IV Monitoring Device Wins FDA Nod

April 9, 2015

The ivWatch Model 400 device, capable of continuously monitoring peripheral IVs to detect adverse infiltration and extravasation events, has received 510(k) FDA clearance, its devicemaker claimed Thursday. The company plans on launching the product this fall, a spokeswoman told Device Daily.

Williamsburg, Va., devicemaker ivWatch, LLC says its flagship product has been in development since 2000 and features an optical sensor that illuminates tissue surrounding the IV site using visible and near-infrared light. The sensor scan is processed by the patient monitor though a propriety algorithm and notifies health professionals if adverse events are detected.

Healthcare providers could reap potential benefits, including:

  • a reduction in medication dosing errors and adverse patient events;
  • minimized malpractice liability and associated financial and reputation costs;
  • diminished peripherally inserted central catheter line use, which is more invasive and expensive; and
  • greater nurse productivity and lessened medication waste.

More than 80 percent of U.S. hospital patients receive PIVs, with an estimated 30 percent of these failing because of infiltration and extravasation issues. These adverse events occur when IV fluids, known as infusates, enter surrounding tissue by accident. Infiltrations result in less harmful leaks that may cause pain, skin redness and swelling; while extravasations are more harmful leaks, such as those involving chemotherapy medications. Severe cases could result in tissue necrosis, loss of function, amputation or death.

This is ivWatch, LLC’s first FDA-cleared product. — Jason Scott