Microbiological risks and biofilms on instruments/surfaces: validation of disinfection/sterilization protocols

The study presents a comprehensive examination of microbiological threats associated with the formation of microbial biofilms on the working surfaces of medical instruments and equipment in the healthcare realities of 2024–2025. On the basis of updated information from international organizations, as well as a synthesis of specialized publications indexed in Scopus and Web of Science, the analysis elucidates the problem of heightened resistance of biofilm communities to standard disinfection and sterilization regimens. Key strategies by which microorganisms maintain viability within the extracellular polymeric matrix are described in detail, including mechanical protection, restricted diffusion of antimicrobial factors, and the development of heterogeneous microzones with altered metabolic activity. In parallel, the dynamics and statistical regularities of healthcare-associated infections (HAIs) at the global level are examined, enabling biofilm-associated persistence mechanisms to be linked to epidemiological trends. A separate emphasis is placed on the transformation of international regulation and practice-oriented requirements for the reprocessing of medical devices, including the release of updated standards in the ISO 15883:2024/2025 series and their significance for evidence-based validation of technological processes in central sterilization departments. Within a comparative analysis, contemporary approaches to detecting biological contamination are considered, including ATP bioluminescence and fluorescent visualization methods, which are characterized by differing sensitivity and applied diagnostic value at stages of cleanliness control. The effectiveness of innovative enzymatic detergents in acting on mature biofilms is additionally assessed, where the critical factor is the capacity to degrade matrix components and thereby increase the accessibility of microbial cells to standard decontamination interventions. The integrated conclusions underscore the fundamental importance of transitioning from universal control schemes to biofilm-oriented validation protocols aimed at reducing residual contamination, enhancing patient safety, and limiting the contribution of the clinical-diagnostic environment to the accelerated spread of antimicrobial resistance.

biofilms, microbiological risk, HAIs, sterilization validation, ISO 15883:2024, extracellular polymeric matrix, ATP metry, antimicrobial resistance, medical devices.

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