In December 2017, the Food and Drug Administration issued its final rule on the safety and efficacy of active ingredients that can be used in antiseptic hand soaps in all healthcare settings, including long-term care.
As of Dec. 20, 2018, manufacturers can no longer manufacture and distribute triclosan antibacterial handwashes for the healthcare market.1
Long-term care facilities currently using soaps containing triclosan may be unsure of what to do next. Below are three next steps they should take if they are, or think they might be, using a triclosan-based soap:
• Verify that a triclosan-based soap is being used. Historically, hand hygiene programs (rightfully so) have focused on hand sanitizer because it is the preferred method for cleaning hands that are not visibly soiled. Less attention has been given to soap. Therefore, some providers are unaware of the type of soap they are using. If you are uncertain, your soap supplier will be able to help you.
• Determine how much triclosan soap 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 one year of the December 2017 announcement. If a 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 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, so be aware of that date by reaching out to your supplier.
• Discuss triclosan alternatives. The FDA’s decision is an opportunity to re-evaluate current products. Some providers will want to continue using an antimicrobial soap and others may use this opportunity to explore switching to a non-antimicrobial soap. Discuss triclosan alternatives with your manufacturer or supplier.
Choosing a soap can be confusing, especially given current recommendations. Both the Centers for Disease Control and Prevention’s and the World Health Organization’s 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.2
In addition, CMS F-Tag 880 states to perform hand hygiene when hands are visibly soiled with soap and water, and does not give further instruction on whether the soap should be non-antimicrobial or antimicrobial.4
Therefore, healthcare facilities (including long-term care operators) are permitted to choose 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 transmission of pathogens 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 to the resident’s home environment, and adjustment to product change for healthcare workers means it’s especially important to carefully select the right product and the right dispensing solution for the long term.
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:
1. 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
2. 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.
3. 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.
4. Centers for Medicare & Medicaid Services (CMS); Department of Health and Human Services. State operations manual: Guidance to surveyors for long-term care facilities. State Operations Manual. 2017;1-696.
Megan DiGiorgio MSN, RN, CIC, FAPIC, is Clinical Manager at GOJO Industries.
