Biosensor Technology Detects IV Extravasation Events during Iron Infusions

Iron is often administered intravenously to patients with iron deficiency anemia. However, these individuals, especially newborns and elderly patients with delicate veins, are at an increased risk of intravenous (IV) extravasation, where the fluid unintentionally leaks into the surrounding tissue. Such incidents can cause permanent skin staining from iron and potentially extensive tissue damage over time. Now, a new monitoring device uses biosensor technology to detect extravasation events during iron infusions.

ivWatch’s (Newport News, VA, USA) patient monitoring technology combines a predictive algorithm with multi-spectral light to rapidly identify the earliest signs of fluid leakage from the vein, safeguarding patients from unforeseen IV complications. The company has applied for 510(k) clearance from the U.S. Food and Drug Administration (FDA) based on test results demonstrating the system's high sensitivity in detecting iron leakage into surrounding tissues. This monitoring technology has already established itself as highly sensitive to even optically clear infusions, capable of detecting infiltrations with as little as 0.2 mL of IV fluid, averaging a detection volume of 2 mL.

Image: ivWatch is the inventor and manufacturer of the only FDA-cleared and CE Marked continuous IV site monitoring technology (Photo courtesy of ivWatch)

While the primary aim of the tests was to prove the detection of iron was at least as effective as that for optically clear injections, the findings suggest an even greater sensitivity to iron injections across various dilutions. ivWatch, a pioneer in its field, is the creator and manufacturer of the only FDA-cleared and CE Marked continuous IV site monitoring technology, supported by over 30 clinical evidence bodies. The ivWatch SmartTouch Sensor, initially FDA cleared and granted CE Marking in 2020, is designed to detect optically clear fluids for patients of all ages, sizes, skin tones, and peripheral IV sites. The company's inaugural sensor was launched in 2015 for adults and expanded to include pediatrics in 2016.

“We are confident that this new expanded capability to detect infiltrating iron will elevate the way that clinicians care for their patients and solve their everyday problems when administering IVs,” said Gary Warren, ivWatch’s President and CEO. “This is just another example of how we, at ivWatch, listen to our customers to fuel our technology development engine where we relentlessly build great products that perform for clinicians and patients alike by acting as a second set of eyes on IVs.”

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