title: World Health Organization-recommended hand-rub formulations do not meet European efficacy requirements for surgical hand disinfection in five minutes.
abstract: The World Health Organization (WHO) has recommended two hand-rub formulations for local production based on 80% ethanol or 75% isopropanol (both v/v). We have looked at their efficacy according to EN 12791. Twenty-six subjects treated their hands with the reference procedure (n-propanol, 60%) for 3 min or with one of the two formulations for 1.5, 3 or 5 min (Latin square design). Post-values (immediate effect) were taken from one hand, the other hand was gloved for 3 h. After the glove had been taken off, the second post-value was taken (3 h effect). The mean log(10) reduction of each hand rub at all three application times was compared to Hodges and Lehmann's reference procedure for non-inferiority. In the first block the reference procedure reduced bacterial load by 2.43 log(10) (immediate effect) and 2.22 log(10) (3 h effect). The efficacy of the ethanol-based formulation (e.g. immediate efficacy of 1.41 log(10) at 5 min) was inferior to the reference procedure at all application times [lower 95% confidence interval (CI): less than -0.75]. In the second block the reference procedure reduced bacterial load by 2.72 log(10) (immediate effect) and 2.26 log(10) (3 h effect). The efficacy of the isopropanol-based formulation (e.g. immediate efficacy of 2.05 log(10) at 5 min) was also inferior to the reference procedure at all application times (lower 95% CI: less than -0.75). Both WHO-recommended hand-rub formulations failed to meet the EN 12791 efficacy requirements for surgical hand disinfection within 5 min. A higher concentration of the active ingredients may improve the efficacy.
authors: BODE Chemie GmbH, Scientific Affairs, Hamburg, Germany. guenter.kampf@bode-chemie.de
authors: G
authors: G
authors: Kampf
authors: C
authors: C
authors: Ostermeyer
mesh_terms: D019840:2-Propanol / Q000008:administration & dosage*; D058491:Bacterial Load; D002626:Chemistry, Pharmaceutical / Q000379:methods; D000431:Ethanol / Q000008:administration & dosage*; D005060:Europe; D006235:Hand Disinfection / Q000379:methods* / Q000592:standards; D006801:Humans; D012867:Skin / Q000382:microbiology; D013514:Surgical Procedures, Operative / Q000379:methods* / Q000592:standards; D013997:Time Factors; D016896:Treatment Outcome; D014944:World Health Organization
chemical_list: D000431:Ethanol; D019840:2-Propanol