As a result, manufacturers were given one year to comply with the final rule by reformulating their products or removing them from the market.
Triclosan was previously banned as an active ingredient in consumer settings back in
Sept. 2016. Both the health care and consumer final rules are part of FDA’s ongoing, comprehensive review of over-the-counter antiseptic active ingredients to ensure they are safe and effective.
What to Do Next
LT/PAC centers using triclosan-based soap may be wondering what to do next. There are key steps to take if a facility is using, or thinks it is using, triclosan:
- Verify that triclosan-based soap is being used. In some centers, the same type of soap has been used for years without much further thought. Hand hygiene programs (rightfully so) have emphasized the importance of hand sanitizer because it is the preferred method for cleaning hands that are not visibly soiled. Less attention has been given to soap in the past, so moving away from triclosan is an opportunity to reevaluate what is currently being used.
- Determine how much triclosan soap inventory is on hand. The final rule does not say that centers must immediately stop using triclosan; rather, it means that manufacturers must stop selling it by Dec. 19, 2018. If the facility has a large inventory of triclosan soap, the options are to use it up or discard it.
- Keep in mind that staff may have concerns around the FDA announcement and about ongoing use of the triclosan, so be prepared to answer questions, justify the rationale for continuing use until inventory is gone, and discuss the planned course of action. At some point, suppliers will no longer provide triclosan soap.
- Discuss triclosan alternatives. Some centers will want to stay with an antimicrobial soap, and others may use this opportunity to explore switching to a nonantimicrobial soap. Know the available options, and discuss triclosan alternatives with the product manufacturer or supplier.
Choice Confusing
Choosing a soap can be confusing, especially given current recommendations. Both the
Centers for Disease Control and Prevention (CDC) and the
World Health Organization hand hygiene guidelines allow the use of either an antimicrobial or a nonantimicrobial soap, and due to a lack of evidence demonstrating clinical benefit (that is, resulting reduction of infection rates), do not recommend one over the other.
Clinical evidence is lacking due to complexity of designing such a study, difficulty eliminating confounding variables, and cost. However, studies of bacterial reduction on the hands support that alcohol-based hand rub (ABHR) is most efficacious, followed by antimicrobial soap, followed by nonantimicrobial soap as least efficacious, according to CDC. That said, LT/PAC centers are permitted the choice between antimicrobial and nonantimicrobial soap, or may use a combination of the two.
A good way to approach the decision of whether to choose an antimicrobial or a nonantimicrobial soap is to consider risk reduction. Table 1, below, shows comparisons of the average log10 reductions against bacteria after a single hand wash using water, nonantimicrobial soap, and antimicrobial soap. The greatest risk reduction will be achieved by using an antimicrobial soap.
For example, if a health care worker’s hands are contaminated with 10,000 bacteria and he or she were to wash with plain water only, a 110-log reduction would be achieved, leaving 1,000 bacteria behind. Nonantimicrobial soap would result in around a 2 log10 reduction and leave 100 bacteria behind. Washing with an antimicrobial soap would result in around a 2.5 to 3 log10 reduction, leaving between 10 to 30 bacteria on the hands.
Depending on the organism, the difference between exposure to 10 to 30 bacteria versus 100 bacteria could potentially mean the difference between acquiring an infection or not. Therefore, centers seeking the highest level of risk reduction should choose an antimicrobial soap.
Table 1. Average log10 Reductions of Different Hand Washing Preparations
Chlorhexidine gluconate (CHG)-based hand soaps follow a different regulatory pathway than other antiseptic active ingredients. CHG undergoes individual FDA evaluation through the New Drug Application (NDA) process, during which FDA determines whether the product is safe and effective when used as proposed, whether the drug’s labeling is appropriate, and whether the drug was manufactured in a way that maintains the quality of the drug.
If the NDA is approved, then the product may be marketed and sold in the United States. The use of CHG hand soaps may increase given their trusted efficacy, broad spectrum activity, proof of safety and efficacy, and regulatory stability as NDA products.
Putting it All Together
There are other factors that should be considered when selecting a soap, such as whether the product meets FDA efficacy requirements; is gentle on skin; and whether staff and residents like aspects of the soap such as the lather, scent, and rinsing factor. In addition, the logistics involved with potentially switching dispensers, disruptions to the clinical workflow, and adjustment to change for staff and residents means it is especially important to carefully select the right product and the right dispensing solution.
For in-depth information on recent FDA regulatory changes and factors to consider when selecting a soap in health care, download this
whitepaper.
Megan DiGiorgio MSN, RN, CIC, FAPIC, is clinical manager at GOJO Industries. She can be reached at digiorgm@gojo.com.