What is it about?
This article details the establishment of a rigorous biocidal validation study protocol aimed at routinely monitoring the antibacterial efficacy (power) of commercially available disinfectants used in a healthcare facility. The study was prompted by the recurrent isolation of a specific Gram-negative microorganism, the Burkholderia cepacia complex (BCC), on inanimate surfaces within the facility. The researchers sought to create a standard procedure, executed as part of Good Practices (GxP) activity, to ensure disinfectants can effectively manage the microbial burden. The protocol involved: Selection: Testing four chemically distinct antimicrobial formulas (alcohols, amphoteric detergent, and peroxygen products). Neutralization Study: Performing a preliminary test to confirm that a neutralizing agent could completely stop the disinfectant's activity after the specified contact time, ensuring accurate measurement of microbial kill. Contact Surface Method: Applying the disinfectants to test surfaces (coupons) made from common hospital materials, which were inoculated with the microorganism of concern (BCC). The results showed that all tested disinfectant groups achieved an acceptable microbial reduction level, indicating the validated protocol is successful in confirming the antibacterial efficacy needed to maintain a safe hospital environment.
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Why is it important?
This study is of prime importance because it provides a practical, standardized, and validated framework for hospitals to ensure the safety of their environment, thereby mitigating the risk of Nosocomial Infections (Healthcare-Associated Infections or HAIs). Protecting Patients and Staff: The primary role of the protocol is to protect patients and working staff from infections spread through contaminated surfaces, which is a crucial public health goal in any healthcare setting. Combating Resistance: By specifically targeting and validating efficacy against a known persistent organism like the Burkholderia cepacia complex (BCC), the protocol helps hospitals stay ahead of emerging or resistant bacteria that might otherwise cause outbreaks. Quality Assurance (GxP): It elevates environmental disinfection from a simple cleaning procedure to a validated quality control process, ensuring that the antimicrobial formulas purchased and used by the hospital are truly effective when applied.
Perspectives
The findings and the established protocol introduce several critical perspectives on infection control in clinical settings: From Testing to Validation: The work shifts the focus from simple product testing (i.e., does the manufacturer's product work in a lab?) to system validation (i.e., does this product work effectively in our hospital environment, against our specific microbes, under our routine conditions?). Microorganism Tolerance is Key: Other related studies (as cited in the search results) indicate that the microorganism’s tolerance often contributes more to variation in response than the disinfectant or surface type. This suggests that the continuous monitoring protocol is essential for detecting when resident bacteria are developing resistance and a change in disinfection strategy is needed. The GxP Standard: The insistence on executing the disinfection program as part of "GxP activity" (Good Practices) underlines the perspective that maintaining environmental microbial control is as fundamental to quality assurance in hospitals as it is in pharmaceutical manufacturing. It means hospitals should operate with the same rigor and validation standards to ensure patient safety.
Independent Researcher & Consultant Mostafa Essam Eissa
Read the Original
This page is a summary of: Establishment of biocidal activity evaluation study protocol in healthcare facility for routine monitoring of antibacterial power of disinfectants, Journal of Experimental and Clinical Medicine, October 2022, Ondokuzmayis University, Faculty of Medicine,
DOI: 10.52142/omujecm.39.4.4.
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