Advertisement
Research Article|Articles in Press

Evolving the EN 1500 test method for alcohol-based hand rub closer to clinical reality by reducing the organic load on hands and enabling product to be applied to dry hands

      Summary

      Background

      The methods currently used in Europe and North America to evaluate the bactericidal efficacy of hand hygiene products have some limitations, e.g., in the selection of test organisms or the method of contamination, and none of the methods allows prediction of actual clinical efficacy. WHO has therefore proposed to develop methods that better reflect typical clinical reality.

      Methods

      In a first experiment, we investigated two contamination methods (immersion according to EN 1500 and low-volume according to ASTM E2755) with the EN 1500 test organism Escherichia coli and using 60% v/v iso-propanol. The second experiment was for comparison of the two contamination methods with Enterococcus faecalis. Finally, the two test organisms were compared using the low-volume contamination method. Data within each experiment was statistically compared using the Wilcoxon test for paired samples and data from all experiments were combined and fit to linear mixed effects models.

      Results

      Mixed-effects analysis confirmed that the test organism and contamination method both impacted the pre-values and all three of these were factors that influenced log10 reductions. Higher pre-values resulted in significantly higher log10 reductions, immersion contributed to significantly higher log10 reductions, and E. coli affected significantly lower log10 reductions.

      Conclusion

      An efficacy evaluation against E. faecalis with a low-volume contamination method could be considered as an alternative to the EN 1500 standard. This could help improve the clinical relevance of the test method with including a Gram-positive organism and reducing soil load which allows a product application closer to reality.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Journal of Hospital Infection
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

      1. EN 1500. Chemical disinfectants and antiseptics: Hygienic hand disinfection: test method and requirement (phase 2/step 2). Brussels: Comité Européen de Normalisation; 2013.

        • Kampf G.
        The puzzle of volume, coverage and application time in hand disinfection.
        Infect Control Hosp Epidemiol. 2017; 38: 880-881https://doi.org/10.1017/ice.2017.85
      2. WHO. WHO guidelines on hand hygiene in health care. First Global Patient Safety Challenge Clean Care is Safer Care. Geneva: WHO; 2009.

      3. ASTM E2755: Standard test method for determining the bacteria-eliminating effectiveness of healthcare personnel hand rub formulations using hands of adults. ASTM International; 2015.

        • Macinga D.R.
        • Beausoleil C.M.
        • Campbell E.
        • Mulberry G.
        • Brady A.
        • Edmonds S.L.
        • et al.
        Quest for a realistic in vivo test method for antimicrobial hand-rub agents: introduction of a low-volume hand contamination procedure.
        Appl Environ Microbiol. 2011; 77 (AEM.06134-11): 8588-8594
        • Dharan S.
        • Hugonnet S.
        • Sax H.
        • Pittet D.
        Comparison of waterless hand antisepsis agents at short application times: raising the flag of concern.
        Infect Control Hosp Epidemiol. 2003; 24: 160-164https://doi.org/10.1086/502182
        • Rice L.B.
        Progress and challenges in implementing the research on ESKAPE pathogens.
        Infect Control Hosp Epidemiol. 2010; 31: S7-S10https://doi.org/10.1086/655995
        • Rotter M.
        • Suchomel M.
        • Weinlich M.
        • Kunid M.
        Impact of shortening the duration of application and the standardized rubbing sequence as well as the reduction of the disinfectant volume used for the hygienic hand rub with 2-propanol (60 % V/V).
        Hyg Med. 2009; 34: 19-23
        • Boyce J.M.
        • Pittet D.
        Guideline for Hand Hygiene in Health-Care Settings: Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force.
        Infect Control Hosp Epidemiol. 2002; 23: S3-S40
        • Rotter M.
        • Sattar S.
        • Dharan S.
        • Allegranzi B.
        • Mathai E.
        • Pittet D.
        Methods to evaluate the microbicidal activities of hand-rub and hand-wash agents.
        J Hosp Infect. 2009; 73: 191-199https://doi.org/10.1016/j.jhin.2009.06.024
        • Eggers M.
        • Suchomel M.
        In vivo efficacy of alcohol based hand rubs against noroviruses: A novel standardized European test method simulating practical conditions.
        J Hosp Infect. 2023; (00079-8): S0195-S6701https://doi.org/10.1016/j.jhin.2023.03.005
        • Suchomel M.
        • Lenhardt A.
        • Kampf G.
        • Grisold A.
        Enterococcus hirae, Enterococcus faecium and Enterococcus faecalis show different sensitivities to typical biocidal agents used for disinfection.
        J Hosp Infect. 2019; 103: 435-440https://doi.org/10.1016/j.jhin.2019.08.014
        • Pidot S.J.
        • Gao W.
        • Buultjens A.H.
        • Monk I.R.
        • Guerillot R.
        • Carter G.P.
        • et al.
        Increasing tolerance of hospital Enterococcus faecium to handwash alcohols.
        Sci Transl Med. 2018; 10 (eaar6115)https://doi.org/10.1126/scitranslmed.aar6115
        • Kampf G.
        • Ostermeyer C.
        Intra-laboratory reproducibility of the hand hygiene reference procedures of EN 1499 (hygienic hand wash) and EN 1500 (hygienic hand disinfection).
        J Hosp Infect. 2002; 52: 219-224https://doi.org/10.1053/jhin.2002.1299