Advertisement

Combined application of simulated reuse and quantitative carrier tests to assess high-level disinfection: Experiments with an accelerated hydrogen peroxide-based formulation

      Abstract

      Background: Heat-sensitive medical devices require chemical disinfection between patients, and certain formulations for this purpose can be reused for several days. Because dilution, evaporation, and breakdown or neutralization of active ingredients can occur during reuse, it is vital to ensure that the solution retains its broad-spectrum germicidal activity even at the end of the recommended reuse period. Objective: The purpose of this study was to combine the US Environmental Protection Agency's and the Food and Drug Administration's recommended simulated reuse method with recently developed quantitative carrier tests (QCT) to assess the broad-spectrum germicidal activity of a 7% solution of accelerated hydrogen peroxide (pH 2.9) stressed for 14 days. Materials And Methods: On alternate days baths with 3 lots of the test formulation were stressed by the addition of bacteria (Salmonella choleraesuis, Staphylococcus aureus, and Pseudomonas aeruginosa ) on glass beads and spores (Bacillus subtilis and Clostridium sporogenes ) on metallic penicylinders. In addition, one set of respiratory therapy equipment was subjected to 3 daily cycles of disinfection in each bath. The pH and H2O2 levels in the test samples were measured, and they were also subjected to QCTs for their sporicidal, bactericidal, virucidal, fungicidal, and mycobactericidal activities. Results: After 14 days of reuse, the pH of the test solutions remained essentially unchanged. Although the level of H2O2 dropped from a high of 7.66% to as low as 6.40%, all lots showed the required level of broad-spectrum germicidal activity after 14 days of stress. Conclusions: The stress test and QCT were successfully combined in demonstrating the broad-spectrum germicidal activity of a high-level disinfectant subjected to 14 days of simulated reuse. (Am J Infect Control 2002;30:449-57.)
      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 American Journal of Infection Control
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Bond WW
        • Favero MS
        Chemical disinfection of medical and surgical materials.
        in: Disinfection, sterilization, and preservation. Lippincott William & Wilkins, New York2001: 881-918
        • Mbithi JN
        • Springthorpe VS
        • Sattar SA
        • Paquette M
        Bactericidal, virucidal, and mycobactericidal activities of reused alkaline glutaraldehyde in an endoscopy unit.
        J Clin Microbiol. 1993; 31: 2988-2995
        • Spach DH
        • et al.
        Transmission of infection by gastrointestinal endoscopy.
        Ann Intern Med. 1993; 118: 117-128
        • Environmental Protection Agency US
        Reuse test protocol specifications.
        EPA, Washington, DC1984
        • US Food and Drug Administration
        Guidance for industry and FDA reviewers: content and format of premarket notification [510(k)] submissions for liquid chemical sterilants/high-level disinfectants.
        in: Center for Devices and Radiological Health, Food and Drug Administration, Rockville (MD)2000: 8-9
        • Miner N
        Principles to guide international standard tests for liquid chemical germicides: a proposal.
        J AOAC Int. 1999; 82: 669-675
        • Sattar SA
        • Springthorpe VS
        New methods for efficacy testing of disinfectants and antiseptics.
        in: Disinfection, sterilization, and antisepsis: principles and practices in healthcare facilities. Association for Professionals in Infection Control and Epidemiology, Washington, DC2001: 173-186
        • Sattar SA
        • Springthorpe VS
        • Rochon M
        A product based on accelerated and stabilized hydrogen peroxide: evidence for broad-spectrum germicidal activity.
        Can J Infect Control. 1998; 13: 123-130
        • ASTM International
        Standard quantitative carrier test method to evaluate the bactericidal, fungicidal, mycobactericidal, and sporicidal potencies of liquid chemical germicides.
        ASTM International, West Conshohocken (PA)2000 (Document # E-2111)
        • Sattar SA
        • Springthorpe VS
        Methods of testing virucidal activity of chemicals.
        in: Disinfection, sterilization, and preservation. Lippincott William & Wilkins, New York2001: 1391-1421
        • ASTM International
        Standard quantitative carrier test method to determine the bactericidal, virucidal, fungicidal, mycobactericidal and sporicidal activities of liquid chemical germicides.
        ASTM International, West Conshohocken (PA)2002 (Document #E-2197)
        • Canadian General Standards Board
        Assessment of efficacy of antimicrobial agents for use on environmental surfaces and medical devices.
        Canadian General Standards Board, Ottawa, Canada:1997 (Document #CAN/CGSB-2.161-M97)
        • Johnson RM
        • Siddiqi IW
        The determination of organic peroxides.
        in: Pergamon Press, New York1970: 23-28
        • AOAC International
        Official methods of analysis of the AOAC.
        AOAC International, Washington, DC1998