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

摘要 PuraCath的第二阶段SBIR的目标是开发一种FDA批准的治疗系统，用于对 用于外周插入中心静脉导管(PICC)的无针连接器(NC)，可降低腔内风险 定植是导管相关血流感染(CRBSI)的来源之一。更具体地说，它利用紫外线 (UV)光以99.99%(减少4个对数)消除微生物和生物膜(来自真菌和细菌)，以防止 导管相关血流感染(CLABSI)。在这项SBIR项目的第二阶段，我们建议完成 FirefyTM治疗性紫外线NC消毒系统的设计和开发以及验证和验证。这 系统由中性、正负位移、直通阀、紫外线透射式NC和手持式 具有紫外线LED和传感器技术的设备。这项治疗发展测试将被要求并用于 FDA 510(K)提交流程和临床前99.99%的生物被膜减少数据，用于7天NC使用，以及 联合出版的出版物将有助于支持这种治疗系统的销售、采用和分销 在全国的医院里。在第一阶段，PuraCath Medical对具有以下特性的原型进行了一系列台式测试 治疗性紫外线消毒系统(FirefyTM)用于4log(99.99%)消毒的概念验证 与具有足够样本大小的NC的对照组进行比较。在这里，我们用三个步骤完成商业化所需的步骤 目标：1)设计，2)开发，3)系统集成。 该项目的完成将使大部分核查和确认工作得以完成 ISO13485和FDA 510(K)II类提交所需的治疗性萤火虫系统。

Abstract 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.