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SafeBreak Vascular - Force-Activated Separation Device
Harmful forces on peripheral IV lines can lead to dressing disruption, phlebitis, dislodgement, occlusion, infiltration and ultimately to an IV restart. The IV line shown in Figure 1 below has not dislodged, but no one should have a damaging force like this placed on their IV line. SafeBreak Vascular separates, as shown in the video in Figure 2, to remove these harmful forces
That’s why it is called a Force-Activated Separation Device - it separates to protect the patient and the peripheral IV catheter. 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. Table 1 shows the results from the D.I.P.P.E.R. Study (Dislodgment, Infiltration, Phlebitis Prevention Eliminating PIV Restarts). 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%. (2) Click here for a copy of the D.I.P.P.E.R. Study White Paper.
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 as seen in Figure 3. 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, as seen in Figure 4. SafeBreak Vascular is then connected to the patient`s needleless connector, as shown in Figure 5. A short video of how it’s done in the clinical setting is to the right.
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.(3) 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 5.6 minutes on average to replace a separated SafeBreak.(2)
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. 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.
REASSEMBLY NOT POSSIBLEIt is very important that a well intending faly 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 that 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.