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IV Therapy Monitoring Device Gets FDA Nod

Monitor alerts caregivers to infiltration and extravasation

The FDA has cleared ivWatch Model 400, a first-of-its-kind continuous monitoring device that can quickly detect IV infiltration and extravasation.

With more than 150 million peripheral IVs placed every year in the U.S. and nothing previously available to continuously monitor them, ivWatch Model 400 will provide a significant advancement in patient safety, according to the device’s manufacturer, ivWatch LLC.

In the U.S., more than 80% of hospitalized patients receive peripheral IVs, and about 30% 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.

Currently, the most widely used methods for detecting these problems are visual and tactile examinations of IV sites by nurses, typically every 1 to 4 hours. However, these methods are highly subjective and unreliable. In development since 2000, the ivWatch technology 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 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 been conducted. “This device impacts every unit and almost every patient. For clinicians and patients, this will change the experience.”

According to ivWatch, the potential benefits of the new device for health care providers include:

  • Reduced medication dosing errors and adverse events
  • Minimized malpractice liability and associated financial and reputation costs
  • Reduction in the use of PICC lines, which are more invasive and expensive
  • Improved nurse productivity and reduced medication waste

Source: ivWatch; April 9, 2015.

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