Recall of hand sanitizer – what other option do we have now?

Hand hygiene has become an integral part of our preventive measures towards reducing our risk to COVID19. The situation associated with hand hygiene product has evolved from the initial shortage of alcohol-based hand rub (ABHR) to a plethora of ABHR to cater for the surge in demand, and now, recall episodes of rogue products by various health authorities around the world (1,2,3).

Rogue hand sanitizer, as the name suggests is a substandard product which contains sub-optimal concentration of alcohol, the wrong type of alcohol and microbial contaminants that can have detrimental/adverse effects when applied onto the hands. To inactivate enveloped viruses, such as SARS-CoV-2 (the coronavirus responsible for COVID-19), the hand sanitizer has to contain the right concentration of alcohol and be applied in the right way, and for the right duration (30 seconds) to render it effective (4,5). This however, can seriously be compromised when a substandard hand sanitizer (e.g. containing the wrong concentration and type of alcohol) is used.


Recall in USA
Since June 2020, the spotlight on rogue hand sanitizers has been brought to full attention by U.S Food & Drugs administration (FDA) through a series of warnings on methanol and subsequently, 1-propanol contamination in hand sanitizers (1).


Methanol, also known as wood alcohol is a substance often used to create fuel, antifreeze and as an industrial solvent. Methanol must never be used in products for human use because oral, pulmonary and/or skin exposures can result in severe systemic toxicity. When repeatedly used as a hand rub, skin absorption resulting in chronic toxicity occurs, particularly if methanol-induced desquamation and dermatitis are present (6). Acute poisoning using undeclared methanol in hand sanitizer is not uncommon except that the frequency of adversity has been magnified in this unprecedented period of hand sanitizer used worldwide (6). In the context of hand hygiene, methanol is definitely not acceptable as a contaminant within hand hygiene products.


The danger of using rogue hand sanitizer (especially those contaminated with methanol) has been well-echoed by Dr. Pamela LEE (7), an infection prevention control expert who highlighted the associated toxicity and compromised antimicrobial efficacy of using rogue/questionable ABHR.


Recall in Australia
In Australia, a leading consumer advocacy group, CHOICE, has also recently published their testing report on the presence of hand sanitizers containing sub-optimal concentration of alcohol (as low as 23%) despite being labelled as 70% (2). Together with FDA, this report demonstrates the ubiquitous nature of defective hand sanitizers across different nations, warranting significant attention and actions upon.


Recall in Singapore
Closer to home, Singapore is not immune to rogue hand sanitizers either - a recall by Health Science Authority (HSA) on 18 brands of hand sanitizers, including a couple of well-known household brands has recently surfaced (3). The primary reason of recall concerns the detection of acetaldehyde and/or methanol beyond the acceptable level laid out by pharmaceutical pharmacopeia limit in those affected products. This recall is a welcome move by the authority to firstly, remove unfavourable products from the market and secondly, protect the public from potential harm due to misuse of those products.
Policing by the authority remains the key to safe-keep the public interest via direct removal of rogue hand sanitizers from the market, but the protection of the consumer(s) against such products would also relies heavily on the responsibility of manufacturer(s) to make sure that the formulation within the ABHR are of suitable standards and quality.


Hospital grade vs. normal grade ABHR
As more hospital-grade ABHR made their way into pharmacy and/or over-the-counter sales channels, these ABHR has increasingly become a viable choice for consumers looking for a higher quality product that comes with certain efficacy assurance. Hand hygiene products meant for hospital use must be tested under recognized standards (e.g. European Norm or ASTM). In Singapore (and many other ASEAN countries), most of the non-hospital grade ABHR sits within the cosmetic regulatory framework which is less tightly regulated compared to those under medical devices or drugs classification - meaning that there is no mandatory requirement to provide evidence to support marketing claims unless being requested upon.


Hospital grade ABHR
The formulation of ABHR is considered critical as both antimicrobial agents and other components (e.g. moisturizer) has to work in tandem without compromising the chemistry within. Most if not all ABHR for hospitals have undergone a series of stringent tests (e.g. antimicrobial tests governed by European Norm (EN): EN 1500 and/or EN 12791) to make sure the final product is performing as what it should be doing - to eliminate bacteria/viruses on the hands.


Antimicrobial tests

• EN 1500 test - A specific test on healthy volunteers’ hands to make sure the formulation of the ABHR suffice the specific requirement for bacteria reduction for normal hand hygiene.
• EN 12791 test - A specific test on healthy volunteers’ hands to make sure the formulation of the ABHR suffice the specific requirement for bacteria reduction for surgical hand hygiene (for surgery mainly).
• Additionally, many will have efficacy test done against viruses...
• EN 14476 test - A specific in vitro test of the ABHR formulation against viruses (e.g. enveloped viruses, such as those which causes COVID-19)

Skin caring component
Most of the hospital-grade product are formulated with skin caring ingredients to cater for the high usage frequency experienced by healthcare workers (minimal 50 times of hand sanitizing) in their daily rounds in the wards/hospitals.
Additionally, dermatological test is carried out by most manufacturers to ensure that the final hospital-grade ABHR formulation is skin friendly.


Conclusion
The recall by authorities will continue to serve as a strong deterrence to rogue ABHR, and to ensure consumers have access to only bona fide products for hand hygiene. Amid this recall, hospital-grade ABHR is seemingly a better option for those consumers looking for assurance in both efficacy and quality. Nevertheless, it is still prudent to look out for information on the product label on evidences of antimicrobial testing, ingredient lists (e.g. moisturizer) and importantly, question a little further beyond the marketing message to make a more informed choice the next time you pick up another ABHR!

References

1. FDA (2021), “FDA updates on hand sanitizer consumers should not use”, URL: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use (Assess date: 03.05.2021)
2. CHOICE (2020), “White Knight hand sanitizer recalled by ACCC”, https://www.choice.com.au/health-and-body/beauty-and-personal-care/skin-care-and-cosmetics/articles/hand-sanitiser-alcohol-content-test (Assess date: 03.05.2021)
3. HSA (2021), “Recall of hand sanitisers (Feb to April 2021), URL: https://www.hsa.gov.sg/announcements/product-recall/recall-of-hand-sanitisers-(feb-to-april-2021), (Assess date: 03.05.2021)
4. CDC (2020), “Hand Hygiene Recommendations - Guidance for Healthcare Providers about Hand Hygiene and COVID-19”, URL: https://www.cdc.gov/coronavirus/2019-ncov/hcp/hand-hygiene.html (Accessed: 03.05.2021)
5. WHO (2009), “WHO Guidelines on Hand Hygiene for Healthcare: First Global Patient Safety Challenge Clean Care Is Safer Care. Geneva: World Health Organization”, URL: https://www.ncbi.nlm.nih.gov/books/NBK144013/ (Accessed: 03.05.2021)
6. Chan, A., & Chan, T. (2018). Methanol as an Unlisted Ingredient in Supposedly Alcohol-Based Hand Rub Can Pose Serious Health Risk. International journal of environmental research and public health, 15(7), 1440. https://doi.org/10.3390/ijerph15071440
7. CodeBlue (2020), “Are you using the correct alcohol-based hand rub? – Dr Lee Yew Fong, URL: https://codeblue.galencentre.org/2020/02/17/are-you-using-the-correct-alcohol-based-hand-rub-dr-lee-yew-fong/ (Assess date: 03.05.2021)