Heart Rhythm
Volume 7, Issue 1 , Pages 99-107 , January 2010

In vitro tests reveal sample radiofrequency identification readers inducing clinically significant electromagnetic interference to implantable pacemakers and implantable cardioverter-defibrillators

  • Seth J. Seidman, MS

      Affiliations

    • U.S. Food and Drug Administration, Silver Spring, Maryland
    • Corresponding Author InformationAddress reprint requests and correspondence: Seth J. Seidman, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, White Oak Building 62 Room 1117, Silver Spring, Maryland 20993
    • ,
  • Randall Brockman, MD

      Affiliations

    • U.S. Food and Drug Administration, Silver Spring, Maryland
    • ,
  • Brian Marc Lewis, MD

      Affiliations

    • U.S. Food and Drug Administration, Silver Spring, Maryland
    • ,
  • Joshua Guag, BS

      Affiliations

    • U.S. Food and Drug Administration, Silver Spring, Maryland
    • ,
  • Mitchell J. Shein, MS

      Affiliations

    • U.S. Food and Drug Administration, Silver Spring, Maryland
    • ,
  • Wesley J. Clement, BS

      Affiliations

    • Medtronic, Inc., Minneapolis, Minnesota
    • ,
  • James Kippola, BS

      Affiliations

    • Boston Scientific, Saint Paul, Minnesota
    • ,
  • Dennis Digby, BS

      Affiliations

    • Biotronik, Berlin, Germany
    • ,
  • Catherine Barber, MS

      Affiliations

    • St Jude Medical, Saint Paul, Minnesota
    • ,
  • Dan Huntwork, MS

      Affiliations

    • Sorin, Milano, Italy

Received 16 June 2009 ,Accepted 28 September 2009.

  • Image Result

    A drawing of the human torso simulator.

    A drawing of the human torso simulator.

  • Image Result

    Percentage of pacemaker reactions graded for clinical significance. The percentage of tests with a reaction for pacemakers graded for clinical significance (there were no class II reactions). Pacemake

    Percentage of pacemaker reactions graded for clinical significance. The percentage of tests with a reaction for pacemakers graded for clinical significance (there were no class II reactions). Pacemaker tests at nominal sensitivity during HF RFID exposure had 1% class I reactions and 1% class III reactions. HF = high frequency; LF = low frequency; RFID = radiofrequency identification; UHF = ultra high frequency; Max = maximum sensitivity; Nom = nominal sensitivity.

  • Image Result
    Percentage of ICD reactions graded for clinical significance. The percentage of tests with a reaction for ICDs graded for clinical significance (there were no class II reactions). ICD = implantable ca

    Percentage of ICD reactions graded for clinical significance. The percentage of tests with a reaction for ICDs graded for clinical significance (there were no class II reactions). ICD = implantable cardioverter-defibrillators; other abbreviations as in Figure 2.

  • Image Result
    Percentage of pacemaker reactions versus distance. The percentage of pacemaker tests (at each sensitivity level) with a reaction within distance ranges during LF and HF RFID exposure. There were no pa

    Percentage of pacemaker reactions versus distance. The percentage of pacemaker tests (at each sensitivity level) with a reaction within distance ranges during LF and HF RFID exposure. There were no pacemaker reactions caused by either of the 2 UHF RFID readers. Abbreviations as in Figure 2.

  • Image Result
    Percentage of ICD reactions versus distance. The percentage of ICD tests (at each sensitivity level) with a reaction within distance ranges during LF and HF RFID exposure. There were no ICD reactions

    Percentage of ICD reactions versus distance. The percentage of ICD tests (at each sensitivity level) with a reaction within distance ranges during LF and HF RFID exposure. There were no ICD reactions caused by either of the 2 UHF RFID readers. Abbreviations as in Figure 2.

  • Image Result
    Feed-through filter performance. Performance of 4 different valued feed-through capacitors. The majority of attenuation occurs at 915 MHz (UHF RFID), less attenuation at 13.56 MHz (HF RFID), and less

    Feed-through filter performance. Performance of 4 different valued feed-through capacitors. The majority of attenuation occurs at 915 MHz (UHF RFID), less attenuation at 13.56 MHz (HF RFID), and less than 1 dB of attenuation at 134 kHz (LF RFID). Abbreviations as in Figure 2.

 Data acquisition was performed by Seidman (FDA) and Guag (FDA), and each device manufacturer provided an engineer for testing of their devices (Clement, Kippola, Digby, Barber, Huntwork). Brockman, Lewis, and Shein (FDA) were responsible for analyzing the clinical significance of the results. No authors have any financial or personal relationships that would influence or bias the authors' decisions, work, or manuscript other than their employment and voluntary, nonpaid membership with the AAMI CRMD EMC Task Force.

 The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services.

PII: S1547-5271(09)01146-1

doi: 10.1016/j.hrthm.2009.09.071

Heart Rhythm
Volume 7, Issue 1 , Pages 99-107 , January 2010

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