title: Modified World Health Organization hand rub formulations comply with European efficacy requirements for preoperative surgical hand preparations.
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.
  
  
  METHODS
  Randomized Latin-square design.
  
  
  METHODS
  Microbiology laboratory of the Medical University of Vienna, Vienna, Austria.
  
  
  METHODS
  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%.
authors: Institute of Hygiene and Applied Immunology, Medical University of Vienna, Vienna, Austria. miranda.suchomel@meduniwien.ac.at
authors: Miranda
authors: M
authors: Suchomel
authors: Michael
authors: M
authors: Kundi
authors: Didier
authors: D
authors: Pittet
authors: Manfred L
authors: ML
authors: Rotter
mesh_terms: D019840:2-Propanol; D000704:Analysis of Variance; D000891:Anti-Infective Agents, Local / Q000737:chemistry* / Q000592:standards*; D000431:Ethanol; D005060:Europe; D005990:Glycerol; D017408:Guidelines as Topic; D006225:Hand / Q000382:microbiology; D006235:Hand Disinfection / Q000379:methods / Q000592:standards*; D006801:Humans; D006861:Hydrogen Peroxide; D017053:Infection Control; D013514:Surgical Procedures, Operative; D013997:Time Factors; D014944:World Health Organization
chemical_list: D000891:Anti-Infective Agents, Local; D000431:Ethanol; D006861:Hydrogen Peroxide; D019840:2-Propanol; D005990:Glycerol