Thursday, January 20, 2011

"Contaminated Alcohol Swabs Recalled in U.S., Canada & Europe Under Brand Names: Triad, Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin Brands PART ONE" By Reverend Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

Dear Ones:
     There is a common misconception that agents such as soaps and alcohol which are intended to clean the skin are impervious to microbial contamination by their very nature.
     FALSE.
     In fact, soap and water solutions can be GREAT culture media for deadly pathogens such as Pseudomonas aeruginosa, among others.
     And alcohol used as an antiseptic can similarly be contaminated, in this case below with the microbe known as Bacillus cereus (pronounced bah-SILL-us SEER-ee-us (like 'serious' in English)
     Contrary to the somewhat cavalier tone of Triad's initial voluntary recall notice below, Bacillus cereus can, indeed, cause a nasty skin infection or worse, as will be addressed in Dear Ones Healing Ministry UPDATES in my FREE 2011 NEWSLETTER.
     (Note: You can have all breaking health news sent right to your email box by signing up for Rev. Barb's FREE 2011 HEALTH NEWSLETTER.  Just send your name and email address with 'please send me your Free 2011 Health Newsletter' in the subject line to BarbaraKSexton@aol.com and that's it!  Nothing else is required and no data is collected.  Sign-up now and get important breaking health news explained in an understandable way by 'The Biblical Biochemist-Where Science Meets the Cross'.  Don't let your family and other loved ones go 'unprotected', especially with the flu season now fully upon us with spiking activity.)
     Contaminated alcohol swabs used as an antiseptic may not cause a problem on healthy, unbroken skin, but remember that these swabs are usually intended for use with an injectable drug.  This means the skin barrier is breeched, which sends any surface microbes (including disease-causing pathogens ) underneath the skin into the tissue below.
     The subject of 'pathogenicity' (the ability of a microbe to 'infect' someone and cause a disease) is not as straight-forward as the 'cookbook-medicine mentality' traditional medicine would have it be.
     As an example, I give you the various E. coli species.  In the gut, some E.coli species are fine...even desirable... as they assure proper function of our digestive systems.
     But put this E.coli, whatever the sub-species, somewhere else such as in the female urinary and reproductive tract (a not uncommon result of improper wiping, poor hand-washing technique, vigorous sex, unclean undergarments, etc) and infection and disease result. 
     The hapless female ends up with bladder/kidney infection and/or vaginitis.
     Simply put from my alternative medicine perspective (having been trained in traditional biomedicine initially), 'pathogenicity' is most accurately described as having 'the wrong microbe in the wrong place at the wrong time'.
     And you can quote me on that.
     I have personally witnessed awful infections caused by what are generally considered to be 'low-grade' pathogens as a result of 'the wrong microbe in the wrong place at the wrong time.' 
     In fact, in my jump into the world of drug and cosmetic manufacturing, I 'cut my teeth' on a case involving just this, brought in as 'fresh blood' in an interesting case involving products for our military service members in the field, amongst others.
     For various reasons, I see similarities and potential similarities with the Triad alcohol prep pad and swab bacterium in question here and the case I mention above.  Thus I will dissect the current situation with this in mind.
     Just to be clear, the B. cereus species contaminating the Triad products is either yet to be sub-typed by the FDA or if it already has been, awaits disclosure.  The nomenclature "Bacillus cereus" actually covers a wide spectrum of variants, including B. anthracis, also known as Anthrax.
"Bacillus cereus is a Gram-positive, facultatively aerobic sporeformer whose cells are large rods and whose spores do not swell the sporangium. These and other characteristics, including biochemical features, are used to differentiate and confirm the presence B. cereus, although these characteristics are shared with B. cereus var. mycoides, B. thuringiensis and B. anthracis. Differentiation of these organisms depends upon determination of motility (most B. cereus are motile), presence of toxin crystals (B. thuringiensis), hemolytic activity (B. cereus and others are beta hemolytic whereas B. anthracis is usually nonhemolytic), and rhizoid growth which is characteristic of B. cereus var. mycoides."
LINK:  http://www.fda.gov/food/foodsafety/foodborneillness/foodborneillnessfoodbornepathogensnaturaltoxins/badbugbook/ucm070492.htm     The B. cereus family of pathogens are known to infect humans, animals, affecting mainly those who are weak and/or immunocompromised and/or suffer the conequences of  cancer, diabetes, post-transplant, steroid-therapy, etc. and the therapies and treatments thereof.
     Despite some of the sources claiming that B. cereus is relatively 'harmless' causing but mild food-poisoning, the bacterial species affecting Triad alcohol prep pads very much deserves it's place in the FDA's 'BBB' ('Bad Bug Book') LINK: http://www.fda.gov/food/foodsafety/foodborneillness/foodborneillnessfoodbornepathogensnaturaltoxins/badbugbook/ucm070492.htm
     It is a law of microbiology, that soil-born pathogens are amongst the worst of all disease-causing microbes, be they aerobes (needing oxygen to live) or anaerobes (not needing oxygen to live.)
    The irony of a skin antiseptic being a source of contamination itself is obviously manifold.  Many seem to dismiss B. cereus as a major concern when it comes to cutaneous infection, pointing to the fact that this bacterial species primarily causes food-poisoning.
     But to do so insults the reality of known cases of severe cutaneous B. cereus infections all over the world as well as an extensive cutaneous outbreak in healthy military cadets in Georgia.
LINK:  http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5448a3.htm  
     The link above is from the MMWR (Morbidity & Mortality Weekly Report) website.  Cases do not get published on or in MMWR unless they are deserving of it, as well I know from the field.
     I'll be dissecting this Triad alcohol prep pad recall situation in a series of articles, including some basic 'background' on the biochemistry of topical antiseptics.  (Note: antiseptics are intended for use on skin and tissues, whereas 'disinfectants' are meant for 'hard', non-living surfaces)
     In fact, there are many factors that are overlooked, misunderstood and misinterpreted regarding wound healing and the use of so-called 'antiseptics' when it comes to wound-healing.
     As it happens, those of us in the field of alternative medicine often 'see' cases of intractable wounds which fail to heal after numerous vigorous attempts by the medical establishment. 
     Question all you want the potions and powders of herbal medicine--they can sometimes work when nothing else will, as in the case of chronic diabetic ulceration.
     And we 'alternative health care providers' were using the amino acid L-lysine in our topical preparations for herpes sufferers long before the drugstore shelves became stocked with the lysine-containing lip balms and ointments commonly available today.
     "In treatment of disease and conditions which do not easily 'resolve', combine the 'best of both' of traditional and alternative medicine", I say. 
     And use the 'best of both', similarly, when confronted with matters such as the Triad Recall under discussion here.
      To begin and to begin understanding how an alcohol antiseptic can become contaminated, it is important to know that it is not so much the alcohol moiety of the prep pads and swabs that it at fault, as it is that of the 'water' component.
     Everyone knows SOAP needs WATER to work properly.  But did you know that the water component is critical in order for the alcohol to 'do it's thing', also?
     It's true.  And it's due to the characteristics of bacterial cell walls and the ability of an antiseptic to act as a 'surfactant' and as a bacterial cell wall 'disruptor',
     Suggestions over the years after the first use of 'carbolic acid' (phenol) were to use high-strength/low water alcohol concentrations such as  90% isopropyl alcohol.
     However, higher alcohol percentage anticeptics met with poorer test results than did preparations with lower alcohol concentrations.  
     They don't kill bacteria as well and are more likely to irritate and damage skin, which can only invite enhanced infection and inhibition of satisfactory wound-healing.  Indeed, it has also been my observation over the years that the use of ever-present 'povidone-iodine' solutions in the treatment of chronic wounds can substantially cause more negative effects on tissue than previously believed.
     Hence, after years of study, most of the alcohol prep pads and swabs in use today contain 70% isopropyl alcohol, which is considered to be an ideal concentration.
     Our skin and everything we touch and live with is contaminated with good and bad microbes. 
     Obviously the last thing we need is for something intended to clean the skin prior to injection to be contaminated with B. cereus, a spore-forming bacteria which can cause chronic and serious skin infections...or with any other microbe, for that matter, pathogen or not.
     We don't need 'the wrong thing in the wrong place at the wrong time'.  Surely, the most innocuous microbe 'injected' below the skin has the potential to cause both cutaneous and systemic infection.
     Worse still, the spores of B. cereus are difficult to kill and a simple alcohol swab will NOT do the job!  In the lab we use the autoclave (steam under pressure) to kill spores. 
     High temperature incineration can also be effective in killing spores, though it is less practical for use in many settings.  Similarly, 'irradiation' is used to sterilize things like bandages and certain medical devices, which begs the question...
     How did Triad alcohol prep pads get contaminated, how many of the recalled pad are contaminated and what is the source of said contamination?  What happened with their raw material, hard component, in-line, final product and 'retains' testing, not to mention 'stability testing'?
     The initial 1/4/11 Triad voluntary recall did not grab my attention initially, but subsequent FDA updates on 1/6/11 and updated 1/14/11 certainly have.
LINK: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm 
     Who knows?  Maybe the scope of the B. cereus contamination will be small and limited in scope.  Still, it has the potential to be far-reaching and all I can say is 'caveat emptor'
     This 21st century has seen a plethora of previously 'non-pathogenic and non-ubiquitous' microbial species....including bacteria....evolve into species with grossly increased virulence as pathogens.
     Among these are "Salmonella spp.,Clostridium botulinum, Staphylococcus aureus, Campylobacter jejuni, Yersinia enterocolitica and Yersinia pseudotuberculosis, Listeria monocytogenes, Vibrio cholerae O1, Vibrio cholerae non-O1,Vibrio parahaemolyticus and other vibrios, Vibrio vulnificus, Clostridium perfringens, Bacillus cereus, Aeromonas hydrophila and other spp., Plesiomonas shigelloides, Shigella spp,Miscellaneous enterics, Streptococcus, Enterovirulent Escherichia coli Group (EEC Group), Escherichia coli - enterotoxigenic (ETEC), Escherichia coli - enteropathogenic (EPEC), Escherichia coli O157:H7 enterohemorrhagic (EHEC), Escherichia coli - enteroinvasive (EIEC),Parasitic Protozoa and Worms, Giardia lamblia, Entamoeba histolytica, Cryptosporidium parvum,Cyclospora cayetanensis, Anisakis sp. and related worms, Diphyllobothrium spp., Nanophyetus spp., Eustrongylides sp., Acanthamoeba and other free-living amoebae, Ascaris lumbricoides and Trichuris trichiura, Viruses, Hepatitis A virus, Hepatitis E virus, Rotavirus, Norwalk virus group, Other gastroenteritis viruses, Other Pathogenic Agents, Prions and Transmissible Spongiform Encephalopathies."
LINK: http://www.fda.gov/Food/FoodSafety/FoodborneIllness/FoodborneIllnessFoodbornePathogensNaturalToxins/BadBugBook/default.htm
     Don't let anyone tell you that microbial contamination of what you use in and on your body is NOT of major concern, ever.
     And don't let a drug-maker tell you that they are exercising 'an abundance of caution', even while acknowledging the seriousness of the contamination of it's products...whatever the extent of it and whatever it's source.
     (Read Triad's 'mixed message' highlighted in green below.)
      Know that B. cereus is also causes chronic skin infections that are difficult to eradicate though less aggressive than necrotizing fasciitis caused by the Streptococcus bacterium.  Most of us are aware of it. 
"Necrotizing fasciitis (occasionally described by the media as "the flesh-eating bacteria") is a rapidly progressive disease which destroys muscles, fat, and skin tissue. LINK: http://www.cdc.gov/ncidod/dbmd/diseaseinfo/groupastreptococcal_g.htm  
      B. cereus can also cause a condition known as 'keratitis'. It is considered to be a pathogen akin tBacillus anthracis known as the infective agent in systemic and cutaneous Anthrax.
    "Bacillus anthracis, Bacillus cereus, and Bacillus thuringiensis are members of the Bacillus cereus group of bacteria.  This determination is not only a formal matter of taxonomy but may also have consequences with respect to virulence and the potential of horizontal gene transfer within the B. cereus group."
LINK: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC110590 
     What this means that it is only a matter of time before plain old B. cereus turns into a virulent rogue pathogen via transfer of genetic material between 'bacterial cousins'.
     It is a law of microbiology that the natural tendency is for a microbe...be it a bacterium, a virus, a prion or whatever to tend to mutate into a state more favorable to it's replication and survival...which means to a more VIRULENT state.
     Of course various factors 'help' this process along, including, but not limited to:
--airline travel which increases exposure risk to all microbes, pathogenic or not
--the use and overuse of pharmacological agents which may inadvertently prompt enhanced mutation rates in microbes
--the 'deliberate or inadvertent' introduction of experimentally manipulated or native 'good' or pathogenic microbes into the environment
--natural disasters which result in the uncovering and or release of microbes long 'hunkered down' such as the the virus responsible for the 1918 (Spanish) Influenza Pandemic.
--continued 'core sampling' and exploration and disruption of the earth's crust by man which have the potential to dislodge long-sequestered microbes resulting in 'surface exposure'.
--cruel, unhygienic 'animal food-farming practices' which provide an ideal state for contamination of the human food supply via 'genetic transfer' between different bacterial species resulting in 'superbugs' which infect animals and then humans
--the use of irrigation water contaminated with 'superbugs' on produce crops intended for human and animal consumption
--the feeding of 'offal' (the entrails, internal organs, i.e. the guts and other undesirable parts left over after processing animals for consumption) to animals themselves
--and last, but not least, acts of God which affect believers and non-believers, alike.
     When B. cereus manifests in it's 'food'born' state, causing what is commonly known as 'food poisoning', it is difficult to distinguish from Clostridium perfringens, also known as the infectious agent which causes 'gas gangrene'.
     "Although no specific complications have been associated with the diarrheal and vomiting toxins produced by B. cereus, other clinical manifestations of B. cereus invasion or contamination have been observed. They include bovine mastitis, severe systemic and pyogenic infections, gangrene, septic meningitis, cellulitis, panophthalmitis, lung abscesses, infant death, and endocarditis."
LINK: http://www.fda.gov/food/foodsafety/foodborneillness/foodborneillnessfoodbornepathogensnaturaltoxins/badbugbook/ucm070492.htm     There is no justification for this attitude at all if even one person is harmed.  Stay tuned for additional articles in my FREE 2011 NEWSLETTER and here online and for additional updates from Triad and the FDA, including my comments on "Genentech Informs Customers Of Important Information"
LINK:  http://www.fda.gov/Safety/Recalls/ucm240131.htm    
     Please be careful and check your medical supplies today! 
     In the meantime, use sterile gauze with 70% isopropyl alcohol to wipe-down before injecting, being careful to use as close to 'aseptic technique' as you can.
     Be sure to consult your health care provider for individual advice!
God Bless and Keep You
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
www.dearoneshealingministries.blogspot.com 
Triad Group Issues a Voluntary Nationwide Recall of All Lots of Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks Due to Potential Microbial Contamination

FOR IMMEDIATE RELEASE - January 5, 2011 - Hartland, Wisconsin, Triad Group, a manufacturer of over-the-counter products has initiated a voluntary product recall involving ALL LOTS of ALCOHOL PREP PADS, ALCOHOL SWABS, and ALCOHOL SWABSTICKS manufactured by Triad Group but which are private labeled for many accounts to the consumer level. This recall involves those products marked as STERILE as well as non-sterile products. This recall has been initiated due to concerns from a customer about potential contamination of the products with an objectionable organism, namely Bacillus cereus. We are, out of an abundance of caution, recalling these lots to ensure that we are not the source of these contamination issues.

Use of contaminated Alcohol Prep Pads, Alcohol Swabs or Alcohol Swabsticks could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients. To date we have received one report of a non-life-threatening skin infection.

Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either “Triad Group,” listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging:
Triad, Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin

These products were distributed in the United States, Canada and Europe.

Specific customers distributing the product and selling it at the wholesale, hospital and retail pharmacy level have been notified by certified mail with instructions on how to return the product. If a consumer has any of these types of products in their possession listing “Triad Group” as the manufacturer, they should not use the product and should return it to the place it was purchased for a full refund or call Triad Group Customer Service Monday through Friday between the hours of 8:30 A.M. and 4:00 P.M. Central Time: 262.538.2900.
DO NOT RETURN THE PRODUCT ON YOUR OWN, simply call the Triad Group Customer Service listed below and we will issue you a return authorization number and make all return arrangements.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Online: http://www.fda.gov/MedWatch/report.htm9   
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm10  Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food & Drug Administration.

Posted by: Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
www.DearOnesHealingMinistry.blogspot.com
DISCLAIMER FOR HEALTHCARE PROFESSIONALS & THEIR PATIENTS
Please understand that I am a biochemist and alternative healthcare provider with several decades of experience in the field of biomedical science. The information provided at http://www.dearoneshealingministry.blogspot.com/ and in any emails sent out by BarbaraKSexton@aol.com is for educational and entertainment purposes only and is in no way intended to replace the advice of your regular medical doctor or healthcare provider and you are urged to follow his/her advice. You are encouraged to share the contents at http://www.dearoneshealingministry.blogspot.com/ and of any e-mails specifically sent to you by Reverend Barbara Sexton, M.Sc. with your medical doctor and/or other healthcare providers with the understanding that all Intellectual Property Rights belong to Reverend Barbara Sexton, M.Sc. As such, this intellectual property may not be copied, transferred, transmitted, utilized or distributed by or for anyone else without my express permission and in accordance with all applicable laws. Any case-specific e-mails sent out by Reverend Barbara Sexton, M.Sc. are for the individuals for whom they are intended only and are subject to the Intellectual Property Rights restrictions above. Healthcare professionals may contact BarbaraKSexton@aol.com for terms, restrictions and fees (if any) if they wish to utilize this intellectual property for themselves or in their practices. Exceptions: FREE NEWSLETTER RECIPIENTS may share their copies with friends and family. Healthcare Professionals may sign up for the SAME FREE Dear Ones Healing Ministry NEWSLETTER by sending their name, address and email address to Reverend Barbara Sexton, M/Sc. at BarbaraKSexton@aol.com Public Domain: This disclaimer published 3/8/10 on http://www.dearonesministry.blogspot.com/ 1/20/11 updated.

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