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Selecting the right blood/fluid warmer

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.

For more information click below,

Team Bell Medical



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An Evolving New Paradigm in Blood Warming: “A Bridge To Rapid Infusers”

QINFLOW WARRIOR FROM BELL MEDICAL

Initially created on JANUARY 15, 2022 BY ARIEL KATZ, CEO QINFLOW

Rapid infusers are a great option for treating patients with severe hemorrhage. However, they require significant commitment from the hospitals: they are expensive to purchase, expensive to operate, and expensive to maintain. As importantly, they require significant ongoing investment in training so as to keep the staff adequately comfortable using them. Too often emergency personnel would avoid using their state-of-the-art rapid infusers simply because they are overwhelmed with their complex operation and time-consuming troubleshooting. In today’s environment, that requires hospital to rely on ‘travelling nurses’ to complement their staff. The situation is worsened since continuous education on rapid infusers is simply impractical.

Therefore, a growing number of hospitals are approaching us with a similar request: “we need a bridge to the rapid infusers”, they say. Indeed, there are other more practical solutions to transfuse warm blood fast. When used with flow-inducing devices such as pressure bag, hand pump, push-pull, electro-mechanical pump, or LifeFlow infuser, the Warrior line of next-generation blood warmers is an excellent bridge to the rapid infusers.  The following paragraphs introduce some of the key benefits of the Warrior over rapid infusers.

  • Speed. It is important to note that in over 95% of the cases rapid infusers are not required.  The patient will receive anywhere between 1 and 3 units of blood and rushed to the OR. In such instances, we celebrate that the Warrior delivers 1-3 units of warmed blood to patients much faster than rapid infusers, simply because set up time is reduced to just a few seconds.
  • Simplicity. Moreover, unlike rapid infusers, anyone can be trained to operate the Warrior. This removes the pressure that only a few expert nurses can operate the device flawlessly, as is often the case with rapid infusers. In addition, and unlike rapid infusers, troubleshooting the Warrior is fast and easy.  The Warrior’s simplicity has even greater value in situations of a mass casualty event since a stretched medical staff will greatly struggle to operate multiple rapid infusing devices concurrently.
  • Portability. One additional key advantage of the Warrior over rapid infusers is its portability. With rapid infusers, warm blood cannot be administered during a patient’s transfer to the next level of care, whereas the Warrior has been designed to facilitate patient’s transports (from field to ED, trauma, OR, and ICU). Unlike rapid infusers, the Warrior can be simply attached to the bed during patient’s transfer from ED to OR, thus freeing the hands of caregivers to perform more important stuff.
  • Unique Continuum of Emergency Care Proposition. The portability aspect enables a unique continuum of care proposition, whereby the same consumable can be used across the entire continuum of emergency care, thus simplifying patient handoff between emergency settings and reducing costs. If fully adopted by the hospital, further ROI benefits can be attained by streamlining training efforts, reducing dependency on dedicated staff, reducing spare part inventory, and eliminate monthly service calls and calibration endeavors that raid infusers typically require. If the hospital has a critical care transport team, treatment with the Warrior can commence even prior to the arrival of the patient to the ED.
  • Pediatric Applications. Another benefit of the Warrior is its ability to operate even with small-size catheters, designed for pediatric patients. Rapid infusers are limited to larger catheters which is part of the reason that a growing number of pediatric hospitals have adopted the Warriors along with the LifeFlow infusion device.
  • Maintenance Free. The Warrior does not require any routine service or any annual calibration.  It requires just one inspection every 5 years. Rapid infusers typically demand monthly service and calibration endeavors that overload the biomed team.
  • Aluminum Free. The Warrior is aluminum free; some rapid infusers contain aluminum in their fluid path.
  • Improved ROI. Finally, cost — both capital and consumables — is another huge benefit of the Warrior over rapid infusers.  A rapid infuser may cost $30k. At this price you can get approximately 8 Warrior AC devices…  A rapid infuser’s consumables are in the range of hundreds of dollars, considerably higher than the Warrior’s Compact Disposable Unit. There are also significant benefits related to reduction of indirect costs, such as simplified training, elimination of spare inventory, and elimination of complex service requirements, to name just a few.

To summarize, even the best-equipped medical centers are too often reluctant to use their rapid infusers due to their complexity. In such cases, therefore, the patients will get cold blood/fluid. While the Warrior is not a rapid infuser, it will outperform rapid infusers in greater than 95% of the cases, when just a few units of blood/fluid are required. In such cases, the Warrior will perform the job faster, more effectively, and more economically than the over-sized, complex, and expensive to operate rapid infusers.  Even in those few cases that rapid infusers are required, the Warrior can be used initially so as to accelerate the delivery of the first few units of blood to the patient.  In all these cases, the Warrior acts as an optimal bridge to the rapid infusersContact us for more information.

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Good News Line is OPEN!

Northeast Georgia Medical Center in Gainsville, GA has ordered and received 10 Warrior AC systems from Bell Medical and QinFlow for use in their operating rooms. 

This is our third order in the last 3 months for Warrior fluid warmers.  Children’s of Alabama, Birmingham, AL purchased 8 Warriors including the Warrior Hybrid and Warrior AC including the Warrior base unit with battery operation.  Kings Daughters Children’s hospital in Norfolk, VA. Has also invested in the Warrior with 8 systems. 

Warrior uses medical grade stainless steel tubing and state of the art micro processing to automatically adjust and control the temperature of fluids.  Warrior delivers 38 degrees C consistently regardless of flow rates from KVO to 290ml/min. The Warrior is perfect for the operating room, ED and Trauma but also has battery option offering unique portability for patient transport to ICU or use on Helicopter.  Combat hypothermia with the Warrior!   WE ARE ON A ROLL WITH WARRIOR!  Why:  Because Smith’s Level One is on recall for aluminum leaching and Smith’s Hotline is having warming set supply shortages AND the Warrior is amazing!  The Warrior is the only fluid warmer approved to work with the LifeFlow rapid infuser and the only warmer that excels in handling intermittent flow rates.  Bell Medical has the GOOD STUFF! 

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Aluminum: The Hidden Danger in Blood Warmers

Posted on by Stephen Alexander

Recently, there have been growing concerns from regulatory agencies, such as the FDA, as to the safety of aluminum containing medical devices, especially those involved with the infusion of fluids into patients. Just this past year, the FDA has recalled six intravenous fluid warming products due to evidence showing increased levels of aluminum. According to the FDA, “Exposure to toxic levels of aluminum may not be easily recognized and exposure effects may cause serious adverse events including death”. Some manufacturers have provided a potential solution by using coated aluminum surfaces. While these solutions certainly show improvement, they still release detectable levels of aluminum into infused fluids. The question is, are these levels safe or not? In this article, I will unfold some information about the recent recalls, the risk in aluminum, and other safety considerations regarding blood/fluid warmer. But I would like to start by making it clear to the reader that —

I’m not an expert, just an informer. First let me say that I am no expert in the field of toxicology, therefore it is beyond me to say for certain the safety of aluminum based warmers. That job I leave to regulatory agencies such as the FDA. However, once I reviewed the evidence and recalls put out by the FDA, I felt that I needed to make sure other providers are aware of the risks and recent recalls of these products. We should trust the sophisticated and rigorous medical approval system that we have in place. Therefore, it is my viewpoint that aluminum-based heaters that are regulatory cleared must be 100% safe to use. Nonetheless, we as critical care paramedics, nurses, and physicians must, as a minimal requirement, understand the risks associated with this method of warming. We owe it to our patients to be as well informed and up to date with the risks of certain treatments we provide, especially given the growing number of recalls of aluminum based warming devices.

Peer reviewed research of the risks. Aluminum toxicity can lead to a plethora of diseases ranging from Alzheimer’s, autism, breast cancer, to pancreatitis and pneumonia just to name a few (Igbokwe, 2019). In infants, aluminum toxicity is associated with impaired neurological development (Bishop, 1997). What’s even more alarming is that aluminum can also cause decreased iron absorption and anemia. Imagine trying to infuse blood products to correct anemia, and exposing your patient to toxic aluminum that causes the problem you are trying to reverse! Recalls of blood/fluid warmers due to the potential of aluminum leaching are typically identified as Class I recalls. These are the most serious as they are for devices that may cause serious injury or death! Patients most at risk are pediatric patients, specifically neonates and infants, pregnant women, geriatric populations, and those with decreased renal function or on dialysis.

Why manufacturers like to use aluminum in fluid warmers. Aluminum is used in a wide spectrum of medical devices, and when compared to other materials, it’s easy to see why. Aluminum has a large strength-to-weight ratio. This means that aluminum compared to other materials is stronger and lighter. Aluminum is also a good thermal conductor. In addition, aluminum is very malleable, thus it can be formed to almost any specification. Aluminum is a plentiful material as well; in fact, it is the most abundant metal in earth’s crust, making it very cost effective. All these reasons are why we find aluminum, not just in medical equipment, but in our everyday lives. It’s a good, plentiful, strong material that has countless applications. However, this article seeks to explain why using aluminum may not be the best option with respect to blood/fluid warmers.

Advancements in analytical technology have changed the stance on aluminum. If aluminum is unsafe, then why did the FDA approve of its use in fluid warmers initially? The answer is basically “you don’t know what you don’t know”. Regulatory agencies such as the FDA are only as good as the technology they have available to them. In recent years, advancements in technology have enabled regulators to measure more accurately the levels of aluminum produced from blood warmers that use that material. Keep in mind that when the FDA approved aluminum containing medical devices, it was before sensitive testing instruments were used to detect the minimum allowable limits of aluminum that is set forth today. This means that there was no way of knowing if these devices were leaching aluminum or not into the infused fluids. Therefore, these devices were developed, approved, and put on the market. Only until recently are regulatory agencies capable of measuring the threshold limits produced by these products, and the results — for some of these devices — are concerning.

Increased concern over aluminum containing warmers evident by 3 FDA recalls of 6 warming devices in just 6 months. Since March of this year there have been three separate recalls on fluid warmers that contain aluminum. The FDA has warned that the aluminum used in the heating elements is leaching into the fluids and being infused into patients. In March of 2021 ThermaCor 1200 disposable sets were recalled. The customers were notified of a Toxicological Assessment that there was potential aluminum leaching into fluids. Later, Eight Medical International’s Recirculator disposables were recalled in July of this year. The most recent recall was of 4 Smith Medical’s Level 1 configurations for the same reason, leaching of aluminum. This is on top of yet another global recall of the enFlow device in 2019. With so many recalls in such a short period, it does raise concern that blood warmers containing aluminum in their heating elements pose a potential risk to patients. You can read the FDA’s Letter to Health Care Providers on the recent recalls here.

Researchers find that coated aluminum may not prevent leaching. Manufacturers of blood/fluid warmers with aluminum heaters often make a distinction between uncoated and coated aluminum heaters. The latter (i.e. coated aluminum) is expected to be safer for patients, compared with non-coated aluminum. This makes sense. However, even blood/fluid warmers that utilize coated aluminum may pose a risk to patients. In June of 2019, researchers found that aluminum was still detectable in fluids infused with devices that use coated aluminum. The study compared aluminum release of coated and uncoated fluid-warming devices. The results of the study found that while aluminum release was less in coated devices, it still was elevated above baseline. In fact, the researchers stated that “our methodology does not have the ability to differentiate between the concentrations we measured and the FDA threshold.”(Perl, 2019).

Manufacturers may be predisposed to maintain the status quo. Despite the recent recalls, the default claim of manufacturers that use aluminum heaters is that the aluminum remains below the acceptable limits set forth by regulatory agencies. However, the accuracy of this claim is debatable, and the data that is used to defend these claims is often open for contradicting interpretations. At least in one recent case, the Canadian FDA publicly refuted such a claim proposed by Smiths Medical. Without getting into the specifics of this particular case, it’s easy to understand why manufacturers may resist a change. It goes without saying that they must trust that their solution is 100% safe in order to commercialize it. However, is it possible that this high level of confidence may also be fueled by some sort of an ‘organizational predisposition’? Let me try to explain: these manufacturers assumed significant risks and invested millions of dollars to overcome the demanding regulatory barriers that stand between any medical device innovation and the marketplace. Even after commercializing the product, they had to invest significant budgets in continuous engineering and regulatory affairs. Therefore, they need to see positive returns following these huge investments, otherwise future innovation might suffer. Certainly, a very complex and delicate situation that manufacturers must contend with.

Other associated risks of blood/fluid warming. It should be noted that warming fluids does come with other risks besides aluminum leaching. Let’s review some of these other risks:

  • Hemolysis. One risk is hemolysis due to the age of blood products given. This isn’t necessarily a risk associated only with warming blood products, but just a general risk overall. As the products age, red blood cells have a higher chance of rupturing. That’s why it’s important to infuse blood products before the expiration date.
  • Excessive sheer force, turbulence, and cavitation. 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. Why don’t you simply try to look under the hood of your chosen warmer?
  • Over/under heating. Another risk is over/under heating the fluids/blood being infused. I believe that under heating is a bigger and more common issue especially with high flows and with intermittent flow methods. If your agency requires high flows or uses an infusion device that utilizes intermittent flow, most warmers cannot keep up with the job. If the warmer can’t physically warm the fluids to body temperature at the rate being infused, you’re introducing hypothermic fluids into your patient. Even room temperature fluids are far below body temperature, especially for severely sick patients suffering from shock.
  • Aggressive heat transfer process. It seems logical that a relaxed heat transfer process from the heat exchanger to the blood/fluids 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.
  • 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 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.

A solution. Clearly the wrong answer to prevent aluminum leaching from blood/fluid warmers is to not utilize a warmer. Myself and other colleagues have written extensively about the importance of warming fluids, especially blood products in rapid transfusions. You can read some of those articles here .One practical solution to this problem is utilizing a warmer that is aluminum free in the first place, or, if you decide to use an aluminum warming solution, then do your due diligence about the solution. There are several prehospital and hospital solutions that are aluminum free, such as the Thermal Angel, Quantum, and Ranger, to name just a few. QinFlow’s Warrior is another excellent example of an aluminum-free warmer: it has battery and AC power sources and it therefore fits both prehospital and hospital settings. It has amazing performance levels, measured in maximum delivery rates. And as importantly, its per-use price is very competitive. You can read more about the Warrior here.

Summary & Conclusion. New, more sensitive, monitoring technology has made it possible for regulatory agencies to detect trace levels of aluminum, before unknown to us. Exposure to toxic levels of aluminum, according to the FDA, “may cause serious adverse events including death”. With that information, three recalls of 6 devices have been issued within the past few months over growing concern of elevated aluminum levels in fluids infused by products containing aluminum heating elements. We’ve seen that not even coated aluminum surfaces prevent leaching into fluids. The only way to ensure that zero aluminum is leaching into your patients is most probably to utilize solutions that are aluminum free. While there are several options out there, the QinFlow’s Warrior is a good place to start. Their fluid path is 100 percent aluminum free. They are also amongst the most cost efficient solutions on the market. A true win win. QinFlow’s disposable cassettes have a comfortable and gentle priming volume of 19mL. Finally, the Warrior is rugged enough to withstand high pressures of intermittent flow and can warm near freezing blood products to body temperature within seconds, safely!

***

Bishop NJ, Morley R, Day JP, Lucas A. Aluminumneurotoxicity in preterm infants receiving intravenous-feeding solutions. New England Journal of Medicine 1997;336: 1557–61

Igbokwe, I. O., Igwenagu, E., & Igbokwe, N. A. (2019). Aluminium toxicosis: a review of toxic actions and effects. Interdisciplinary toxicology, 12(2), 45–70. https://doi.org/10.2478/intox-2019-0007

Perl, T., Kunze-Szikszay, N., Bräuer, A., Quintel, M., Röhrig, A.L., Kerpen, K. and Telgheder, U. (2019), Aluminium release by coated and uncoated fluid-warming devices. Anaesthesia, 74: 708-713. https://doi.org/10.1111/anae.14601

Stephen Alexander

Stephen Alexander is a Critical Care Paramedic residing in Little Rock Arkansas. He enjoys writing informative and educational articles about pre-hospital medicine. Stephen started his career in EMS by enlisting in the Army as a 68W Combat Medic. He then attended the U.S Army Flight Medic program through UTHSCSA and received his paramedic license through NREMT. He then went to RUSH Advanced Trauma Training Program in Chicago and attained his CCEMTP. He currently flies for the Arkansas Army National Guard MEDEVAC unit.

Full article can be found here: https://www.qinflow.com/aluminum-the-hidden-danger-in-blood-warmers/

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LifeFlow Blood and Fluid Infuser: Volume resuscitation when minutes matter!

LifeFlow offers improved resuscitation through earlier and controlled fluid delivery. LifeFlow is a hand operated rapid infuser for critically ill patients who require urgent fluid delivery. 

  • Controlled hand-operated rapid infuser
  • Easy to use, intuitive and safe
  • Four times plus faster than pressure bag delivering 500ml in less than 2 minutes
  • Reverses shock and restores tissue perfusion saving lives
  • Improves outcomes and reduces mortality
  • Easy set up and priming with set up in less than 40 seconds
  • Measured delivery with 10ml delivered with each trigger pull
  • Built in “force reducer” reducing infuser force protecting IV site from blow outs
  • Works with the QinFlow Warrior blood warmer
  • Eliminates “Pull/Push technique for pediatrics
  • Fluids can be delivered through 24 gauge catheter and blood through a 22g. 
  • 5 times faster than pressure bag
  • Great for hypotension
  • Safety system prohibits more than 200PSI pressure delivery

Click to view a short training video

Can be used with Warrior Blood and Fluid Warmer