Evaluating antimicrobial efficacy in medical devices: The critical role of simulating in use test conditions

Biofilm infections represent the greatest risk associated with medical devices and implants, constituting 65 %-70 % of all device associated infections. Efforts to develop antimicrobial technologies for biomedical applications aim to reduce infection rates, antibiotic use, and the induction of antimicrobial resistance. However, standard laboratory test conditions often overestimate efficacy, highlighting the need for experimental designs that simulate real-world settings. To this end, we evaluated four commercially available antimicrobial materials containing silver (AG1, AG2, AG3) or zinc (ZN1) to assess their ability to mitigate microbial proliferation in for longer duration or multi-use medical devices. The materials' homogeneity and surface topography were characterized through Scanning Electron Microscopy (SEM) coupled with Energy Dispersive Spectroscopy (EDS) and Atomic Force Microscopy (AFM). Antimicrobial efficacy was tested using a modified ISO 22196 protocol under clinically relevant conditions and a dry contact test developed to mimic in-use conditions for many extracorporeal medical devices. Results revealed homogeneous elemental distributions in AG1, AG2, and ZN1, and heterogeneous clusters for AG3. Surface roughness was highest for AG2 (170.1 nm), followed by TPE control (155.3 nm), ZN1 (83.51 nm) and silicone control (66.74 nm). All test materials demonstrated antimicrobial efficacies against S. aureus and E. coli, but not against C. albicans. In the dry contact assay, only AG2 proved effective against E. coli, and P. aeruginosa, underlining the role of humidity in antimicrobial action. Results were further corroborated by measurement of ion release by the materials at various temperatures, revealing greater release at higher temperatures. These outcomes emphasize the importance of testing antimicrobial materials under in use conditions to minimize discrepancies between laboratory results and clinical outcomes. Our findings provide a valuable framework for testing and integrating these materials into next-generation multi-use medical devices.