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

Advanced Biodevices, Llc, Princeton NJ

Investigators

Abstract

7. Project Summary/Abstract More than 50 million procedures were performed with GI endoscopic devices in 2009. Since endoscopes cannot be sterilized, risk of infection from contaminated endoscopes can be tangible and needs to be urgently addressed. Infection at endoscopy has recently been recognized as a significant risk after two patient deaths from CRE infection transmitted by contaminated duodenoscopes at the UCLA Medical Center in 2015. Since 2013, more than 100 patients have been affected by CRE in Chicago, Seattle, Pittsburgh, and Los Angeles. These and many other outbreaks have been reported to CDC over the years. Endoscope contamination is directly linked to inadequate cleaning by current manual cleaning protocols and by automated endoscope reprocessors (AERs). Despite manual brushing of the wider suction/biopsy channels, narrower channels cannot be brushed, and can only be flushed with enzymatic cleaners. It is now recognized that existing cleaning methods are deficient, and this is further magnified by the difficulty of removing biofilm from endoscope internal channels. To overcome the above limitations, we have developed a highly effective technology based on the flow of special nano- and microfibers through the endoscope internal channels, which results in the unparalleled removal of organic soil, bioburden and, most importantly, biofilm. During flow, floc fibers make contact with a channel surface and generate a high hydrodynamic force which, at a close distance (<100 nm), is capable of removing contaminants, including biofilm. High-level cleaning and removal of multispecies biofilm have been demonstrated in our Preliminary Studies, including in narrow 1.6 mm air/water channels that cannot be currently brushed. The technology can be envisioned as cleaning the surface of channels at nanometer or molecular levels, and can be termed ?nano-brushing.? The proposed technology is based on rigorous and rational formulation of flow of suspensions and can be properly modeled as described in the proposal. This Phase I SBIR includes three Specific Aims to: i) Define MFC formulations and process parameters in simulated experiments; ii) Optimize process parameters to remove biofilm from endoscope internal channels; and iii) Adapt, refine and optimize the cleaning and rinsing processes in actual endoscopes.