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Continuous monitoring device for peripheral IVs, ivWatch Model 400, scores FDA approval

by Lauren Dubinsky, Senior Reporter | April 09, 2015
Medical Devices
Courtesy of ivWatch, LLC
Medication dosing errors are major issues in U.S. hospitals that can lead to tissue necrosis, loss of function, amputation and even death. But the FDA recently approved a new continuous monitoring device, ivWatch Model 400, developed by ivWatch, LLC that has the potential to reduce those errors by rapidly spotting common adverse events before they become dire.

"Our goal is to be on every IV pole in the country and provide continuous monitoring of every IV placed," Gary Warren, president and CEO of ivWatch, LLC, said in a statement. "This issue is so prevalent and we finally have a way to address it."

The device consists of an optical sensor and a patient monitor. The sensor uses visible and near infrared light to illuminate the tissue by the IV site and then the patient monitor uses a proprietary algorithm to analyze the light reflected from the tissue. A clinician is then alerted if an adverse event has occurred.

According to ivWatch, more than 80 percent of patients in hospitals receive peripheral IVs (PIVs) but about 30 percent are not successful. That is usually due to infiltrations and extravasations that happen when the IV fluids unintentionally leak into the nearby tissue.

Infiltrations are when less-harmful IV fluids are leaked, which can cause pain, skin redness and swelling and extravasations are when potentially harmful IV fluids such as chemotherapy medications are leaked. But the ivWatch device can provide early detection for both of those events.

Right now, nurses are responsible for detecting those errors through visual and tactile examinations of IV sites every one to four hours. That approach can be very subjective and unreliable, according to ivWatch.

In addition to reducing medication errors, the device also has the potential to lessen malpractice liability and its related financial and reputation costs, reduce the use of the more expensive and invasive PICC lines and enhance nurse productivity and decrease medication waste.

The device underwent extensive testing with a focus on hardware and software, patient dynamics and clinician workflow. To date, it has more than 75 utility patent applications filed worldwide.

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