ADVANCED BIODEVICES LLC — Department of Health and Human Services SBIR Phase I: NIAID

Description

Project Summary Abstract More than million procedures were performed with GI endoscopic devices in 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 Since more than 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 andlt 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 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 Project Narrative This is a tangible Phase I SBIR designed to develop a novel technology for cleaning endoscope channels of all diameters including the narrow air water channels mm ID that cannot be brushed by current manual cleaning methods The technology is based on flowing nano or microfibrillated cellulose or equivalent suspensions gels MFC in the channels for to minutes at specified velocities followed by water rinsing During flow fibers of MFC flocs make contact with the endoscope channel wall and generate a high hydrodynamic force in the contact zone sufficient to remove organic soils bioburden and biofilm Fiber wall contact occurs at high frequency and it has been estimated that a single floc makes about contacts from the time of entering to that of exiting meter channels As there are billions of MFC flocs in the suspension and there are hundreds of fibers floc the total contact area during flow can be estimated We derived an equation to estimate the number of channel surface treatments that can be achieved during the minute flow Treatment Number TN and have found that this TN may be about Accordingly we are able to treat the channel surface about times during the MFC flow As the generated hydrodynamic force is high about times that of bulk shear the shear stress created is sufficient to provide nearly perfect removal of contaminants including biofilm In our Preliminary Studies we have demonstrated the high level cleaning that can be achieved with the new MFC technology MFC flow in narrow channels can be made with the aid of a simple pumping system hence it is easy to apply and to readily implement the technology in the field Since suspension flow can be described by physical modeling the technology can be developed on the basis of rational science The utility and need for this technology are high in light of new findings that biofilm contamination of channels may have been an important factor in the recent CRE outbreaks that resulted in patient deaths at the UCLA Medical Center in We believe that this new technology will significantly improve endoscope cleaning and decrease risk of infection such as CRE This Phase I study is planned to collect essential data necessary to complete the development of the technology in Phase II We have assembled a highly experienced team to execute the tasks of this Phase I study Members of the team have an excellent track record in developing medical devices that were cleared by FDA as detailed in the Biosketches We have included Dr Paul Stoodley as a consultant to assist in biofilm studies during the project Our facilities are more than sufficient to execute all of the Aims in house except for the SEM investigation which will be outsourced as needed Considering that there are more than million GI endoscopic procedures performed annually in the United States the MFC technology has significant commercial potential because of its superior performance in cleaning endoscope channels compared to existing technologies The Phase I study includes three 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