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.
Endoscope?caused infections, which are a serious public health hazard, occur because the internal channels of an endoscope are so long and narrow that it is difficult to remove contaminants, such as biofilm, which harbors and protects bacteria and actually helps bacteria survive traditional high?level disinfection, from them. Phase I demonstrated that flow of a safe nanofiber?based material in an aqueous composition through an endoscope channel can scrub biofilm and other contaminants to such an extent that the channel is indistinguishable from a channel that has never been exposed to bacteria or biofilm. This is an unprecedented accomplishment in the endoscope reprocessing industry. Phase II will advance this technology toward commercialization by: 1) developing and validating a delivery pump system, 2) scaling up the nanofiber?based cleaning composition and manufacturing processes, 3) testing the new technology in repeated simulated?use cycles with the most challenging three types of actual endoscopes, and 4) testing patient?used endoscopes through multiple (20) consecutive uses in a healthcare facility.
