The author of this article is a principal of JLC Group, a Westport, Connecticut consulting firm that specializes in advising manufacturers of consumer and institutional products and professional services. Clients of JLC Group include competing manufacturers of hand sanitizer products.
July 2009
With yet another summer camp season is concluding and many camp nurses will be returning to their roles within school venues, the issue of Swine Flu, and the best practices insofar as hand hygiene strategies, and specifically, hand sanitizer products that can mitigate the transmission of H1N1 continues to remain at the forefront of concerns.
For years, health care professionals have been indoctrinated with the notion that alcohol gels and rubs are the “recommended” hand sanitizing alternative when washing with soap and water is not readily convenient. After all, this is what the US Centers for Disease Control has recommended without any amendment since 1996. So why would anyone want to fix what isn’t broken?
Aside from the fact that Richard Besser, the recently replaced Director of CDC acknowledged in May of this year that “CDC has some communication issues” and “might be off-message” with regard to their exclusive promotion of alcohol hand sanitizer products (see below), CDC’s promotion of alcohol-based hand sanitizer has been discounted, if not completely disregarded by hundreds of schools throughout the US and Canada, all of whom have either restricted or out-right banned alcohol hand sanitizer products from their facilities. Instead, these institutions, along with a wide range of government, corporate, and health care facility managers have migrated to non-alcohol hand sanitizer products that have proven to be equally if not more effective insofar as killing pesky pathogens, and necessarily safer to the skin.
Here’s the rub: While alcohol-based products have been embraced because of their ability to kill pathogens that might be immediately present on the skin, they have become equally notorious for (i) causing dry/irritated skin, in turn increasing the risk of exposure to pathogens, (ii) destroying protective skin cells, (iii) having limited persistency, and of course, these products are (iv) flammable, (v) potentially toxic and (vi) destroy physical material including industrial floor wax, paint, clothing, jewelry and furniture ; creating a variety of risks and opening the door to unintended consequences resulting from purposefully re-purposing the product, inadvertent ingestion, or improper placement within physical settings. For the purpose of white paper brevity, one need only search YouTube.com using the key words “hand sanitizer” to fully appreciate the many “alternative uses” of alcohol hand sanitizers that have been discovered adolescents, teens and young adults.
Within a summer camp setting, it should be obvious that alcohol-based hand sanitizers can prove to be a superb accelerant when attempting to start a camp fire, and an equally effective libation ingredient for camp counselors seeking to take the edge off after an arduous day. Insofar as the product’s ability to kill germs on the skin, the more responsible manufacturers of alcohol-based sanitizers acknowledge alcohol does not penetrate dirt, and they recommend washing with soap and water prior to application. Leading any first year summer camper, as well as supervisory staff to wonder why they should be applying alcohol to their skin if they’ve just washed with soap and water. And, let’s not overlook the (negative) ramifications of applying alcohol-based sanitizers to hands that might have cuts/abrasions. Show me a camper that has clean hands and no minor abrasions on his/her hands, and I’ll show you a camp that takes place exclusively on-line and strictly within the confines of the Internet.
These “features” are barely-noticed “footnotes” in the US Centers For Disease Control hand hygiene white paper; the “bible for hand hygiene.” This white paper, exclusively intended for hospital workers (HCW’s), was originally prepared in 1996, and slightly modified in 2002 (with no significant changes). However, as recently as October 2007, Kathleen Stewart, a senior spokesperson for the CDC, stated unabashedly that “..the report is widely misinterpreted, as CDC does not in fact “recommend” the use of alcohol-based gels (we only recommend washing with soap and water), and contains numerous statements cautioning against the use of alcohol-based hand sanitizer rubs and gels..”
Although CDC staff subsequently redacted Ms. Stewart’s comments in May 2009 and stated “CDC recommends alcohol-based hand sanitizer products; CDC does not recommend products..” below extracts from the CDC publication illustrate Ms. Stewart’s observations.
§ When evaluating hand hygiene products for potential use in health care facilities, administrators or product selection committees should consider the relative efficacy of antiseptic agents against various pathogens and the acceptability of hand hygiene products by personnel. Characteristics of a product that can affect acceptance and therefore usage include its smell, consistency, color and the effect of dryness on hands.
§ Allergic contact dermatitis due to alcohol hand rubs is relatively uncommon. However, with increasing use of such products by health care personnel, it is likely that true allergic reactions to such products will occasionally be encountered.
§ Alcohols are rapidly germicidal when applied to the skin, but they have no appreciable persistent (i.e., residual) activity.
§ Depending on the alcohol concentration, the amount of time that hands are exposed to the alcohol, and viral variant, alcohol may not be effective against hepatitis A and other nonlipophilic viruses. The inactivation of nonenveloped viruses is influenced by temperature, disinfectant-virus volume ratio, and protein load
§ Alcohols are not appropriate for use when hands are visibly dirty or contaminated with proteinaceous materials.
§ Further studies are warranted to determine the relative efficacy of alcohol-based rinses and gels in reducing transmission of health-care--associated pathogens.
§ Even well-tolerated alcohol hand rubs containing emollients may cause a transient stinging sensation at the site of any broken skin (e.g., cuts and abrasions). Alcohol-based hand-rub preparations with strong fragrances may be poorly tolerated by HCWs with respiratory allergies.
§ Alcohols are flammable. Flash points of alcohol-based hand rubs range from 21ºC to 24ºC, depending on the type and concentration of alcohol present (169) One recent U.S. report described a flash fire that occurred as a result of an unusual series of events, which included an HCW applying an alcohol gel to her hands, immediately removing a polyester isolation gown, and then touching a metal door before the alcohol had evaporated
§ In certain surveys, approximately 25% of nurses report symptoms or signs of dermatitis involving their hands, and as many as 85% give a history of having skin problems (249).
§ Affected persons often complain of a feeling of dryness or burning; skin that feels "rough;" and erythema, scaling, or fissures. Detergents damage the skin by causing denaturation of stratum corneum proteins, changes in intercellular lipids (either depletion or reorganization of lipid moieties), decreased corneocyte cohesion, and decreased stratum corneum water-binding capacity (250,251). Damage to the skin also changes skin flora, resulting in more frequent colonization by staphylococci and gram-negative bacilli (17,90). Although alcohols are among the safest antiseptics available, they can cause dryness and irritation of the skin (1,252)
§ Skin that is damaged by repeated exposure to detergents may be more susceptible to irritation by alcohol-based preparations (253)
§ Allergic reactions to products applied to the skin (i.e., contact allergies) may present as delayed type reactions (i.e., allergic contact dermatitis) or less commonly as immediate reactions (i.e., contact urticaria). The most common causes of contact allergies are fragrances and preservatives; emulsifiers are less common causes (256--259). Liquid soaps, hand lotions or creams, and "udder ointments" may contain ingredients that cause contact allergies among HCWs (257,258).
§ Allergic reactions to alcohol-based products may represent true allergy to alcohol, allergy to an impurity or aldehyde metabolite, or allergy to another constituent of the product (167). Allergic contact dermatitis or immediate contact urticarial reactions may be caused by ethanol or isopropanol (167).
With respect to non-alcohol based alternatives, the limited references from CDC’s 1996 version of the report were repeated in the 2002 “update”, and consist of less than 150 words, compared to the extensive references throughout the document with respect to alcohol-based products, which at the time, were considered to be the “only” ingredient insofar as hand sanitizer products.
Quaternary Ammonium Compounds
§ In the
§ One laboratory-based study reported that an alcohol-free hand-rub product containing a quaternary ammonium compound was efficacious in reducing microbial counts on the hands of volunteers (215). Further studies of such products are needed to determine if newer formulations are effective in health-care settings.
§ No recommendation can be made regarding the routine use of nonalcohol-based hand rubs for hand hygiene in health-care settings. Unresolved issue.
*The above-underlined excerpt is an important notation, as the CDC spokesperson referenced above, along with numerous independent studies are consistent in recommending washing with soap and water to be the most appropriate and most effective hand hygiene strategy, and that alternative strategies/products should necessarily be researched by those implementing hand sanitizer products as an adjunct to hand washing.
Which is exactly why alcohol-based products are being systematically banned from corporate, government, correctional, and educational venues, why the New York State Department of Education issued a memorandum in 2004 that prohibited alcohol-based hand sanitizers without the express written permission of a parent or family physician, why the United States Navy outright banned alcohol-based hand sanitizers in January 2009, and why a continuously growing number of infection control experts are embracing the use of non-alcohol, rinse free, fragrance free and dye free products; and specifically those that incorporate the organic compound Benzalkonium Chloride (BAC) as the active ingredient.
There are no less than one dozen alcohol-free hand sanitizer brands readily available within the marketplace
Per below table, illustrating efficacy studies of one of several brands readily available in the consumer and institutional marketplace and uses a formula that contains a .24 concentration of BAC (the majority of brands use a .13 BAC concentration, and the distinction between the two can be found in respective log rates, not actual efficacy), BAC-based alcohol-free sanitizers are proven to be equally, if not more effective i.e. germ/bacteria and virus killing, safer to the skin, and safer within dispensing systems.
That said, the mainstream hospital industry (not to be confused with senior care industry) has been reticent to embrace these findings, simply because the “research” is based on most recent 5-7 year time frame, and that CDC has repeatedly said their role limits their ability to continuously conduct research on commercial products.
Before reviewing the comparisons of this one alcohol-free brand of non-alcohol hand sanitizer to alcohol-based alternatives, it is critically important to put the topic of hand sanitizers into proper perspective.
We’re not talking about chemotherapy; we’re talking about safe, effective hand hygiene products that can successfully protect children and adults against easily transmitted pathogens when washing with soap and water is not readily convenient.
And, in deference to the realities of the “new economy”; one that imposes all of us to balance our budgets and be particularly sensitive to procurement costs, it is equally important to note that foam format, alcohol-free alternatives are 2x-3x more economical when compared to legacy, alcohol-based gels and rub products.
| In Vitro Antimicrobial Efficacy | | | | | | |
| ||||||
| (72% Alcohol) vs. Alcohol-Free (.24 Benzalkonium Chloride) | | | |||||||||||
| (% Reduction based on 15 second exposure) | | | | | | | |||||||
| | | | | | | | | | | ||||
| Test Microorganism | | | | Alcohol Product | Non-Alcohol Product | | | ||||||
| Pseudomonas aeruginosa | | | >99.99 | | 99.99 | | | ||||||
| Klebsiella pneumonaie | | | | >99.99 | | 99.99 | | | |||||
| Escherichia coli | | | | >99.99 | | 99.99 | | | |||||
| Staphylococcus aureus | | | | >99.99 | | 99.99 | | | |||||
| Staphylococcus epidermidis | | | >99.99 | | 99.99 | | | ||||||
| Micrococcus luteus | | | | >99.99 | | 99.99 | | | |||||
| Candida albicans | | | | >99.99 | | 99.99 | | | |||||
| Clostridium difficile (veg) | | | | >99.99 | | 0 cfu/ml | (Different test method , 0 cfu/ml = total kill) | | |||||
| VRE | | | | | >99.99 | | 99.99 | | | ||||
| Salmonella cChlorocraesuis | | | >99.99 | | 99.99 | | | ||||||
| Aspergillius | | | | 99.99 | | 99.99 | | | |||||
| Listeria monocytogenes | | | >99.99 | | 0 cfu/ml | (Different test method) | | ||||||
| MRSA | | | | | >99.99 | | 99.99 | | | ||||
| Note: Additional microorganisms were tested with non-alcohol brand which is dye free and has no fragrance) | |||||||||||||
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At this point, the under-informed reader might be swayed to embrace the arguments in favor of non-alcohol formulas, and otherwise sold on the above value propositions.
The more informed are inclined to ask “And what are the negative ‘features’ of benzalkonium chloride?” Or, the very informed reader might be familiar with a memorandum submitted in 2003 by GOJO Industries, Inc., the manufacturer of Purell hand sanitizers, to the Federal Drug Administration (FDA), in which GOJO solicited the FDA to prohibit the registration of benzalkonium chloride-based hand sanitizer products. This request, which was denied by FDA, suggested that BAC-based products were “ineffective and potentially dangerous.”
1. Even if BAC is the common active ingredient in cleaning formulas used for hot tubs and swimming pools, this writer does not recommend continuously swimming in high concentrations of benzalkonium chloride. Certain studies have found that while BAC is one of the safest organic compounds, excessive inhalation can have a negative effective on those suffering from asthma. Merely proving the common wisdom that too much of anything is not good. Including tap water.
2. While BAC is the most common active ingredient in OTC contact lens solutions, some studies have found that excessive application within eye drops can have negative effects on the cornea. This writer wears eye glasses, and wouldn’t think of applying a hand sanitizer product to the eyes, and most responsible manufacturers of BAC-based hand sanitizer products caution against applying the product to the eyes, and if inadvertently applied, the recommendation includes washing the eyes with water. One need not be a trained health care professional to opine on the impact of applying an alcohol gel to the eyes.
3. Select lab studies have found that certain pathogens develop a resistancy to benzalkonium chloride when applied in high doses and with excessive frequency. Again, proving that too much of anything is no good. For any nurse that has an extended history of applying alcohol gel or rub to their hands, take a look at your hands while you’re reading this article.
4. Johnson and Johnson Inc., undeniably a prominent and highly-respected health care product company and the marketing licensee for the Purell brand, continues to affirm the position taken by its licensor GOJO Industries. Yet, when J&J executives overseeing the Purell brand were recently questioned on their defending GOJO’s position, despite the fact that a separate division of J&J markets BandAid brand Foaming Antiseptic, a foam-formatted product that not only uses .13 concentration of benzalkonium chloride as its active ingredient, but is otherwise identical in composition to many alcohol-free hand sanitizer products, the same executives indicated they “can’t speak for other divisions of the corporation or other products marketed under the corporate umbrella.”
In summary, this writer maintains the view that washing with soap and water remains the most effective hand hygiene protocol, yet when soap and water is not readily available, one need not be an epidemiologist to recognize that certain non-alcohol hand sanitizer formulas are more pragmatic than alcohol. Most consumer advocates would appreciate the cost efficiencies derived from foam-formatted, BAC-based products, and any product safety expert would raise both hands when voting on the proposition that non-alcohol hand sanitize products are the obvious option when choosing between these “newer” products vs. the legacy products that have outlived their purpose.
But this writer is not a licensed health care professional. Instead, I’d defer to accomplished experts that have relied on CDC’s recommendations to re-evaluate and otherwise draw their own conclusions after reviewing the string of email messages below:
From: xxxx
To: Besser, Rich (CDC/COTPER/OD)
Sent: Fri May 01 18:18:25 2009
Subject: FW: Lab Report: BAC vs. Swine Flu
Dr. Besser..
You might be the busiest guy in the country right now.
Just a note...my note to you i.e. the confusion CDC is creating i.e. alcohol hand sanitizer was not a "business request."
US DOT, GSA and US Navy have all contacted clients of our company specifically requesting alcohol-free hand sanitizer and expressing frustration that CDC continues to recommend alcohol when those agencies prohibit it.
Spokespeople at CDC have said informally "we don't recommend alcohol hand sanitizers', yet its pervasive in all CDC news releases.
From: Besser, Rich (CDC/COTPER/OD) [mailto:reb0@cdc.gov]
Sent: Saturday, May 02, 2009 6:37 AM
To: @.com
Subject: Re: Lab Report: BAC vs. Swine Flu
Got it. I understand now. I appreciate the heads up re: inconsistency. I'll see if we can address it.
Best,
Rich
Richard E. Besser, MD
Acting Director, CDC and
Acting Administrator, ATSDR
From: EOC Swine Influenza, (CDC) [mailto:SwineInfluenza@cdc.gov]
Sent: Saturday, May 02, 2009 2:00 PM
To: xxx
Cc: EOC Swine Influenza, (CDC)
Subject: Follow-up Reply - Lab Report: BAC vs. Swine Flu
Sir, Dr. Besser requested that I respond to your inquiry. See the follow-up reply below.
John Aldahondo
Task Tracker Lead
2009 H1N1
xxxxxx@cdc.gov
404-553-xxxx
1. CDC is currently recommending alcohol based sanitizers products.
2. Correct, CDC does not recommend specific products.
3. Your inquiry regarding non-alcohol hand sanitizer is beyond the scope of the Infection Control Desk in the Emergency Operations Center. For more general comments like this we would refer the writer to HICPAC (Healthcare Infection Control Practice Advisory Committee) which is the group that completes the hand hygiene (http://www.cdc.gov/ncidod/dhqp/hicpac.html).
4. The most appropriate product for cleansing hands when caring for patients with C. difficile remains controversial.
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