An expert panel report of a proposed scientific model demonstrating the effectiveness of antibacterial handwash products

Abstract

In 2005, a US Food and Drug Administration Nonprescription Drug Advisory Committee (NDAC) review of consumer antiseptic handwash product studies concluded that the data regarding existing products failed to demonstrate any association between specific log reductions of bacteria achieved by antiseptic handwashing and reduction of infection. The NDAC recommended that consumer antibacterial handwashing products should demonstrate a reduction in infection compared with non-antibacterial handwash products. In response to the NDAC review, a consumer product industry-sponsored expert panel meeting was held in October 2007 to review new methods for assessing the efficacy of antibacterial handwashes. The expert panel reviewed a newly proposed model for linking the effectiveness of antibacterial handwashing to infection reduction and made recommendations for conducting future studies designed to demonstrate the efficacy of antibacterial handwash formulations. The panel concluded that using the surrogate infection model to demonstrate efficacy has a sound scientific basis, that the use of Shigella flexneri as a test organism coupled with a modified hand contamination procedure is supported by published data, and that the model represents a realistic test for the efficacy of consumer antibacterial handwash products. This article summarizes the expert panel's deliberations, conclusions, and recommendations.