Jump to content

Hand sanitizer: Difference between revisions

From Wikipedia, the free encyclopedia
Content deleted Content added
JSHibbard (talk | contribs)
No edit summary
Line 28: Line 28:
| publisher = [[US Federal Drug Administration]]}}</ref>
| publisher = [[US Federal Drug Administration]]}}</ref>


In the past, alcohol-free hand [[sanitizer]]s tended to significantly under-perform alcohol or alcohol rubs as germ killers in [[clinical studies]] using standard [[Medical guideline|protocols]] such as EN1500. More recently, advanced [[formulation]]s have been developed, some of which have been shown to out-perform alcohol. An example of this is HandClens, with a patented SAB (Surfactant, Allantoin and Benzalkonium Chloride) formulation. A further aspect of [[efficacy]] that is sometimes overlooked is the effect of repeated use. The efficacy of alcohol as a hand [[disinfectant]] has been shown to decrease after repeated use, probably due to progressive adverse skin reactions, whereas the efficacy of an alcohol-free hand [[sanitizer]] based on [[Benzalkonium Chloride]] as its [[active ingredient]] has been shown to increase with repeated use.<ref>AORN; Dyer, etal; Aug 1998; VOL 68, No2;http://www.aornjournal.org/article/abstracts?terms1=&terms2=&terms3= </ref> However, in a more recent study, the effectiveness of alcohol did not decrease after repeated use. This study also demonstrated that, unlike Benzalkonium Chloride, alcohol does not have persistent or cumulative antimicrobial activity after application.<ref>Garcia R, Hibbard JS. Antimicrobial activity of a recently approved chlorhexidine isopropyl alcohol antiseptic vs. 70% isopropyl alcohol: a randomized, blinded trial. An oral presentation at the 28th Annual Educational Conference and International Meeting of the Association for Professionals in Infection Control and Epidemiology, June 12, 2001.</ref> However, alcohol-based sanitizers have been previously shown to fail to meet the FDA 21 CFR 333.470 performance standards for health-care personnel antiseptic hand washes not just as a consequence of the decrease in effectiveness with repeated use, but also due to a lack of persistence in antimicrobial activity after application and the decrease in effectiveness with heavy soil loads. <ref>AORN; Dyer, etal; Aug 1998; VOL 68, No2;http://www.aornjournal.org/article/abstracts?terms1=&terms2=&terms3= </ref> In the same study, HandClens was shown to meet and exceed the FDA performance standards.
In the past, alcohol-free hand [[sanitizer]]s tended to significantly under-perform alcohol or alcohol rubs as germ killers in [[clinical studies]] using standard [[Medical guideline|protocols]] such as EN1500. More recently, advanced [[formulation]]s have been developed, some of which have been shown to out-perform alcohol. An example of this is HandClens, with a patented SAB (Surfactant, Allantoin and Benzalkonium Chloride) formulation. A further aspect of [[efficacy]] that is sometimes overlooked is the effect of repeated use. The efficacy of alcohol as a hand [[disinfectant]] has been shown to decrease after repeated use, probably due to progressive adverse skin reactions, whereas the efficacy of an alcohol-free hand [[sanitizer]] based on [[Benzalkonium Chloride]] as its [[active ingredient]] has been shown to increase with repeated use.<ref>AORN; Dyer, etal; Aug 1998; VOL 68, No2;http://www.aornjournal.org/article/abstracts?terms1=&terms2=&terms3= </ref> However, in a more recent study, the effectiveness of 70 % isopropyl alcohol did not decrease after repeated use. This study also demonstrated that, unlike Benzalkonium Chloride, alcohol does not have persistent or cumulative antimicrobial activity after application.<ref>Garcia R, Hibbard JS. Antimicrobial activity of a recently approved chlorhexidine isopropyl alcohol antiseptic vs. 70% isopropyl alcohol: a randomized, blinded trial. An oral presentation at the 28th Annual Educational Conference and International Meeting of the Association for Professionals in Infection Control and Epidemiology, June 12, 2001.</ref> However, Purell has been previously shown to fail to meet the FDA 21 CFR 333.470 performance standards for health-care personnel antiseptic hand washes not just as a consequence of the decrease in effectiveness with repeated use, but also due to a lack of persistence in antimicrobial activity after application and the decrease in effectiveness with heavy soil loads. <ref>AORN; Dyer, etal; Aug 1998; VOL 68, No2;http://www.aornjournal.org/article/abstracts?terms1=&terms2=&terms3= </ref> In the same study, HandClens was shown to meet and exceed the FDA performance standards.


==Uses==
==Uses==

Revision as of 17:21, 30 June 2009

File:Hand sanitizer with aloe.jpg
One of many brands of alcohol gel, which is a type of alcohol rub

An alcohol rub, also known as a hand sanitizer or healthcare personnel hand wash or a hand antiseptic according to the latest FDA definition, is used as a supplement or alternative to hand washing with soap and water. The active ingredient in alcohol rubs may be isopropanol, ethanol, or (in Europe) n-propanol. A variety of preparations are available, including gels, foam and liquid solutions. Hand sanitizers containing alcohol are more effective at killing germs than soaps and do not dry out hands as much as soaps.[1] Inactive ingredients in alcohol rubs typically include a thickening agent such as Carbomer (a trade name for polyacrylic acid) for alcohol gels, humectants such as glycerin for liquid rubs and propylene glycol, or essential oils of plants. Popular alcohol rub brands include Baccide, Purell, Germ-X, Aqium, Avant, GermOut, and Aquawet. Lysol, and Method Products, also produce popular alcohol-based hand sanitizers.

In recent years, some brands started combining alcohol rubs with natural products and essential oils to provide luxury lines for the growing skin care industry. [2] Such brands include Burt's Bees, EO, Frais, Jao and The Body Shop.

Some hand sanitizer products use agents other than alcohol, such as triclosan or benzalkonium chloride, to kill germs. Cleanwell, Remi-D, Soapopular, Safe Hands, Safe4Hours, Gentle Care, X3 Clean and No Rinse are among non-alcohol hand sanitizer brands. Cleanwell however contains all natural ingredients and no harsh chemicals and has not been shown to cause an resistance in any known bacteria.[3] However, one un-collaborated laboratory study has shown benzalkonium chloride may be associated with but not cause antibiotic resistance in MRSA.[4] [5] No mechanism for resistance to alcohol has been described in bacteria”.[6] Triclosan has been shown to accumulate in biosolids in the environment, one of the top seven organic contaminants in waste water according to the National Toxicology Program[7] Triclosan leads to various problems with natural biological systems [8], and triclosan, when combined with chlorine e.g. from tap water, produces chloroform, a probable carcinogen in humans.[9] In June, 2009, alcohol-free Clarcon Antimicrobial Hand Sanitizer was pulled from the US market by the FDA which found the product contained high levels of various bacteria, including those which can "cause opportunistic infections of the skin and underlying tissues and could result in medical or surgical attention as well as permanent damage".[10]

In the past, alcohol-free hand sanitizers tended to significantly under-perform alcohol or alcohol rubs as germ killers in clinical studies using standard protocols such as EN1500. More recently, advanced formulations have been developed, some of which have been shown to out-perform alcohol. An example of this is HandClens, with a patented SAB (Surfactant, Allantoin and Benzalkonium Chloride) formulation. A further aspect of efficacy that is sometimes overlooked is the effect of repeated use. The efficacy of alcohol as a hand disinfectant has been shown to decrease after repeated use, probably due to progressive adverse skin reactions, whereas the efficacy of an alcohol-free hand sanitizer based on Benzalkonium Chloride as its active ingredient has been shown to increase with repeated use.[11] However, in a more recent study, the effectiveness of 70 % isopropyl alcohol did not decrease after repeated use. This study also demonstrated that, unlike Benzalkonium Chloride, alcohol does not have persistent or cumulative antimicrobial activity after application.[12] However, Purell has been previously shown to fail to meet the FDA 21 CFR 333.470 performance standards for health-care personnel antiseptic hand washes not just as a consequence of the decrease in effectiveness with repeated use, but also due to a lack of persistence in antimicrobial activity after application and the decrease in effectiveness with heavy soil loads. [13] In the same study, HandClens was shown to meet and exceed the FDA performance standards.

Uses

When hands are not visibly dirty, the United States Centers for Disease Control and Prevention considers alcohol hand sanitizers as an acceptable alternative to soap and water for hand hygiene.[14]

Alcohol concentration must be above 60% for alcohol rubs to be effective in killing microbes. Researchers at East Tennessee State University found that products with alcohol concentrations as low as 40% are available in American stores.[15] For health care settings like hospitals and clinics, optimum alcohol concentration to kill germs is 70 to 95 %.[16][17] Alcohol rubs containing two different germ killers (i.e. alcohol and chlorhexidine gluconate), are significantly more effective as preoperative skin topical antiseptics in hospitals than alcohol alone.[18] Most alcohol rub formulations include a moisturizer to keep hands from drying out.


Hospital environment

Alcohol based hand rubs are extensively used in the hospital environment as an alternative to antiseptic soaps. Alcohol based hand rubs provide a better skin tolerance as compared to antiseptic soap due to the moisturizing and softening agents in the formulation. Hand rubs also prove to have more effective microbiological properties as compared to antiseptic soaps.

Brands of hospital hand-rubs

Most common brands of alcohol hand rubs include Aniosgel 85 NPC, Sterillium, Desderman and Allsept S. All hospital hand rubs must conform to certain regulations like EN 12054 for hygienic treatment and surgical disinfection by hand-rubbing. Products with a claim of “99.99% reduction” or 4Log reduction are ineffective in hospital environment, since the reduction must more than “99.99%”.

Types of hand-rubs

Hand rubs are available both in gel and liquid forms, gel forms being the preferred choice for their ability to stay in the palm and not drip on the floor. The gel form insures that the proper dose of the hand-rub is applied in the palm and that it stays in the palm. Liquid hand rubs are more difficult to keep in the palm, since they will drip in between the fingers, this might cause a risk of incorrect dosage and thus ineffective antimicrobial activity. After application, gel hand rubs quickly turn to a liquid state (thixotropic effect), in order to penetrate the various cracks and folds in the skin and ensure a proper microbiological activity. Gel forms that do not poses a thixotropic effect, may prove to be ineffective for hand disinfection if the product does not penetrate in the folds and cracks in the skin.

Composition

Same ingredients used in over the counter hand rubs are used in hospital hand-rubs, those include alcohols (ethanol, isopropanol and others) sometimes combined with other compounds like quats (Benzalkonim chloride). The use of quats is primarily to increase the antimicrobial effectiveness of the product, nevertheless it might cause allergic reactions with some personnel. Quats also tend to build up on the skin, and since medical staff use hand rubs heavily during the day, this build up might cause a “sticky effect”. Hand rubs bases solely on alcohol eliminate the sticky effect as well as risk of allergic reactions.

Applications in the hospital environment

Hand-rubs in the hospital environment have two applications: hygienic hand rubbing and surgical hand disinfection.

Hygienic hand rubbing

Hygienic hand rubbing is recommended when administering medical treatments and in all circumstances where hand disinfection is necessary (during contact with the patient or the patient's environment, particularly before medical examination between each treatment, if the treatment is interrupted). Hygienic hand rubbing in addition to the hospital staff is strongly recommended to be practiced by visitors and patients themselves whenever possible.

Surgical hand disinfection by hand-rubbing

Surgical hand disinfection by hand-rubbing is to be practiced before any surgical procedure. Surgical hand-rubbing is to be preceded by hand washing with mild soap. Hand washing prior to hygienic hand rubbing is not necessary unless hands are visibly dirty. Surgical hand disinfection by hand-rubbing generally requires a larger dose of the hand-rub and a longer rubbing time, usually done in two applications.

Both hygienic hand treatment and surgical hand disinfection must be applied and rubbed according to a specific hand-rubbing technique EN 1499 and EN 1500. This technique is specifically designed to ensure that the antiseptic is applied everywhere on the hand surface.

Dosing systems

Different dosing systems are available for hospital hand-rubs, those are usually dosing systems incorporated into the bottle itself like dosing pumps screwed into the bottle or airless pump systems. The dosing systems are designed to deliver a certain amount of the product, and thus to assist the staff to correctly measure out the correct dose. Application of the hand-rub can also be assisted by placing the bottle in specially designed dispensers, dispensers for surgical hand disinfection are usually equipped with elbow controlled mechanism or infrared sensors to avoid any contact between with the pump. It is strongly not recommended use the product in its original packaging and never to pour the product into a dispenser, as the dispenser itself may become the cause of infection.

Effectiveness

The Centers for Disease Control says the most important way to prevent the transmission of dangerous diseases is to frequently wash your hands with soap or use a hand sanitizer that contains at least 60 percent alcohol.[19] Alcohol rubs kill many different kinds of bacteria, including antibiotic resistant bacteria and TB bacteria. Alcohol rubs inactivate many different kinds of viruses, including the flu virus and the common cold virus[20][21]. Alcohol rubs also kill fungi.[22]

Not all pathogens are equally susceptible. Certain bacteria, especially the spore-forming gram positives (e.g. Clostridium difficile) are relatively resistant and remain biologically viable. During the Anthrax attacks on the United States Postal Service, authorities warned that alcohol hand rubs would not kill anthrax spores. In environments with high lipids or protein waste (such as food processing), the use of alcohol hand rubs alone may not be sufficient to ensure proper hand hygiene.

Research shows alcohol hand sanitizers do not pose any risk by eliminating "good" germs. The body quickly replenishes the good germs on the hands, often moving them in from just up the arms where there are fewer harmful germs. [23]

A controlled study of 200 workers at FedEx in 2004 showed that placing hand sanitizer dispensers in an office and educating workers about their use resulted in a 21% reduction in absenteeism. [24] Controlled studies showed an even greater reduction in absenteeism (51%) in elementary schools[25] and college dormitories (43%).[26]

Safety

Alcohol gel can catch fire, producing a dim blue flame. This is due to the flammable alcohol in the gel. Some hand sanitizer gels may not produce this effect due to a high concentration of water or moisturizing agents. There have been some rare instances where alcohol has been implicated in starting fires in the operating room, including a case where alcohol used as an antiseptic pooled under the surgical drapes in an operating room and caused a fire when a cautery instrument was used. Alcohol gel was not implicated. To minimize the risk of fire, alcohol rub users are instructed to rub their hands until dry, which indicates that the flammable alcohol has evaporated.[27]

The US FDA controls antimicrobial handsoaps and sanitizers as over-the-counter drugs because they are intended for topical anti-microbial use to prevent disease in humans. [28] The FDA requires strict labeling which informs consumers as to proper use of this OTC drug and dangers to avoid, including warning adults not to ingest, not to use in the eyes, to keep out of the reach of children, and to allow children to use only under adult supervision. [29] According to the American Association of Poison Control Centers, there were nearly 12,000 cases of hand sanitizer ingestion in 2006. [30] If ingested, alcohol-based hand sanitizers can cause alcohol poisoning in small children.[31] However, the Centers for Disease Control recommends using hand sanitizer with children to promote good hygiene, under supervision, and furthermore recommends parents pack hand sanitizer for their children when traveling, to avoid their contracting disease from dirty hands. [32]

Sources

  1. ^ "Alcohol Hand Rub and Hand Hygiene" (PDF). Clinical Excellence Commission, Health, New South Wales, Australia. Retrieved 2007-05-18.
  2. ^ M.O. (March 2009). "Vital Beauty, Soothing Hand Sanitizers". Natural Health Magazine. p. 22.
  3. ^ http://cleanwelltoday.com/#/powered/
  4. ^ "Increase in Resistance of Methicillin-Resistant Staphylococcus aureus to β-Lactams Caused by Mutations Conferring Resistance to Benzalkonium Chloride, a Disinfectant Widely Used in Hospitals". American Society for Microbiology.
  5. ^ "Antibacterial Household Products: Cause for Concern". Centers for Disease Control and Prevention. {{cite web}}: Text "accessdate 2001-06-01" ignored (help)
  6. ^ Dix, Kathy (December 1, 2002). "CDC's Endorsement of Alcohol Hand Rubs Launches New Era in Hand Hygiene". Infection Control Today.
  7. ^ "Hand NTP Research Concept: Triclosan" (PDF). National Toxicology Project. Retrieved 2008-11-20.
  8. ^ McMurry LM, Oethinger M, Levy SB (1998). "Triclosan targets lipid synthesis". Nature. 394 (6693): 531–2. doi:10.1038/28970. PMID 9707111.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  9. ^ "Environmental Emergence of Triclosan" (PDF). Santa Clara Basin Watershed Management Initiative. Retrieved 2006-01-01.
  10. ^ "Consumers Warned Not to Use Clarcon Skin Products". US Federal Drug Administration. June 15, 2009. Retrieved 2009-06-15.
  11. ^ AORN; Dyer, etal; Aug 1998; VOL 68, No2;http://www.aornjournal.org/article/abstracts?terms1=&terms2=&terms3=
  12. ^ Garcia R, Hibbard JS. Antimicrobial activity of a recently approved chlorhexidine isopropyl alcohol antiseptic vs. 70% isopropyl alcohol: a randomized, blinded trial. An oral presentation at the 28th Annual Educational Conference and International Meeting of the Association for Professionals in Infection Control and Epidemiology, June 12, 2001.
  13. ^ AORN; Dyer, etal; Aug 1998; VOL 68, No2;http://www.aornjournal.org/article/abstracts?terms1=&terms2=&terms3=
  14. ^ "Hand Hygiene FAQ". Infection Control in Dental Settings. Centers for Disease Control and Prevention. July 15, 2006. Retrieved 2007-02-01.
  15. ^ Reynolds, Scott A. (2006). "Hand Sanitizer Alert". Emerging Infectious Diseases. 12 (3). Centers for Disease Control and Prevention. Retrieved 2007-02-02. {{cite journal}}: Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  16. ^ Kramer, Axel (2002). "Limited efficacy of alcohol-based hand gels". Lancet. 359 (April 27): 1489–1490. doi:10.1016/S0140-6736(02)08426-X. {{cite journal}}: |access-date= requires |url= (help); Unknown parameter |coauthors= ignored (|author= suggested) (help)
  17. ^ Pietsch, Hanns (2001). "Hand Antiseptics: Rubs Versus Scrubs, Alcoholic Solutions Versus Alcoholic Gels". J. Hospital Infection. 48 (Supl A). Hospital Infection Society: S33–S36. doi:10.1016/S0195-6701(01)90010-6. {{cite journal}}: |access-date= requires |url= (help)
  18. ^ Hibbard, John S. (May/June 2005). "Analyses Comparing the Antimicrobial Activity and Safety of Current Antiseptic Agents". J. Infusion Nursing. 28 (3). Infusion Nurses Society: 194–207. {{cite journal}}: |access-date= requires |url= (help); Check date values in: |date= (help)
  19. ^ "Dirty Hands Spread Dangerous Diseases like H1N1 (aka swine flu)". San Jose Mercury News. 25 April, 2009. {{cite journal}}: |access-date= requires |url= (help); Check date values in: |date= (help)
  20. ^ Sandora, Thomas J TJ Reducing absenteeism from gastrointestinal and respiratory illness in elementary school students: a randomized, controlled trial of an infection-control intervention Journal: Pediatrics (Evanston) ISSN: 0031-4005 Date: 06/2008 Volume: 121 Issue: 6 Page: e1555 PMID: 18519460 DOI: 10.1542/peds.2007-2597
  21. ^ Infection Control Campaign brochure
  22. ^ www.learnwell.org//handhygiene.htm
  23. ^ Aiello; et al. (2007). "Consumer antibacterial soaps: effective or just risky?". Clin Infect Dis. {{cite journal}}: |access-date= requires |url= (help); Explicit use of et al. in: |last= (help)
  24. ^ Arbogast, Ferrazzano-Yaussy, Cartner (2004). "FedEx Custom Critical Outcome Study Executive Update, Interim Report". GOJO Industries, Inc. {{cite journal}}: |access-date= requires |url= (help)CS1 maint: multiple names: authors list (link)
  25. ^ Guinan, M., M. McGuckin, and Y. Ali. (2002). "The effect of a comprehensive handwashing education program on absenteeism in elementary schools". American Journal of Infection Control. 31: 1-8. {{cite journal}}: |access-date= requires |url= (help)CS1 maint: multiple names: authors list (link)
  26. ^ White, C., R. Kolble, R. Carlson, N. Lipson, M. Dolan, Y. Ali, M. Cline (2003). "The effect of hand hygiene on illness rate among students in university residence halls". American Journal of Infection Control. 13: 364-370. {{cite journal}}: |access-date= requires |url= (help)CS1 maint: multiple names: authors list (link)
  27. ^ "Alcohol-Based Hand-Rubs and Fire Safety". Centers for Disease Control and Prevention. September 15, 2003. Archived from the original on 2007-04-03. Retrieved 2007-04-26.
  28. ^ Daniel S. Wagner, Manager of Regulatory Compliance, ISSA (2000). "GENERAL GUIDE TO CHEMICAL CLEANING PRODUCT REGULATION" (PDF). International Sanitary Supply Association, Inc.{{cite web}}: CS1 maint: multiple names: authors list (link)
  29. ^ Judith E. Foulke (May 1994). "Decoding the Cosmetic Label". FDA Consumer magazine. U.S. Food and Drug Administration.
  30. ^ >"Paging Dr. Gupta, Hand sanitizer risks". CNN. June 21, 2007.
  31. ^ "Hand Sanitizers Could Be A Dangerous Poison To Unsupervised Children". NBC News Channel. Retrieved 2007-07-15.
  32. ^ "International Travel with Infants and Young Children". Travelers' Health - Yellow Book. 8. Centers for Disease Control. March 2009.

See also