A device to reduce catheter related bloodstream infection rates in patients with peripherally inserted central catheters (PICCs)

摘要 PuraCath的目标是开发一种FDA批准的导管座消毒系统， 中心静脉导管（PICC），可显著减少导管相关血流感染（CRBSI）， LED-紫外线（UV）灯。在SBIR项目的第一阶段，我们建议优化易用性， 坚固耐用，使家庭使用。目前CRBSI感染率估计在1.8至5.3之间 CRBSI/1，000个患者日，每个CRBSI的成本在34，508美元至56，000美元之间， 归因死亡率为12%至25%（或每个CRBSI。美国CRBSI的年发病率为 大约25万。这相当于美国医疗保健系统的年度成本 在85亿到140亿美元之间。由于CRBSI的治疗费用由医院承担， 医疗保险，医院有巨大的动力来减少这些感染的发生率。患者接受 化疗时，患者经常需要将PICC植入数月。PICC需要仔细清洁导管 这需要患者或其护理人员执行许多复杂的清洁步骤。 观察性研究表明，专业护理提供者的依从率低至35%， 适当的导管消毒方案，家庭护理患者的感染率通常高于住院患者 rates.我们提出的器械最大限度地减少了导管清洁所需的时间和步骤，不依赖于用户 技术，并具有故障安全感测能力。因此，预计将大幅降低CRBSI 率PuraCath Medical已成功获得FDA批准用于腹膜透析（PD） 使用汞灯产生紫外线的导管消毒装置。虽然腹膜透析导管在概念上 类似地，为使PICC适应这一概念而面临的重大技术挑战要求有一个独特的商业 发展努力。需要开发的PICC器械的技术差异包括：使用LED， 生成紫外线、无针连接器的工程设计以及集成的使用监控。 目的1：设计一种易于使用、故障安全且可靠的基于UV消毒的导管灭菌装置 使用LED技术。 目标2.设计无针连接器 目标3：进行微生物台架试验。 PuraCath计划使用PuraCath的PD获得FDA批准，将该器械作为510 K 2类器械 器械作为等同器械。

ABSTRACT PuraCath's goal is to develop an FDA-approved catheter hub disinfection system for peripherally inserted central catheter (PICC) that dramatically reduces catheter related blood stream infections (CRBSIs) using LED-Ultra Violet (UV) light. In Phase I of this SBIR project, we propose to optimize the ease of use and robustness to enable home use. The current CRBSI infection rate is estimated to be between 1.8 to 5.3 CRBSIs/1,000 patient days and costs the provider between $34,508 to $56,000 per CRBSI, with an attributable mortality rate of 12% to 25% (or each CRBSI. The annual incidence of CRBSIs in the US is approximately 250,000. This equates to an annual cost on the health care system in the United States alone of between $8.5 billion and $14 billion. Because the cost of treatment of CRBSI is borne by hospitals and not Medicare, hospitals have tremendous incentive to minimize incidence of these infections. Patients receiving chemotherapy frequently have PICC implanted for many months. PICCs require careful cleaning of catheter connections, which requires a number of complex cleaning steps performed by the patient or their care-giver. Observational studies have shown the professional care providers have as low as a 35% compliance rate for proper catheter disinfection protocols, and home care patients often have higher infection rates than inpatient rates. Our proposed device minimizes time and steps required for catheter cleaning, does not rely on user technique, and has failsafe sensing capability. Therefore, it is expected to dramatically reduce the CRBSI rate. PuraCath Medical has already successfully obtained FDA approval for a peritoneal dialysis (PD) catheter sterilization device that uses mercury lamps to generate UV. While the PD catheter is conceptually similar, significant technical challenges to adapt this concept for PICC require a distinct commercial development effort. Technical differences in PICC device that require development include; use of LED to generate UV, engineering of a needleless connector, and integrated usage monitoring. Aim 1: To engineer an easy to use, failsafe, and reliable catheter sterilizing device based on UV disinfection using LED technology. Aim 2. Design needle-less connector Aim 3: Conduct microbiologic bench testing. PuraCath intends to obtain FDA for approval for the device as a 510K, Class 2 device, using PuraCath's PD device as a predicate.