In May, European IV pump provider Fresenius Kabi finalized its acquisition of infusion pump manufacturer Ivenix to expand its portfolio in the U.S. market. On the heels of this merger, Robert Canfield, director of marketing at Fresenius Kabi USA, LLC, sat down with 24×7 Magazine to discuss the state of the infusion therapy sector and whether concerns about infusion pump security are overblown.

24×7 Magazine: How has the COVID-19 pandemic impacted the infusion therapy sector?

Robert Canfield: The practice of moving the infusion pump outside the patient room continues to be a critically important consideration during these challenging times. We’ve seen many studies and opinions published about this practice; clinicians continue to share concerns about valid reasons against it. New technology is needed to adapt to these changing clinical conditions.

The Ivenix Infusion System addresses this challenge of adding extension sets and moving the pump just outside the door. The device can pump accurately in all clinical conditions and is the only infusion pump that measures and adjusts flow. 

The Ivenix large-volume pump (LVP) can also automatically follow medication delivery with fluids to keep the patient sufficiently hydrated—and it can do this through a single line into a patient. This feature can also flush the medication that remains in the IV line, ensuring the patient receives the entire treatment as intended.

Moreover, visibility into a patient’s infusion status is even more critical in an isolation room setting. When an Ivenix infusion pump is placed inside a patient’s room, the large and bright display allows healthcare workers to safely see infusion status from meters away. The pump is also easy to clean and is tested to withstand repeated exposure to the harshest-rated disinfectants against coronavirus. 

Nurses administering treatment and pharmacists can virtually follow and review a patient’s infusion status from a mobile device, see when bags are empty, and observe alarm conditions from anywhere in the hospital. The Ivenix Infusion System also provides a way to disseminate information without interrupting patient care. Rapidly evolving COVID-19 safety guidelines and drug regimens can be made available on Ivenix pumps in just minutes—and they’re just a “swipe away.”  

24×7: What are some of the biggest innovations in the infusion therapy sector, and how are they influencing the design and development of infusion pumps?

Canfield: The mechanics of pumping technology has not changed dramatically for over a decade­—until now. The most significant innovation we are now utilizing on patients is pneumatic pumping technology. Pneumatics allow the Ivenix LVP to measure and control an infusion to ensure a consistent delivery rate under all clinical conditions. This dosing accuracy is critical to providing quality event data that originates at the pump. When a traditional pump delivers at a different rate than the counter in the pump’s processor, the data reported to the electronic medical record (EMR) may be inaccurate. To achieve quality reporting, the system must start with quality fluid delivery.

We see closed-loop medication delivery and personalized medicine as up-and-coming innovations in the industry. As we consider the impact varying medication levels can have on a patient, we strive to monitor these levels and automatically respond in faster and safer ways. Each product involved must be cybersecure and designed to handle modern processing requirements to allow this. 

Eliminating the reasons to collect infusion pumps is also driving change. Gone are the days of collecting infusion pumps for drug library changes, software updates, cybersecurity network changes, and annual preventative maintenance.

24×7: Before purchasing infusion pumps, what should clinicians know?

Canfield: The bar is being raised by hospitals seeking increased infusion-related patient safety. Healthcare teams should choose a manufacturer based on how they answer these challenging questions:

  • Is pump programming intuitive? 
  • Does the pump guide the user through complex infusions like bolus and weight-based drugs? 
  • Can the pump identify issues such as the same drug infusion or incompatibility? 

Don’t assume that a pump can perform accurately with varying positions of the pump on the pole, relative to the patient, or with varying medication viscosity. 

Don’t assume that an administration set is easy to load, has a foolproof design, and won’t free flow. A pump evaluation should challenge a manufacturer to show better safety designs. Does the pump address [Institute for Safe Medication Practices] recommendations for secondary infusion safety via innovation and not nurse burden? Determine if the pump can withstand long-term, rigorous daily use and features a strong battery and a rugged, durable exterior.

It’s especially important to determine if the pump can integrate into your health IT systems. Workflows should support EMR, alarm communication, real-time location systems, and admission-discharge-transfer systems to increase safety, improve visibility into infusion status, help reduce nuisance alarms, and improve response time. Investigate the true return on investment and the total cost of ownership. Remember: The differences between each manufacturer’s financial impact on your facility are substantial.

24×7: What do you want 24×7 readers to know about infusion pumps—a type of equipment known for its vulnerability to cyberattacks?

Canfield: From a cybersecurity perspective, all pumps are not created equal. According to a recent study, 75% of the infusion pumps scanned had known security gaps. But most of these cyber-risks could be attributed to pumps with legacy versions of software that weren’t upgraded.

Even when they’re manufacturer-recommended, pump operating system updates are often not applied due to labor and expense challenges. Fortunately, Fresenius Kabi has solved this problem.

The Ivenix Infusion System is automatically updated wirelessly and through everyday clinical use. Moreover, clinical engineering staff doesn’t have to physically collect the Ivenix LVP to update cybersecurity software changes or configurations. And when Ivenix releases a cybersecurity software update, the software change is provided to customers for evaluation. Once complete, the server sends the updates to the pumps for immediate clinical use.

Challenge/response and protection of secrets are also critical. Modern techniques are implemented to ensure only devices authorized with a unique and dynamic secret can communicate, blocking all other devices. 

Finally, meeting FDA standards for cybersecurity is excellent; every manufacturer should do that. But a deep, under-the-hood evaluation of how the product will support your hospital in the long term is critical to buying the right pump.