SafeBreak® Vascular is not FDA cleared and is not available for sale
harmful mechanical forces
IV complications such as phlebitis, infiltration, occlusion and dislodgement have been shown clinically to lead to peripheral IV lines failing before the end of their intended use. The combination of all these complications results in an overall peripheral IV failure rate of 46% on average.(1) IV lines and IV securements ideally should be able to handle the forces delivered by a patient's activities of daily living. Our research tells us the point at which forces start to become harmful to the IV's function is approximately 4.3 pounds of force. We tested four different market leading securements and found that three of the 4 start to fail in the 5 to 8 pound range.
From our testing, the ideal peripheral IV securement is one that protects the IV site, handles activities of daily living without compromising the IV catheter, and will not dislodge until the forces across the line are above five pounds. Three of the securements we tested met this criteria. But we were left with the question, "What can be done about the forces that are above 4.3 pounds but below the amount of force required to compromise the catheter or dislodge it?" That is where our new product, SafeBreak® Vascular fits into the equation.
Eliminating Harmful forces with SafeBreak Vascular
Lineus Medical is developing a unique and patented "break-away" mechanism that fits into all standard IV lines anywhere in the world. SafeBreak Vascular will fit in-between the patient's catheter and the IV pump/bag. SafeBreak Vascular is designed to separate at 3.7 pounds, eliminating harmful forces from being delivered to the patient's catheter.
As the graph at the top of the page indicates, we believe the forces between 4.3 pounds and 8 pounds play a significant role in the development of IV complications: infiltration, phlebitis, dislodgement and occlusion. We are designing SafeBreak Vascular to eliminate stresses in this harmful range from the IV line, before they can cause problems. It doesn't do much good to hold onto an IV line for forces above 10 pounds, because we believe it is highly likely that the IV will fail prematurely anyway.
1 Helm, R.E., et al., Accepted but Unacceptable: Peripheral IV Catheter Failure. Journal of Infusion Nursing. 2015; 38(3):189-203.