Therapeutic UV Disinfection System to Prevent Catheter Related Bloodstream Infections (CRBSIs) in Patients with Peripherally Inserted Central Catheters (PICCs)

摘要

Abstract The goal of PuraCath’s Commercial Readiness Pilot is to prepare for commercialization of a therapeutic system for disinfection of a needleless connector for Peripherally Inserted Central Catheters that reduces the risk of intraluminal colonization as a source of catheter-related bloodstream infections. The system uses ultraviolet light to eliminate microbes and biofilm derived from fungi and bacteria by 99.99%, a 4-log reduction, to prevent Catheter Line Associated Bloodstream Infections. We propose to develop a commercialization-ready Firefly™ UV Disinfection System. This system consists of a neutral displacement, straight valve, UV-transmissive, needleless connector; and a handheld device with UV LEDs and sensor technology. In Phase II, PuraCath Medical developed and validated the Firefly™ UV Disinfection System performance. The FDA 510(k) submission process was initiated, and an initial clearance was received for the Firefly Needleless Connector (K203796, cleared July 30, 2021). The Firefly UV Disinfection Handpiece and Charging Station are currently under review with the FDA with clearance for the initial design pending (K213160, application filed November 12, 2021). In this Commercial Readiness Pilot, we will complete the steps needed to support clinical use and commercialization, with four aims: 1) Establish readiness for commercial manufacturing, 2) Prepare for clinical trials, 3) Develop a Quality System, integrate manufacturing partners, and design and prepare training materials and; 4) Develop software to monitor and ensure proper use and compliance. These results will enable us to conduct clinical studies that will support our efficacy claims and provide evidence of the benefit of the system. In parallel, we are seeking Phase IIb support to conduct the clinical trials. The outcome of this entire SBIR program will be a body of clinical evidence to drive adoption of the Firefly™ UV Disinfection System by hospitals. The proposed project will improve scientific knowledge in the UV disinfection space for colonized surfaces and clinical practices for infection control in hospitals and outpatient clinics. Additionally, with the help of this NIH CRP grant we will generate data supporting other UV LED applications for disinfection in hospital settings.