Hand Sanitizer Update: COVID-19, Methanol, Benzalkonium Chloride, Testing, Regulation and Outlook


Read the full article in the June 2021 digital edition. . .

By the beginning of 2021, it became apparent that the COVID-19 pandemic would endure well into the New Year. In the medium term, experts predict it is unlikely that COVID-19 will disappear,1 but it will instead become endemic and accepted as a health risk, similarly to flu. However, COVID-19 will require a fundamentally different approach than the usual response to flu.

With flu, public health measures such as hand sanitization, masking, social distancing, contact tracing, quarantining and isolation are usually abandoned once community transmission becomes established. On the other hand, COVID-19 is significantly more lethal than most forms of influenza, and elimination of the disease by vaccination is preferable to the achievement of herd immunity by widespread infection. However, the current form of COVID-19 and its variants will likely continue as a public health concern since the global penetration of this pandemic could make it difficult for vaccines to confer herd immunity ahead of the evolution of variant strains of the virus. This will be exacerbated by the zoonotic characteristic of this virus; that is, it appears to be communicable between human beings and animals.

Moreover, the RNA genome of coronaviruses is the largest among all RNA viruses2 and the frequent recombination of its genetic material results in new strains with altered virulence.3 As coronavirus variants evolve, repeated vaccination will likely be necessary, and public health preventatives such as masking, hand sanitization and physical distancing will need to persist. This is emphasized in a report from McKinsey & Company that concludes populations that adequately and promptly adopt public health preventative measures could achieve a much better economic outcome than countries attempting a “balancing act.4

The rapid geographical spread of viruses is enabled by fast and easy international travel, and this poses the risk of further pandemics. This is the third time, within the last two decades, that an animal coronavirus has cross-infected humans to cause an epidemic, and following COVID-19, it is likely that the global community will be sensitized to the possibility of further devastating pandemics. The perceived continuing uncertainty will encourage proactive preventative measures to protect health and livelihoods, including diplomatic efforts for global cooperation by responsible governments to detect and control emerging diseases, and the implementation of corresponding hygiene measures as the norm for the successful functioning of nations.5 In this context, preventative measures can be expected to continue: respiratory control by masking and social distancing to lower the potential of aerosol transmission, and hand hygiene to limit the transfer of pathogens by contact.6, 7

Importance of Hand Hygiene

As news of the COVID-19 pandemic broke, the importance of hand hygiene was saturation-broadcasted by noted epidemiologists and public health experts. Universal hygiene measures were especially pertinent because infected people can transmit the virus even when they have no, or only mild, symptoms,8, 9 and this can hamper contact tracing and control of the pandemic.

Hand hygiene is a cornerstone of infection prevention10, 11 and its purpose is to minimize the colonization and the transmission of infection among health care workers and the public. Hand hygiene is imperative to prevent transmission of disease via the respiratory route and the fecal-oral route because people habitually touch their faces. Although the need for hand hygiene came to the forefront during the COVID-19 pandemic, its importance extends to many other sources of infection. Before the current pandemic, Linda Homa, the Manager of Clinical Affairs at Ecolab, expressed this poignantly when she stated, “75,000 patients die every year from health care-associated infections and that’s unacceptable. Hand hygiene is the number one way to prevent the transmission of health care-associated infections. We’re spending our time on the things that matter most.”12

Hand hygiene includes hand-washing with soap and water, hand-washing with antiseptic washes, and the use of antiseptic hand rubs, most commonly in the form of alcohol-based hand sanitizers.13 Globally, the vast majority of health care workers is aware of the need for hand hygiene and they are not antipathetic to the use of alcohol-based hand sanitizers. However, these principles of hand hygiene are not always followed due to lack of availability, relatively high cost, forgetfulness and/or the onset of skin or ocular irritation with frequent hand-washing or hand sanitization.14

Antiseptic Rub or Hand-washing?

Consistent with Lister’s 19th century antiseptic regime, soap hand-washing coupled with an alcohol gel sanitizer was shown to be more effective than either agent used alone, and the antiseptic activity persisted for longer.15 Also, the increased reduction of murine norovirus was observed with a wash-sanitizer regimen rather than washing with 70% ethanol alone.16

For the purpose of hand hygiene, the Centers for Disease Control (CDC) and the U.S. Food and Drug Administration (FDA) recommend washing hands with soap and water whenever possible, to remove virtually all types of pathogens. Hand-washing is preferable for soiled hands, as hand sanitizers cannot effectively penetrate the layer of dirt before reaching pathogens on the skin surface. It is important to remove soil from hands before treating them with a hand sanitizer. In fact, hand-washing with soap and water alone has been found to be more effective than alcohol-based rubs for hands soiled with meat.17

Moreover, potentially harmful substances can be washed away but they cannot be removed by leave-on hand sanitizers. However, hand-washing facilities are not readily available at work or public places, and in instances where hand sanitization is needed frequently, the use of alcohol-based antiseptic rubs is an effective and convenient infection-preventive measure.18

In many work settings, alcohol-based hand sanitizers are more versatile, convenient, quick and less irritating than hand-washing with soap and water. However, hand sanitizers work only when formulated properly and used correctly,19, 20 and the choice of container, closure and dispenser is also vital in dispensing the correct amount of the sanitizer for each use.

In the United States, hand sanitizers are regulated as OTC drugs and in the Final Rule for Antiseptic Hand-Rubs, the FDA allows only three active ingredients to be used for hand sanitizers.64 The three ingredients are ethyl alcohol, isopropanol and benzalkonium chloride. Note that these ingredients are not “approved” by the FDA. Rather, they are classified as Category III and have been allowed as eligible actives during the time in which data is being generated to determine if they could be recognized as “Generally Safe and Effective” for use as antiseptic rubs.

. . .Read more in the June 2021 digital edition. . .


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