Study type: Medical/biological study (experimental study)

Absence of acute adverse in-vitro effects on AS-1 RBCs and whole blood-derived platelets following prolonged exposure to 13.56 MHz radio energy med./bio.

By: Davis R, Gottschall J, Gutierrez A, Hohberger C, Veeramani D, Holcombe J
Published in: Transfusion 2010; 50 (7) Pt 2: 1596-1603
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Aim of study (acc. to author)

To study the temperature and biological effects of 13.56 MHz radiofrequency exposure on red blood cells and whole blood-derived platelets under extreme exposure conditions.

Background/further details

There is growing interest in radio frequency identification (RFID) technology application for tracking blood products to achieve higher productivity and safety in the transfusion medicine supply chain.
A FDA-approved protocol with specific criteria concerning e.g. hemolysis or pH value was used.

Endpoint

Exposure

Exposure Parameters
Exposure 1: 13.56 MHz
Exposure duration: continuous for 7 h or 23 -25 h

Exposure 1

Main characteristics
Frequency 13.56 MHz
Type
Exposure duration continuous for 7 h or 23 -25 h
Exposure setup
Exposure source
Setup samples placed in the center of a 86 cm Helmholtz coil; magnetic field uniform within 1% in the exposure area; coil placed in a chamber made of Plexiglas laminates; positioned on a non-metallic, perforated test platform; exposure unit placed in a Faraday cage: Red blood cell products were tested in a walk-in refrigerator at a constant temperature of 1 - 6° C; whole blood-derived platelets products were tested in a temperature-controlled room at 20 - 24 °C
Parameters
Measurand Value Type Method Mass Remarks
magnetic field strength 5 A/m - - - -
magnetic flux density 6.28 µT - - - -
power 100 W - - - -

Exposed system:

Methods Endpoint/measurement parameters/methodology

Investigated system:
Time of investigation:
  • before exposure
  • after exposure

Main outcome of study (acc. to author)

Hemolysis after 23-25 hours of very high radiofrequency energy exposure was 0.09% and 0.05%, respectively, for exposure and control red blood cell units and well within the ≤ 1% limit in the FDA-approved acceptance criteria.
For platelet units, the mean pH of exposure and control units was 7.27 and 7.19, respectively, following 23-25 hours of radiofrequency exposure, and well above the ≥ 6.2 acceptance limit value.
Furthermore, there was no detectable acceleration in cellular degradation of red blood cells and whole blood cell derived platelet products. While there was minimal temperature rise, the relative temperature increase between exposure and control units never exceeded the 1.5°C acceptance criterion.
In conclusion, 13.56 MHz-based RFID technology is unlikely to have any significant temperature or biological effects on red blood cells and whole blood cell derived platelet units under the normal operating conditions (a maximum of 4 W radiofrequency exposure for about 20 nonconsecutive minutes for RFID tracking during the life of the blood product).

Study character:

Study funded by

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