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

摘要 PuraCath的商业准备试验的目标是为商业化做准备 用于消毒用于外周插入的无针连接器的治疗系统 可降低腔内定植风险的中心导管 导管相关的血流感染。该系统使用紫外光消除 来自真菌和细菌的微生物和生物膜减少99.99%，减少4个对数 预防导管相关的血流感染。我们建议开发一种 商业化就绪的萤火虫™紫外线消毒系统。该系统由一个 中档排量、直通阀、紫外线透射式无针连接器； 具有紫外线LED和传感器技术的手持设备。 在第二阶段，PuraCath Medical开发并验证了Firefly™紫外线消毒 系统性能。FDA 510(K)提交程序已经启动，初步的 收到了Firefly无针连接器的许可(K203796，7月30日批准， 2021年)。萤火虫紫外线消毒手机和充电站目前正在 与FDA一起审查初始设计的审批待定(K213160，申请 2021年11月12日提交)。 在此商业就绪性试点中，我们将完成支持临床 使用和商业化，有四个目标：1)为商业做好准备 制造，2)准备临床试验，3)开发质量体系，集成 制造合作伙伴，设计和准备培训材料；4)开发 监控并确保正确使用和合规的软件。 这些结果将使我们能够进行临床研究，支持我们的疗效声明 并提供该系统的益处的证据。与此同时，我们正在寻求第二阶段 支持开展临床试验。整个SBIR计划的结果将是 推动采用Firefly™紫外线消毒系统的临床证据 医院。拟议中的项目将提高紫外线消毒的科学知识。 医院和医院内用于控制感染的殖民表面和临床实践的空间 门诊部。此外，在NIH CRP拨款的帮助下，我们将生成数据 支持其他紫外线LED应用于医院环境的消毒。

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.