SafeBreak® Vascular is not FDA cleared and is not available for sale

ELIMINATING HARMFUL FORCES WITH SAFEBREAK VASCULAR

 The first of it's kind, breakaway IV technology

The first of it's kind, breakaway IV technology

SafeBreak Vascular is an innovative safety device that is installed in the patient’s IV line between the the IV tubing from the pump and the needleless connector. It allows medication to flow freely through the device, but whenever IV line tension threatens the catheter, SafeBreak intentionally separates to relieve the tension and protect the catheter.

SafeBreak Vascular installed in a peripheral IV line with a moderate force load placed on the line, as can be seen by the tenting of the skin.

SafeBreak Vascular is designed to separate when a harmful force is placed on the IV line, eliminating the stress from being transferred to the IV catheter.

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IV Line Tension

IV catheter securements and adhesives are typically able to handle the forces delivered by a patient's activities of daily living, but we wanted to test their limits. After pull testing four market leading securements, we observed that IV line tension above 4.3 pounds of force begins to damage and threaten the catheter. This research allowed us to engineer the separation force of SafeBreak Vascular with clinical precision.

SAFEBREAK VASCULAR SEPARATES TO SAVE IV LINES

FORCE REQUIRED TO SEPARATE

SafeBreak Vascular is designed to separate when a force over 4 pounds is applied across the IV line. As the graph above indicates, we believe the forces between 4 pounds and 8 pounds play a significant role in the development of IV complications:  infiltration, phlebitis, dislodgement and occlusion. We designed SafeBreak Vascular to eliminate stresses in this harmful range from the IV line, before they can cause problems.

SafeBreak Vascular in an infusion line

SafeBreak Vascular Separated

POTENTIAL BENEFITS OF USING SAFEBREAK VASCULAR

REASSEMBLY NOT POSSIBLE

SafeBreak Vascular has a proprietary anti-reconnect feature that prevents anyone from accidentally putting the device back together. Once SafeBreak Vascular separates to protect an IV line, it is very important that a well intending family member or medical personnel is unable to put the device back together, as the disconnected IV line might fall into the patient's hospital bed or onto the floor. If someone were to put the device back together, the medication would run through a potentially contaminated line, which could lead to an infection.

VALVES CAN'T BE REOPENED

Upon separation, valves on each side of the device close to stop the flow of medication, and prevent any blood loss from the patient. As can be seen in Figure 1, the valves designed into SafeBreak Vascular are embedded deep within the device. It is very important that the valves can't be reopened by a patient or family member by pressing on them either accidentally or on purpose. If the valves can be manually opened, then blood or medicine would come out of the device, neither of which is a good situation. It is not possible for someone to manually manipulate the valves in SafeBreak. 

 Figure 1. SafeBreak Vascular separates and valves are embedded in the device so that they can't be accidently opened.

Figure 1. SafeBreak Vascular separates and valves are embedded in the device so that they can't be accidently opened.

WORKS WITH ALL IV LINES

SafeBreak Vascular is compatible with both gravity fed tubing and infusion pump tubing. SafeBreak Vascular will connect with any ISO standard luer connector on any peripheral IV, PICC, central line or mid-line. Maintaining IV lines is a global problem, and SafeBreak Vascular is designed to work on any IV line from Australia to Zambia.

Breakaway IV

SMOOTH EDGES

During a patient's activities of daily living, they might roll or turn in bed, walk the halls, shower, or do physical therapy with their IV line. SafeBreak Vascular is designed, as can be seen in Figure 2, with rounded edges to avoid it catching on bed rails or any other object. The rounded edges and smooth surfaces minimize any discomfort that might happen when someone sleeps on their IV line. 

 Figure 2. SafeBreak IV installed in a peripheral IV line.

Figure 2. SafeBreak IV installed in a peripheral IV line.

How SafeBreak Works

VALVES STOP THE FLOW OF FLUIDS

Once SafeBreak Vascular has separated a valve on each end of the device closes. The valve connected to the line that goes to the IV pump, closes and causes the IV pump to sound an alarm. This lets the nursing staff know they need to come into the room and investigate the situation. The valve on line connected to the patient closes and prevents the patient from bleeding. Currently when an IV dislodges, the pump doesn't know the IV catheter is out of the patient, so it continues to pump medication on the floor or in the patient's bed until someone turns the pump off. The inner workings of the valves can be seen in the Product Introduction video at the top of the page.

FAST AND EASY TO INSTALL

SafeBreak Vascular is inserted between the IV pump/bag and the catheter in the patient's arm. The medical professional first attaches the device via a luer connection to the IV tubing as seen in Figure 4. The device is then primed (completely filled with fluid), ensuring no air is left inside the device.

 Figure 3. SafeBreak Vascular is packaged sterile for one-time use

Figure 3. SafeBreak Vascular is packaged sterile for one-time use

 Figure 4. SafeBreak Vascular is attached to the IV tubing and then primed

Figure 4. SafeBreak Vascular is attached to the IV tubing and then primed

After priming the device and scrubbing the luer connection of the IV tubing that comes from the patient's IV access site, SafeBreak Vascular is connected to the patient's needleless connector, as shown in Figure 5. With both ends of SafeBreak Vascular attached, a sealed connection is created that allows the flow of fluid from the patient's IV bag to the patient's catheter, as seen in Figure 6.  For full instructions on how to use SafeBreak Vascular, please consult the product's Instructions for Use.

 Figure 5. SafeBreak Vascular is connected to the needleless connector/extension tubing at the patient's IV site

Figure 5. SafeBreak Vascular is connected to the needleless connector/extension tubing at the patient's IV site

 Figure 6. Fully installed SafeBreak Vascular in a peripheral IV line

Figure 6. Fully installed SafeBreak Vascular in a peripheral IV line


MKG-0012 09/17

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