Intravascular Port and Disinfection System (PortProtek)

摘要 医院获得性感染(HAI)，特别是导管相关血流感染(CRBSI)， 是美国和全世界死亡率、发病率和经济成本的主要原因。这些 感染可能具有巨大的破坏性，导致约24,000人死亡，每人的住院费用约为20亿美元 仅在美国一年，以及显著的残留发病率。 许多禽流感是可以预防的。海普罗克的技术已经在预防禽流感方面发挥了积极作用。 商业用途的无菌生理盐水冲洗注射器和消毒帽系统，SwabFlush®广泛销售。 目前市场上的消毒系统都是简单的IV端口盖，含有乙醇作为杀菌剂，无法解决 一些关键问题。乙醇溶液不会穿透由重要病原体形成的生物膜，甚至不会 防止它们的形成。因此，它们在预防或根除细菌和真菌方面无效。 耐甲氧西林金黄色葡萄球菌(MRSA)等病原体对IV口的感染， 铜绿假单胞菌，耐粘菌素和多药耐药鲍曼不动杆菌。 乙醇对艰难梭菌等芽胞形成细菌无效。乙醇浓度 需要有效的，因为单一的消毒剂可能会对婴儿和其他虚弱的患者造成风险，在这种情况下 进入血液循环。最后，高浓度的乙醇会损坏通常用于 导尿管。 海普罗克开发了一种系统PortProtek®并申请了专利，该系统包括一个冲洗或锁定溶液注射器，一个 (或更多)可拆卸的鲁尔锁盖(S)和海普罗克专利高级消毒剂浸泡的海绵 (HLD)解决方案。根据Hyprok的多年测试，HLD既可以安全使用，又可以高效地预防 未经乙醇或葡萄糖酸氯己定消毒剂预防或治疗的病原体。 Hyprok的HLD由三种试剂组成：乙二胺四乙酸(EDTA)、过氧化氢和 乙醇。每种成分单独对感染源都有一定的疗效。然而，它是 Hyprok独一无二的专利组合，迄今在测试中被证明是唯一强大的 浮游(自由漂浮)细菌、酵母和细菌孢子。 拟议的调查旨在进一步证明Hyprok的HLD的安全性和有效性。 虽然HLD中的每一种成分都被FDA认为是安全的，但Hyprok将对 配料混合在一起。安全测试还将包括进一步检查Hyprok的影响 该公司的PortProtek系统中的硬件元件和普通导管管材料上的HLD。 后者是浓缩乙醇降解的一种成分，但不应受到低得多的 Hyprok成分组合中的乙醇浓度水平。

ABSTRACT Hospital acquired infections (HAIs), and in particular catheter related bloodstream infections (CRBSIs), are a major cause of mortality, morbidity and economic costs in the U.S. and throughout the world. These infections can be enormously damaging, resulting in ~24,000 deaths and hospitalization costs of ~$2 billion per year in the U.S. alone, as well as significant residual morbidity. Many HAIs are preventable. Hyprotek's technology is already playing an active role in the prevention of HAIs. Commercial use of a sterile saline flush syringe and disinfecting cap system, SwabFlush® is widely marketed. Disinfecting systems currently on the market are simple IV port caps containing ethanol as biocide, fail to address certain key problems. Ethanol solutions do not penetrate the biofilms formed by significant pathogens, or even prevent their formation. Consequently, they are ineffective in preventing or eradicating bacterial and fungal infections of IV ports from pathogens such as methicillin resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa, and, colistin resistant and multi-drug resistant (MDR) Acinetobacter baumannii. Ethanol is ineffective against spore-forming bacteria such as Clostridium difficile. Concentrations of ethanol needed to be effective as a single disinfectant can be risky for infants and other weakened patients in cases it enters the bloodstream. Finally, ethanol in high concentrations can damage the materials commonly used in catheter tubing. Hyprotek has developed and patented a system, PortProtek®, comprising a flush or lock solution syringe, one (or more) removable Luer lock cap(s) and a sponge saturated with Hyprotek's patented High Level Disinfectant (HLD) solution. Based on years of Hyprotek's testing, HLD is both safe for use and highly effective against pathogens not prevented or treated by ethanol or chlorhexidine gluconate disinfectants. Hyprotek's HLD comprises three reagents; ethylenediaminetetraacetic acid (EDTA), hydrogen peroxide and ethanol. Each component individually has some efficacy against the sources of infections. However, it is Hyprotek's unique and patented combination that is proving to be uniquely powerful in testing to date against planktonic (free-floating) bacteria, yeast and bacterial spores. The proposed investigation is intended to develop further evidence of the safety and efficacy of Hyprotek's HLD. While each of the ingredients in the HLD is deemed safe by the FDA, Hyprotek will conduct further testing of the ingredients in combination. The safety testing will also include the further examination of the effects of Hyprotek's HLD on the hardware elements in the company’s PortProtek system and on common catheter tubing materials. The latter is a component that concentrated ethanol degrades, but should not be affected by the much lower levels of concentration of ethanol in the Hyprotek combination of ingredients.