Hospital-acquired infections are currently one of the biggest concerns within hospitals. There are two million hospital acquired infections annually in US, 90,000 result in death. A typical infection can cost as much as $47,000 per patient to treat. Tubing, respirators and humidifiers are among the devices that can be entry points for and sources of respiratory-associated infections. Airborne bacteria and viruses can cause infection and disease through inhalation and are particularly problematic for patients with weakened immune systems. Sterilization by autoclaving or use of caustic chemicals such as Cidex can be harmful to patients and/or components. Therefore there is a great need for the development of medical components that contain non-toxic antimicrobial agents, which prevent the growth or the colonization of infection causing bacteria on the surface. Upon sharing preliminary data with Respironics, a leading medical device manufacturer and supplier of respiratory ventilators, masks and devices, they became extremely interested in seeing if NanoDynamics's nanosilver-based technology could be utilized in their devices. The overall goal of the project is to address the need for developing new antimicrobial blends for manufacturing respiratory and related medical devices. The main objective is to demonstrate that nanosilver-based technology can be incorporated into medical plastic (both hard and soft type plastics) components such as respirators and masks to provide bacteria-free surfaces that are biocompatible, that does not adversely affect the plastic's mechanical or physical properties, and is cost effective. The use of nanosilver materials translates to high effective surface areas of silver and very low concentrations to obtain desired efficacies, thus minimizing costs. Research on Phase I will be structured in four specific aims.
The first aim i s the preparation and optimization of the nanosilver-based materials.
The second aim i s based on dispersability studies of the nanomaterials into plastics. Two types of plastic will be tested, a thermoplastic (polycarbonate) and a liquid injection molding silicone elastomers. After the processing parameters are optimized to obtain the best dispersability, the third aim of the project will next be the focus, which is the determination of the loading levels of the nanosilver-based materials used in the plastics to obtain the best antibacterial properties. The last aim and a very critical one will be to test the biocompatibility of the optimized materials. Phase II studies will naturally follow that will entail molding, testing and evaluating actual components, FDA required testing, and expanding the use of nanosilver for other critical components within the respiratory device. Also, incorporation of the nanosilver-based materials into two other thermoplastics (ethyl vinyl acetate and the opaque DuPont Hytrel) used to manufacture respiratory devices will be investigated. PUBLIC HEALTH REVELANCE: According to the U.S. Centers for Disease Control and Prevention, about 90,000 Americans die each year from hospital-acquired infections. It is essential to understand that any medical device used in long-term care facilities, nursing homes or private homes also has the potential to cause infections if not used, stored, cleaned and disinfect properly. Therefore there is a great need for the development of medical components that contain non- toxic antimicrobial agents, which prevent the growth or the colonization of infection causing bacteria on the surface. ? ? ?
