Improved cleaning technology for reducing risk of transmitting infection in endoscopy.

改进的清洁技术可降低内窥镜检查中传播感染的风险。

• 批准号: 9759757
• 负责人: MOHAMED E LABIB
• 金额: $ 100万
• 依托单位: ADVANCED BIODEVICES, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-03-02 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9759757
• 关键词: 3-Dimensional; Advocate; Award; Bacteria; Caliber; Cellulose; Cessation of life; Characteristics; Colonoscopes; Congresses; Consensus; Cross Infection; Cyclic GMP; Data; Data Set; Dental; Devices; Diagnostic Procedure; Disease Outbreaks; Disinfection; Documentation; Duodenoscopes; Endoscopes; Endoscopy; Environment; Excision; Exposure to; Feedback; Fiber; Flushing; Formulation; Gastroscopes; Guidelines; Health Hazards; Health care facility; Healthcare; Human; Industry; Infection; Infection Control; Laboratories; Life; Manufacturer Name; Medical Technology; Medical center; Methods; Microbial Biofilms; Modeling; Multi-Drug Resistance; National Institute of Allergy and Infectious Disease; Patients; Phase; Procedures; Process; Production; Protocols documentation; Public Health; Pump; Recording of previous events; Reporting; Residual state; Risk; Sampling; Site; Soil; Solid; Speed; Sterilization; Surface; System; Techniques; Technology; Technology Assessment; Technology Transfer; Testing; Variant; Work; Workplace; Writing; aqueous; base; carbapenem-resistant Enterobacteriaceae; commercialization; comparative efficacy; design; flexibility; improved; manufacturing process; meetings; microbial; nano; nanofiber; new technology; phase 1 study; prevent; prototype; quality assurance; scale up; simulation; success; transmission process

7. Project Summary/Abstract: Outbreaks of infection caused by contaminated endoscopes are a serious public health problem that has even resulted in patient deaths. Currently, because of the narrowness of the channels and complexity of the endoscope, there simply is no reliable way of achieving this. The existing cleaning protocols also are highly dependent on operator technique. Accordingly, this is an urgent public health problem. The work in Phase I has demonstrated that cleaning can be achieved by flowing, through endoscope channels, a new material based on safe nanofibers in an aqueous composition. The new material forms a highly‐entangled network. The Phase I study included testing with soils containing live bacteria, and various types of biofilm. This work included testing many compositions, including variations of both the entangled material and the aqueous composition. The work included investigating the characteristics and manufacturing processes of this new material, formulating the aqueous composition, and determining the operating parameters for the cleaning process, including adaptations for different diameters of channels. Several new methods were developed and used for recovering, sampling, detecting and quantitating bacteria and organic materials. It has been shown that the flowing composition can effectively scrape and remove biofilm, even build‐up biofilm, from the walls of the channels of all endoscope‐relevant sizes, even in channels that are too narrow to brush. It has also been shown that this composition can be fully rinsed from the channels and that it does not clog the endoscope. The results demonstrated that channels that have been cleaned by the new technology are essentially indistinguishable from tubing that has never been exposed to bacteria or biofilm. Such effective cleaning has never before been achieved in endoscope reprocessing. Phase II is intended to move this NanoClean technology from these current laboratory results to a point that is close to commercialization. Phase II will involve developing a robust clinician‐usable system for delivering the cleaning composition to endoscopes. It will involve scaling up procedures for manufacturing the new nanofiber‐based material and the overall cleaning composition because it will be necessary to manufacture these in significantly large batch sizes in a GMP environment. Packaging of the composition for use will also be investigated. Stability and shelf life will be tested with a target value of one year. Phase II will involve simulated testing in actual endoscopes to compare NanoClean against current manufacturer‐prescribed cleaning methods for three types of endoscopes (gastroscopes, colonoscopes and duodenoscopes) from the three major manufacturers (Olympus, Pentax and Fujinon). Phase II will also include assessing the NanoClean technology with patient‐used endoscopes in an endoscopy facility, and comparing the NanoClean to manufacturer‐prescribed cleaning methods. Again, this will be done for 20 consecutive uses with patient‐ used endoscopes. Endoscopes that are used on patients will continue to receive currently approved reprocessing protocols in addition to the NanoClean procedures so that there will not be any need for a special review process. Finally, feedback from staff will be obtained to use in the commercialization of the product.

7.项目概要/摘要： 由污染的内窥镜引起的感染爆发是一个严重的公共卫生问题， 病人死亡率。目前，由于通道的狭窄和内窥镜的复杂性， 并不是实现这一目标的可靠方法。现有的清洁方案也高度依赖于操作者的技术。 因此，这是一个紧迫的公共卫生问题。 第一阶段的工作已经证明，清洁可以通过使一种液体流过内窥镜通道来实现。 一种基于水性组合物中的安全纳米纤维的新材料。这种新材料形成了一个高度纠缠的网络。 第一阶段的研究包括对含有活细菌的土壤和各种类型的生物膜进行测试。这项工作包括 测试许多组合物，包括缠结材料和含水组合物的变化。工作 包括研究这种新材料的特性和制造工艺， 组合物，并确定用于清洁过程的操作参数，包括对不同组合物的适应性。 通道的直径。开发了几种新的回收、取样、检测和分析方法， 定量细菌和有机物。已经表明，流动的组合物可以有效地刮擦并 从所有内窥镜相关尺寸的通道壁上清除生物膜，甚至是积聚的生物膜，即使是在通道中 因为太窄而不能刷。还已经表明，该组合物可以从通道中完全冲洗出来， 它不会堵塞内窥镜。结果表明，已经被新的清洁剂清洁的通道 技术与从未暴露于细菌或生物膜的管道基本上没有区别。等 在内窥镜再处理中以前从未实现过有效的清洁。 第二阶段旨在将NanoClean技术从目前的实验室结果转移到 接近商业化。第二阶段将涉及开发一个强大的临床医生可用的系统，用于提供清洁 组合物到内窥镜。它将涉及扩大制造新的铝基材料的程序 因为必须以相当大的批量生产这些组合物 在GMP环境下。还将研究用于使用的组合物的包装。稳定性和有效期将 以一年的目标值进行测试。第二阶段将涉及在实际内窥镜中进行模拟测试，以进行比较 NanoClean与当前制造商规定的三种类型内窥镜（胃镜， 结肠镜和结肠镜），来自三大制造商（奥林巴斯，宾得和富士）。第二阶段还将 包括在内窥镜检查机构中使用患者使用的内窥镜评估NanoClean技术，并比较 NanoClean符合制造商规定的清洁方法。同样，这将在患者中连续使用20次- 使用内窥镜。用于患者的内窥镜将继续接受目前批准的再处理 除了NanoClean程序之外，还需要其他方案，因此不需要任何特殊的审查过程。 最后，将获得工作人员的反馈，用于产品的商业化。