Hostname: page-component-78c5997874-xbtfd Total loading time: 0 Render date: 2024-11-10T05:32:56.766Z Has data issue: false hasContentIssue false
  • English
  • Français

Modified World Health Organization Hand Rub Formulations Comply with European Efficacy Requirements for Preoperative Surgical Hand Preparations

Published online by Cambridge University Press:  02 January 2015

Miranda Suchomel ,
Michael Kundi ,
Didier Pittet  and
Manfred L. Rotter
Miranda Suchomel*
Affiliation:
Institute of Hygiene and Applied Immunology, Medical University of Vienna, Vienna, Austria
Michael Kundi
Affiliation:
Center for Public Health, Medical University of Vienna, Vienna, Austria
Didier Pittet
Affiliation:
First Global Patient Safety Challenge, World Health Organization Patient Safety, World Health Organization, Geneva, Switzerland Infection Control Programme, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland World Health Organization Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland
Manfred L. Rotter
Affiliation:
Institute of Hygiene and Applied Immunology, Medical University of Vienna, Vienna, Austria
*
Institute of Hygiene and Applied Immunology, Medical University of Vienna, Kinderspitalgasse 15, 1090 Vienna, Austria (miranda.suchomel@meduniwien.ac.at)
Get access Rights & Permissions [Opens in a new window]

Abstract

Background.

The World Health Organization (WHO) has published “Guidelines on Hand Hygiene in Health Care” recommending 2 hand rub formulations based on 80% vol/vol ethanol or 75% vol/vol isopropanol for local production in healthcare settings where commercial products are not available or are too expensive. Previous investigations have shown that neither formulation meets the efficacy requirements of European norm (EN) 12791, which is the most stringent available norm for surgical hand rub preparations. Even when modified with approximately 5% higher alcohol content, the formulations proved to be inferior to the reference of the norm when measured after 3 hours.

Objective.

Because the high glycerol content of the formulations was suspected to negatively influence their efficacy, additional investigations were performed with varying glycerol content.

Methods.

Modified formulations with higher alcohol concentration (mass instead of volume percentage) and lower glycerol concentration (0.725% instead of 1.45%) or without the addition of glycerol were evaluated for their conformity with the efficacy requirements of EN 12791, which demands noninferiority in comparison with a reference hand antisepsis procedure immediately and 3 hours after treatment on volunteers’ hands.

Design.

Randomized Latin-square design.

Setting.

Microbiology laboratory of the Medical University of Vienna, Vienna, Austria.

Participants.

Twenty-five healthy volunteers.

Results.

Reducing the concentration of glycerol or omitting it completely rendered both WHO formulations noninferior to the reference, both immediately and 3 hours after surgical hand antisepsis.

Conclusions.

Both WHO-recommended formulations meet the efficacy requirements of EN 12791 by increasing their alcohol concentrations by 5%, prolonging their application to 5 minutes and reducing the glycerol concentration to 0.725%.

Type
Original Article
Information
Infection Control & Hospital Epidemiology , Volume 34 , Issue 3 , March 2013 , pp. 245 - 250
Copyright
Copyright © The Society for Healthcare Epidemiology of America 2013

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1. World Health Organization (WHO). WHO Guidelines on Hand Hygiene in Health Care. Geneva: WHO, 2009.Google Scholar
2. European Norm (EN) 12791. Chemical disinfectants and antiseptics. Surgical hand disinfection: test method and requirement (phase 2/step 2). Brussels: Comité Européen de Normalisation, 2005.Google Scholar
3. Kampf, G, Ostermeyer, C. World Health Organization-recommended hand-rub formulations do not meet European efficacy requirements for surgical hand disinfection in five minutes. J Hasp Infect 2011;78(2):123–127.CrossRefGoogle Scholar
4. Suchomel, M, Kundi, M, Allegrami, B, Pittet, D, Rotter, M. Testing of the World Health Organization-recommended formulations for surgical hand preparation and proposals for increased efficacy. J Hosp Infect 2011;79:115–118.CrossRefGoogle ScholarPubMed
5. Lehmann, EL. Nonparametrics: statistical methods based on ranks. San Francisco: Holden-Day, 1975.Google Scholar
6. Rotter, ML. Hand washing and hand disinfection. In: Mayhall, CG, ed. Hospital Epidemiology and Infection Control. 4th edition. Philadelphia: Wolters Kluwer, Lippincott, Williams and Wilkins, 2011:1365–1383.Google Scholar
7. Suchomel, M, Gnant, G, Weinlich, M, Rotter, M. Surgical hand disinfection using alcohol: the effects of alcohol type, mode and duration of application. J Hosp Infect 2009;71:228–233.Google Scholar
8. Suchomel, M, Koller, W, Kundi, M, Rotter, M. Surgical hand rub: Influence of duration of application on the immediate and 3hour effects of n-propanol and isopropanol. Am J Infect Control 2009;37:289–293.Google Scholar
9. Suchomel, M, Rotter, M. Ethanol in surgical hand rubs: concentration and duration of application for achieving European Norm EN 12791. J Hosp Infect 2011;77:263–266.Google Scholar
10. Kampf, G, Ostermeyer, C. Efficacy of two ethanol-based hand rubs for surgical hand disinfection: a controlled trial according to prEN 12791. BMC Inf Dis 2005;5:17.Google Scholar
11. Rotter, ML, Kundi, M, Suchomel, M, et al. Reproducibility and workability of the European test standard EN 12791 regarding the effectiveness of surgical hand antiseptics: a randomized, multicenter trial. Infect Cont Hosp Epidemiol 2006;27:935–939.CrossRefGoogle ScholarPubMed
12. Houben, E, de Paepe, K, Rogiers, V. Skin condition associated with intensive use of alcoholic gels for hand disinfection: a combination of biophysical and sensorial data. Contact Dermatitis 2006;54:261–267.CrossRefGoogle ScholarPubMed
13. Kampf, G, Wigger-Alberti, W, Schoder, V, Wilhelm, KP. Emollients in a propanol-based hand rub can significantly decrease irritant contact dermatitis. Contact Dermatitis 2005;53(6):344–349.Google Scholar
14. European Norm 1500. Chemical Disinfectants and Antiseptics: Hygienic Hand Disinfection—Test Method and Requirement (Phase 21 Step 2). Brussels: Comité Européen de Normalisation, 1997.Google Scholar
15. Suchomel, M, Kundi, M, Pittet, D, Weinlich, M, Rotter, ML. Testing of the World Health Organization recommended formulations in their application as hygienic hand rubs and proposals for increased efficacy. Am J Infect Control 2012;40(4):328–331.Google Scholar