Hand washing and infection prevention
Since the onset of the COVID-19 pandemic in the US, the Centers for Disease and Control Prevention (CDC) has advised the general public to exercise frequent and thorough hand washing.
Like many other communicable diseases, COVID-19 can be transmitted when susceptible hosts touch an inanimate surface such as a door knob or countertop which has previously been contaminated with the novel coronavirus (SARS-CoV-2) from an infected person that coughed or sneezed on said surface. The susceptible host hands can also be contaminated when shaking hands with those of others who carry the virus. After the susceptible hosts subsequently touch their own mucous membranes like eyes, mouth or nose with the contaminated hands, these membranes become a portal of entry for the infectious pathogen. If the number of viral pathogens entering the body meet or exceed the usually very low minimum infective dose, then the infection is basically inevitable.
Accordingly, and per the CDC, hand washing with soap and warm water for at least 20 seconds will help wash off bodily fluid residue carrying viral particles from contaminated hands and thus prevent the transmission of infections, including that caused by the novel coronavirus.
Hand sanitizers vs. hand washesThe FDA classifies over the counter hand antiseptics into two groups: hand washes and hand rubs. Per the FDA, “antiseptic wash products, also known as antibacterial soaps, are intended for use with water and are rinsed off after use, and include hand washes, soaps and body washes.” Conversely, “rubs are leave-on products, or hand sanitizers, as well as antiseptic wipes. These products are intended to be used when soap and water are not available and are left on and not rinsed off with water.”3 The CDC supports use of standard hand soaps for infection transmission prevention. Table 1 summarizes some of the key differences between hand washes and hand sanitizers.
When should alcohol-based sanitizers be used?In general, alcohol-based hand sanitizers are not a replacement for hand washing. This is particularly true in food service operations. Consistent with the FDA’s Food Code, workers handling food in establishments subject to State and local food safety regulations should not use hand sanitizers in lieu of hand soap. Hand sanitizers can be used after hand washing, provided that food is to be handled after the sanitizer has completely dried on the worker’s hands. Even though hand soaps have been shown to be more effective at removing infectious agents such as Norovirus or Clostridium difficile spores from hands than alcohol-based hand sanitizers, in healthcare settings, use of the latter generally results in better compliance than hand soaps, conversely.4
The CDC recognizes that hand soaps are not always readily available. In such scenario, the CDC recommends using alcohol-based hand sanitizers containing at least 60 %v/v of ethanol. Ethanol has long been known as a skin antiseptic (i.e. an active ingredient that reduces the presence of bacteria, viruses and fungi on contaminated skin) and it can be marketed in over-the-counter hand sanitizing formulations provided that such formulations abide by strict ingredient purity specifications and formulation preparation standards (known as FDA Monographs.)
Safety and efficacy considerations
Due to the public health emergency stemming from the COVID-19 pandemic, the FDA has allowed compounders of alcohol-based hand sanitizers to manufacture and market their products provided that they meet certain criteria as indicated in the “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)” guideline. Manufacturers who register with the FDA, including those with no previous experience in the production of hand sanitizers, can immediately produce hand sanitizers that follow WHO ‘s recommended formulation specifications.
Packaging label is a dead giveaway
In summary, products resembling foods or beverages, or lacking a clear over-the-counter drug label format, should result in a “first moment of truth” outcome of rejection for said products.
Alcohol-based sanitizers are an important tool to prevent transmission of infectious diseases such as COVID-19 when hand soap and water are not available, so much as to being named an essential medicine by the WHO (they do not replace hand soap and water for workers handling food in food service establishments, though.) The benefits of alcohol-based sanitizers are only realized as long as the formulations they are based on and the packaging they are delivered in comply with strict purity and quality specifications, and the minimum recommended amounts of active ingredient (ethanol or isopropyl alcohol) are present in the hand sanitizers. As long as the right amount of sanitizer is used to thoroughly cover the user’s hands, any sanitizer form (gel, foam or spray) will be acceptable provided the abovesaid considerations are met.
- https://www.cdc.gov/handwashing/when-how-handwashing.html (Last accessed on 09/22/2020)
- US Food and Drug Administration Food Code (2017)
- https://www.fda.gov/drugs/information-drug-class/topical-antiseptic-products-hand-sanitizers-and-antibacterial-soaps (Last accessed on 09/22/2020)
- https://www.cdc.gov/coronavirus/2019-ncov/hcp/hand-hygiene.html (Last accessed on 09/2/2020)
- “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) - Guidance for Industry” US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) March 2020, Updated on August 7th, 2020.
- https://www.fda.gov/news-events/press-announcements/fda-issues-final-rule-safety-and-effectiveness-consumer-hand-sanitizers (Last accessed on 09/22/2020) 7.https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use (Last accessed on 09/22/2020)
- DOI: 10.1016/j.ajic.2020.06.182
- https://www.fda.gov/drugs/drug-information-consumers/otc-drug-facts-label (Last accessed on 09/22/2020)
- 21 CFR 201.15 - Drugs; prominence of required label statements.