What do you and your customers need to know?
If you haven’t already heard, in December 2017, the Food and Drug Administration (FDA) issued a final rule on the safety and efficacy of certain active ingredients used in antiseptic hand soaps in healthcare. The biggest impact to healthcare facilities is that triclosan, the most commonly used soap active, is no longer permitted as an active ingredient. As a result, triclosan-based hand soaps can no longer be marketed and sold, and manufacturers will have one year to comply with the final rule by reformulating their products or removing them from the market. 1 Sales representatives and distributors are uniquely positioned to guide customers and key decision makers who may not fully understand the final rule and its implications. There are three things you will want to do when approaching your customers on this topic:
- First, verify that the facility is using a triclosan-based soap.
Some facilities are unaware of the type of soap they are using. The focus of many hand hygiene programs is (rightfully so) 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 these changes are an opportunity to evaluate current products. - If a triclosan soap is being used, determine how much product inventory is on-hand.
The final rule does not state that healthcare facilities must immediately stop using triclosan; rather, it means that manufacturers must stop selling it within 1 year. If the facility has a large inventory of triclosan soap, the options are to discard it or use it up. Keep in mind that healthcare workers may have concerns around the FDA announcement and about ongoing use of the triclosan, so advise healthcare facilities that they should be prepared to answer questions, justify the rationale for continuing its use until inventory is gone, and discuss the planned course of action. At some point, suppliers will no longer provide triclosan soap. Make sure the customer is aware of that date and help them prepare. - Discuss triclosan alternatives.
Some customers will want to stay with an antimicrobial soap and others may use this opportunity to explore switching to a non-antimicrobial soap. They may look to you for guidance, so it will be helpful to know how to walk them through that decision-making process.
Helping customers choose a soap
Choosing a soap can be confusing, especially given current recommendations. Both the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) hand hygiene guidelines allow the use of either an antimicrobial or a non-antimicrobial soap, and due to a lack of evidence demonstrating clinical benefit (i.e. resulting reduction of infection rates), do not recommend one over the other. 2,3 However, studies of bacterial reduction on the hands support that alcohol-based hand rub (ABHR) is most efficacious, followed by antimicrobial soap, followed by non-antimicrobial soap as least efficacious (see figure above). 2 That said, healthcare facilities are permitted the choice between antimicrobial and non-antimicrobial soap, or may use a combination of the two.
A good way to approach the decision of whether to choose an antimicrobial or a non-antimicrobial soap is to consider risk reduction. The greatest risk reduction will be achieved by using an antimicrobial soap, which will result in a higher log reduction of bacteria on hands. Non-antimicrobial soap will result in a lower log reduction of bacteria on hands and leave more bacteria behind, which could potentially mean pathogens are transmitted to patients. Therefore, facilities seeking the highest level of risk reduction should choose an antimicrobial soap.
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 healthcare workers 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 healthcare workers means it’s especially important to work with healthcare facilities 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 healthcare, download this free whitepaper from GOJO by visiting http://gojo.com/HealthcareSolutions.
References:
- FDA issues final rule on safety and effectiveness for certain active ingredients in over-the-counter health care antiseptic hand washes and rubs in the medical
setting [FDA In Brief]. Silver Spring, MD. U.S. Food and Drug Administration; December 19, 2017. https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm589474.htm. Accessed April 17, 2018 - Centers for Disease Control and Prevention. Guidelines for hand hygiene in health-care settings—2002. Recommendations of the Healthcare Infection Control
Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. MMWR 2002;51 (RR-16):1-45. - World Health Organization. WHO guidelines on hand hygiene in health care. First global patient safety challenge: clean care is safer care.
http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf. Published 2009. Accessed April 6, 2018.