Selecting the right blood/fluid warmer for your organization is a critical decision. Nowadays, due to multiple recent recalls of aluminum warmers — that according to the FDA’s warning their aluminum leaching levels “may cause serious adverse events including death”– decisionmakers should be fully aware of what’s inside their warmers of choice. The last thing you want is to face a recall situation just after you have invested considerable funds in procuring new warming devices.
A study published in 2019 expressed concerns regarding non-coated aluminum solutions. At the same time, the authors stated that “Even in a coated warming device, aluminum concentrations are detectable, but remain below the limit of quantification, LOQ (i.e. our methodology does not have the ability to differentiate between the concentrations we measured and the FDA threshold)”[1]. Of note, some of the recent devices that were recalled are based on coated aluminum. Similarly, in TCCC’s recent Management of Hypothermia in Tactical Combat Casualty Care guidelines (2020), the authors also raised a concern regarding the utilization of aluminum warmers.
The risk of aluminum toxicity is nonexistent with the Warrior line, which is utilizing commonly-used medical-grade stainless steel coil for the fluids path and heat exchange functions. Our compact disposable unit (CDU) also includes PVC line with standard luer lock connection, to fit common blood/IV lines. A few temperature sensors are attached to the coil and report the blood/fluid temperature hundreds of time per second to the controller. Based on these readings, the controller regulates the energy distribution so as to ensure 38 degree Celsius output temperature.
Our technology is packaged in a compact and lightweight Expanded Polypropylene (EPP) casing. As per the British Plastic Federation, EPP “is a highly versatile closed-cell bead foam that provides a unique range of properties, including outstanding energy absorption, multiple impact resistance, thermal insulation, buoyancy, water and chemical resistance, exceptionally high strength to weight ratio and 100% recyclability”. With its excellent thermal insulation properties, the EPP casing ensures that heat is not dissipating; thus, allowing unmatched efficiency which is then translated into top warming performance.
Our technology is designed to address risks that may be associated with blood/fluid warming:
- Hemolysis. Hemolysis might be accelerated by suboptimal design of the fluid path of the warming element. You expect your blood/fluid line to be smooth and homogeneous, then why make exceptions for the warmer’s fluid path (or as it is often called, the cassette)? In other words, preferably the fluid path of the warmer should be designed in an ‘undisrupted’ fashion. That is, and to the extent possible, the fluid path design should avoid for example abrupt turns, connection points, and flow changes (e.g. from a wide to narrow carrier and vice versa) in order to minimize sheer force, turbulence, cavitation, and air bubble formation, to name just a few potential complications associated with high flows and elevated pressure. Our fluid path has been designed in an undisrupted fashion so as to address the complications listed above.
- Over/under heating. Another risk is over/under heating the blood/fluid being infused. Under heating is a more common issue especially with high flows and with rapid intermittent (bolus) flow methods, since most warmers cannot keep up with the job. If the warmer is unable to warm the fluids to body temperature at the rate being infused, you are introducing hypothermic fluids into your patient. Even room temperature fluids are far below body temperature, especially for severely sick patients suffering from shock. Our technology has been designed to support high flow rates and rapid intermittent (bolus) flow methods.
- Aggressive heat transfer process. It seems logical that a relaxed heat transfer process from the heat exchanger to the blood/fluid is safer than an aggressive heat transfer process. Therefore, why not add this to your evaluation criteria? The most relaxed heat transfer mechanisms require a warming surface of 15-20 ml. We all love solutions with small priming volume, but we need to acknowledge that this may come at a ‘price’. And the price is a potentially aggressive heat transfer process from the heater to the blood, especially at elevated flows. With its 19ml priming volume, our heat exchange process is amongst the most relaxed heat exchange processes in the industry.
- Unavailability. One of the most prominent risks associated with your blood/fluid warmer over the past years is that you will not be able to use it since there is a shortage of disposable sets or (as explained in the first part of this mail) due to a recall of the device. Ask users of enFlow, Level 1, ThermaCor, Thermal Angel, and several others to understand how frustrating this can get. And if there is one thing that COVID taught us, it is that complex solutions lead to complex supply chains and therefore to many months of lead times when the unexpected strikes. Therefore, make sure that the consumable of your solution of choice is simple enough to manufacture in large quantities, fast! Make sure that there are no chips that need to be placed into this consumable, otherwise you will be at the mercy of the market availability of chips, which is currently experiencing significant shortages. Our CDU has been designed for mass production and we have not experienced any shortage due to the adverse impact of COVID on global supply chains.
Finally, it should be noted that not only that our technology delivers unmatched performance, but also our per-use price is very affordable, especially compared with other modern warming solutions. A true win-win solution.
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