Healthcare Workers Blog

FDA Announces a Final Rule for Healthcare Skin Antiseptics - What Does It Mean?


By Jeff Hall

Healthcare Business VP & GM, GOJO Industries

Yesterday, the U.S. Food and Drug Administration (FDA) issued a final rule for healthcare skin antiseptics, including hand hygiene products used in hospitals and healthcare facilities. What is this rule, and what does it mean?

An Overview of the Final Rule
In this rule, the FDA determined that 24 active ingredients, including triclosan, will no longer be allowed in over-the-counter healthcare skin antiseptics. Manufacturers have one year to comply with this final rule by either reformulating or removing their products from the market.

Triclosan is the only active ingredient used in GOJO products that is not permitted under the new rule. We have already phased triclosan out of much of our soap portfolio as part of our Sustainable Chemistry Policy implementation. We have also developed new soap solutions, both antimicrobial and non-antimicrobial, which are part of our breakthrough PURELL SOLUTIONTM portfolio.

The FDA is seeking additional data and has granted a deferral for six other active ingredients – ethyl alcohol (ethanol), isopropyl alcohol, povidone-iodine, benzalkonium chloride (BAK), benzethonium chloride (BEC) and chloroxylenol (PCMX) – as they collect additional data. In its press release, the FDA stated this does not mean that products containing these six ingredients are ineffective or unsafe, or that their use should be discontinued.

Centers for Disease Control and Prevention (CDC) Guidelines for Healthcare Have Not Changed 
Hand hygiene is considered the single most important measure for preventing the spread of infection in healthcare settings. The current CDC Hand Hygiene Guidelines for Healthcare recommend alcohol-based hand sanitizers as the primary hand hygiene method. These guidelines have not changed. Alcohol-based hand sanitizers, like PURELL® Advanced Hand Sanitizer, which is triclosan-free, remain the gold standard for hand hygiene in healthcare.  

In addition, the FDA reinforced in its statement yesterday that healthcare antiseptic products remain an important resource in healthcare settings, and healthcare workers should continue to use them, consistent with infection control guidelines. Alcohol-based hand sanitizers, as well as hand soaps, are critical to improving healthcare worker and patient safety by reducing the spread of germs in healthcare settings.

Transitioning to Better Alternatives
This final rule may require a healthcare facility to change its soap, and GOJO will work with them to transition to better alternatives. We have been preparing for this anticipated change, and have already developed an innovative portfolio of options. 

In 2016, GOJO launched PROVON® Antimicrobial Foam Handwash with 2% CHG.This new formulation exceeds the FDA Healthcare Personnel Handwash requirement1, and is gentle on hands making it mild enough for everyday use throughout a healthcare facility.

This year, GOJO launched a new non-antimicrobial soap, PURELL® Healthcare CRT HEALTHY SOAP High Performance Foam which sets a new standard in soap performance.  Formulated for frequent use and designed with CLEAN RELEASE™ Technology, this exceptionally mild formulation contains no antimicrobial active soap ingredients or harsh preservatives. PURELL® Healthcare CRT HEALTHY SOAP™ reaches into skin’s cracks and crevices 2x better than regular soap2, lifting and washing away more than 99% of soil and germs3 leaving 3.4 times fewer germs left on dry, irritated skin than with regular soap4.  

GOJO has a long history of developing safe, effective and sustainable hand hygiene solutions as part of our Purpose – Saving Lives and Making Life Better Through Well-Being Solutions. We relentlessly pursue scientific advancements to develop safe, effective hand hygiene solutions that help save lives, improve quality of care, and enhance patient and healthcare worker safety.

Additional Resources
GOJO Healthcare Solutions

1. Meets FDA requirements for Healthcare Personnel Handwash (transient microorganisms) and Surgical Hand Scrub (resident microorganisms)
2. Regular soap is based on our top-selling non-antimicrobial handwash
3. Augustine Scientific, Newbury OH, Surface and Interfacial Rheology Analysis, June 30, 2017; Augustine Scientific, Newbury OH, Ex Vivo Soil Removal Analysis, August 5, 2017; BioScience Laboratories, Inc.; Bozeman, MT, Study# 170398-101, Evaluation of In-Vivo Germ Removal, July 5, 2017
4. GOJO Industries Inc, Akron OH, Evaluation of handwashes for germ removal from ex vivo skin, Study # EV-2017-002, August 15, 2017

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Contact: Samantha Williams

Phone Number: 330-255-6397

Email: willisam@gojo.com

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