National center for infection control professionals, healthcare experts, manufacturers, distributors, suppliers and consumers focused on best practices in hand hygiene and hand sanitizer products

Thursday, May 27, 2010

FDA Probes Purell's Johnson & Johnson; Hundreds of Complaints

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.

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.

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.