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，住院费用约为20亿美元。 年仅在美国，以及显着的剩余发病率。 许多HAI是可以预防的。Hyprotek的技术已经在预防HAI方面发挥了积极作用。 无菌盐水冲洗注射器和消毒帽系统的商业用途，SwabFlush®被广泛销售。 目前市场上的消毒系统是含有乙醇作为杀生物剂的简单IV端口帽，未能解决 一些关键问题。乙醇溶液不能穿透由重要病原体形成的生物膜，甚至不能穿透由细菌形成的生物膜。 防止其形成。因此，它们在预防或根除细菌和真菌方面无效。 来自病原体如耐甲氧西林金黄色葡萄球菌（MRSA）的IV端口感染， 铜绿假单胞菌，和粘菌素耐药和多重耐药（MDR）鲍曼不动杆菌。 乙醇对芽孢形成细菌如艰难梭菌无效。浓度的乙醇 需要有效的单一消毒剂可能对婴儿和其他虚弱的患者有风险， 进入血液最后，高浓度的乙醇会损坏通常用于制造的材料。 导管管路 Hyprotek开发了一种系统PortProtek®并获得专利，该系统包括一个冲洗或封管液注射器，一个 (or更多）可拆卸鲁尔锁帽和浸透Hyprotek专利高水平消毒剂的海绵 (HLD)溶液根据Hyprotek多年的测试，HLD既安全使用，又能高效对抗 乙醇或葡萄糖酸氯己定消毒剂不能预防或处理的病原体。 Hyprotek的HLD包含三种试剂;乙二胺四乙酸（EDTA）、过氧化氢和过氧化氢。 乙醇每种成分单独对感染源都有一定的功效。但据 Hyprotek独特的专利组合，在迄今为止的测试中被证明是独一无二的强大， 浮游（自由漂浮）细菌、酵母菌和细菌孢子。 拟定的研究旨在进一步证明Hyprotek HLD的安全性和有效性。 虽然FDA认为HLD中的每种成分都是安全的，但Hyprotek将对HLD中的每种成分进行进一步的测试。 成分组合。安全性测试还将包括对Hyprotek的影响的进一步检查。 HLD对公司PortProtek系统中的硬件元件和常见导管管路材料的影响。 后者是浓缩乙醇降解的组分，但不应受到低得多的 Hyprotek成分组合中乙醇的浓度水平。

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.