Abstract

BACKGROUND: Recently the Centers for Disease Control and Prevention has codified guidelines for hand hygiene practices, recommending a handwash regimen that alternates between waterless alcohol products and antimicrobial or non-antimicrobial soap and water. The advent of an alcohol-based product that can be used with or without water to decontaminate the hands while providing immediacy of kill with antimicrobial persistence could allow for increased compliance with handwash guidelines. Such a product has been developed and has proven to be fully compliant with the Food and Drug Administration (FDA). METHODS: FDA-required testing was performed as outlined in the Tentative Final Monograph for Health-Care Antiseptic Drug Products. The virucidal capacity and the skin-conditioning properties of this formulation were assessed. RESULTS: The in vitro results documented the antimicrobial prowess of this formulation as bacterial strains were reduced by not less that 4 log10 and frequently 6 log10 in 15 seconds or less. Data generated in vivo confirmed the in vitro findings, as this product easily produced a >3.0 log10 reduction in the indicator strain (S. marcescens) following the first wash, exceeding the 2.0 log10 FDA requirement. This level of performance was maintained through the tenth wash, surpassing the 3.0 log10 FDA requirement. The formulation is virucidal for several DNA and RNA viruses. The product is not a dermal irritant and contributes positively to overall skin conditioning. CONCLUSION: This product exceeds all FDA criteria and is a significant advancement in concept of handwashing. It represents a single product suitable for use in all hand hygiene settings.

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