Standard Practice for Testing Antimicrobial or Disinfectant Efficacy Against Biofilms Grown on a Medical Device or Surface by the Biofilm Surface Test Protocol (BSTP)


Importancia y uso:

5.1 Vegetative biofilm bacteria are phenotypically different from suspended planktonic cells of the same genotype (9). 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.

5.2 Biofilm growth reactors are engineered to produce biofilms with specific characteristics. Altering either the engineered system or operating conditions will modify those characteristics. The goal in biofilm research and efficacy testing is to choose the growth reactor that generates the most relevant biofilm for a particular study (10). Common systems used to grow biofilms in laboratories include flow cells, drip flow reactors, spinning-disk reactors, and tube biofilm reactors. These specialized models have several advantages, including growth of biofilms to high population densities and controlled fluid dynamics. The purpose of this practice is to direct a user in how to grow, treat, sample, and analyze a biofilm on the surface of virtually any medical device or material of interest, using the more simplistic BSTP.

5.3 The BSTP was originally designed as a rapid and reproducible assay for evaluating biofilm growth on surfaces (9 and 11). The design allows for the simultaneous evaluation of multiple parameters—such as testing multiple disinfectants or multiple concentrations of the same disinfectant, testing multiple surfaces (for example, coated versus uncoated), multiple challenge organisms, various growth media, growth/challenge times, and so on—making it an efficient screening tool. In addition to the throughput afforded by the use of a multi-well plate, the BSTP allows for extremely facile rinses, media changes, challenges, and recovery steps by virtue of immobilizing the test devices/surfaces to the lid of the multi-well plate. Moreover, the BSTP requires no specialized reactors or equipment and, as it does not depend upon continuous flow, uses relatively small volumes of media and other reagents.

Subcomité:

E35.15

Volúmen:

11.08

Número ICS:

07.100.10 (Medical microbiology), 71.040.20 (Laboratory ware and related apparatus)

Palabras clave:

antimicrobial; antimicrobial surface; biofilm; biofouling; BSTM device; BSTP; catheter; coating; corrosion; efficacy testing; encrustation; endotracheal tube; extraluminal; growth reactor; lumen; qualitative; quantitative; screening; semi-quantitative; stent;

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Norma
E3435

Versión
25

Estatus
Active

Clasificación
Practice

Fecha aprobación
2025-07-01