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Updates

October 17, 2020

Comparing the performance of blood warmers against the "ideal parameters", as defined by TCCC

Users of equipment are always anxious to objectively compare available solutions based on an “ideal list” of parameters, prior to making a purchasing decision. When it comes to blood/fluid warmers, deriving such a list is nothing but trivial since the requirements vary considerably between settings. In its recent TCCC Guidelines for Management of Hypothermia in Tactical Combat Casualty Care, the TCCC attempted to address this challenge by deriving a list of ideal parameters for a blood warmer in combat settings.

The TCCC guidelines also state that to date, there is no optimal portable fluid/blood-warming device that has been evaluated independently among other devices with ideal features and performance characteristics for use on the battlefield. It also acknowledges that new products are in development. We took the initiative of comparing – as objectively as we can possibly be – the gap between what is available and what is required. The results are provided in the table below. The table compares the devices that are mentioned in the guidelines against the ideal parameters. We also took the liberty of adding the Warrior lite with Extra Power battery configuration (FDA pending) to the evaluation since we believe that this device is the closest to meeting the "ideal requirements" (column [B] in the table below).

It should be noted that as can be naturally expected, commercial data was not part of the TCCC assessment. Nonetheless, we added indicative per-use cost information in section 12 of the table below since this constitutes a major constraint for many organizations.

Finally, please make sure to review the disclaimers below the table.

Comparison of the Blood Warming Devices 

 

Warrior lite with Extra Power Battery

Warrior and Warrior EXTREME

Quantum™

Buddy Lite™

Thermal Angel™

[A]

[B]

[C]

[D]

[E]

[F]

1.       Rapid battery recharge duration (<100 min)

Warms 3 units of whole blood after 90 minutes of charging

Warms 3.5 units of whole blood after 90 minutes of charging

Warms 2 units of whole blood after 90 minutes of charging

NA (150 minutes for full charge yet please see performance constraints in [8] below)

<60 minutes to charge the ultra-battery (warming capacity TBD)

2.       Lightweight (~2 lb) and small dimensions (height, width, length)

2.64lb (2lb with the lite battery)

3.9lb

1.38lb

1.69lb

2.16lb

3.       Rugged for field use; flight approved (airworthy)

Tested for 15,000 ft. altitude

Tested for 15,000 ft. altitude

Tested for 12,000 ft. altitude

Altitude tests: TBD

Altitude tests: TBD

4.       Rapid start up (<30 s); functions in hypo/hyperbaric environments

Warmup time: a few seconds

Warmup time: a few seconds

Warmup time: 24 seconds

Warm up time: TBD

Warmup time: 45 seconds

5.       Water resistant: Operating conditions for battlefield temperature (−10°C to 45°C) and humidity (5%–95% relative humidity)

·   IP56

·   Operating temperature -5° to 50°C and

·   Relative Humidity 0% to 90%

·   Transition Operating temperature -20°C to 50°C & 90% RH

·   IP22/IP56 (Warrior/EXTREME)

·   Operating temperature -5° to 50°C and

·   Relative Humidity 0% to 90%

·   Transition Operating temperature -20°C to 50°C & 90% RH

·   IP53 (controller)

·   Operating temperature -15° to 50°C (controller)

·   Relative Humidity 0% to 95%

·   IPX1

·   Operating temperature 10° to 35°C

·   Relative Humidity 10% to 80%

·   IP rating: TBD

·   Operating temperature 10° to 40°C

·   Relative Humidity TBD

6.       Low noise and light signature

Complies

Complies

Seems to comply

Seems to comply

Seems to comply

7.       Long-life battery powered with easy replacement (reusable warming device)

3 years

3 years

3 years

TBD

TBD

8.       Battery duration for 4 units of whole blood at ≥100 to 150mL/min (4°C starting temperature)

Up to 6 units of whole blood at up to 180mL/min

Up to 7 units of whole blood at up to 200mL/min

Up to 2 units of whole blood at up to 100mL/min

·   Per product spec: limited to 50mL/min at 10°C fluid input!

·   Based on Lehavi et al study: unable to warm at 50mL/min and 10°C fluid input!

·   Per product spec: 150ml/min at 20°C fluid input!

·   Based on Lehavi et al study: 1 liter of blood (i.e. 2 units of whole blood) at <100mL/min and 10°C fluid input!

9.       Aluminum free to prevent aluminum toxicity

Complies

Complies

Seems to comply

Seems to comply

Seems to comply

10.    Set temperature below 42°C to prevent hemolysis

Complies

Complies

Seems to comply

Seems to comply

Seems to comply

11.    FDA status

Pending

Cleared

Cleared

Cleared

Cleared

12.    Per-use price

Moderate ($50-100)

Moderate ($50-100)

High ($100-150)

Low (<$50)

High ($100-150)

         

 

DISCLAIMERS:
Buddy Lite™ is a registered trademark of Belmont Instrument Corporation®. Thermal Angel® is a registered trademark of Estill Medical Technologies, Inc®. Quantum™ is a registered trademark of Life Warmer®. Quality in Flow is not affiliated with these manufacturers. The performance benchmarking of their devices is based on the following sources:

It should be noted that the sources above may not be up-to-date! Please contact the manufacturer with any question pertaining to the benchmark study. Please let us know if you find any inaccuracy so that we can fix it (info@qinflow.com).

This benchmark does not intend to cover all the differences between the devices and it focuses on key parameters only. Further, with the exception of sections 11 and 12, the parameters for the benchmark study were taken for the referenced TCCC guidelines.

The benchmark study was commissioned by QinFlow alone and not all data points were independently verified. The manufacturers of the other solutions were not part of this benchmark study.

The benchmark study only mentions devices that were included in the referenced TCCC guidelines (with the exception of the enFlow™, a registered trademark of Vyaire Medical™, which is on a global recall due to aluminum toxicity concerns). There are other active warming devices in the market (or in development) that were not included in this benchmark study.

Use of the Warrior is subject to QinFlow’s terms of use. QinFlow does not guarantee that any of the devices will achieve the results or perform as mentioned in the study. QinFlow only warrants the information published in its Instructions for Use. The Warrior lite is FDA pending. Therefore, performance claims may change without notice. The claims in the table above are consistent with the claims for the EU market.

Commercial per-use data is merely indicative. Please contact the manufacturer for exact information.