Hand hygiene is the primary measure for providing safer care in healthcare facilities1. Although substantial improvements in hand hygiene practices have occurred in recent years, many healthcare facilities continue to encounter challenges in achieving optimal hand hygiene practices. Proper hand hygiene is more than just washing and sanitizing regularly. If healthcare personnel (HCP) have dry or cracked sink they are not only compromising their first line of defense against illness, they are also less likely to wash or sanitize hands because it is uncomfortable to do so. Choosing products that are formulated with mild and effective ingredients available offers HCP protection against skin damage and is a critical foundation for a hand hygiene program.
Product formulation can also greatly influence the overall antimicrobial efficacy of alcohol-based hand rubs (ABHRs), the preferred method of hand hygiene when hands are not visibly soiled. It is more of an important factor than alcohol concentration alone. Product formulation can also influence the amount of ABHR needed to achieve efficacy. When formulated properly, ABHRs containing 70% ethanol have been proven to meet global standards when tested at volumes more representative of normal product use in healthcare environments.2 Almost all previous studies evaluating the efficacy of ABHR products have used application volumes of 3-5 mL or more.3 However, such large volumes are seldom used in clinical practice in US healthcare settings. Two studies in which HCP were given the opportunity to select the volume of ABHR to apply to their hands during routine nursing activities, the mean volume of product applied ranged from 0.73-1.09 mL per application.4,5 These findings suggest that HCP apply variable amounts of ABHR to their hands at much lower volumes than the recommended product application for efficacy. HCP are prone to do this to achieve short dry times that allow them to return quickly to their duties.
The fact that HCP prefer to use low volumes of ABHR questions the efficacy of product in use. Can an ABHR meet efficacy at real world dosing standards? Two novel ABHR formulations containing 70% ethanol were evaluated according to American Society for Testing and Materials (ASTM) E1174 (Health Care Personnel Handwash [HCPHW]) and European Norm (EN) 1500 global standards. Additionally, using ASTM E1174, the efficacy of these formulations was compared head-to-head against 7 representative commercially available ABHRs and 2 World Health Organization (WHO) recommended formulations containing alcohol concentrations of 60% to 90%. These tests used an application volume of 2mL, which is a more realistic volume used by healthcare workers.
The two ABHR products based on 70% ethanol, in a gel and foam format, met US Food and Drug Administration (FDA) efficacy requirements when tested at a volume of 2 mL. In contrast, the 7 additional ABHR products and 2 WHO-recommended formulations failed to meet the same efficacy standard, suggesting that the majority of ABHRs used in US hospitals may have substandard efficacy at realistic volumes. The two 70% ethanol ABHR formulations were also evaluated at dispenser output of 1.1mL, the mean product outputs for 8 commercially available ABHR product/dispenser combinations. Given the fact that HCP prefer lower volumes, they are also less likely to actuate a dispenser more than once to save time. If the ABHR in the dispenser isn’t formulated properly, HCP are not achieving proper efficacy with a single dose of product. Both the gel and foam test products met FDA efficacy requirements at both the first and the tenth application. This is the first report to demonstrate that well-formulated ABHR can meet FDA efficacy requirements at a volume achievable with a single-dispenser actuation.
In conclusion, these studies collectively demonstrate that when formulated properly, ABHRs can meet efficacy standards at volumes that accurately reflect actual use in clinical settings. Our results demonstrate the importance of careful ingredient selection and proper formulation when developing ABHRs to maximize antimicrobial efficacy.