ASTM WK74562

    New Test Method for Intraluminal Catheter Model used to Evaluate Antimicrobial Urinary Catheters for Prevention of Escherichia coli Biofilm Growth

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    Developed by Subcommittee: E35.15 | Committee E35 | Contact Staff Manager


    1. Scope

    1.1 This test method specifies the operational parameters required to assess the ability of antimicrobial urinary catheters to prevent or control biofilm growth. Efficacy is reported as the log reduction in viable bacteria when compared to a repeatable (1)2 Escherichia coli biofilm grown in the intra-lumen of a urinary catheter under a constant flow of artificial urine. 1.2 The method is versatile and may also be used for growing and/or characterizing biofilms and suspended bacteria of different species, although this will require changing the operational parameters to optimize the method based upon the growth requirements of the new organism. 1.3 This test method may be used to evaluate surface modified urinary catheters that contain no antimicrobial agent. 1.4 This test method describes how to sample and analyze catheter segments and effluent for viable cells. Biofilm population density is recorded as log colony forming units per surface area. Suspended bacterial population density is reported as log colony forming units per volume. 1.5 Basic microbiology training is required to perform this test method. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.


    biofilm; Foley catheter; intraluminal catheter model; Escherichia coli; sampling, antimicrobial surface


    In the battle to reduce medical device and implant-related infections, prevention of bacterial colonization of surfaces is a logical strategy. Bacterial colonization of a surface is a precursor to biofilm formation. Biofilm is the etiological agent of many implant and device-related infections and once established, microorganisms in biofilm can be up to 1000 times more tolerant to antibiotic therapy. Often the best treatment strategy is removal of the implant or device at a high socioeconomic cost. Catheter associated urinary tract infections (CAUTI) are the most prevalent of the device-related healthcare associated infections. Catheter associated infections account for 37% of all hospital acquired infections (HAI) and 70% of all nosocomial urinary tract infections (UTI) in the U.S. The Intraluminal Catheter Model (ICM) was developed to evaluate the ability of antimicrobial catheters to inhibit biofilm growth on the catheter lumen. The purpose of this test method is to direct a user in how to grow, sample, and analyze an E. coli biofilm in a urinary catheter under a constant flow of artificial urine. It will be used by persons interested in understanding the ability of their antimicrobial catheter to control biofilm.

    The title and scope are in draft form and are under development within this ASTM Committee.

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    Work Item Status

    Date Initiated:

    Technical Contact:
    Darla Goeres


    E35.15 (21-02)

    Withdrawn From Balloting


    E35 (21-03)

    In Balloting