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批准的用于外周插入的导管集线器消毒系统 使用中心导管(PICC)可显著减少导管相关血流感染(CRBSI) LED-紫外线(UV)灯。在此SBIR项目的第一阶段，我们建议优化易用性和 坚固耐用，可在家中使用。目前CRBSI的感染率估计在1.8至5.3之间 CRBSI/1,000个病人日，每个CRBSI的提供者费用在34,508美元到56,000美元之间， 可归因性死亡率为12%至25%(或每个CRBSI。在美国，CRBSI的年发病率为 大约25万人。这相当于仅在美国一年的医疗保健系统成本 在85亿至140亿美元之间。因为CRBSI的治疗费用由医院承担，而不是 在医疗保险制度下，医院有巨大的动机将这些感染的发生率降至最低。患者接受 化疗经常需要植入PICC数月。PICCs需要仔细清洗导管 连接，这需要由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，专业护理提供者的合规率低达35% 正确的导管消毒方案，家庭护理患者的感染率往往高于住院患者 费率。我们建议的设备最大限度地减少了清洗导管所需的时间和步骤，不依赖于用户 技术，并具有故障保护感测能力。因此，预计它将大幅降低CRBSI 费率。PuraCath Medical已经成功地获得了FDA的腹膜透析(PD)批准 使用汞灯产生紫外线的导管灭菌装置。虽然PD导管在概念上是 将这一概念应用于中国人保面临类似的重大技术挑战，需要一种独特的商业 发展努力。PICC设备中需要开发的技术差异包括：使用LED 生成紫外线、设计无针连接器以及集成使用情况监控。 目的1：设计一种基于紫外线消毒的简便、安全、可靠的导管灭菌装置 使用LED技术。 目标2.设计无针连接器 目的3：进行微生物台架试验。 PuraCath打算获得FDA的批准，使用PuraCath的PD将该设备作为510K的2类设备 设备作为谓词。

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.