Intravascular Port and Disinfection System (PortProtek)

摘要

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.