SBIR Phase I: Color Based Use Indicator for Infection Prevention

This Small Business Innovation Research Phase I project is for the development of a color-based use-time indicator for intravenous (IV) needle-free connectors to prevent blood stream infections. By indicating to a nurse or health care provider when to change needle-free connectors, the technology will improve compliance with the Centers for Disease Control guidelines and prevent blood-stream infections (BSIs) that are the result of contamination introduced during the IV delivery of fluids and drugs. Simple and clear color-based use indicators on IV needless connectors will also standardize processes for changing connectors, leading to a reduction in associated mortality, and also lower overall healthcare costs. Additional impacts will include a decrease in the average length of a hospital stay, a reduction in workload for the already taxed health care industry, and an improvement in the quality of life during and after extended medical care. By increasing compliance in changing the connectors, the indicator will also translate to an immediate increase in the utilization of needle-free connectors, products that are manufactured inside the U.S. The total addressable market for this device is estimated at $90 million domestically and $180 million worldwide. The intellectual merit of this project is the development of a novel nanotechnology-based indicator technology that will change color when critical medical components need to be changed. Research will be performed to i) fabricate and optimize the novel color change material, ii) characterize the color shifts, iii) integrate the color change material into the appropriate medical grade substrates and produce master batches of hybrid materials, iv) optimize the color shift process in one or more hybrid materials, v) produce a prototype IV-line connector, and vi) translate the indicator technology into existing IV line components. Anticipated results are the production of a novel hybrid colorimetric indicator material capable of a clear visual indication of the time-of-use of an intravenous line component, the realization of an indicator prototype, and the demonstration that the indicator technology can be integrated within existing IV line components.