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.

References 

  1. van der Togt R, van Lieshout EJ, Hensbroek R, Beinat E, Binnekade JM, Bakker PJ. Electromagnetic interference from radiofrequency identification inducing potentially hazardous incidents in critical care medical equipment. JAMA. 2008;299:2884–2890
  2. Christe B, Cooney E, Maggioli G, Doty D, Frye R, Short J. Testing potential interference with RFID usage in the patient care environment. Biomed Instrum Technol. 2008;42:479–484
  3. American Nationals Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI). Active implantable medical devices—electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators (Standard PC69). Arlington, VA: ANSI/AAMI; 2007;
  4. Seidman S. Electromagnetic compatibility of pacemakers and implantable cardiac defibrillators exposed to RFID readers. Paper presented at: RFID Journal LIVE! Conference, April 30–May 2, 2007; Orlando, FL.
  5. Seidman S, Ruggera P, Brockman R, Lewis B, Shein M. Electromagnetic compatibility of pacemakers and implantable cardiac defibrillators exposed to RFID readers. Int J Radio Freq Identif Technol Appl. 2007;3:237–246
  6. Clement W. Estimation of effective lead loop area for implantable pulse generators and cardioverter/defibrillators for determination of susceptibility to radiated electromagnetic interference. Paper presented at: CRMD EMC Task Force Meeting, April 12, 2004; Washington DC.
  7. British Standards Institute. Active implantable medical devices (Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) (Standard BS EN 45502-2-1)). London, United Kingdom: British Standard; 2003;
  8. Hayes D, Wang P, Reynolds D, et al. Interference with cardiac pacemakers by cellular telephones. N Engl J Med. 1997;21:1473–1479
  9. Steffens R, Valmonte C, Carlo G, et al. A comparison of clinical and bench test results from pacemaker/wireless phone interference studies: does bench testing adequately predict clinical pacemaker interference?. J Clin Eng. 1999;3:166–171
  10. Ashar BS, Ferriter A. Radiofrequency identification technology in health care: benefits and potential risks. JAMA. 2007;298:2305–2307

 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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