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 in an infusion line

SafeBreak Vascular Separated

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.

Bar+chart+of+mean+force+at+loss+of+catheter+function.png

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.

SAFEBREAK VASCULAR SEPARATES TO SAVE IV LINES

FORCE REQUIRED TO SEPARATE

Our lab testing tells us that harmful forces start to impact IV lines around 4.3 pounds of force, so it is very important to separate before that point. SafeBreak Vascular is designed to separate when a force over 3.7 pounds is applied across an IV line. 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.

POTENTIAL BENEFITS OF USING SAFEBREAK VASCULAR

REASSEMBLY NOT POSSIBLE

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. When SafeBreak Vascular separates to prevent damage to the IV catheter, 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. SafeBreak Vascular has a proprietary anti-reconnect feature that prevents anyone from accidentally putting the device back together.  Please watch the video to see how SafeBreak Vascular is designed to operate.

VALVES CAN'T BE REOPENED

It is also important that the valves can't be reopened by a patient or family member by pressing on them on accident 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. As can be seen in Figure 1, the valves designed into SafeBreak Vascular are embedded deep within the device. It will not be possible for someone to stick a finger into the device to open a valve. 

 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 will be compatible with both gravity fed lines or IV lines using an electronic pump. The luer connectors on SafeBreak Vascular will work on any line in the world because they are manufactured to the latest international standard - ISO 80369. 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, turn, walk, shower, and much more 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. Please watch the brief video to the right that shows the inner workings of SafeBreak Vascular in detail.

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 IV tubing, 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.