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.

项目总结/摘要 我们提出了一种新的方法来净化中心静脉导管和预防中心静脉导管污染。 线路相关血流感染（CLABSI），一种重要的医疗保健相关感染。CLABSI 每年花费美国医疗保健系统约23亿美元（Pronovost，NEJM，2009）。此外，本发明还 CLABSI可能危及生命，特别是在非常年轻和危重的病人中。即使得到适当的治疗， 可引致心内膜炎，脑膜炎，骨及关节感染。当前预防CLABSI的指南 包括通过擦洗15分钟来净化中心静脉导管（CVC）的关键建议 每次使用前使用70%异丙醇垫（例如静脉内给药）。 在忙碌的工作流程中（例如重症监护室），对这些建议的遵守情况不一致。 SnapCap是一种一次性器械，在非圆周之间放置可压缩的酒精浸泡泡沫 塑料外壳内的母鲁尔螺纹。为了净化NC，供应商使用SnapCap 螺纹连接到NC上，并将其旋转5次，每次都感觉到一个可听到的和有形的点击，以及 用浸有酒精的清洁海绵擦拭NC的声音。这个净化过程 将焦点从时钟转移到患者，速度快（约3秒），易于执行，并且始终适用 比手动擦洗更大的力到NC的表面。在我们的第一阶段工作中，我们证明了SnapCap 使用产生与15秒手动擦洗相同的细菌负荷减少。我们还证明 SnapCap将清洁标准的合规性从8%（用酒精拭子擦洗≥15秒）提高到 在模拟环境中为87%（≥5个SnapCap快照）。我们提出以下目标，以过渡到 商业化 目标1。在小批量研发生产线的设置中建立SnapCap的可制造性。 目标2.完成最终设计的药物非临床研究质量管理规范（GLP）有效性试验以及密封和剥离试验 SnapCap产品，并通过510 K监管途径获得FDA批准。 目标3。评估SnapCap在活跃临床环境中的可用性，量化采用频率， 其对遵守清洁措施的影响，并获得最终用户的设计反馈。 如果成功，这项工作将导致SnapCap的短期商业化，并将创造一个 补充，高效，有效的设备，以提高遵守清洁建议。由于 CVC去污在预防CLABSI中的重要性，该装置可降低CLABSI的发生率 降低医疗成本。在第二阶段工作取得成功后，我们提出了关键的合作和资金， 建立全面的生产、营销、分销和临床应用。