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

摘要 PuraCath II期SBIR的目标是开发一种FDA批准的治疗系统， 用于外周插入中心静脉导管（PICC）的无针连接器（NC），可降低管腔内 定植是导管相关性血流感染（CRBSI）的来源。更具体地说，它利用紫外线 (UV)光消除微生物和生物膜（来自真菌和细菌）99.99%（4个对数减少），以防止 导管管路相关血流感染（CLABSI）。在SBIR项目的第二阶段，我们建议完成 设计和开发，并验证和确认FiidoyTM治疗紫外线NC消毒系统。这 系统由中性、正或负位移、直阀、UV透射、NC和手持式 紫外线LED和传感器技术的设备。需要进行该治疗开发试验，并将其用于 FDA 510（k）提交流程和7天NC使用的临床前99.99%生物膜减少数据，以及 联合出版物将有助于支持该治疗系统的销售、采用和分销 在全国的医院里。在第一阶段，PuraCath Medical对原型进行了一系列台架测试， 展示了治疗性紫外线消毒系统（FiidoyTM）的概念验证，可实现4 log（99.99%）消毒 与具有足够NC样本量的对照相比。在这里，我们完成了商业化所需的三个步骤， 目标：1）设计，2）开发和3）系统集成。 完成本项目后，可完成 ISO13485和FDA 510（k）II类申报所需的治疗性Firefly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.