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Saturday, June 13, 2009

US Dept of Education Statement on Hand Sanitizers & Swine Flu

To: ''
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Subject: DOE release: Hand Sanitizers/H1N1
Importance: High

Dear Ms. Patrick:

In all due respect, the June 11 “information update” published by the US Department of Education re: H1N1, and your apparent promotion of the use of “alcohol hand sanitizers when washing is not convenient” has not only dismayed many school health care experts, but it has inflamed a "messaging issue" that even the CDC acknowledged as recently as three weeks ago is “inconsistent.”

The fact that the federal government’s leading school-centric agency is apparently recommending that students and teachers use alcohol-based hand sanitizers (as opposed to “appropriate hand sanitizers”) is simply frightening when considering the fact that among others, hundreds of schools and day care centers (not to mention several government agencies as well as the US Navy) have all banned alcohol-based hand sanitizers due to local mandates, or simply due to their own concerns about product efficacy and facility safety.

These entities have instead sought alcohol-free hand sanitizer products for staff, student and facility use.

In point of fact, the New York State Department of Education issued a ban on alcohol-based hand sanitizers as far back as 2004.

While many schools in question often cite a 2007 report from the US Association of Poison Control Centers, which found that in 2006 alone, alcohol-based hand sanitizers were the cause of 12,000 cases of alcohol poisoning in children; the fact is that all of these schools have determined that while alcohol might kill germs, these alcohol-based hand sanitizer products are

1. toxic

2. flammable

3. cause the skin to become dry/irritated (which in turn, increases risk of exposure to germs/viruses

4. destroy protective skin cells

5. have no efficacy when applied to dirty hands (manufacturers such as Purell recommend washing hands before applying the product),

6. cannot be applied to cuts/abrasions; which is typically the most common way that MRSA is transmitted with school environments.

7. Destructive to physical facilities (ask any hospital facilities administrator what happens when the hand sanitizer dispenser drips on to industrial floor wax)

This is a product that DOE is actually recommending for use in schools? Despite the fact that non-alcohol alternatives are widely-available, similar in price, and manufactured by a number of leading companies?

Ms. Patrick, and again, with all due respect, one merely needs to use the search term “hand sanitizer” on to find hundreds of “home videos” that demonstrate the many innovative ways in which students are “re-purposing” alcohol hand sanitizers, and why they’ve been banned by many school systems.

That said, it would seem obvious that DOE is deferring to the US Centers for Disease Control 1996 hand hygiene ‘guideline’, which, according to recently-replaced interim director Dr. Richard Besser, “is inconsistent” when referring to CDC’s ubiquitous use of the word alcoholand CDC recommendations.

Dr. Besser’s statement, acknowledging that CDC is providing unclear guidance on the topic of alcohol vs. non-alcohol hand sanitizers was provided in a May 2 email to the undersigned, and Besser concluded with: “But we’re working on the communication issues..”

Besser then designated a staff member to follow up and provide the CDC’s position on the topic.

Per your communication with Dr.Besser, and in response to your inquiry…

1. CDC recommends alcohol hand sanitizer products

2. CDC does not recommend products

3. Your inquiry [non-alcohol hand sanitizers] is beyond the scope of the CDC Infection Control Desk to reply to.

As you all know, Dr. Besser’s tenure as interim director concluded at the end of May, three weeks after his reply.

While the response from Besser’s staffer might be considered “classic Washington-speak”, ("we recommend ..products...we don't recommend products.." ); that email exchange was initiated after we received numerous calls in the midst of the Swine Flu crisis from several different government agencies, including GSA and DOT, and each caller indicated “our agency prohibits alcohol hand sanitizers in our facilities and we need a non-alcohol hand sanitizer…”

We contacted CDC because we thought it only appropriate that CDC might want to ‘re-evaluate’ the mixed message that its been sending out in the midst of yet another hand hygiene related emergency. We’re not holding our breath waiting on a CDC language change, but the DOE release sets the stage for a potential crisis.

Over the past three years, we’ve documented no less than several thousand unsolicited requests for alcohol-free hand sanitizer products from health care officials representing more than 450 schools, government agencies, countless correctional facilities, day care centers, senior care centers, and a variety of corporate venues, including the country’s largest manufacturer of medical devices.

More recently, the US Navy formally banned alcohol hand sanitizers on board its vessels due to product concern, and has made the decision to use non-alcohol hand sanitizer products.

Each of these groups has informed us that they prohibit alcohol-based sanitizers for at least one of the following reasons, and that CDC’s communication messages are not only “off point”, but dangerously misconstrued, and completely out-dated.

The three top reasons alcohol hand sanitizers have been banned (in favor of non-alcohol, rinse free alternatives):

1. Flash point risk / property damage liability. (Ask any facility manager at a major hospital how much they spend on repairing floors and walls that have been subjected to alcohol hand sanitizer drippage)

2. Toxicity.

3. Product safety/Efficacy.

All of this makes one scratch their head in wonder when reading that CDC recommends rubbing your hands with it.

More to the point, it makes one wonder why the US Department of Education is recommending that students and teachers embrace a “product” that other government agencies have determined to be inappropriate.

The active ingredient in most non-alcohol, rinse free sanitizers is an organic compound called Benzalkonium Chloride (a/k/a BAC, a/k/a BZK). This ingredient has been widely-used for decades in dozens of health care products, including Bactine antiseptic, spermicidal foams, contact lense solution, and many other OTC products.

With regard to its application as the active ingredient within a rinse-free hand sanitizer formula, this compound has been widely-documented to be equally, if not more effective than alcohol when tested against a broad spectrum of pathogens, including MRSA, Staph, Salmonella, Hepatitis, AIDS, and even H1N1.

As such, many infection control experts that have researched the topic acknowledge that these non-alcohol hand sanitizers are safer to the skin (do not cause dry/irritation like alcohol does), they’re antiseptic, hypoallergenic, non-toxic, and non-flammable.

The single largest marketer of alcohol based hand sanitizers is Johnson & Johnson; they own the license to the Purell brand, which, according to Neilsen, controls more than 52% of the hand sanitizer market, and according to estimates, will generate $250 million in US sales in 2009. Purell is manufactured by Gojo Industries, Inc., and J&J acquired the license to market the product several years ago through a corporate transaction with Pfizer.

In 2003 Gojo Industries filed a formal request with the FDA asking that FDA prohibit the registration of hand sanitizers that incorporate benzalkonium chloride, and in that brief Gojo stated “…our research has determined.…compound is not effective against germs/viruses” and “..potentially dangerous..” The FDA dismissed the filing out of hand, presumably for its lack of supporting documentation.

J&J maintains the Gojo Industries position, and its senior executives have stated that “only alcohol hand sanitizers are effective against germs”. Yet, J&J also manufactures and markets BandAid Foaming Antiseptic for Kids; which is comprised of the same active ingredient and virtually identical formula that's found in the majority of alcohol-free hand sanitizer products in the market today.

When J&J’s senior executive overseeing the Purell brand was asked about the "disconnect" and apparent inconcistentcy in their messaging at a recent conference, the executive said “BandAid is a different division here, so I can’t comment on their marketing or their products…but I’d Iove if you could send me a sample of your product to my home..!”

If DOE is actually going to take steps to investigate this matter, we’d caution you not to defer to the Chief of the Staff of the Office of the Attending Physician (OAP).

When we communicated with him last week after the Office of the Architect (AOC) stated they "relied upon OAP’s insight with regard to implementation of portable hand sanitizer stations in numerous government buildings", and we pointed out that the devices in question were dispensing alcohol foam and contained incendiary material that most fire marshals have concluded to be "potentially very dangerous", the Chief of Staff stated that “ I didn’t know that alcohol hand sanitizers are flammable…we do what the CDC says, but thanks for calling and have a great day!”

Instead, someone may actually want to ask recently appointed CDC Director Tom Frieden if they could sample the alcohol-free hand sanitizer product that's in his family's hands. Its alcohol-free, rinse free, fragrance free and dye free and dispensed in a soft foam format.

We're not looking to sell DOE anything. And we're not looking to win any federal government contracts. We've done that on the merits of our product, not with having to depend on lobbying politicians.

All that we’re asking is for a rational human being that has some type of influence to re-phrase the directives issued by DOE on the matter of hand sanitizers—and to simply recommend “wash with soap and water, and when not convenient, to use the appropriate hand sanitizer for the circumstances..”

DOE should be aware that recommending teachers and students be provided bottles of product that, aside from destroying their skin, can be converted into mini- Molotov cocktails, or mid-morning cocktails, seems “off message” to anyone that voted for the current administration, and certainly off-message within to tens of thousands of school health officials and hundreds of thousands of parents that rely upon the Government to counsel their local schools responsibly.

1 comment:

Anonymous said...

well said. don't hold your breadth i.e. anyone at CDC or DOE doing anything or realizing that alcohol hand sanitizers aren't really the smartest product in the world...they're busy twittering or tweeting, or whatever they call it.

washington hasn't changed. the rents have gone up a bit, but the ability to accomplish change, especially when one single company dominates the market in a particular can figure it out....