SBIR/STTR Award attributes
Project Summary/Abstract We propose a new approach to the decontamination of central venous catheters and the prevention of central line-associated bloodstream infections (CLABSI), an important healthcare-associated infection. CLABSIs cost the US healthcare system approximately $2.3 billion annually (Pronovost, NEJM, 2009). Additionally, CLABSIs can be life threatening, especially in the very young and critically ill. Even when treated appropriately, they can result in endocarditis, meningitis, bone and joint infections. Current guidelines to CLABSI prevention include a key recommendation to decontaminate the central venous catheter (CVC) by scrubbing for 15 seconds using a 70% isopropyl alcohol pad prior to each use (e.g. administration of an intravenous medication). In busy workflows (e.g. the intensive care unit), compliance with these recommendations is inconsistent. SnapCap is a disposable device that houses a compressible alcohol-soaked foam between non-circumferential female luer threads inside of a plastic housing. To decontaminate a NC, a provider engages the SnapCap threads onto the NC and turns it 5 times, each time sensing an audible and tangible click, as well as the squeegee sound of the NC against the cleansing alcohol-soaked sponge. This decontamination process changes the focus from the clock to the patient, is fast (~3 seconds), is easy to perform and consistently applies a greater force to the face of the NC than manual scrubbing. In our Phase I work, we demonstrated that SnapCap use produces an equivalent reduction in bacterial load as a 15 second manual scrub. We also demonstrated that SnapCap improves compliance with cleaning standards from 8% (≥15 second scrub with alcohol swab) to 87% (≥5 SnapCap snaps) in a simulated environment. We propose the following aims to transition to commercialization. Aim 1. To establish manufacturability of SnapCap in the setting of a low volume Randamp;D production line. Aim 2. To complete good laboratory practice (GLP) efficacy testing and seal and peel testing of final-design SnapCap product, and to obtain FDA approval via 510K regulatory pathway. Aim 3. To assess the usability of SnapCap in active clinical environments, quantifying frequency of adoption, its impact on compliance with cleaning measures, and obtaining end-user design feedback. If successful, this work would result in near-term commercialization of SnapCap and would create a complementary, efficient, effective device to improve compliance with cleaning recommendations. Due to the importance of CVC decontamination in CLABSI prevention, this device may decrease the incidence of CLABSI and reduce healthcare costs. Following a successful Phase II effort, we present key collaborations and funding to establish full-scale manufacturing, marketing, distribution and clinical adoption.Project Narrative Central line-associated bloodstream infections (CLABSI) are a major healthcare problem, caused in part by bacteria which reside on a catheter and are injected into the bloodstream. We propose an alternative to the current approach to cleaning a central line prior to use that is easy, efficient, and cost-effective. If successful, this device would decrease the incidence of CLABSI, improve patient outcomes, and decrease healthcare costs.
