PuraCath?s goal with the Phase II SBIR is to develop an FDA-approved therapeutic system for disinfection of a needleless connector (NC) for Peripherally Inserted Central Catheters (PICC) that reduces the risk of intraluminal colonization as a source of catheter-related blood stream infections (CRBSI). More specifically, it utilizes Ultraviolet (UV) light to eliminate microbes and biofilm (derived from fungi and bacteria) by 99.99% (4 log reduction) to prevent Catheter Line Associated Bloodstream Infections (CLABSI). In Phase II of this SBIR project, we propose to complete design and development, and verification and validation for the FireflyTM Therapeutic UV NC Disinfection System. This system consists of a neutral, positive, or negative displacement, straight valve, UV-transmissive, NC; and a handheld device with UV LEDs and sensor technology. This therapeutic development testing will be required and used for the FDA 510(k) submission process and pre-clinical 99.99 percent biofilm reduction data for a 7 day NC use, and publications in conjunction will help support sales, adoption and distribution of this therapeutic system in hospitals nationwide. In Phase I, PuraCath Medical performed a series of bench-top tests on prototypes that have demonstrated proof-of-concept of the Therapeutic UV Disinfection System (FireflyTM) for 4 log (99.99%) disinfection versus controls with adequate sample sizes of NCs. Here, we complete steps needed for commercialization with three aims: 1) Design, 2) Development and 3) System integration. Completion of this project allows for the completion of the majority of the verification and validation of the Therapeutic Firefly System necessary for ISO13485 and FDA 510(k) Class II submission.
For hospitals, including Intensive Care Units, operating rooms, emergency rooms, dialysis clinics, interventional radiology, vascular suites, and burn centers, the current Peripherally Inserted Central Catheter (PICC) connection disinfection process is a time-consuming process that relies upon strict nurse protocol and compliance for efficacy. Improper, or incomplete disinfection is a significant cause of catheter related blood stream infections (CRBSIs), which can result in sepsis and even death, as well as a costly event for the hospital or care facility since CMS will no longer reimburse hospitals for their treatment. This project proposes a therapeutic medical device to reduce CBSRIs in patients with PICCs, this reducing mortality, morbidity, and cost of care.
