ivWatch is a medical device manufacturer who we met with during CES 2018 in Las Vegas a couple months ago. They have developed of a non-invasive device that aims to establish a new standard of care for peripheral intravenous (IV) monitoring. The FDA-cleared ivWatch continuously monitors a patient’s IV for the early detection of infiltrations and extravasations – when medication or fluid leaks outside the vein into the surrounding tissue.
ivWatch has achieved many milestones since its inception in late 2010 to include a significant pediatric pilot study at a leading children’s hospital, three FDA clearances for the ivWatch Model 400, the granting of several patents, and full-scale manufacturing of the device. The company currently has a direct-to-customer sales model and an OEM solution. We spoke with Gary Warren, President and CEO of ivWatch, who is an engineer and technology entrepreneur with more than 30 years of experience with several global high-technology companies.
Medgadget: At CES, your display had a dramatic picture of a child’s hand with the skin necrosed from an extravasated maintenance fluid. How does this scenario develop and what are the other clinical scenarios you are trying to prevent?
Gary Warren: Hospital departments spanning Intensive Care Units (ICUs) to pediatric-only floors treat millions of patients each year whose medications and fluids must be administered through peripheral intravenous (IV) therapy. Yet, this procedure has a 20-23% failure rate due to infiltration and extravasation which occurs when fluid or medication intended for the vein leaks into the surrounding tissue. Infiltration is the inadvertent administration of non-vesicant drugs or fluids into the subcutaneous tissue, and an extravasation occurs when the leakage is of a vesicant agent such as certain antineoplastic drugs or fluids. Simply put, our mission is to prevent patient harm when these events occur.
The current standard of care to check for a possible infiltration are visual and tactile examinations by a nurse on a regular basis as defined by an organization’s protocol. This could be every hour or every four hours. Unfortunately, serious issues can happen within minutes if it’s a fast leak of a vesicant medication, while slow leaks that aren’t visible to the eye can be just as dangerous. Slow leaks with a rate of infiltration as low as 1-2ccs per hour will cause the extremity (typically a hand, arm, leg or foot) to swell gradually and possibly in its entirety, where a faster leak can cause significant swelling or blistering in one area close to the IV insertion site. Every infiltration is a medication dosing and delivery error that can impact the patient through prolonged hospital stays, increased health care expenses, or permanent injuries. In addition to the impact on a patient, any of these adverse events may result in significant legal risk and reputation damage for health care providers and facilities.
ivWatch technology significantly improves the level of quality and patient safety through early detection. Our continuous monitoring device is the new and next step for reducing the risk of injury to the patient. Our hope is ivWatch technology will become as ubiquitous as seat belts.
Medgadget: What patient populations do you target?
Gary Warren: Because peripheral IV catheter insertion is the most common invasive hospital procedure performed worldwide with more than 150 million placements annually, there is a significant opportunity for patient safety improvements across the spectrum. We are currently focused on populations who are particularly vulnerable to peripheral IV complications.
For example, general pediatric patients are susceptible to IV infiltrations because of their small, fragile veins, limited communication skills, and their tendency to be very active. And both adult and pediatric ICU patients are at-risk because their illnesses may be severe or they may have lost their ability to communicate. Other areas of focus include the OR where there is often limited visibility of the IV site during a procedure – and on medical-surgical floors where the staffing level is often one nurse to five or six patients and patient assessment may not be as frequent, despite hospital protocol and the best intentions of the clinician.
IV infiltration is a hospital-acquired condition (HAC) getting more notice as of late due to the severity of the outcomes. Several years ago the preventative solution by many hospitals was moving from peripheral IVs to a peripherally-inserted central catheter (PICC or PIC line) to lessen the frequency and severity of these adverse events. Unfortunately, the significant increase in their use has led to inappropriate placement and a heighted risk of hospital-acquired infections (HAIs) like CLABSI and DVT, both of which can be deadly.
ivWatch is in a class of its own introducing a new category within the Vascular Access space – a monitored peripheral IV.
Medgadget: What is your biggest market now?
Gary Warren: Patients are affected by this type of preventable harm every day, but the good news is many hospitals and health care systems are pursuing solutions. Early on as a company, we were fortunate enough to have a team from Cincinnati Children’s Hospital Medical Center reach out about our technology as they were working on quality improvement measures to address this HAC. So, we moved our clinical trials there and through the sharing of resources we advanced our shared initiative to improve patient safety in this area. Children’s hospitals are often the leaders in adopting technology to transform patient care, solve accepted but unacceptable problems, equalize the relationship between physicians and patients, and to provide affordable and more efficient solutions. They remain our biggest base, and I believe they will help foster wide-spread adoption.
While infiltration is a common term within hospital walls, IV therapy risks are typically the furthest thing from a patient’s mind when receiving treatment or going in for surgery. There is a need for patient awareness around this topic. We’ve recently helped build a platform, myIV.com, to educate patients and family caregivers so they can be their own advocates and know what protocols and technologies are in place and available to keep themselves and their family members safe from preventable harm.
Medgadget: Can you give us an overview of the underlying technology? What are the new notable features in of the ivWatch Model 400?
Gary Warren: Major medical device companies have been trying to solve the IV infiltration problem for years, and have been unsuccessful. We’ve pursued and continue in-depth research and development, conducted thousands of hours of clinical trials and evaluations, been awarded patent grants and have secured steady funding to get to the point where ivWatch customers include world-class health facilities. One of our core technologies for mitigating the effects of tissue blood volume changes is an example of how we prospered where others failed. The science is directly related to the ability of the ivWatch Model 400 to reduce the number of “false” notifications helping combat an epidemic of alarm fatigue.
The ivWatch Model 400 consists of three components; the ivWatch patient monitor, a sensor cable, and a disposable receptacle that is placed next to the peripheral IV to secure the sensor to the patient. The device uses visible and near-infrared light to continuously monitor a patient’s subcutaneous tissue and measures the changes in the optical properties of the tissue. The sensor cable delivers the light signals from the ivWatch patient monitor to the patient’s skin through the sensor head. The sensor head transmits the reflected light from the tissue back to the patient monitor through the sensor cable. If changes in the optical properties of the tissue near the IV insertion site are consistent with an infiltration, the ivWatch monitor will provide audible and visual notifications, alerting clinicians of an infiltration event. Another core technology ensuring the device’s high sensitivity is the geometry of our ivWatch sensor heads. The combination of these features have secured ivWatch’s position as the first, and only, technology of its kind in the market to aid health care providers in an early diagnosis of these most serious events during IV therapy.
In most cases, the ivWatch device will identify infiltrations prior to the clinician, given its purpose as an aid that provides an extra set of eyes that monitor constantly. The final decision to replace the IV will always be made by the clinician. Our device is a patient care partner and by working together with care providers, we can reduce harm and improve outcomes.
Medgadget: What are the efforts your company is making to change standards of care industry-wide to integrate infiltration and extravasation event monitoring into the everyday clinical practice?
Gary Warren: The current gold standard in health care for the detection of infiltrations is primed for improvement. Even in the best of hands, frequent or periodic monitoring of the IV site is not enough to prevent harm. Several hospitals and patient safety organizations have defined and are focused on the “PIVIE” HAC (peripheral IV infiltration/extravasation hospital-acquired condition). As more of these progressive and innovative facilities and associations see how our technology and device positively impacts their patients and members – through fewer severe events, minimized patient harm and improved patient experience and satisfaction scores – we expect the standards bodies to recommend and eventually require continuous monitoring for IVs, just as they do for the heart and pulse.
Building a team, both internally and with our customers who are dedicated to solving this issue, has been instrumental in getting us to this point. We are working with our partners to improve this area of potential liability through the use of technology without dramatically affecting the workflow and staffing requirements of clinical teams. As we get their feedback, we take it back to our engineering and design teams for future applications and products. As clinical needs change in the hospital and at-home care environments and we build upon our technology, you’ll see new versions of ivWatch sensors and products available using the IV to monitor overall health.
Flashbacks: ivWatch Detects Leaks Near IV Placement Sites…; ivWatch Monitors IV Placement Sites for Leakage Outside Veins…; ivWatch Enters Into Licensing and Distribution Agreement With Terumo to Help Improve Patient Safety…