SBIR/STTR Award attributes
Project Summary Abstract Outbreaks associated with contaminated duodenoscopes are still occurring at high ratesRecent clinical studies evaluating patient used endoscopes reported that culture endoscope contamination rates range from andltup toExperts now recognize that there is an urgent need for an inexpensive and highly reliable sampling method to check on the adequacy of reprocessing duodenoscopesNovaFlux has developed a novel method utilizing two phase flowTPFto extract material from channels of flexible endoscopes using a mixture of filtered air and sterile reverse osmosis waterPreliminary testing indicates that the efficacy of this method provides a detection level that is similar to extraction methods that use destructive testing of build up biofilm within narrow channelsThe channel extraction process used for the TPF method is based on aclosedsystemthereby reducing the risk of introducing external contamination of the sample collected or the endoscopeThis technology will improve both the integrity of the sample as well as the sensitivity of extraction from channels of patient used endoscopesWe propose to develop a duodenoscope sampling system based on two phase flow extraction technology to obtain a reliable sample for culture and chemical analysisprotein and carbohydrateThe TPF sampling system will be tested with the most challenging traditional biofilmTBFand build up biofilmBBFprepared from a mixture of organisms representative of those that may contaminate duodenoscopesThe TPF duodenoscope sampling system includes two main componentsa TPF mixture generation deviceanda complete sterile tubing kitThe TPF sampling system is designed to extract contaminants from the surfaces of all the channelswithout brushingincluding the suction biopsy channel and the narrow air water channelsas well as the surfaces of the elevator assembly including the lever recessA specialLever Assembly Sampling Fixturehas been designed to fit around the endoscope distal end and harness the high velocity droplets exiting the channels to direct them to impinge over the surface of the lever mechanism of the duodenoscopeThe two phase technology is based on aair to sterile water volumetric ratio which can travel at high velocitiestom sin narrow endoscope channelsIn this flow regimethe liquid transforms into high velocity droplets that impact the surface of the channels with forces that are approximatelytotimes higher than those which can be obtained from a simple liquid flow at the same pressure dropA second main advantage of TPF extraction arises from the very high number of times that the surface of a channel can be treated with droplets in a short timeWe estimated that the surface of an endoscope channel is treated abouttimes inminutesThe volumetric flow rate air used to sample the endoscope channels with TPF is highliters minute at standard temperature and pressureThe Specific Aims are tocompare TPF sampling of build up biofilm versus destructive testingcompare TPF sampling with the new FDA CDC ASM protocol in duodenoscopes with high and low CFU challengeanddevelop the design of the TPF sampling system based on the results of channel and endoscope testingProject Narrative Outbreaks associated with contaminated duodenoscopes are still occurring at high ratesand there is an urgent need for a reliable method to sample the channels and lever recess of duodenoscopesNovaFlux has developed a sampling method based on two phase flow dynamics that can reliably sample build up biofilm from endoscope channelsIn contrast to existing methodsthe two phase flow is a closed loop system that prevents contamination of the endoscope or the collected liquid sample during extraction
