Project: Safe disinfection of intravenous catheters by portable UVC light technology

Background_x000D_Intravenous (IV) catheters are widely used for e.g. chemotherapy), parenteral nutrition and for hemodialysis. In 2011 the global market for the intravenous (IV) catheter segment was valued at 2.0 billion euro and approximately 1 billion catheters were used. Thus, IV catheters are essential tools in modern medicine. Unfortunately, for both short and long-term catheter use, microbial contamination is practically unavoidable. If bacteria from the IV catheter reach the blood stream the patient is at high risk of acquiring an infection; a so-called Central Line-Associated Blood Stream Infection (CLABSI). CLABSIs are costly for the health care system as they require prolonged hospital stays and catheter removal and replacement (€28,000-40,000 per incidence). Mortality is increased in catheterized patients and it is estimated that in the OECD area more than 110.000 die of CLABSIs annually amounting to total costs worldwide of €20 billion (WHO data). _x000D__x000D_Clinical studies have shown that the predominant cause of CLABSIs in long-term catheterized patients is the intraluminal route of infection: Initially an inadvertent microbial contamination of the catheter causes adherence of microorganism and biofilm build-up in the intraluminal space of the catheter hub and tube. Free-flowing (planktonic) pathogens from the biofilm are subsequently shed to the blood which leads to bacteremia and sepsis. In essence, CLABSIs can be avoided if the intraluminal part of the catheter hub can be regularly disinfected after administration while the catheter still resides in the patient. Various chemical and antibiotics-based approaches have been developed, but unfortunately they are either not effective on all microorganisms, associated with side effects or believed to result in microbial resistance to antibiotics. Thus, novel preventative strategies are urgently needed._x000D__x000D_Goal _x000D_The goal of the current project is to improve the safety of critically ill patients by developing a highly effective, chemical-free, UVC-based device for disinfection of IV catheters. This disinfection is performed after each therapeutic session while the catheter still resides in the patient._x000D__x000D_Technological approach and product_x000D_The Danish SME U-vivo has developed a lab prototype device to demonstrate that UV light provides highly effective and safe preventative disinfection of the intraluminal catheter hub and tube. The present consortium will refine the lab prototype into a portable UVC device for prevention of CLABSIs in the hospital environment (see computer-animated illustration in the annex). The device will exploit highly germicidal UVC light (wavelengths from 200-280nm) and it will consist of both the UVC device and sterile connectors that will be discarded after each session. The project encompasses in vitro testing, industrial engineering and design, a small-scale clinical trial and filing for CE-approval._x000D_The device will be simple to implement in clinical routine and easy-to-operate. Importantly, the device can both be used as an add-on infection prevention strategy in conjunction with all other existing methods and it can be used as a stand-alone disinfection method allowing a reduction in operational costs for catheter disinfection. Overall, the UVC device is expected to reduce the incidence of CLABSIs which will translate into reduction of health care expenses. _x000D__x000D_Market_x000D_The device is intended for disinfection of IV catheters in the health care sector and as such can reach the global intravenous catheter segment. Based on Nordic MedCOMs strong market share in the hemodialysis segment in the Nordic and Baltic countries the consortium is focusing to establish the first sales here. Based on CE approval and strategic Ping we expect a market share of 10% in the European hemodialysis sector within 5 years of completion of the project._x000D__x000D_Consortium_x000D_This project brings together two highly innovative R&D-performing SMEs with highly complementary skills, a leading clinical department and a research and technology institute with strong competences in clinical microbiology and development of medical devices:_x000D__x000D_• U-vivo ApS (U-vivo) is the inventor of the disinfection device and has highly specialized expertise within exploitation of LED for intraluminal disinfection. _x000D_• Nordic Medcom AB (NM) has strong market access as one of the leading distributors of catheters and disposables for hemodialysis in the Nordic countries. Moreover, NM is adept at developing innovative catheter products for hemodialysis. _x000D_• The Danish Technological Institute (DTI) is a leading technical institute with special expertise on medical devices and quantitative analyses of biofilm-forming pathogenic microorganisms on medical devices._x000D_• The dialysis unit at Karolinska Institutet (KI) has a long tradition for clinical trials and the consortium will benefit from both a professor in nephrology as well as a research leader in clinical microbiology and microbial resistance._x000D_

Acronym SafeCATH (Reference Number: 7970)
Duration 04/03/2013 - 28/02/2015
Project Topic Patients subject to catheterization are at elevated risk of acquiring life-threatening infections and current disinfection methods are inadequate. The current project assures the development of a highly efficient, portable UV light-based device for disinfection of intravenous catheters.
Network Eurostars
Call Eurostars Cut-Off 9

Project partner

Number Name Role Country
4 Karolinska Institutet Partner Sweden
4 Nordic MedCOM AB Sverige Partner Sweden
4 Danish Technological Institute Partner Denmark
4 U-Vivo Aps Coordinator Denmark