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: 9904081
• 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/9904081
• 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.

摘要