” that healthcare antiseptic products containing one of those six deferred active ingredients will ultimately remain on the market — which would come as a great relief to Luebbert.
“That is the one that gives me the most heartburn, if there are going to be issues with the use of alcohol in our waterless antiseptics,” she says, pointing out that they are “primarily what our healthcare workers are using to disinfect their hands.”
In the meantime, as the industry waits for the FDA’s final rulemaking on those deferred ingredients, Luebbert notes that it isn’t a bad idea to let your staff know that you are currently using what are considered to be safe products for hand hygiene.
“A simple email or message lets them know it is still safe to keep cleaning their hands,” she says. “I would worry about the employee who saw it on the news, was concerned, and stopped cleaning their hands. The greater the knowledge, the less the doubt.”