SnapCap: a device to decontaminate central venous catheters (CVC) with 5 snaps

SnapCap：一种带有 5 个卡扣的中心静脉导管 (CVC) 净化装置

• 批准号: 10383994
• 负责人: John Nagi Kheir
• 金额: $ 103.62万
• 依托单位: CONTECH MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-21 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10383994
• 关键词: Adoption; Alcohols; Back; Bacteria; Blood Circulation; Boston; Catheters; Clinical; Collaborations; Critical Illness; Decontamination; Deterioration; Development; Devices; Discipline of Nursing; Elements; Emergency Situation; Endocarditis; Engineering; Environment; Event; Excision; Face; Feedback; Female; Frequencies; Funding; Future; Generations; Guidelines; Guilt; Health Care Costs; Health Expenditures; Healthcare; Healthcare Systems; Hospital Costs; Housing; Incidence; Infection prevention; Institution; Intensive Care Units; Isopropanol; Lead; Left; Legal patent; Life; Manuals; Marketing; Measures; Mechanics; Medical; Meningitis; Morbidity - disease rate; Nurses; Osteomyelitis; Patient-Focused Outcomes; Patients; Pediatric Hospitals; Pediatrics; Pharmaceutical Preparations; Phase; Porifera; Prevention; Process; Production; Progress Reports; Provider; Recommendation; Regulatory Pathway; Rotation; Sales; Sepsis; Series; Small Business Technology Transfer Research; Specific qualifier value; Swab; System; Techniques; Technology; Testing; Time; Training; Venous; Work; alpha-SNAP; arm; base; commercialization; cost; cost effective; design; efficacy testing; experimental study; good laboratory practice; healthcare-associated infections; improved; innovation; intravenous administration; joint infection; manufacturability; medical supply; medication administration; methicillin resistant Staphylococcus aureus; microbial; mortality; novel strategies; pathogen; prevent; research and development; response; seal; sound; usability

Project Summary/Abstract We propose a new approach to the decontamination of central venous catheters and the prevention of central line-associated bloodstream infections (CLABSI), an important healthcare-associated infection. CLABSIs cost the US healthcare system approximately $2.3 billion annually (Pronovost, NEJM, 2009). Additionally, CLABSIs can be life threatening, especially in the very young and critically ill. Even when treated appropriately, they can result in endocarditis, meningitis, bone and joint infections. Current guidelines to CLABSI prevention include a key recommendation to decontaminate the central venous catheter (CVC) by scrubbing for 15 seconds using a 70% isopropyl alcohol pad prior to each use (e.g. administration of an intravenous medication). In busy workflows (e.g. the intensive care unit), compliance with these recommendations is inconsistent. SnapCap is a disposable device that houses a compressible alcohol-soaked foam between non-circumferential female luer threads inside of a plastic housing. To decontaminate a NC, a provider engages the SnapCap threads onto the NC and turns it 5 times, each time sensing an audible and tangible click, as well as the squeegee sound of the NC against the cleansing alcohol-soaked sponge. This decontamination process changes the focus from the clock to the patient, is fast (~3 seconds), is easy to perform and consistently applies a greater force to the face of the NC than manual scrubbing. In our Phase I work, we demonstrated that SnapCap use produces an equivalent reduction in bacterial load as a 15 second manual scrub. We also demonstrated that SnapCap improves compliance with cleaning standards from 8% (≥15 second scrub with alcohol swab) to 87% (≥5 SnapCap snaps) in a simulated environment. We propose the following aims to transition to commercialization. Aim 1. To establish manufacturability of SnapCap in the setting of a low volume R&D production line. Aim 2. To complete good laboratory practice (GLP) efficacy testing and seal and peel testing of final-design SnapCap product, and to obtain FDA approval via 510K regulatory pathway. Aim 3. To assess the usability of SnapCap in active clinical environments, quantifying frequency of adoption, its impact on compliance with cleaning measures, and obtaining end-user design feedback. If successful, this work would result in near-term commercialization of SnapCap and would create a complementary, efficient, effective device to improve compliance with cleaning recommendations. Due to the importance of CVC decontamination in CLABSI prevention, this device may decrease the incidence of CLABSI and reduce healthcare costs. Following a successful Phase II effort, we present key collaborations and funding to establish full-scale manufacturing, marketing, distribution and clinical adoption.

项目摘要/摘要 我们提出了一种新的方法来净化中央静脉导管和预防中央 线相关的血液感染（CLABSI），这是一种重要的医疗保健相关感染。 clabsis 每年约23亿美元的美国医疗保健系统（Pronovost，NEJM，2009年）。此外， clabsis可能会威胁生命，尤其是在年轻且重病的情况下。即使得到适当处理， 它们可能导致心内膜炎，脑膜炎，骨骼和关节感染。当前预防CLABSI的准则 包括一个关键建议，通过擦洗15 每次使用之前，使用70％的异丙醇垫（例如静脉注射药物给药）秒。 在繁忙的工作流程（例如重症监护室）中，遵守这些建议是不一致的。 SNAPCAP是一种一次性设备，可容纳非圆形泡沫 塑料外壳内部的雌性luer线。为了净化NC，提供商可以参与快照 将线程伸到NC上，并将其转到5次 北卡罗来纳州的Squeegee声音与清洁酒精浸泡的赞助商。这种净化过程 从时钟到患者的焦点变化很快（〜3秒），易于执行，并且始终应用 与手动擦洗相比，北卡罗来纳州的脸更大的力量。在我们的阶段工作中，我们证明了Snapcap 使用可作为15秒的手动磨砂膏产生等效的细菌负荷减少。我们也证明了 该快照可以提高对清洁标准的符合性，从8％（≥15秒用酒精棉签磨砂）到 在模拟环境中87％（≥5个快照快照）。我们建议以下目的过渡到 商业化。 目标1。在低音量R＆D生产线的设置中建立SnapCAP的生产性。 目标2。完成良好的实验室实践（GLP）有效测试以及最终设计的密封和剥离测试 快照产品，并通过510K调节途径获得FDA批准。 目标3。评估在活动临床环境中快照的可用性，量化采用频率， 它对遵守清洁措施的影响，并获得最终用户设计反馈。 如果成功的话，这项工作将导致Snapcap的近期商业化，并将创建一个 完全，高效，有效的设备可以提高对清洁建议的遵守。由于 CVC去污染在CLABSI预防中的重要性，该设备可能会降低Clabsi的事件 并降低医疗保健成本。在成功的第二阶段工作之后，我们提出了关键的合作和资金 建立全尺度制造，营销，分销和临床采用。