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24 May 2011

Patient invents adhesive-free peripheral IV securement device while in the hospital

Midwest Site Saver | www.SiteSaver.biz

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When Bob Heitkamp walked into the hospital one morning for a minor knee surgery, he expected an easy surgery and a quick recuperation. However, two pulmonary embolisms a week later left him critically ill and hospitalized for 17 days. An undiagnosed clotting disorder caused the embolisms, which lodged in his lungs, nearly killing him.

“The amount of attention to the IV site, the taping and untaping, the swelling and bruising, plus all the times I was stuck for an IV was a surprise to me. There had to be a better way to manage IV sites.”
-Bob Heitkamp

During his recovery, Bob had a peripheral IV to deliver life-saving fluids and blood thinners.  "I found myself lying awake at night trying not to pull out my IV because it was so painful."  The nurses used tape and gauze to keep the IV protected and secure but nothing worked.  Bob's hand began to swell and the IV was replaced several times during his recovery.

Most of the pain and resulting complications associated with IVs are related to how stable the IV catheter is going into the vein.  When the IV catheter moves it can cause a host of problems. Consequently, tape and gauze are used as an attempt to secure the IV and prevent as much of the IV catheter movement as possible. 

To Bob, tape and gauze seemed to be part of the problem and during his hospital stay he contemplated a comfortable, simple, inexpensive and tape-free way to keep IVs in place. Heitkamp worked on some ideas in his hospital bed and eventually drew a sketch on the back of an insurance form and gave it to his wife.

They immediately started doing market research, which indicated that there are 300 million peripheral IVs installed in the U.S. The Centers for Disease Control and Prevention (CDC) recommend that IVs be changed every 72 to 96 hours but 70 percent of peripheral IVs that are initially placed and secured with tape fail before then.  In fact, tape-secured catheters do not last as long in the vessel, the average dwell time being just 44 hours.

Moreover, studies show that up to 48 percent of all tape-secured IVs result in complications. These complications are caused by movement of the IV catheter within the vein and include pain, phlebitis, migration, dislodgment, infiltration, extravasation injuries, non-thrombotic and thrombotic occlusions. All of these conditions require IV restarts and costly interventions.  Heitkamp's researched showed that every IV restart minimally costs $32 in supplies alone equating to a $6.7 billion problem in the U.S. 


Heitkamp's idea did not use tape at all.  His invention is plastic apparatus called Site SaverTM, which is designed to mitigate the pain and complications associated with peripheral IVs and to reduce the unnecessary costs associated with IV restarts.  Site Saver is a technically advanced, simply designed, recyclable, single-use vascular access accessory.  Available in various sizes, Site Saver is a tape-free, lightweight, infinitely adjustable plastic stabilization device that can withstand a jerking force of more than 100 pounds (four times the breaking point of tested IV tubing). With Site Saver, clinicians can quickly align and secure tubing to prevent IV loss and reduce pain.

Heitkamp launched Midwest Applied Technologies LLC with business partner Jim Anderson to develop Site Saver. Since 1991, Bob has worked with injection molding while employed by 3M, Imation and now ComDel Innovation Inc. "I talked to the owner and showed him my Site Saver sketches.  He introduced me to the venture planning process, helped me develop the mold for the product and assisted with the patenting process". As a result, Site Saver will be manufactured at the ComDel plant he works at. 

The inadequacies of tape are being brought to clinicians' attention.  The Infusion Nurses Society, which sets standards for IV care, recently recommended manufactured catheter stabilization devices in order "to prevent catheter migration and loss" (www.ins1.org).  This leaves healthcare facilities looking for a better securement technology to help improve patient outcomes and create operational efficiencies. 

Site Saver is a cost-effective, easy-to-use solution. After an IV is started, Site Saver is strapped to the top of the patient's hand.  By using an ergonomic design, Site Saver, available in a variety of sizes, is extremely lightweight and comfortable for patients. The IV tubing is snapped into one of several alignment clips to accommodate numerous IV insertion sites.  Then the IV tubing is secured by snapping it into a series of clips around the periphery of the device.  Site Saver can withstand a jerking force of more than 100 pounds (four times the breaking point of tested IV tubing) and allows for many different IV configurations. 

Clinical testing indicates that by keeping the IV tubing still yet allowing for a full range of patient movement, Site Saver can help decrease pain, phlebitis, migration, dislodgement and other serious complications that lead to costly intervention and IV restarts. Early testing shows that Site Saver improves IV success rate (dwell times to 96 hours) by 90% (data on file). Longer dwell times combined with lower restart rates could mean an $8 savings for every U.S. patient with an IV or a $2.4 billion annual savings overall.

Beyond the cost savings, clinicians could realize vast timesavings by using Site Saver.  Because Site Saver is easy to apply and allows for clear visibility for IV management nurses could avoid the time wasted un-taping, re-taping or restarting IVs.  During a clinical study one nurse said, "Site Saver worked amazingly well. Normally if a patient has an IV in their hand during surgery, it comes out before they leave recovery.  With Site Saver, the IV stayed in until the patient was discharged 3 days later. That is phenomenal!"

"I cannot believe the picture in my head during a sleepless night in the hospital turned into a real product," said Heitkamp. "It is so important to me that Site Saver gets to market and helps to reduce, if not eliminate, IV pain and complications like I experienced."

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