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的两部分冷高水平消毒（HLD）/灭菌技术，该技术在使用前几分钟通过在水中混合即可工作。这两种成分分别是相对不活跃，无毒和稳定的化学品，具有良好的保质期，与目前使用的HLD产品相比，易于处理限制，确保其仓储，运输和诊所人员的安全。在使用前将两种成分混合在水中，混合物会同时产生两种独立的消毒剂，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）限制人员暴露于普通商业HLD产品的成分，例如醛、过酸等的蒸气;（2）作为两种高氧化性组分的制剂，表现出更宽的消毒能力谱;（4）没有储存和运输危险，并且在长期储存时相当稳定;（5）甚至适用于严酷条件，例如在战争和其他灾区，除了使用饮用水之外，没有正常的消毒条件。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，其将在对B进行FDA要求的杀孢子试验之前加入水中以形成活性消毒剂溶液。枯草芽孢杆菌和C.生孢子菌和AOAC定量TB测试。还将对上述实验制剂进行生物负载强制降解处理试验，并与对照市售消毒剂溶液进行比较。长期目标是在下一阶段的高级研究之后将该产品商业化，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）]，其中包括最佳消毒剂配方优化、有效期稳定性、仪器和人体安全性以及生物相容性。 公共卫生相关性：目前市售的高水平消毒剂（HLD）有几个局限性，包括涉及其运输、储存和临床使用的人员的暴露;二醛对某些重要微生物和孢子的潜在无活性也是一个问题。这项研究工作将试图从人类可消费成分开发持续释放的HLD/灭菌剂制剂，同时解决上述两个问题。成功完成本可行性研究后，将开展与该产品商业化长期目标相关的未来研究，在第II阶段进行高级研究后，将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）]，其中将包括最佳消毒剂配方优化、有效期稳定性、仪器和 人体安全性和生物相容性。