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Nationwide Children’s Hospital Becomes First in Columbus with Continuous IV Monitoring Technology

Recent product implementation adds a new layer of care

COLUMBUS, Ohio, September 13, 2018 – Patients at Nationwide Children’s Hospital, one of America’s largest not-for-profit freestanding pediatric health care systems, now have the latest enhancement for intravenous (IV) therapy with the installation of the ivWatch Model 400.

The ivWatch Model 400 is a first-of-its-kind and FDA-cleared device that continuously monitors peripheral IV sites. The device, which is being implemented in the operating room at Nationwide Children’s, provides early detection of inadvertent leakage of fluid or medication from the vein into the surrounding tissue.

“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,” said Scott Hensley, vice president of sales and business development at ivWatch.

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.

“Nationwide Children’s is the first institution in Columbus and among the leading pediatric hospitals in the country to adopt ivWatch infiltration detection technology,” said Hensley. “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 percent1 of hospital patients in the U.S. receive peripheral IV therapy during a visit or extended stay. 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

To learn more about ivWatch, visit www.ivWatch.com.

Helm, R. E., Klausner, J.D., Klemperer, J.D., Flint, L.M., and Huang, E. (2015). “Accepted but Unacceptable: Peripheral IV Catheter Failure.” Journal of Infusion Nursing, 38(3), 189-203.

ivWatch Internal Document: DR-1001024: Device Validation for Infiltrated Tissues

About Nationwide Children’s Hospital:
Named to the Top 10 Honor Roll on U.S. News & World Report‘s 2018-19 list of “Best Children’s Hospitals,” Nationwide Children’s Hospital is one of America’s largest not-for-profit freestanding pediatric health care systems providing wellness, preventive, diagnostic, treatment and rehabilitative care for infants, children and adolescents, as well as adult patients with congenital disease. Nationwide Children’s has a staff of more than 13,000 providing state-of-the-art pediatric care during more than 1.4 million patient visits annually. As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s physicians train the next generation of pediatricians and pediatric specialists. The Research Institute at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded freestanding pediatric research facilities. More information is available at NationwideChildrens.org.

About ivWatch:
ivWatch, LLC is the leading medical device manufacturer and biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. Our dedicated and passionate team is focused on our company vision of eliminating patient harm caused by infiltrations and extravasations. Through our innovative monitored IV solutions, we help minimize the risks associated with adverse IV events. Follow us on Twitter @ivWatch or Facebook @ivWatchLLChttps://www.ivwatch.com/

MEDIA CONTACT: Amara Betoney, amara.betoney@ivwatch.com, Office (855) 489-2824 x7007, Mobile (757) 660-4949

ivWatch Receives CE Mark for the ivWatch Model 400

Recent regulatory approvals and global certification pave the way for international distribution 

HAMPTON, Va., August 29, 2018 – ivWatch, the only provider of continuous monitoring devices for the early detection of intravenous (IV) infiltrations and extravasations, announced the CE marking of the ivWatch Model 400. In addition to conforming to European standards, the company obtained ISO 13485:2016 Certification through the Medical Device Single Audit Program (MDSAP), a global standard for medical device quality management systems. The first-of-its-kind and FDA-cleared device is currently sold in the U.S. through direct sales by ivWatch utilizing group purchasing contracts from Premier and Vizient, Inc.

“Peripheral IV therapy is among the most common invasive hospital procedures performed worldwide. Having the ability to extend the only surveillance monitoring technology for early detection of these common IV complications to new markets will help improve patient safety and effectiveness of IV therapy on a much larger scale,” said Gary Warren, president and CEO of ivWatch. “Navigating the comprehensive process to secure these regulatory milestones not only makes ivWatch positioned for growth but gives us the ability to respond quickly to new opportunities.”

MDSAP enables medical device manufacturers to contract with an authorized third-party auditing organization to conduct a single audit which satisfies all regulatory authorities in a given market. In addition to the U.S. FDA, other authorities participating in the program include those in Australia, Brazil, Canada and Japan. These achievements come only weeks after ivWatch was issued a medical device license by Health Canada, and supports an ongoing licensing and distribution partnership with Terumo Corporation in Japan.

Because the ivWatch Model 400 continuously monitors the IV site, it offers a significantly improved measure of security to a standard, unmonitored peripheral IV, thereby also reducing costs associated with wasted medications and adverse events. Reliable early detection and notifications of infiltration is the next step for improving patient outcomes during IV therapy.

To learn more about ivWatch and the Model 400, visit www.ivWatch.com.

About ivWatch:
ivWatch, LLC is the leading medical device manufacturer and biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. Our dedicated and passionate team is focused on our company vision of eliminating patient harm caused by infiltrations and extravasations. Through our innovative monitored IV solutions, we help minimize the risks associated with adverse IV events. Follow us on Twitter @ivWatch or Facebook @ivWatchLLChttps://www.ivwatch.com/

MEDIA CONTACT: Amara Betoney, amara.betoney@ivwatch.com, Direct (757) 224-2606, Office (855) 489-2824 x7007, Mobile (757) 660-4949

 

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ivWatch company and product information is available. If you would like more information, please contact us at info@ivwatch.com with your request.

ivWatch Monitored PIV Infographic: Download

ivWatch Patient Safety Infographic: Download

ivWatch Company Brochure: Download

ivWatch Pediatric Brochure: Download

ivWatch ICU Brochure: Download

ivWatch OR/Anesthesia Brochure: Download

ivWatch Med/Surg Brochure: Download

ivWatch Oncology Brochure: Download

Model 400 Fact Sheet: Download

Model 400 White Paper: Download

Model 400 Product Manual: Download

OEM Tech Sheet: Download

For media inquiries, please contact:

Amara Betoney
ivWatch Manager, Public Relations
Direct: 757-224-2606
Office: 855-489-2824 ext. 7007
Mobile:757-660-4949
amara.betoney@ivwatch.com

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