Inclusion of chlorhexidine gluconate in alcohol-based presurgical hand antiseptics: Can a product be considered 'superior' if it does not meet established efficacy requirements?

摘要

We read with great interest the recent manuscript by Olson et al comparing the in vivo activity of a dual-active, waterless presur-gical hand antiseptic (61% ethyl alcohol, 1% chlorhexidine gluco-nate [CHG]) to waterless presurgical hand antiseptics containing alcohol only.1 The study demonstrated that the mean bacterial counts on the hands of test subjects were significantly lower when using the dual-active antiseptic compared with 2 alcohol-only antiseptics 6 hours after product use and glove wear. There were no differences in mean bacterial counts immediately after use. We respectfully disagree that these results indicate any advantage of chlorhexidine gluconate (CHG) containing alcohol-based products over those containing alcohol as a single active ingredient. The , US Food and Drug Administration (FDA) has established efficacy criteria for pre-surgical hand antiseptics that are identical regardless of whether products contain alcohol alone or whether they are new drugs containing CHG. These criteria include log reduction requirements immediately after use on days 1, 2, and 5 and 6 hours after use when occluded by a surgical glove on the first day of use.2 Olson et al failed to mention that none of the products tested in the study met FDA minimum efficacy requirements for a 3-log reduction immediately after use on day 5 of product use. In fact, at no time during the study did any of the products achieve' a 3-log reduction. Because none of the products met the FDA's minimum efficacy requirements for presurgical hand antiseptics, it is inappropriate and irrelevant to make conclusions regarding superiority of one product versus the others. Furthermore, the clinical relevance of the Olson et al findings is unknown and questionable.