The FIVA Flow attaches to any standard gravity-fed I.V. set to monitor fluid flow. It has been used since January 2023.

The FIVA Flow attaches to any standard gravity-fed I.V. set to monitor fluid flow. It has been used since January 2023.

The scene is typical – a dim OR filled with distracting noises, beeps, alarms, conversations, and the whine of surgical instruments. The anesthesiologist is busy checking the patient’s heart rate, blood pressure, breathing, oxygen saturation level, temperature, pain, and level of consciousness. Then, all too often, the nurse gently reminds the doctor that the I.V. fluid bag is empty. That very much irritated anesthesiologist Orlando Hung, MD, FRCPC, Medical Director of Research, Department of Anesthesia, Dalhousie University, Halifax, Nova Scotia.

However, after giving it some thought, his irritation turned into inspiration. “I was annoyed because it happened more than once, but it really got me thinking. A dry I.V. bag is more than an annoyance for the anesthesiologist, it’s a big deal for the patient. They may not be getting needed medications, fluid, or anesthesia. When I realized this, it became my problem to solve.”

Dr. Hung, who focuses on airway management, clinical pharmacology, and drug delivery systems, has developed and patented several innovative drug delivery systems and medical devices through collaborations with clinicians and scientists at Dalhousie, Stanford, and the University of Toronto.

Dr. Hung’s first step was setting up a research study by instructing respiratory students working with anesthesiologists in the OR to watch how many times the I.V. bags ran empty during surgery. In that study, 29% of the bags ran dry. These could have been empty for one minute or an hour, indicating to Dr. Hung that the problem was widespread. Working with an engineer, they developed the first iteration of a fluid I.V. alert device later named FIVA™. Created in 2014, the device detected air in the line, and it would sound an alarm. However, during the last 10 years, most I.V. bags no longer have air in the system, or some clinicians will bleed the air, so the team added a drop sensor.

“The drop sensor was a groundbreaking improvement. The top reading shows the rate of infusion at milliliters per hour, and the bottom shows the total amount of fluid given. With a large bore I.V. (e.g., #16 gauge I.V.), it can easily happen that the whole bag of IV fluid runs into the patient. That’s a liter of fluid, which for most adults is O.K., but if it’s a child, that could be too much fluid.”

To manufacture this new iteration of the I.V. fluid monitor now called FIVA™ Flow, Dr. Hung and other collaborators launched the FIVA™ Med company in 2023. The FIVA Flow is currently undergoing Class I device approval by the U.S. Food and Drug Administration (FDA). According to Dr. Hung, such devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices, which is why disposable batteries were used. Rechargeable batteries could be a fire hazard in the OR by leaking and causing other problems. Once the device get FDA approval, it can be sold in India, China, and the developing world, in addition to the U.S. Its cost, size, and ease of use also make it suitable for use in ambulances, nursing homes, and veterinary clinics.

Despite its advantages, Dr. Hung admits they haven’t had a lot of interest in the U.S. and Canada. “Anesthesiologists like the device but their hospitals are already using infusion pumps, and purchasing managers often don’t see the point of having both devices. However, FIVA Flow is faster to set up, completely mobile, and can be used with any I.V. tubing set. It’s also much cheaper than an infusion pump, and you don’t need to sterilize it because it doesn’t touch the patient.”

“A dry I.V. bag is more than an annoyance for the anesthesiologist, it’s a big deal for the patient. They may not be getting needed medications, fluid, or anesthesia. When I realized this, it became my problem to solve.”

Dr. Hung, who was born in Macau, a former Portuguese colony in China, says a Jesuit priest urged his father to send his children to a Jesuit high school in Hong Kong (Wah Yan College) for a better education. “I wasn’t the best student,” he confesses. “I was playing soccer, playing in a rock band, riding motorcycles, and not doing much studying.” But after graduating, he was admitted to Saint Mary’s University (a former Jesuit University) in Halifax. Since he was interested in medical science, he switched to Dalhousie University, where he studied pharmacy and then medicine. After completion of his anesthesiology training at Dalhousie, he received a Medical Research Council of Canada scholarship to do a research fellowship in pharmacology at Stanford University in California. He could have stayed there and conducted research, but the 1989 earthquake helped him decide to return to Halifax.

The FIVA Flow wasn’t his first invention. Back in the 1990s, he developed a liposomal fentanyl inhaler for pain relief. “It really was a magic bullet,” he says wistfully. “It had quick onset of drug effect, was long-lasting, and could be delivered without needles. However, it never got regulatory approval because it could be too easily abused.

“Which just goes to show you that there are many patents filed every day and more than 60% are never fully developed. I’ve learned that you can have a great idea that addresses a real-world problem, but to bring a workable device that can be thoroughly assessed, marketed, and distributed takes a certain skillset. A clever or innovative idea in and of itself is not enough. You must solve all these other issues – regulatory, manufacturing, supply chain, marketing, business partnerships, and contracting.”

Even with all the roadblocks, he enjoys the challenge of inventing and bringing an idea to fruition. “I love it! I’m 71 this year, and I’m always looking for ways to solve problems. I don’t care if I make money. I’m happy if I save lives and improve patient outcomes.” Dr. Hung wants to inspire all his students to do the same and gives them these four principles for success:

  1. Be flexible. Problems aren’t one-size-fits-all. Think outside the box.
  2. Adapt. Mold the solution to contextual factors in its environment.
  3. Persevere. Don’t just try something once. Refine and improve an idea. Finish the job.
  4. Use evidence. Whatever decision you make, base it on some evidence, personal experience, anecdotes, or research (randomized controlled trials).

For his fellow anesthesiologists, Dr. Hung emphasizes the importance of paying attention to the irritations they encounter because they may stumble onto a previously unknown problem, such as the issue he uncovered. “We are still not always doing a good job of monitoring perioperative fluid intake. We did a follow-up study that showed 50% of the time the I.V. bags ran dry in a dimmed OR environment,” Dr. Hung advised “We’re too cavalier on this point. We must be more vigilant and improve the way we give fluid today” (Can J Anaesth 2021;68:1266-7).