Watch out for Armadillos!

Research released today in the New England Journal of Medicine points to what many leprosy researchers have suspected for years: that armadillos can likely transmit leprosy to humans.

Leprosy, also called Hansen ’s disease, is caused by Mycobacterium leprae. The bug likes cooler temperatures than are found at the cores of human bodies, which is why it infects our extremities and skin. Armadillos have a low core body temperature, about 89 degrees Fahrenheit, which Mycobacterium leprae finds quite comfortable.

How did armadillos, of all creatures, get leprosy? Humans gave it to them. Richard Truman, the study’s first author, tells NPR health blog “Shots” that leprosy was brought to the New World by European settlers. It’s not known exactly how or when we gave it to the armadillos, but now about 15% of them carry the disease.

The study looked at the genetics of the bacterial strains found in leprosy patients in the southern U.S., and compared them with the genetics of the bacteria from wild armadillos living in the same area. A majority of both the patients and the armadillos carried the same strain of bacteria, and this strain hasn’t been reported anywhere else in the world. The conclusion is that the patients got leprosy from the armadillos.

Truman tells NPR that the risk of contracting leprosy from brief contact with an armadillo is low, so how did they give it to us? In some southern states, barbecued armadillo and armadillo chili are folk favorites. That’s right; the humans got leprosy from eating armadillo. Fortunately, if treated early with antibiotics, the bacteria are eradicated from the body and people become healthy again. Nonetheless, I don’t think you’ll catch me ordering up an armadillo burger anytime soon.

New England Journal of Medicine article: http://www.nejm.org/doi/full/10.1056/NEJMoa1010536

NPR "Shots" blog post: http://www.npr.org/blogs/health/2011/04/28/135740951/mysterious-leprosy-cases-linked-to-armadillos

FDA warns makers of hand sanitizers on false claims

The FDA sent warning letters to four manufacturers of over-the-counter hand sanitizer products that claim to prevent infection from MRSA, H1N1, and E. coli.  The FDA found insufficient data to support the claims made by these companies regarding their products and considers their labeling a violation of federal law.

 

The four companies and their products are:

• Tec Laboratories for Staphaseptic First Aid Antiseptic/Pain Relieving Gel
• JD Nelson and Associates for Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant
• Dr. G.H. Tichenor Antiseptic Co. for Dr. Tichenor’s Antiseptic Gel
• Oh So Clean, Inc dba CleanWell Company for CleanWell All-Natural Foaming Hand Sanitizer, CleanWell All-Natural Hand Sanitizer, CleanWell All-Natural Hand Sanitizing Wipes, and CleanWell All-Natural Antibacterial Foaming Handsoap

Major concerns cited in FDA's letters were:

1.  The manufacturer's claims about the effectiveness of the products fall under the FDA drug category.  FDA defines drugs as anything that cures, mitigates, treats or prevents disease. None of the products have been approved by FDA as drugs.
2.  Some products are defined as new drugs because the combination of ingredients included in the product do not match any similar product that has been approved by FDA as a drug.
3.  Several do not have sufficient details about the ingredients.  FDA requires that the name, quantity and proportion of each ingredient be listed on the label.  The lists must match all product marketing materials.
4.  One citation indicated that a product has a combination of ingredients that have not been tested by FDA in combination.  That is, each ingredient has been found safe alone but not in combination with other ingredients.  However, a troubling citation is a citation for a product that contains Triclosan.  Triclosan has not yet received FDA widespread approval for safety.  The other products contain ingredients that are probably harmless, if not effective, but this product may contain ingredients that are harmful.
5.  Three of the four manufacturers have been notified that they need to respond to the FDA within 15 days of the letter with plans to come into compliance.  In some cases, formal requests for FDA approval are necessary.  However, in others only re-labeling may be necessary.
6.  FDA has ordered the manufacturer of  CleanWell All Natural Foaming Hand Sanitizer to stop producing their product(s).  This company was cited in 2010 for FDA violations and their response has not been approved by FDA.  Their response included "technology" briefs intended to show scientific proof of efficacy.  These have been denied by FDA.  Finally, this company was cited for lack of quality control of the manufacturing process and states that the product may be subject to adulteration because of this.

 So what to look for in a sanitizer?  We recommend a sanitizer that contains at least 61% alcohol and has been approved by the FDA.  Also, look for sanitizers with lotion in them since alcohol alone makes the skin very dry.  

Full FDA press release

Updates from NHSN

Updates from NHSN about HAI Reporting

I recently returned from the SHEA conference where I attended as many sessions as I could that dealt with NHSN’s thoughts about current or future reporting. You will be happy to know that someone has heard IP’s cries of pain when it comes to the amount of time that we spend on data collection! Here are some of the specific messages from the forums I attended.

The overall theme was that NHSN has a mandate (that they call their Action Plan) to reduce the time, effort and money spent on surveillance. They spoke several times about the need to (a) provide definitions that will track the effects of interventions, (b) will have clinical as well as surveillance meaning, and (c) will give IPs more time on clinical units helping patients and staff to improve care.

They will be issuing a new SSI form as soon as OMB approves it. They have changed the form so required data is more relevant to specific surgeries. For instance, information about implants will be required for orthopedic procedures but not for hysterectomies.

NHSN is currently having consensus meetings to finalize the criteria for VAP. They expect to have a statement by mid-summer. It will then take them some time to develop the software for NHSN submission. They expect that VAP reporting will become “mandatory” no sooner than January 1, 2013.

The biggest changes they are considering related to the definition of VAP include:

- making the chest x-ray a confirmatory finding rather than a key criterion of the definition,

-specifying PEEP settings and FiO2 readings as the specific indicators for worsening gas exchange, and

- specifying the time on a vent at 4 or more days before considering pneumonia as a possibility.

The SHEA forums with NHSN content were very satisfying. For the first time in memory the phrase “I’m the government and I’m here to help” wasn’t the introductory joke of the sessions.

"I Watch the Line" selected to be shown at the APIC Film Festival

The APIC Film Festival committee notified us yesterday that Ron's music video, "I Watch the Line," has been selected to be shown at the APIC Film Festival.  The Film Festival will take place during the Annual APIC Conference from June 27 to June 29 in Baltimore, MD.

New Partnership for Patients aims to improve care, reduce cost

The federal government took a step towards sustainable healthcare this month by launching a new initiative to reduce preventable errors in hospitals.  The Partnership for Patients: Better Care, Lower Costs aims to achieve $10 million in health care savings over the next three years. 

The two key objectives of the partnership are to:

• Keep patients from getting injured or sicker by reducing preventable hospital-acquired conditions by 40% by 2013.  Achieving this goal would mean approximately 1.8 million fewer injuries to patients and more than 60,000 lives saved over three years.
• Help patients heal without complications by reducing hospital readmissions by 20% by 2013.  Achieving this goal would mean more than 1.6 million patients would recover from illness without suffering a preventable complication requiring re-hospitalization within 30 days of discharge.

The partnership will bring together leaders from hospitals and state and federal governments to devise strategies to achieve these objectives.  The details of the partnership are still being worked out so stay tuned!

Read more about the Partnership

Likely outcomes of public HAI reporting

As mandatory healthcare-associated infection (HAI) reporting takes hold, and as NHSN data becomes available publicly on CMS Hospital Compare, what are the likely outcomes?

Will healthcare consumers become more savvy?

Let’s take a look at existing international reporting systems as analogues. University of Exeter performed a study in 2000 on seven health reporting systems. The study found that consumers and purchasers rarely sought out publicly available information, and did not understand the data when it was found. AHRQ similarly makes the case that public reporting does not affect consumer behavior. ARHQ’s Talking Quality web site states: 1) that information is not used, 2) quality data can be misleading, and 3) quality data can be difficult to understand.

Will infection rates decrease?

While public reporting may not affect consumer behavior, it still holds the potential to positively affect health outcomes and quality improvement. The same University of Exeter study found that hospitals tended to be the most responsive to publicly reported data with some correlation between public performance data and quality of care improvement. Another 2008 study published in the Annals of Internal Medicine similarly states that “publicly releasing performance data stimulates improvement activity at the hospital level.”

Let’s hope this holds true for the latest iteration of public reporting in the US. Perhaps self-scrutiny (rather than consumer pressure) will be part of the solution.

Meet the bloggers at SHEA

Ron, Joan, and I will be attending SHEA in Dallas this weekend.  You can find us at booth #302.  We will be posting throughout the conference.