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ivWatch Receives FDA Clearance And Significantly Advances Safety of IV Therapy

Tuesday, April 14, 2015  
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Peripheral IV therapy is a common part of many hospital visits, but it can often result in adverse events that, until now, have been accepted as the norm. The FDA recently cleared ivWatch Model 400 from ivWatch, LLC, a first-of-its-kind continuous monitoring device that will improve patient care by quickly detecting common adverse events: IV infiltration and extravasation. With over 150 million peripheral IVs placed every year in the United States and nothing previously available to continuously monitor them, ivWatch will provide a significant advancement in patient safety.

In the United States, over 80 percent of hospital patients receive peripheral IVs (PIVs) and about 30 percent of these fail. Many of these failures are due to infiltrations and extravasations that occur when IV fluids, called infusates, inadvertently enter the surrounding tissue. Infiltrations are leaks of less-harmful infusates that can cause pain, redness of the skin, and swelling. Extravasations are leaks of potentially harmful infusates such as chemotherapy medications. Infiltrations and extravasations are considered to be medical-dosing errors and, in severe cases, may result in tissue necrosis, loss of function, amputation or even death. The ivWatch sensor technology aids clinicians in the early detection of both types of events.

“I hope this technology will be broadly adopted so that we no longer allow these complications to be the status quo,” said Gregory J. Schears, M.D., associate professor of anesthesiology and physician liaison for the nurse PICC team at the Mayo Clinic. “I believe this will be a paradigm shifting technology, causing a dramatic reduction in the frequency and severity of infiltration injuries that we see.”

Currently, the most widely used methods for detecting these problems are visual and tactile examinations of IV sites by nurses, typically every one to four hours. However, these methods are highly subjective and unreliable. In development since 2000, the ivWatch technology provides continuous assessment to give patients and their caregivers a better solution.

“It’s very rare that one gets an opportunity to be involved in something that can have such a large impact affecting so many people,” said Gary Warren, President and CEO of ivWatch, LLC. “IVs are probably the most common medical procedure performed and 30 percent of them fail, often as a result of infiltration. It’s a huge problem. Others have tried to solve it, but we are the first to develop the technology and bring a practical and cost-effective solution to market.”

The technology developed by ivWatch, LLC uses an optical sensor coupled with a patient monitor. The sensor illuminates tissue near the IV site with visible and near infrared light; the light returning from the tissue is processed by the patient monitor using a proprietary algorithm. Caregivers are notified if conditions suggest that an infiltration or extravasation has occurred.

“This is really a game-changing technology for infusion therapy and should become the new standard of care,” said Darcy Doellman, MSN, RN, CRNI, VA-BC, clinical manager of the Vascular Access Team at Cincinnati Children’s Hospital Medical Center, where clinical trials of the technology have taken place. “This device impacts every unit and almost every patient. For clinicians and patients, this will change the experience.”

The device has gone through extensive testing and rounds of quality improvement, with attention to hardware and software as well as to human factors that account for the patient dynamics and clinician workflow. The patent portfolio for the technology includes over 75 utility patent applications filed in the United States and around the world, with over 60 of those applications published and one patent awarded thus far.

“Our goal is to be on every IV pole in the country and provide continuous monitoring of every IV placed,” said Warren. “This issue is so prevalent and we finally have a way to address it.”

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