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

7.项目摘要/摘要： 由受污染的内窥镜引起的感染暴发是一个严重的公共卫生问题，甚至导致 在病人死亡方面。目前，由于内窥镜的通道狭窄和复杂，简单地 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员的技术。 因此，这是一个紧迫的公共卫生问题。 第一阶段的工作表明，清洁可以通过流过内窥镜通道来实现 基于安全纳米纤维的水性组合物的新材料。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 测试许多成分，包括缠绕材料和水组成的变化。这项工作 包括研究这种新材料的特性和制造工艺，配制水 组成，并确定清洁过程的操作参数，包括适应不同的 渠道的直径。开发了几种新的方法并用于恢复、采样、检测和 对细菌和有机物质进行定量。结果表明，该流动组合物能有效地刮擦和 从所有内窥镜相关尺寸的通道的壁上去除生物膜，甚至是堆积的生物膜，即使在通道中也是如此 太窄了，不能刷。还表明，该组合物可以从通道中完全冲洗并 它不会堵塞内窥镜。结果表明，已经被新的 技术与从未接触过细菌或生物膜的管道本质上没有什么区别。是这样的 在内窥镜再处理中，从未实现过有效的清洗。 第二阶段的目的是将这种纳米清洁技术从目前的实验室结果转移到 接近商业化。第二阶段将包括开发一个强大的临床医生可用的系统来提供清洁 内窥镜的成分。它将涉及扩大制造这种新型纳米纤维材料的程序 以及整体清洁组合物，因为需要以相当大的批量制造这些 在GMP环境中。还将调查该组合物的包装以供使用。稳定性和保质期将是 测试的目标值为一年。第二阶段将包括在实际内窥镜中进行模拟测试，以进行比较 针对当前制造商规定的三种内窥镜(胃镜、 三大制造商(奥林巴斯、宾得和富士)生产的结肠镜和十二指肠镜。第二阶段亦会 包括在内窥镜设施中使用患者使用的内窥镜评估NanoClean技术，并比较 NanoClean采用制造商规定的清洁方法。同样，这将对患者连续使用20次- 用过的内窥镜。用于患者的内窥镜将继续接受目前批准的再处理 除了纳米清洁程序之外的其他协议，这样就不需要任何特殊的审查程序。 最后，将从工作人员那里获得反馈，用于产品的商业化。

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.