Study Finds Device Improves IV Safety and Injury Prevention

By Matt Phillion

A recent study in a UK hospital found that a proprietary patient safety monitoring system, created by U.S.-based ivWatch, drastically reduced IV injuries, improved patient safety rates, and lowered costs to treat patients.

“I had set up our infusion unit six or seven years ago, for patients who are having non-chemotherapy infusion treatments as a day patient: antibiotics, iron infusions, and more,” says Andrew Barton, nurse consultant in IV therapy and vascular access and author of the study. “We do about 50 to 60 infusions a day in that unit, and one of the things I was concerned about was when those infusions were happening, some patients were getting infiltrations from the IV.”

When you place a peripheral cannula into a hand or arm, the treatment should just run right into the vein, but there are many ways some of that fluid can leak into the tissue—and that fluid can cause damage to the patient, especially if it’s an irritant or vesicant which can cause an extravasation injury.

“I was concerned about that. Through the work I do nationally, I asked other hospitals, ‘Is this something you’re seeing?’” Barton says. “Extravasation is something that most hospitals associate with chemotherapy, and if you work in a chemo unit you are taught about this and how to avoid it. But a lot of the drugs we use outside of chemotherapy are also an irritant or vesicant and can still cause damage to tissues.”

Barton notes that there have been a lot of claims to NHS (as shown in data published by NHS) looking at these extravasation claims over the last 10 years in which patients have been harmed significantly by it, and only 23% of those claims were related to chemotherapy.

“I looked at that data and said, ‘We need to do something about this,’” he says.

Barton developed an infiltration and extravasation toolkit to raise awareness around this issue, because often hospitals will not have a policy or guideline around non-chemo drug extravasations.

“Nurses are less aware of the problem, and often these injuries aren’t reported correctly,” says Barton. “It was a huge problem in the UK, and we still don’t know the national numbers, so I dug in for more information.”

Barton encountered ivWatch at a national conference, discussed his research, and decided to trial the technology.

“I was skeptical at first, but said, ‘Let’s do a trial in the infusion unit,’ and we looked at every infusion we gave for two weeks,” says Barton. “I thought our rates were about five extravasations per week.”

The device will show a yellow warning if there is a risk of infiltration or extravasation and red if it is occurring.

“The first patient we set up went red, indicating infiltration was occurring. We looked at the patient and we couldn’t see anything wrong—and the patient didn’t feel anything either,” says Barton. “We didn’t think the machine was working so we continued the infusion. But five minutes later we saw it. From that first patient onwards, we trusted the alerts and over that two-week trial, we prevented 15 extravasation injuries from occurring.”

The device was detecting infiltration of such a small amount that it allowed the team to move quickly and prevent injuries from occurring.

“We give a lot of iron infusions, and if this infiltrates the tissue, it will cause a permanent orange stain on the skin, so it’s a psychological as well as a physical injury,” says Barton. “It’s important to prevent these situations as quickly as possible. We started using the device in August of 2022 and collected data through January of 2023 and basically had no injuries on the unit associated with extravasation of drugs. Our patients now expect us to use it and we’re looking to expand its use into other units as well, specifically those that give IV iron.”

How it works

The ivWatch monitoring system is roughly the size of a pencil eraser and works by injecting colors of light into the tissue—think of the album cover of Pink Floyd’s The Dark Side of the Moon, explains Gary Warren, CEO of ivWatch.

“We’ve essentially been working to solve this problem for 14 years,” says Warren. “It sounds simple, but we’re searching for infiltration or extravasation 18 times a second. When a drug shows up outside of the vein that isn’t supposed to be there, it alerts staff to the issue.”

The system is also extremely accurate, Warren says. The FDA states that detection should be possible in 10 ccs or less, and ivWatch detects in as little as .2 ccs with an average of 2 ccs.

“The rate these drugs can leak into the tissue varies,” says Warren. If the needle punctures completely through the vein and you’re infusing 150 ccs an hour, the issue will become apparent faster, but the drugs can also break down the vein wall over time and lead to leakage at a rate the human eye will never see.

“Some of these drugs can cause a lot of damage,” says Warren. “But also, on the flip side, consider drug dosing errors. Every time the drug is leaking it’s a drug dosing error. If you have a stroke patient with an IV tPA going to break down blood clots and it doesn’t go into the vein, it can be fatal. And the frequency these errors happen in many hospitals the rate can be 10% to 15%. Sometimes you’ll never know that there was a small leak, and others are significant.”

Healthcare doesn’t exist without IVs, Warren notes.

‘But we discount them. Without IVs, there is not delivery and the world’s got to wake up to that. Ninety percent of patients have some form of IV treatment.”

Barton points out that this issue is often written off as a nurse-only problem, but it’s something that touches all parts of healthcare.

“When you put caustic drugs, or an expensive drug, into a patient, it’s not if it goes bad, it’s when, and even when it does go bad, the standard of care is to wait for the injury to show up,” says Warren.

“And often the injury is not recognized,” says Barton. “People don’t know it’s a problem when it happens. They see the area around the cannula is inflamed, so often it’s thought to be cellulitis or an infection. The patient is given antibiotics and discharged, and three weeks down the line the patient has a necrotic area on their skin.”

The patient will then see a general practitioner or plastics and so it’s not even reported as extravasation, explains Barton.

“These injuries evolve over days and weeks. By the time the injury is at its worst it’s too late to act to prevent it, the patient could lose a limb,” Barton says. “That’s why we are trying to raise awareness—because there is something we can do about it.”

Identifying and addressing the issue is the first step toward change, Barton notes.

“We are seeing a shift in awareness that this is a problem outside of chemotherapy,” he says. “Prevention is better than a cure. We need to start collecting more data on rates and put something in place for guidelines and policies.”

It’s a problem that can be solved, he says.

“It’s getting people to understand it’s a significant problem and it’s happening globally, everywhere an IV is being given,” says Barton. “In the UK, we monitor bloodstream infections, and the rate is low because of stringent reporting and surveillance and adherence to best clinical practice. The physical impact on patients is so much higher with extravasation. We need recognition and reporting of injuries and need hospitals to buy in on putting processes in place to stop injuries from happening.”

This means policies for non-chemotherapy monitoring of infusion sites, recognizing when an extravasation injury occurs and putting a treatment pathway in place.

“You’ve got an hour or two max to save the tissue and even then, what you can do is limited,” says Barton. “Once it’s taken hold, there is real potential for the injury to manifest into something terrible, so prevention is key.”

“ivWatch isn’t a silver bullet,” says Warren. “Education has to be front and center. A lot of medical and nursing schools aren’t teaching vascular access, let alone extravasation management, and that should be a freshman course. People think these vents happen just because of a catheter poked through a vein wall, but there are many ways it can happen, and so we more need education like [Barton’s] toolkit.”

Barton wants to see more universal awareness and resources dedicated to preventing extravasation in the same way we do for other IV-related injuries.

“My vision and goal is that every hospital has an extravasation lead, and there will be pathways, guidelines, and policies for non-chemotherapy extravasation and infiltrations,” says Barton. “It will be about prevention and recognition, treatment and reporting, and everyone is doing it the same way.”

Matt Phillion is a freelance writer covering healthcare, cybersecurity, and more. He can be reached at matthew.phillion@gmail.com.