As reported throughout the news media, the U.S. House of Representatives will be holding special hearings investigating J&J's recall of more than 40 nonprescription products, and upwards of 1000 complaints about health problems in infants and children given J&J medications.
Johnson & Johnson is the retail market license holder for Purell alcohol-based hand sanitizers. Neither J&J or the FDA would provide comment as to the total of number of complaints filed, or whether the above-noted complaints related to the Purell product.
Thursday, May 27, 2010
Saturday, May 22, 2010
New season of swine flu could be coming
ABC News May 17
Hospitals brace for flu influx
".."We're concerned coming into winter with the reports from the Northern Hemisphere that the swine flu will almost certainly make its way back down.."
Associated Press - May 18, 2010 1:34 PM ET
FAIRBANKS, Alaska (AP) - Alaska's last confirmed case of swine flu was six weeks ago, but public health officials expect it to return later this year.
Rochester, NY --- One year ago a new strain of flu was spreading and on its way to becoming a worldwide pandemic. H1N1 is sure to return... but local health officials are optimistic that we're all better prepared for it after this past year
May 21 Birmingham Mail
World Cup swine flu warning
MIDLAND health bosses have warned of new swine flu outbreaks as football fever sweeps the nation.Fans heading to the World Cup in South Africa are being advised to avoid the risk of picking up the virus abroad and bringing it back to the UK.
The Independent Monday, 3 May 2010
"..Without doubt, fear of avian flu shaped the world's response to swine flu. Avian flu emerged more than a decade ago in the Far East and in 2004 began its march across the globe, infecting poultry flocks, wild birds and the occasional person as it went. With 495 people infected so far and 292 deaths, its 60 per cent death rate posed a serious threat. Swine flu has – mercifully – proved to be a kitten, not a tiger. Will it turn out to be the weakest pandemic in history? It is too early to say; it could yet return with a vengeance next winter.
The Daily Telegraph Apr 22 2010
Swine flu will be back in the winter: scientists
The pandemic is not over and the H1N1 virus is likely to return in the winter when flu would normally be expected, scientists have said.
Suite 101 Mar 2010
Dynamic Swine Flu Threat Will Persist Through 2010, Experts Say
Pratt Tribune May 12 2010
H1N1 Hasn't Gone Away
"...Many people consider the 2009 “swine flu” epidemic as another over-hyped, sky-is-falling media scare, Dr. Jason Eberhart-Phillips, Kansas State Health Officer, acknowledged.“That’s unfortunate,” he wrote in an opinion column, “because now is a good time to take stock of what we have learned about H1N1 flu in the past year, and start to prepare for the unpredictable — but inevitable — next chapter in humanity’s ongoing coexistence with this new virus.”
Wednesday, May 19, 2010
Hand Hygiene Innovators: Kudos to Canada's Cascades
MONTREAL - Paper products maker Cascades is looking for new commercial markets with its antibacterial paper towel aimed at cutting down the amount of bacteria spread by hand contact.
Cascades (TSX: CAS.TO) is launching what it calls an "intelligent" antibacterial paper towel that it says compensates for sloppy hand washing in pubic places and business.
The green-coloured paper towel has an antibacterial ingredient that lasts for 30 minutes after hand drying, the Quebec-based company said Tuesday. Cascades said it has added antibacterial ingredient benzalkonium chloride, used in hand and face washes, to the paper towel. It maintains the ingredient reduces the amount of bacteria left on hands after drying and protects them from "subsequent bacterial contamination."
The product is targeted at the food-processing and restaurant sectors, medical clinics, schools and daycares, it said.
"This innovation responds to a need for improved hand hygiene that is frequently cited by public health experts in recent years," said president and CEO Alain Lemaire.
It's not destined for grocery stores at this time and is only for the Canadian market until the company gets approval to market it in the United States and Europe.
Cascades (TSX: CAS.TO) is launching what it calls an "intelligent" antibacterial paper towel that it says compensates for sloppy hand washing in pubic places and business.
The green-coloured paper towel has an antibacterial ingredient that lasts for 30 minutes after hand drying, the Quebec-based company said Tuesday. Cascades said it has added antibacterial ingredient benzalkonium chloride, used in hand and face washes, to the paper towel. It maintains the ingredient reduces the amount of bacteria left on hands after drying and protects them from "subsequent bacterial contamination."
The product is targeted at the food-processing and restaurant sectors, medical clinics, schools and daycares, it said.
"This innovation responds to a need for improved hand hygiene that is frequently cited by public health experts in recent years," said president and CEO Alain Lemaire.
It's not destined for grocery stores at this time and is only for the Canadian market until the company gets approval to market it in the United States and Europe.
Wednesday, May 5, 2010
Hand Sanitizer War Heats Up: WHO, CDC and Competitive Agendas
With the focus on hand hygiene continuing to remain a forefront issue, and competition between hand sanitizer makers remaining fierce, interesting to make note of a comment made yesterday in a CDC teleconference call in advance of WHO Summit by Katherine Ellingson, a CDC epidemiologist.
In acknowledging professional HCW's rapidly-growing acceptance of non-alcohol hand sanitizer products, Dr. Ellingson, whose research has been supported courtesy of financial grants provided (ironically?) by GOJO Industries, the largest maker of alcohol hand sanitizer products), Ellingson commented that "alcohol remains the preferred product by staff at CDC" [with a twist of lemon??), and that "some makers of non-alcohol-based products were aggressive in marketing their products as effective against the pandemic flu virus (HIN1).." Ellingson referenced warning letters issued against them by the FDA.
We've seen a variety of independent laboratory tests from a variety of manufacturers that use quaternary ammonium elements as the active ingredient in their products. The majority of those test results are consistent, and otherwise indicate that benzalkonium chloride, and/or related compounds, which are used by the majority of non-alcohol hand sanitizer makers, provide similar, and most often better results when compared to legacy alcohol-based products.
As posted here in the past, and despite the fact that most manufacturers have successfully performed lab tests against individual pathogens, the FDA prohibits makers of hand sanitizer products from making pathogen kill claims within their advertising, a policy confirmed by FDA enforcement staff members. According to the FDA, this policy is not limited to advertising efficacy claims re: HINI, but extends to any particular pathogen.
That said, we certainly appreciate and respect the FDA policies re: advertising. We're also familiar with select manufacturers that had inadvertently over-looked FDA advertising guidelines, were since advised by FDA of those errors, and those manufacturers subsequently made immediate corrections to their advertising.
We only wonder why FDA has proven highly-selective in enforcing those rules (only a handful of makers have been cited in the past year), and why FDA continues to allow many other companies to continue to advertise pathogen-specific efficacy claims and flaunt FDA enforcement staff.
If a company is making unsolicited claims, whether it be in connection with H1N1, Clostridium Difficile (c.diff), MRSA, Hepatitis, or other pathogens, they are in clear violation of FDA enforcement rules; FDA does provide for manufacturers to offer these efficacy studies /claims upon request.
This isn't to suggest the products in question are not effective. In fact, most experts that have researched the topic would argue that BZK-based products are actually the smartest choice, if the only other choice were alcohol. It is to suggest however, that if a particular company is irresponsible in its regulatory compliance, it begets the question as to what other compliance issues they are overlooking.
Regrettably, some companies are being so bold as to not only challenge direct competitors by presenting misleading and wholly-inaccurate product comparison "efficacy data", but at the same time, they're distributing material that is clearly in violation of FDA rules.
A perfect example of a company that we cannot endorse is "SafeHands Inc." which is blatantly violating FDA guidelines, and by doing so, they risk besmirching the integrity of responsible manufacturers within the industry.
In acknowledging professional HCW's rapidly-growing acceptance of non-alcohol hand sanitizer products, Dr. Ellingson, whose research has been supported courtesy of financial grants provided (ironically?) by GOJO Industries, the largest maker of alcohol hand sanitizer products), Ellingson commented that "alcohol remains the preferred product by staff at CDC" [with a twist of lemon??), and that "some makers of non-alcohol-based products were aggressive in marketing their products as effective against the pandemic flu virus (HIN1).." Ellingson referenced warning letters issued against them by the FDA.
We've seen a variety of independent laboratory tests from a variety of manufacturers that use quaternary ammonium elements as the active ingredient in their products. The majority of those test results are consistent, and otherwise indicate that benzalkonium chloride, and/or related compounds, which are used by the majority of non-alcohol hand sanitizer makers, provide similar, and most often better results when compared to legacy alcohol-based products.
As posted here in the past, and despite the fact that most manufacturers have successfully performed lab tests against individual pathogens, the FDA prohibits makers of hand sanitizer products from making pathogen kill claims within their advertising, a policy confirmed by FDA enforcement staff members. According to the FDA, this policy is not limited to advertising efficacy claims re: HINI, but extends to any particular pathogen.
That said, we certainly appreciate and respect the FDA policies re: advertising. We're also familiar with select manufacturers that had inadvertently over-looked FDA advertising guidelines, were since advised by FDA of those errors, and those manufacturers subsequently made immediate corrections to their advertising.
We only wonder why FDA has proven highly-selective in enforcing those rules (only a handful of makers have been cited in the past year), and why FDA continues to allow many other companies to continue to advertise pathogen-specific efficacy claims and flaunt FDA enforcement staff.
If a company is making unsolicited claims, whether it be in connection with H1N1, Clostridium Difficile (c.diff), MRSA, Hepatitis, or other pathogens, they are in clear violation of FDA enforcement rules; FDA does provide for manufacturers to offer these efficacy studies /claims upon request.
This isn't to suggest the products in question are not effective. In fact, most experts that have researched the topic would argue that BZK-based products are actually the smartest choice, if the only other choice were alcohol. It is to suggest however, that if a particular company is irresponsible in its regulatory compliance, it begets the question as to what other compliance issues they are overlooking.
Regrettably, some companies are being so bold as to not only challenge direct competitors by presenting misleading and wholly-inaccurate product comparison "efficacy data", but at the same time, they're distributing material that is clearly in violation of FDA rules.
A perfect example of a company that we cannot endorse is "SafeHands Inc." which is blatantly violating FDA guidelines, and by doing so, they risk besmirching the integrity of responsible manufacturers within the industry.
Monday, April 26, 2010
Hand Hygiene Noncompliance and the Cost of Hospital-Acquired MRSA Infection
A new study shows that even minimal improvements in hand hygiene compliance is associated with significant and substantial savings in hospital costs.
Researchers at Duke University Medical Center (Durham, NC, USA) found:
A 200-bed hospital incurs a total of $1,779,283 in annual MRSA infection-related expenses that are directly attributable to hand hygiene noncompliance. According to the researchers, a mere 1% increase in hand hygiene compliance would result in annual savings of $39,650; an increase in hand hygiene adherence by 5% would result in a mean decrease in expected MRSA-related costs of $198,250. The study was published in the April 2010 issue of Infection Control and Hospital Epidemiology.
“Many other pathogens are also spread to patients on the hands of healthcare workers as a result of noncompliance with hand hygiene. In fact, in some reports MRSA accounts for fewer than 8% of all hospital-acquired infections,” concluded lead author Keith Cummings, M.D., and colleagues of the department of medicine. “Because our model focused on costs associated only with MRSA transmission, it substantially underestimated the costs associated with hand hygiene noncompliance.”
Researchers at Duke University Medical Center (Durham, NC, USA) found:
A 200-bed hospital incurs a total of $1,779,283 in annual MRSA infection-related expenses that are directly attributable to hand hygiene noncompliance. According to the researchers, a mere 1% increase in hand hygiene compliance would result in annual savings of $39,650; an increase in hand hygiene adherence by 5% would result in a mean decrease in expected MRSA-related costs of $198,250. The study was published in the April 2010 issue of Infection Control and Hospital Epidemiology.
“Many other pathogens are also spread to patients on the hands of healthcare workers as a result of noncompliance with hand hygiene. In fact, in some reports MRSA accounts for fewer than 8% of all hospital-acquired infections,” concluded lead author Keith Cummings, M.D., and colleagues of the department of medicine. “Because our model focused on costs associated only with MRSA transmission, it substantially underestimated the costs associated with hand hygiene noncompliance.”
Thursday, April 22, 2010
Georgia Poison Control Center Reports 20% Increase in Alcohol-Hand Sanitizer Ingestion
Georgia Poison Control Center says "2-3 reports every day of kids licking alcohol-based hand sanitizer off of their hands.."
Click on the title link for full story from CBS News Reporter Stephany Fisher.
Click on the title link for full story from CBS News Reporter Stephany Fisher.
Lit can of hand sanitizer causes minor explosion in North Fargo
Yes, we've all heard a variety of interesting stories coming out of Fargo, North Dakota...but merely a reminder for those that didn't realize that alcohol-based hand sanitizers are flammable. Anyone from TSA paying attention??
Click on the title link for the story.
Click on the title link for the story.
Thursday, April 8, 2010
FDA Prompted to Review Safety of Triclosan in range of consumer produts..including hand soaps/hand sanitizers
This is the extract from late-breaking news courtesy of Reuters. (full story by clicking on title link)
Important to note that more than one year ago, this blog profiled the questionable use of Triclosan as the active ingredient within select hand sanitizer products (including P&G's Vick's brand)...and pointed out that the majority of alcohol-free hand sanitizer products incorporate benzalkonium chloride, considered to be one of the safest organic compounds.
The U.S. Food and Drug Administration said on Thursday it was reviewing the safety of triclosan, a widely used antibacterial agent found in soap, toothpaste and a range of other consumer products.
One member of Congress, Massachusetts Democrat Edward Markey, called for strict limits.
"Despite the fact that this chemical is found in everything from soaps to socks, there are many troubling questions about triclosan's effectiveness and potentially harmful effects, especially for children," Markey said in a statement.
"I call upon the federal government to ban the use of triclosan in consumer soaps and hand-washes, products intended for use by children, and products intended to come into contact with food. In addition, I will soon introduce legislation to speed up the government's efforts to evaluate and regulate other substances that may pose similar public health concerns."
Important to note that more than one year ago, this blog profiled the questionable use of Triclosan as the active ingredient within select hand sanitizer products (including P&G's Vick's brand)...and pointed out that the majority of alcohol-free hand sanitizer products incorporate benzalkonium chloride, considered to be one of the safest organic compounds.
The U.S. Food and Drug Administration said on Thursday it was reviewing the safety of triclosan, a widely used antibacterial agent found in soap, toothpaste and a range of other consumer products.
One member of Congress, Massachusetts Democrat Edward Markey, called for strict limits.
"Despite the fact that this chemical is found in everything from soaps to socks, there are many troubling questions about triclosan's effectiveness and potentially harmful effects, especially for children," Markey said in a statement.
"I call upon the federal government to ban the use of triclosan in consumer soaps and hand-washes, products intended for use by children, and products intended to come into contact with food. In addition, I will soon introduce legislation to speed up the government's efforts to evaluate and regulate other substances that may pose similar public health concerns."
H1N1 Spread Linked to Seasonal Flu Shots
Four new studies conducted by Canadian researchers conclude that the traditional seasonal flu vaccine seems to have boosted the risk of infection with pandemic H1N1 swine flu by almost double.
In one study, the researchers revealed to use ongoing sentinel monitoring system in order to assess the frequency of prior vaccination with the seasonal flu vaccine in people suffering fromH1N1
swine flu in 2009 compared to people without swine flu.
The study discovered that seasonal flu vaccination was linked with a 68 percent boosted risk of falling in prey to swine flu.
The Canadian sentinel study showed that receipt of TIV in the previous season (autumn 2008) appeared to increase the risk of pH1N1 illness by 1.03- to 2.74-fold, even after adjustment for comorbidities, age, and geography
In one study, the researchers revealed to use ongoing sentinel monitoring system in order to assess the frequency of prior vaccination with the seasonal flu vaccine in people suffering from
The study discovered that seasonal flu vaccination was linked with a 68 percent boosted risk of falling in prey to swine flu.
The Canadian sentinel study showed that receipt of TIV in the previous season (autumn 2008) appeared to increase the risk of pH1N1 illness by 1.03- to 2.74-fold, even after adjustment for comorbidities, age, and geography
Tuesday, March 30, 2010
New Study Raises Questions About Alcohol Foam Hand Sanitizers' Antimicrobial Efficacy in a Practical Clinical Setting
Excerpts below from March 30 news release published by one of the largest distributors of alcohol-based hand sanitizer products..
"...The way 62 percent ethanol foam hand sanitizers are used in a practical clinical setting most likely means they do not provide any more bacterial reduction than simply washing with the same quantity of water alone, says a new study presented at the Fifth Decennial International Conference on HAIs. The study results confirm preliminary data first presented by lead author Dr. Günter Kampf at Medline Industries, Inc.'s Prevention Above All conference late last year.
The study, "Efficacy of ethanol-based hand foams using clinically relevant amounts: a cross-over controlled study among healthy volunteers," was performed according to the EN1500 standards and found that the applied volume of 62 percent alcohol foam healthcare workers used so that their hands would dry in 30 seconds was small -- only 1.6 grams. Compared to published data, even a simple hand wash using 1.6 grams of water alone has similar or better antimicrobial efficacy than the same amount of 62 percent alcohol foam sanitizer. Furthermore, to reach desirable bactericidal levels would require approximately twice the practical amount of product, extending evaporation times upward of 90 to 120 seconds per application -- something that is not practical in a clinical setting given the patient care responsibilities healthcare workers face on a daily basis.
"The data suggests we have a false sense of security with regard to the level of bacterial reduction provided when using 62 percent foam hand sanitizers," said Kampf, who is a member of the German Association for Infection Control and a lecturer at the Ernst Moritz University in Germany.
"While 62 percent foam sanitizers are not entirely ineffective, it is incumbent upon us to educate regarding proper technique," commented Lessem. "If proper application technique is unattainable due to the practical considerations of the healthcare worker's daily job responsibilities, then other product options should be considered...."
The last excerpt in bold/italics was necessarily "striking." Dr. Kampf, a highly-published expert on the topic of hand hygiene, is otherwise pointing to facts that are widely-acknowledged--but are often overlooked by HCW's simply because most are at the mercy of administrators that are influenced not by facts, but by sales people representing alcohol-based hand sanitizer manufacturers, as well as one-sided "recommendations" provided by government agencies that are in turn, influenced by lobbyists representing the same manufacturers.
Equally interesting: the above-note study was distributed via a media release by Medline Industries--which is arguably one of the country's larger distributors of alcohol-based hand sanitizer products. Suggesting to some that their commitment to alcohol-based hand sanitizer is starting to wane.
Here are basic facts, supported by more than a handful of truly independent studies:
1. Repeated use of alcohol-based hand sanitizer products reduces alcohol's effectiveness with respect to killing germs/bacteria
On the other hand, numerous studies that have compared residual efficacy of alcohol-based products to quaternary ammonium-based products have found that quats' efficacy increases with repeated application.
2. Repeated use of alcohol-based sanitizers increases the risk of exposure of pathogens, simply because alcohol causes the skin to become dry/irritated. Dry/irritated skin is akin to a cracked windshield; the pesky pathogens slip through the cracks as easily as tiny bugs can squeeze into the cracked windshield.
3. Quat-based hand sanitizer products have proven to be equally effective against a broad spectrum of pathogens (based on log rate), yet these products are safer to the skin, provided residual protection, and because they are water-based, these products break through any dirty on the hands, and delivery optimal antiseptic and antibacterial benefits.
Unlike alcohol-based products, the quat-based, non-alcohol formulas (those that use benzalkonium chloride or benzethonium chloride) do not require rinsing before or after application, and they won't destroy anything other than the pathogens (alcohol-based products are notorious for destroying industrial floor wax, paint, and materials).
"...The way 62 percent ethanol foam hand sanitizers are used in a practical clinical setting most likely means they do not provide any more bacterial reduction than simply washing with the same quantity of water alone, says a new study presented at the Fifth Decennial International Conference on HAIs. The study results confirm preliminary data first presented by lead author Dr. Günter Kampf at Medline Industries, Inc.'s Prevention Above All conference late last year.
The study, "Efficacy of ethanol-based hand foams using clinically relevant amounts: a cross-over controlled study among healthy volunteers," was performed according to the EN1500 standards and found that the applied volume of 62 percent alcohol foam healthcare workers used so that their hands would dry in 30 seconds was small -- only 1.6 grams. Compared to published data, even a simple hand wash using 1.6 grams of water alone has similar or better antimicrobial efficacy than the same amount of 62 percent alcohol foam sanitizer. Furthermore, to reach desirable bactericidal levels would require approximately twice the practical amount of product, extending evaporation times upward of 90 to 120 seconds per application -- something that is not practical in a clinical setting given the patient care responsibilities healthcare workers face on a daily basis.
"The data suggests we have a false sense of security with regard to the level of bacterial reduction provided when using 62 percent foam hand sanitizers," said Kampf, who is a member of the German Association for Infection Control and a lecturer at the Ernst Moritz University in Germany.
"While 62 percent foam sanitizers are not entirely ineffective, it is incumbent upon us to educate regarding proper technique," commented Lessem. "If proper application technique is unattainable due to the practical considerations of the healthcare worker's daily job responsibilities, then other product options should be considered...."
The last excerpt in bold/italics was necessarily "striking." Dr. Kampf, a highly-published expert on the topic of hand hygiene, is otherwise pointing to facts that are widely-acknowledged--but are often overlooked by HCW's simply because most are at the mercy of administrators that are influenced not by facts, but by sales people representing alcohol-based hand sanitizer manufacturers, as well as one-sided "recommendations" provided by government agencies that are in turn, influenced by lobbyists representing the same manufacturers.
Equally interesting: the above-note study was distributed via a media release by Medline Industries--which is arguably one of the country's larger distributors of alcohol-based hand sanitizer products. Suggesting to some that their commitment to alcohol-based hand sanitizer is starting to wane.
Here are basic facts, supported by more than a handful of truly independent studies:
1. Repeated use of alcohol-based hand sanitizer products reduces alcohol's effectiveness with respect to killing germs/bacteria
On the other hand, numerous studies that have compared residual efficacy of alcohol-based products to quaternary ammonium-based products have found that quats' efficacy increases with repeated application.
2. Repeated use of alcohol-based sanitizers increases the risk of exposure of pathogens, simply because alcohol causes the skin to become dry/irritated. Dry/irritated skin is akin to a cracked windshield; the pesky pathogens slip through the cracks as easily as tiny bugs can squeeze into the cracked windshield.
3. Quat-based hand sanitizer products have proven to be equally effective against a broad spectrum of pathogens (based on log rate), yet these products are safer to the skin, provided residual protection, and because they are water-based, these products break through any dirty on the hands, and delivery optimal antiseptic and antibacterial benefits.
Unlike alcohol-based products, the quat-based, non-alcohol formulas (those that use benzalkonium chloride or benzethonium chloride) do not require rinsing before or after application, and they won't destroy anything other than the pathogens (alcohol-based products are notorious for destroying industrial floor wax, paint, and materials).
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