We are developing a novel two-part cold high-level disinfecting (HLD)/sterilization technology that will be ready to work by mixing in water, just minutes before use. Both components separately are relatively inactive, non-toxic and stable chemicals that have good shelf life, and easy handling restrictions compared to the currently used HLD products, ensuring the safety of personnel involved in its warehousing, transportation and in clinics. After mixing the two components in water just before use, the mixture would concomitantly generate two separate disinfectant agents, including chlorine dioxide, for the reinforcement of bioactivity. The technology allows a controlled and sustained release of chlorine dioxide under almost neutral conditions, allowing the product to have enough contact time with microbes and spores for proposed HLD action without imparting the corrosiveness encountered with common chlorine dioxide formulations. This will (1) limit personnel exposure to the ingredients of common commercial HLD products, such as the vapors of aldehydes, peracids, etc. (2) exhibit a wider spectrum of disinfection capabilities, being a formulation of tw highly oxidizing components, (4) have no storage and transportation hazards and be quite stable on long term storage, (5) be suitable even for austere conditions, like in war and other disaster areas where normal sterilization conditions are not available, except the use of potable water. Our research will include the design and characterization of the needed active ingredients, and packaging of the two parts of inactive formulation, which will be added to water to form an active disinfectant solution just before testing on FDA required sporicidal test on B. subtilis and C. sporogenes, and the AOAC Quantitative TB Test. The above experimental formulations will also be tested for handling the bioburden stress compared to that handled by control commercial disinfectant solutions. The long term objective is to commercialize this product, after an advanced research in the next phase, leading to acquiring the necessary data related to high-level disinfectant and sterilization and submission of pre-market notification [510(k)], which will include optimization of formulation for the best disinfectant, shelf life stablity, instrument and human safety, and biocompatibility properties.
A Better High-level Disinfectant for Endoscopes and Other Medical Equipments/Devices NARRATIVE Current commercial high-level disinfectants (HLDs) have several limitations, including the exposure of personnel involved in their transportation, storage and clinical use;potential inactivity of dialdehydes against certain important microbes and spores is also a concern. This research effort would try to develop a sustained release HLD/sterilant formulation from human consumable ingredients and, at the same time, would solve both of the above problems. The successful completion of this feasibility study will lead to future studies related to the long term objective to commercialize this product, after an advanced research in the phase-II, leading to acquiring the necessary data related to high-level disinfectant and sterilization and submission of pre-market notification [510(k)], which will include optimization of formulation for the best disinfectant, shelf life stability, instrument and human safety, and biocompatibility properties.