Contech Medical, Inc. — Department of Health and Human Services STTR Phase I: NICHD

Description

Project Summary Abstract We propose a new approach to the decontamination of central venous catheters and the prevention of central line associated bloodstream infectionsCLABSIan important healthcare associated infectionCLABSIs cost the US healthcare system approximately $billion annuallyPronovostNEJMAdditionallyCLABSIs can be life threateningespecially in the very young and critically illEven when treated appropriatelythey can result in endocarditismeningitisbone and joint infectionsMost centers recommend toscrub the hubof a central venous catheterCVCforseconds using aisopropyl alcohol pad prior to each usee gadministration of an intravenous medicationIn the busy workflow of an intensive care unit or hospital wardcompliance with these recommendations is inconsistentInsteadSnapCap is a patenteddisposable device that houses a compressible alcohol soaked foam between non circumferential female luer threads inside of a plastic housingTo decontaminate a NCa provider engages the SnapCap threads onto the NC and turns ittimeseach time an audible and tangible clickas well as a squeak of the NC against an alcohol soaked sponge contained within itThis decontamination process changes the focus from the clock to the patientis fastsecondsis easy to perform and appliesX the scrubbing force relative to manual scrubbingPreliminary tests on prototypes have demonstrated equivalent reduction in bacterial load as asecond manual scrubThe research team from Boston Children s Hospital has partnered with a small business concern with extensive expertise in medical device manufacturingContech Medicalto produce a near final cap designTogetherwe propose the following aimsAimTo determine the maximum reductioni elog reductionin pathogen load from NCs contaminated with known CLABSI pathogensincluding antimicrobial resistant organismsusing the SnapCap as intendedsnapscompared with the current standard of careconservativelyasecond alcohol scrubAimIn a series of simulated clinical scenariosto compare the compliance with cleaning recommendations between the current standard of care and using SnapCap as intendede gsnapssubaimaand to obtain user experience feedback with SnapCap from bedside nursessubaimbAimTo complete a biological evaluation of the SnapCap device according to ISOstandardsincluding cytotoxicitysensitizationcutaneous sensitivityand hemocompatibility testingIf successfulthis work would demonstrate that this efficient approach to catheter decontamination is equally effective in removing the bacterial load from a CVC and improves compliance with cleaning recommendationsDue to the importance of CVC decontamination in CLABSI preventionthis device may decrease the incidence of CLABSI and reduce healthcare costsSubsequent work would includek approval and manufacturing Project Narrative Central line associated bloodstream infectionsCLABSIare a major healthcare problemcaused in part by bacteria which reside on a catheter and are injected into the bloodstreamWe propose an alternative to the current approach to cleaning a central line prior to use that is easyefficientand cost effectiveIf successfulthis device would decrease the incidence of CLABSIimprove patient outcomesand decrease healthcare costs