Hand Sanitizer Safety Risks Associated with Poor Formulation and Packaging Approaches: Lessons Learned and Improvements Needed Post-Pandemic

Introduction: The rapid effectiveness of alcohol-based hand rub(ABHR) on microbial pathogens, including viral variants, inspired unprecedented demand for ABHR during the COVID-19 pandemic. A wide variety of new ABHR products that were rapidly produced and released to the public appear to have introduced new and unacceptable human safety risks. Objectives: While the long-term public health impact of exposure to adulterated ABHR will require further study, the immediate need to assess the safety and efficacy of ABHR motivated this study. Methods: Sampling of ABHR provided to the public in community settings (e.g., by a medical center) occurred across a wide variety of global community settings. When possible, ABHR samples of 30.50 ml were analyzed for: alcohol %, visible impurities and chemical impurities (i.e., acetal, acetaldehyde, benzene, and methanol). Validated analytical methods (good laboratory practices (GLP) or International Organization for Standardization (ISO) standards) were used for quantitative measurements. Photographs were taken for visual assessment of packaging design + labeling risks. Results: Alcohol concentrations less than a typical minimum antimicrobial efficacy level of 60% were measured in ≥ 7% of the ABHR samples. Unknown visible impurities were observed in ≥ 11% of samples. Levels of regulated impurities (acetal, acetaldehyde, benzene, and methanol) in excess of US FDA Guidance were observed in ≥ 43% of samples. Photographs demonstrate numerous risks associated with package design and open refillable ("bulk") dispensers, including no lot code nor expiry, and lack of traceable labeling. Conclusion: During the COVID-19 Emergency, demand for ABHR prompted new supply sources, followed by inscrutable donations of surplus products. Though unintended, allowing tainted and poor quality ABHR into communities places clinicians and the public at unnecessary risk. Guidance to consumers, businesses, and communities including medical centers, nursing homes, schools, offices, and retail settings, on the proper evaluation, use, and handling of ABHR, and safe disposal of adulterated or suspect product is needed. Regulatory guidance and enforcement addressing dangerous practices evident in this study including refilling of pump bottles/dispensers with a variety of ABHRs is needed immediately to reduce future exposure to unsafe, ineffective, mislabeled or unlabeled ABHR products.

Considerations toward lower toxicity cleaning in K-12 schools

Surface cleaning and disinfection is a core mitigation strategy to control the spread of germs in K-12 educational settings. These include not only SARS-CoV-2, the virus that causes COVID-19, but also infectious agents that cause illnesses that frequently and persistently manifest in schools, such as colds, influenza, and gastroenteritis. With unprecedentedly high levels of cleaning and disinfection during the COVID-19 pandemic, concerns have started to emerge related to the exposure of school children to potentially harmful chemicals found in some disinfectants that may cause or aggravate common childhood conditions like asthma. The consideration of best practices toward healthy cleaning and disinfection in schools is critical to ensure effective infection prevention while minimizing other potential adverse health effects related to disinfectant chemical exposure. Here we highlight the need to balance disinfectant efficacy with safety, provide guidance on the selection of low toxicity disinfectants, and identify research gaps to further our understanding of secondary exposure and potential health risk to children due to widespread disinfectant usage in the K-12 educational setting.