Dukal's Healthcare Innovation is Redefining Efficiency and Safety in Today’s Existing IV Systems

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Dukal's Healthcare Innovation is Redefining Efficiency and Safety in Today’s Existing IV Systems


In partnership with Dr. Chris Page, Board Certified Anesthesiologist, Dukal is redefining the patient and clinician experience and reducing complications associated with traditional IV systems through healthcare innovation. 

With the increasing complexity of infusion devices and healthcare environments, and the high prevalence of infusion errors and adverse drug events, there is a clear need to reduce patient harm and improve efficiency in multi-infusion line management.

  • 11,000 adverse events and 142 deaths associated with infusion devices are reported to the FDA annually, the highest of any med tech1

  • Hospitals have $300-$610M in medical professional liability every year due to injectable inpatient and adverse drug events2

  • IV medications are associated with 54% of potential adverse events and 56% of medication errors3

Recognizing this prevalence, Dr. Page and his team, in partnership with Dukal, developed a coaxial system of parallel IV lines. We sat down with Dr. Page to hear first-hand how this innovative solution meets the unmet needs of both patients and practitioners and his experience working with Dukal as an innovative partner.
 



In this interview we cover:


 

"Dukal provided the opportunity for myself and my partners to work with an experienced organization that had all the elements required to move the project forward…the teams at Dukal know their business, and I was always confident in their work and dedication to making my idea a reality."
 



What is the current challenge we're facing in healthcare with IV tubing? 

Intravenous infusion of fluids and medications requires the use of tubing as a connection between the source and administration site on the patient. Intravenous tubing sets range from simple, single administration sets to complex ones used for multiple simultaneous drug and fluid administration. Unfortunately, with increasing complexity comes a dramatic increase in the opportunity for errors and patient harm.  

From the provider perspective, IV setups requiring multiple lines and components prolong setup time and management during difficult circumstances in and out of the operating room. 
 



Why is today's setup not working? 

Existing IV tubing constructs lead to a variety of performance and safety issues. Many stem from the fact that these sets are assembled from individual components consisting of primary and secondary administration sets, extension tubing, stopcocks, and manifolds. Although this, in theory, gives the provider flexibility in tailoring their setup to a given clinical situation, most choices involve compromises that lead to detriments in logistics, safety, or both.  

Increased line number, length, and connections can cause entanglement of lines requiring frequent disconnections and reconnections. Consequences of this are: 

  • Inadvertent misconnections

  • Unrecognized disconnections

  • And additional opportunities for infectious contamination

In addition, excessive tubing length and connection sites can lead to inadvertent overdose or delayed medication administration.  

Finally, all of this invariably leads to inefficiency of workflow. Time spent by a provider managing unnecessarily complex setups should be better spent providing other forms of patient care.

 



What is multi-lumen coaxial IV tubing?

Intravenous Solutions created multi-lumen coaxial IV tubing to solve not one but multiple clinical needs related to problems stemming from current IV tubing setups.  

The driving design principle was to create a system that takes advantage of different types of conventional tubing constructs and builds them into effectively a single administration line. Our solution succeeds in this goal, but it also leads to a decrease in complexity, improvement in workflow, and superior patient safety characteristics.  

Unlike current component-based IV tubing used for complex delivery, coaxial tubing is a single component that provides the same and superior function

All connections are limited to the proximal ends of the tubing, where they are readily visible to the provider. Connections to pumps and fluid bags are facilitated using peel-away tubing, so that free length can be adjusted to circumstance. The four independent lines then travel as a single unit to the distal end, connected to the patient. However, using a specially designed manifold maintains fluid separation between these lines until just before entering the patient.    
 



How does multi-lumen coaxial IV tubing meet the current unmet need for multi-line infusions? 

Multi-lumen coaxial IV tubing simplifies complexity without compromising function. 

The total number of connection sites and access points is reduced. Through the proximal location of connections, the operator can observe and change infusions easily, leading to:

  • A decrease in reconnections

  • Rapid identification of disconnections

  • Low contamination potential

A single combined tube without extraneous connectors decreases the time required for line management and entanglement points along the length of the tubing. In addition, because coaxial tubing comes out of the package ready to use, setup time is also reduced. 

The just-in-time medication and carrier fluid mixing at the distal connection of the tubing has several advantages. By minimizing dead space before the patient's IV access point, variations in fluid carrier rate do not significantly change the fidelity of medication administration. Limited dead space prevents the accumulation of mixed medications in the carrier line that can lead to an inadvertent bolus of medication or delayed changes in the dose administered because of slow flow rate.  
 



What's the customer advantage, and how will coaxial multi-lumen tubing revolutionize healthcare and patient experience? 

Multi-lumen coaxial IV tubing can reduce equipment costs and provide savings in terms of improved workflow in the operating room, intensive care units, and during patient movement and transportation. In addition, a significant number of IV infusion errors are attributed directly to the IV tubing as opposed to either infusion pumps or operator errors. Multi-lumen coaxial tubing solves the majority of these problems and will lead to a reduction in patient harm.

Intravenous Solutions' vision is that multi-lumen coaxial tubing will serve as a foundational technology that can rethink and improve all aspects of intravenous administration from pump to patient. 

The COVID-19 pandemic highlights this point. As a result, providers were forced to be inventive in ways to protect both patients and healthcare staff. One such adaptation was to combine individual lengths of IV tubing that allowed infusion pumps to be placed outside of patient rooms to reduce exposure. 

Although a clever solution, this required significant amounts of already scarce disposable equipment and still suffered from many of the dangers described above.  

On the other hand, multi-lumen coaxial IV tubing functions in a length-independent manner. Whether 6 feet or 60 feet long, this tubing will still provide the same fidelity and safety benefits. This same advantage could be extended to other environments where providers have limited patient access during care, such as radiology suites. 
 


 


In conclusion, tell us about your experience working with Dukal as an innovation partner. 

My experience is in the field of clinical medicine. I also have always had a strong desire to create, which has taken the form of inventing innovative medical devices. When I had the idea for multi-lumen coaxial IV tubing, I was able to take some of the early development steps but quickly realized that a successful device requires a team with a variety of skills. Dukal allowed me and my partners to work with an experienced organization that had all the elements required to move the project forward. 

When we first met with the Dukal team, I was struck by their willingness to hear out our whole story and vision for the device. I also felt comfortable that if they took the project on, it would be with a strong commitment to making the device a success.  

Since licensing, there has been a great collaboration between IVS and Dukal. From engineering to marketing, they have kept us informed of the progress and reached out frequently for input.

As a result, they were able to solve complex manufacturing challenges. 

There was a constant back and forth during this time to make sure that what was being done met the requirements for the clinical user. I was invited to be involved in the marketing plan. We worked together to craft materials that efficiently explained the problems with infusions in the current clinical environment and how they could be solved by using coaxial IV tubing. 

As a physician inventor, working with Dukal has been perfect. Having all the resources needed under a single roof was invaluable. 

In addition, the teams at Dukal know their business, and I was always confident in their work and dedication to making my idea a reality.

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Dukal's approach to healthcare innovation is to provide the highest quality manufacturing, sourcing, and quality regulation to solve real clinical problems through new healthcare technologies.


 

 

References:
1. FDA Infusion Pump Improvement Initiative, 2010
2. National Burden of Preventable Adverse Drug Events Associated with Inpatient Injectable Medications: Healthcare and Medical Professional Liability Cost , 2012
3. Errors Associated with IV Infusions in Critical Care, 2012

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