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

用于预防外周插入中心静脉导管 (PICC) 患者发生导管相关血流感染 (CRBSI) 的治疗性紫外线消毒系统

• 批准号: 10092907
• 负责人: Michael Fourkas
• 金额: $ 100万
• 依托单位: PURACATH MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-01 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10092907
• 关键词: Accident and Emergency department; Adoption; Aging; Bacteria; Blood; Blood Vessels; Burn Centers; Catheter-related bloodstream infection; Catheters; Cessation of life; Charge; Clinic; Consumption; Development; Devices; Dialysis procedure; Disinfection; Drops; Electronics; Ethylene Oxide; Event; FDA approved; Failure; Fireflies; Freezing; Goals; Health care facility; Hospitals; Hour; Infection; Intensive Care Units; Interventional radiology; Life; Life Cycle Stages; Light; Liquid substance; Location; Measures; Mechanics; Medical; Medical Device; Microbe; Microbial Biofilms; Microbiology; Morbidity - disease rate; Nurses; Nursing Protocols; Operating Rooms; Output; Patients; Peripheral; Phase; Process; Production; Protocol Compliance; Publications; Risk; Safety; Sales; Sample Size; Sampling; Sepsis; Series; Shipping; Small Business Innovation Research Grant; Source; Sterility; Sterilization; Stream; System; Systems Integration; Testing; Therapeutic; Time; Ultraviolet Rays; Water; Weight; biomaterial compatibility; care costs; commercialization; cost; data reduction; design; efficacy testing; foot; fungus; handheld equipment; manufacturability; mortality; point of care; pre-clinical; pressure; prevent; prototype; public health relevance; sensor technology; therapeutic development; therapeutic evaluation; transmission process; ultraviolet; verification and validation

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.

抽象的 Puracath在II期SBIR中的目标是开发一个由FDA批准的治疗系统，以消毒 无针连接器（NC）用于外围插入的中央导管（PICC），可降低腔内的风险 定植是导管相关血流感染（CRBSI）的来源。更具体地说，它利用紫外线 （紫外线）消除微生物和生物膜（源自真菌和细菌）的光，以99.99％（4 log降低）防止 导管线相关的血液感染（CLABSI）。在该SBIR项目的第二阶段，我们建议完成 设计和开发以及FireflyTM治疗性UV NC消毒系统的验证和验证。这 系统由中性，正或负位移组成，直阀，紫外线交易剂，北卡罗来纳州；和手持式 具有紫外线LED和传感器技术的设备。该理论开发测试将被要求并用于 FDA 510（k）提交过程和临床前99.99％的生物膜减少数据，用于7天NC使用，并且 结合出版物将有助于支持该治疗系统的销售，采用和分发 在全国的医院。在第一阶段，Puracath Medical对具有的原型进行了一系列基准测试 证明了4 log（99.99％）消毒的治疗紫外线消毒系统（FireflyTM）的概念证明 与具有足够样本量的NC的对照相比。在这里，我们完成了商业化所需的步骤 目的：1）设计，2）开发和3）系统集成。 该项目的完成允许完成大部分验证和验证 ISO13485和FDA 510（k）II类提交所需的治疗性萤火虫系统。