GOJO Industries, Inc., Akron, Ohio, United States of America.
Valisure, LLC, New Haven, Connecticut, United States of America.
PLoS One. 2022 Mar 18;17(3):e0265519. doi: 10.1371/journal.pone.0265519. eCollection 2022.
Alcohol-based hand sanitizers (ABHS) have been an important hand hygiene tool during the COVID-19 pandemic. Recently, ABHS from non-traditional drug manufacturers have entered the market, triggered by a lack of ABHS availability. Some of these ABHS contain high levels of chemical impurities that may be harmful with frequent exposure. Additionally, the use of refillable dispensers designed to accept ABHS from bulk containers allows for mixing and evaporation that may compromise ABHS integrity. To understand the risks associated with low quality ABHS and bulk refilling practices, we collected 77 ABHS samples sourced from community settings (restaurants, grocery stores, etc.) and 40 samples from a single school district. All samples were obtained from bulk refillable dispensers that were in use. Samples were analyzed for alcohol content, chemical impurities, aesthetic qualities, and presence of drug labeling information. Additionally, we performed laboratory-based experiments to determine the impact of dispenser design on alcohol evaporation rates. Over 70% of samples for which photos were available showed lack of essential labeling information, including missing "Drug Facts Labels". For ABHS samples acquired from community settings, nearly 14% of samples had visible impurities, and over 30% of samples had concentrations of acetal and acetaldehyde in excess of FDA interim limits. Subpotent ethanol concentrations were observed in 9.09% and 82.05% of samples from community settings and the school district, respectively, with the school district sample results being associated with dispenser misuse. Laboratory-based experiments show dispenser design significantly impacts the rate of ethanol evaporation of ABHS products, especially if stored in open refillable dispensers without an internal reservoir. This study demonstrates risks associated with use of inferior ABHS and bulk refilling practices. Regulatory agencies should issue guidance on best practices in community settings to ensure the integrity of ABHS as an essential public health tool to prevent the spread of COVID-19 and other transmissible diseases.
酒精类手部消毒剂 (ABHS) 在 COVID-19 大流行期间一直是重要的手部卫生工具。最近,由于 ABHS 供应短缺,非传统药物制造商的 ABHS 进入市场。其中一些 ABHS 含有高水平的化学杂质,频繁接触可能有害。此外,使用设计用于接受来自散装容器的 ABHS 的可再填充分配器允许混合和蒸发,这可能会破坏 ABHS 的完整性。为了了解低质量 ABHS 和散装灌装操作相关的风险,我们从社区环境(餐馆、杂货店等)收集了 77 个 ABHS 样本和从一个单一学区收集了 40 个样本。所有样本均取自正在使用的散装可再填充分配器。对样本进行了酒精含量、化学杂质、美学质量和药物标签信息存在情况的分析。此外,我们还进行了基于实验室的实验,以确定分配器设计对酒精蒸发率的影响。在有照片的样本中,超过 70%的样本显示缺乏基本的标签信息,包括缺少“药物事实标签”。对于从社区环境中采集的 ABHS 样本,近 14%的样本有可见杂质,超过 30%的样本的乙缩醛和乙醛浓度超过 FDA 临时限量。在来自社区环境和学区的样本中,分别观察到 9.09%和 82.05%的样本的乙醇浓度不足,而学区样本的结果与分配器误用有关。基于实验室的实验表明,分配器设计会显著影响 ABHS 产品的乙醇蒸发率,尤其是如果将其储存在没有内部储液器的敞开式可再填充分配器中。这项研究表明了使用劣质 ABHS 和散装灌装操作的相关风险。监管机构应就社区环境中的最佳实践发布指南,以确保 ABHS 的完整性,将其作为预防 COVID-19 和其他传染病传播的重要公共卫生工具。