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Disinfection

Hand Washing and Disinfecting with Alcohol Based Antiseptics

By Juan Goncalves

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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. 

The CDC has identified the occasions where hand washing is highly recommended1. These include: before eating or preparing food; before touching one’s face; after using the restroom; after leaving a public place; after blowing one’s nose, coughing, or sneezing; after handling one’s mask; after changing a diaper; after caring for someone sick; and after touching animals or pets.
The CDC has identified the occasions where hand washing is highly recommended1. These include: before eating or preparing food; before touching one’s face; after using the restroom; after leaving a public place; after blowing one’s nose, coughing, or sneezing; after handling one’s mask; after changing a diaper; after caring for someone sick; and after touching animals or pets.Further, the Food and Drug Administration (FDA) Food Code expands the occasions listed above for those handling food to include2: after using a handkerchief or disposable tissue, using tobacco, eating, or drinking; after handling soiled equipment or utensils; during food preparation; when changing tasks in the food service establishment; when switching between working with raw food and working with ready to eat food; before donning gloves to initiate a task that involves working with food; and after engaging in other activities that contaminate the hands.

Hand sanitizers vs. hand washes

The 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.

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.) 

Like ethanol, hand sanitizers based on isopropyl alcohol (also known as rubbing alcohol) are recommended by the World Health Organization. The FDA accepts these isopropyl alcohol formulations for use in the US during the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020. According to the WHO and FDA, isopropyl alcohol-based hand sanitizers should contain an active ingredient level of at least 75 %v/v.5 Isopropyl alcohol is a well-known antiseptic, too. 

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.

One unintended, yet important consequence of this temporary policy is the presence of unsafe formulations that contain impurities which are known to cause severe adverse effects to humans.
One unintended, yet important consequence of this temporary policy is the presence of unsafe formulations that contain impurities which are known to cause severe adverse effects to humans. Due to the great scarcity of ethanol raw material which is compliant with high quality medical standards such as United State Pharmacopoeia (USP) grade ethanol, FDA has allowed distilleries and petrochemical plants to produce ethanol in their facilities via carbohydrate fermentation or other oxidation methods, respectively, for use in hand sanitizers. For the latter, contaminants leaching out of existing petrochemical facility surfaces and the oxidation process itself can lead to the presence of harmful chemicals, most notably 1-propanol (isopropyl alcohol is also known as 2-propanol.) Moreover, the FDA has identified many hand sanitizers contaminated with methanol, or wood alcohol, particularly in raw materials and finished products produced overseas.7
Up to mid September 2020, the FDA has identified almost 190 hand sanitizers contaminated with 1-propanol, methanol, or whose levels of ethanol or isopropyl alcohol are below the minimum recommended for sanitizing potency.
Up to mid September 2020, the FDA has identified almost 190 hand sanitizers contaminated with 1-propanol, methanol, or whose levels of ethanol or isopropyl alcohol are below the minimum recommended for sanitizing potency. More shockingly, some hand sanitizers are being offered in packaging that resembles consumable items such as water bottles or beer cans, or have been added flavoring ingredients to (flavoring ingredients can also interfere with the sanitizing effect of the active ingredients.)7 These practices incite ingestion of these hazardous formulations, which can lead to very toxic and acute illnesses, or even death. Thus, it is of utmost importance to ensure a hand sanitizer formulation is made with raw materials that comply with CDC and WHO guidelines for purity and potency, available in properly design packaging.

Packaging label is a dead giveaway

Starting in 2002, the FDA required all over-the-counter drug product labels (which hand sanitizers are part of) to include the following minimum information: “The product's active ingredients, including the amount in each dosage unit; the purpose of the product; the uses (indications) for the product; specific warnings, including when the product should not be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist. This section also describes side effects that could occur and substances or activities to avoid; dosage instructions (when, how, and how often to take the product); and the product's inactive ingredients.” The label is also printed in a pre-formatted fashion.9Similarly, for hand sanitizers made according to the WHO guidelines as indicated in the temporary policy for compounding alcohol formulations, the label verbatim has already been pre-established by the FDA (including the name of the product listed on the front package panel) and it follows the same content than standard over-the-counter drugs.
Many hand sanitizers found in online broker platforms are sourced from oversees, though, oftentimes exhibiting labels almost entirely written in a foreign language.
Many hand sanitizers found in online broker platforms are sourced from oversees, though, oftentimes exhibiting labels almost entirely written in a foreign language. In these circumstances, it is not even possible to determine if the advertised nominal level of the active ingredient satisfies CDC or FDA guidelines. According to the Code of Federal Regulations (21 CFR 201.15) as it applies to labeling of drugs, including over-the-counter, “all words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language.”10

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.

Conclusion

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. 

  1. https://www.cdc.gov/handwashing/when-how-handwashing.html (Last accessed on 09/22/2020)
  2. US Food and Drug Administration Food Code (2017)
  3. https://www.fda.gov/drugs/information-drug-class/topical-antiseptic-products-hand-sanitizers-and-antibacterial-soaps (Last accessed on 09/22/2020)
  4. https://www.cdc.gov/coronavirus/2019-ncov/hcp/hand-hygiene.html (Last accessed on 09/2/2020)
  5. “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.
  6. 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)
  7. DOI: 10.1016/j.ajic.2020.06.182
  8. https://www.fda.gov/drugs/drug-information-consumers/otc-drug-facts-label (Last accessed on 09/22/2020)
  9. 21 CFR 201.15 - Drugs; prominence of required label statements.

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