Product Selection
With “rogue” products now being offered for sale, here are some facts about how soaps and
sanitizers are regulated by the FDA and what you should look for when buying them:
● Alcohol-based hand sanitizers should only be used if they have a minimum of 60 percent alcohol.
Many healthcare professionals are migrating to at least 70 percent or higher for both professional
and home use.
§ Avoid non-alcohol-based sanitizers, as they are not as effective on pathogenic microorganisms
and they are not recommended by the CDC or WHO.
● While under normal circumstances sanitizers must be made in FDA registered plants and have an
NDC (National Drug Code) assigned and printed on the label, the FDA is allowing a liquid sanitizer
with a final concentration of 80 percent v/v ethyl alcohol or 75 percent v/v isopropyl alcohol to be
made, waiving most of the normal manufacturing requirements but with a set of specific formula
and manufacturing guidelines.
§ That’s why you see a number of distilleries now making hand sanitizer. Note that these
products are liquids as opposed to the normal gels or foams on the market so don’t be surprised
when it comes out runny if you buy one of these.
● Soaps can be plain or antibacterial and the latter are also regulated by the FDA. Note that the
CDC and WHO do not give a specific recommendation for using plain or antibacterial soap. The
key is to clean all parts of the hands for 20 seconds and not miss any surface from the wrists to
the fingertips.
§ The CDC web site states: “handwashing mechanically removes pathogens.”
§ Antibacterial soaps must also be made in an FDA-registered plant and contain an
NDC number on the label.
● Antibacterial soaps and sanitizers must be tested for safety, efficacy against 31 microorganisms
including MRSA and stability. This is also known as GRASE or Generally Regarded as Safe and
Effective.
§ While the CDC states on its web site that: “ABHR [alcohol-based handrubs] formulations
containing 80 percent ethanol or 75 percent isopropanol, both of which are in the range of
alcohol concentrations recommended by CDC, inactivate SARS-CoV-2,” the FDA does NOT
allow for virucidal efficacy claims on soaps or sanitizers sold to hospitals or consumers. This is
an inconsistency that often causes confusion. We would like to see alignment between CDC
and WHO guidance and FDA regulatory requirements.
Are there any special considerations with regard to skin health in the light
of the COVID-19 pandemic?
There has been a dramatic increase in clinician hand hygiene due to the Pandemic. It is more important than ever to
protect the skin’s natural barrier by applying a moisturizer routinely during the day after soap-and-water handwashing
and especially before leaving the facility.
Reference links:
CDC Hand Hygiene Guidance
WHO Recommendations for Hand Hygiene in the Context of Covid-19
NDC Lookup
Covid 19 Hand Sanitizer Tool Kit
Let me know what you think and please send me your specific hand hygiene challenges, frustrations and nagging
problems – I’ll share ideas that might be of interest in this monthly column [email protected]. Connect
with me on LinkedIn.
Paul Alper, BA, led the launch of PURELL®, invented the first electronic hand hygiene monitoring system proven to
reduce infections while improving behavior and eliminating costs and is now the VP Patient Safety Innovation for Medline
Industries, Inc. through an exclusive engagement with his consulting practice, Next Level Strategies, LLC.
www.healthcarehygienemagazine.com • may 2020
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