IV infusion is the most common invasive hospital procedure performed worldwide, but IVs can fail as often as half the time. When they fail, fluid or medication enters the surrounding tissue rather than the patient’s vein — a condition called peripheral IV infiltration — resulting in complications that range from pain and redness to severe tissue damage. Because of this failure, clinicians have defaulted to using other more intrusive vascular access devices that have other serious risks, such as central-line-associated blood stream infections, commonly referred to as CLABSIs.
The ivWatch Model 400 enables an IV to be continuously monitored, aiding clinicians in the early detection of infiltrations by automatically notifying them. The FDA has cleared the device for use with adults and it will be available for sale early in 2016.
“Our Clinical Advisory Council includes highly experienced vascular experts and other clinicians who’ve dedicated themselves to the mission of protecting patients,” said Gary Warren, CEO at ivWatch. “Their input has been invaluable in developing our inaugural safety device, and they are active contributors to other technological advances in our pipeline.”
The ivWatch Model 400 includes a patient monitor, a non-invasive sensor using visible and near-infrared light, and a disposable sensor receptacle applied next to the IV site. A color LCD screen displays the status of the IV and an audible notification sounds if an infiltration occurs.
The Clinical Advisory Council members include:
Gregory J. Schears, MD, Advisory Council Chairman and Chief Clinical Officer
Dr. Schears serves in a variety of roles at Mayo Clinic in Minnesota. He is medical director for ECMO Services, a physician liaison for the Nurse PICC Team, co-medical director of the Cardiovascular Pediatric Surgical ICU and a consultant for the Department of Anesthesiology. Dr. Schears also is a practicing pediatric intensivist and anesthesiologist, and serves as an associate professor of anesthesiology at Mayo Clinic College of Medicine.
Lisa Gorski, RN, MS, CS, CRNI
Ms. Gorski — a clinical nurse specialist with Wheaton Franciscan Home Health and Hospice in Wisconsin — is nationally recognized for her expertise in infusion nursing and chronic illness. Ms. Gorski is widely published on the topic of home-infusion therapy, including the 2010 textbook, “Infusion Nursing in Clinical Practice: An Evidence-Based Approach.” She also is past president of the Infusion Nurses Society.
Melissa C. Whitehead, BSN, RN, CPN, CRNI
Ms. Whitehead is clinical manager for seven teams at Children’s Medical Center in Dallas, Texas. Those teams include Vascular Access, the Wound-Ostomy-Continence Program and Patient Care Technicians. Ms. Whitehead is a member of the Association for Vascular Access and the Infusion Nurses Society. She has presented on numerous topics, including common complications of PIV therapy and current methods used to help minimize complications.
Liz Sharpe, RN, DNP
Ms. Sharpe is a neonatal nurse practitioner and educator, with a special interest in vascular access in neonatal and pediatric patients. An assistant professor at the University of Alabama’s School of Nursing, Ms. Sharpe also serves on the board of the National Association of Neonatal Nurses and the Vascular Access Certification Corporation. She is active in the Association for Vascular Access and the Infusion Nurses Society, and is an author, reviewer and consultant on the topic of vascular access.
Steven Bierman, MD, Chief Medical Officer at Access Scientific
Dr. Bierman founded Venetec International in 1996, which set a worldwide safety standard for management of intravascular and urinary catheters. The company sold to CR BARD in 2006. His new company, Access Scientific, LLC, is dedicated to establishing a new standard of over-wire vascular access.
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About ivWatch, LLC
Headquartered in Virginia, ivWatch develops, markets and sells biomedical sensor technology focused on improving patient safety in infusion therapy and vascular access. The company’s inaugural device, the ivWatch Model 400, is a first-of-its-kind continuous monitoring device, cleared by the FDA, which quickly alerts providers of possible peripheral IV infiltration.
The concept for the ivWatch Model 400 originated in 1999, and is the result of more than 14 years of intensive development and clinical testing. These efforts have led not only to the development of the ivWatch Model 400, but the technology has also resulted in 60+ utility patents that will be used to continue to improve patient safety in other ways.
More information is available at ivwatch.com.