Patients at Nationwide Children’s Hospital, Columbus, Ohio, one of America’s largest not-for-profit, freestanding, pediatric healthcare systems, now have access to the ivWatch Model 400, a first-of-its-kind and FDA-cleared device that continuously monitors peripheral IV sites for infiltration.
The IV monitoring device, which is being implemented in the operating room at the hospital, provides early detection of inadvertent leakage of fluid or medication from the vein into the surrounding tissue. When the ivWatch system detects a leakage, known as an infiltration, it alerts the medical team to inspect the IV site or supports their own evaluation that an infiltration has occurred.
“Patients receiving IV therapy during surgery can be at risk for IV complications as the IV site is often not accessible for visual and tactile assessment during the procedure,” says Scott Hensley, vice president of sales and business development at ivWatch. “Our goal is to provide a technology platform that offers real-time patient monitoring to support Nationwide’s commitment to delivering the highest quality care and creating the best outcomes for children.”
Approximately 80% of hospital patients in the United States receive peripheral IV therapy during a visit or extended stay.1 A continuous monitoring solution can provide confidence to clinicians that their patients will be protected from infiltration harm. Clinical studies confirm the device has the capability of detecting these events in as little as 0.22 mL of IV fluid with average detection of an infiltration at just over 3 mL of IV fluid.2
ivWatch recently earned ISO 13485:2006 certification, and also the CE Mark clearing the Model 400 for sale in Europe.
1. Helm, RE, Klausner, JD, Klemperer, JD, et al. (2015). Accepted but unacceptable: peripheral IV catheter failure. Journal of Infusion Nursing, 38(3), 189-203. doi: 10.1097/NAN.0000000000000100
2. ivWatch Internal Document: DR-1001024: Device Validation for Infiltrated Tissues