Harmful forces on peripheral IV lines can lead to dressing disruption, phlebitis, dislodgement, occlusion, infiltration and ultimately to an IV restart.  

SafeBreak has been cleared by the FDA to aid in reduction of peripheral IV mechanical complications requiring IV replacement.

In a 2021  randomized clinical trial conducted at Hartford Hospital in Hartford, CT with 287 patients, SafeBreak was shown to reduce overall IV complications requiring an IV restart by 44% and caused no additional delays in therapy for patients.   Although the control group had a very low overall complication rate of 27%, the SafeBreak group experienced 44% less complications and had an overall complication rate of only 15%. 

SafeBreak Vascular is inserted between the IV tubing from the pump and the catheter in the patient's arm. The medical professional first attaches SafeBreak to the IV tubing. The device is then primed (completely filled with fluid), ensuring no air is left inside the device. Next, the luer connection on the needleless connector from the patient's IV access site is scrubbed.   SafeBreak Vascular is then connected to the patient's needleless connector. 

After SafeBreak Vascular is installed in the line, the IV infusion can begin.  For full instructions on how to use SafeBreak Vascular, please consult the product's Instructions for Use.

Restarting a peripheral IV normally requires finding a new vein and at least one additional needlestick. The average delay in therapy in one clinical study shows that the patient normally goes without IV medical treatment for 55 minutes.  In the D.I.P.P.E.R. study, the average patient requiring an IV restart experienced 82 minutes delay in therapy. SafeBreak Vascular can eliminate the tedious and stressful process of starting a new IV line.  If SafeBreak is installed in an IV line and separates, the separated SafeBreak components can be thrown away and a new SafeBreak installed in a matter of minutes. The patient’s IV infusion can be restarted with no mess to clean up, no drugs to reorder, and most importantly, without an additional needlestick. In the D.I.P.P.E.R. study, it took only 5.3 minutes on average to replace a separated SafeBreak.

Once SafeBreak Vascular separates, a valve on each end of the device closes. The valve connected to the line that goes to the IV pump closes to stop the flow of medicine and causes the IV pump to alarm. The valve on the line connected to the patient closes and prevents the patient from bleeding. These valves are recessed, inhibiting the likelihood of contamination or infection. Currently when an IV dislodges, the IV pump continues to pump medication on the floor or in the patient's bed until someone turns the pump off. 

It is very important that a well intending family member or medical personnel are unable to put SafeBreak Vascular back together once it has separated, because the disconnected IV line might fall into the patient's hospital bed or onto the floor and become contaminated. If someone were to put the device back together, the infusion would run through a potentially contaminated line, which could lead to an infection. SafeBreak Vascular has a proprietary anti-reconnect feature and prevents anyone from accidentally putting the device back together.  If SafeBreak is separated, the medical team has up to 2 hours to change out the device.  After 2 hours, the entire peripheral IV must be restarted.

SafeBreak Vascular was specifically designed with recessed valves to reduce the likelihood of potential infection caused by bacteria entering the IV line. It is important that an IV line remains protected when SafeBreak separates. It simply does not make sense to protect the IV line from complications with a breakaway device and then leave the line susceptible to an infection.   

Competitive devices have exposed valves that can easily come in contact with bacteria when the IV line separates. SafeBreak’s valves are buried inside the device so that bacterial contact is limited and so that a well meaning patient or nurse does not accidentally press on or manipulate the valves. Pressing on the valves in competitive devices can cause them to open and to leak fluids, blood or medication. SafeBreak’s valves are buried so that they can not be manipulated.  

Lineus Medical has conducted rigorous microbial ingress testing and has completed multiple veterinary and human clinical trials that show SafeBreak’s recessed valves keep the line clean for up to two hours when the IV line is separated. 

MICROBIAL INGRESS WHITE PAPER

1  Helm, R.E., et al., Accepted but Unacceptable: Peripheral IV Catheter Failure. Journal of Infusion Nursing. 2015; 38(3):189-203.

2  Data on file.   

3  Jenks, C., et al., The Ripple Effect - Analysis of the Cascade of Events Associated with Peripheral IV Loss and the Impact on Nurse Workflow and Resource Utilization.  Association for Vascular Access Annual Scientific Meeting Poster Exhibit. 2018.

MKG-0012 Rev 03 

SafeBreak has been cleared by the FDA to aid in reduction of peripheral IV mechanical complications requiring IV replacement.

In a 2021  randomized clinical trial conducted at Hartford Hospital in Hartford, CT with 287 patients, SafeBreak was shown to reduce overall IV complications requiring an IV restart by 44% and caused no additional delays in therapy for patients.   Although the control group had a very low overall complication rate of 27%, the SafeBreak group experienced 44% less complications and had an overall complication rate of only 15%.