A Better High-level Disinfectant for Endoscopes and Other Medical Equipments/Devi

更好的内窥镜和其他医疗设备高级消毒剂/Devi

• 批准号: 8250993
• 负责人: Neera Satsangi
• 金额: $ 22.21万
• 依托单位: INNOVATIVE RESEARCH SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-15 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8250993
• 关键词: Acids; Aldehydes; Alkylating Agents; Area; Attention; Bacillus subtilis; Back; Biocide; Blood; Buffers; Cause of Death; Chemicals; Chlorine; Clinic; Clinical; Clinical Engineering; Clostridium; Data; Devices; Dialysis procedure; Disasters; Disinfectants; Disinfection; Drug Formulations; Endoscopes; Endoscopy; Ensure; Equipment; Exhibits; Exposure to; Feasibility Studies; Formaldehyde; Future; Glutaral; Health; Health Professional; Health care facility; Human; Human Resources; Infection; Journals; Lead; Life; Liquid substance; Marketing; Measures; Medical; Medical Device; Microbe; Mycobacterium tuberculosis; Nosocomial Infections; Notification; Operative Surgical Procedures; Patients; Peracetic Acid; Peroxides; Phase; Process; Property; Psychological reinforcement; Queensland; Reproduction spores; Research; Risk; Safety; Site; Sodium Chloride; Solid; Solutions; Source; Steam; Sterility; Sterilization; Stream; Stress; System; Technology; Testing; Time; Toxic effect; Transportation; Visit; War; Water; Work; aqueous; base; biomaterial compatibility; chlorine dioxide; chlorite; controlled release; cost; design; hazard; instrument; novel; planetary Atmosphere; prevent; reconstitution; sodium chlorite; vapor

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: 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.

描述（由申请人提供）：我们正在开发一种新型两部分冷高水平消毒 (HLD)/灭菌技术，只需在使用前几分钟与水混合即可开始工作。两种成分分别是相对惰性、无毒且稳定的化学品，与目前使用的HLD产品相比，具有良好的保质期，且易于操作限制，确保其仓储、运输和诊所人员的安全。在使用前将两种组分在水中混合后，混合物会同时产生两种单独的消毒剂，包括二氧化氯，以增强生物活性。该技术允许在几乎中性的条件下控制和持续释放二氧化氯，使产品与微生物和孢子有足够的接触时间，以实现拟议的 HLD 作用，而不会产生常见二氧化氯制剂所遇到的腐蚀性。这将 (1) 限制人员接触常见商业 HLD 产品的成分，例如醛、过酸等的蒸气。(2) 作为两种高氧化成分的配方，表现出更广泛的消毒能力，(4 ）没有储存和运输危险，长期储存相当稳定，（5）即使在恶劣的条件下也适用，例如战争和其他灾区，除了使用饮用水外，没有正常的灭菌条件。我们的研究将包括所需活性成分的设计和表征，以及非活性制剂的两部分的包装，在 FDA 要求的枯草芽孢杆菌和艰难梭菌杀孢子测试之前，将其添加到水中形成活性消毒剂溶液孢子发生和 AOAC 定量结核病检测。还将测试上述实验制剂与对照商业消毒剂溶液处理的生物负荷应力的处理情况。长期目标是在下一阶段进行高级研究后将该产品商业化，从而获得与高水平消毒剂和灭菌相关的必要数据并提交上市前通知[510(k)]，其中将包括优化配方以获得最佳消毒剂、保质期稳定性、仪器和人体安全以及生物相容性。 公共卫生相关性：用于内窥镜和其他医疗设备/器械的更好的高水平消毒剂 叙述 目前的商业高水平消毒剂 (HLD) 有一些局限性，包括在运输、储存和临床使用过程中涉及人员的暴露；二醛对某些重要微生物和孢子的潜在不活性也是一个问题。这项研究将尝试从人类消费成分中开发出一种缓释 HLD/灭菌剂配方，同时解决上述两个问题。该可行性研究的成功完成将导致未来与该产品商业化的长期目标相关的研究，经过第二阶段的高级研究，从而获得与高水平消毒剂和灭菌相关的必要数据并提交上市前通知 [510(k)]，其中包括最佳消毒剂配方的优化、保质期稳定性、仪器和 人体安全和生物相容性。