Bioelectrical Impedance Analysis (BIA) and Electronic Medical Device Implants – January 2014

Bioelectrical Impedance Analysis (BIA) and Electronic Medical Device Implants RJL Sciences – January 2014

Note: For informational purposes only. Always consult with your physician regarding the use of BIA with your particular electronic medical implant device.

As part of our commitment to lead the BIA industry, we hope this information will help you and your physician determine if BIA is appropriate for you. Because the manufacturers of implantable electronic medical devices do not generally test their products to ensure that they will continue to operate correctly during and after a BIA test, the FDA has requested that RJL caution against the use of a BIA on individuals with those types of devices.

This issue was addressed and summarized in the international ESPEN 2004 statement on BIA in clinical practice, stating while there was a possibility of altered pacemaker or defibrillator activity, and that cardiac activity should be monitored…no interference with pacemakers or defibrillators is anticipated.1

A 2012 article published in Pacing and Clinical Electrophysiology reported no evidence of BIA interference in 20 subjects with implantable cardioverter defibrillators.2

Comments made by individuals on pacemaker website blogs show little to no concern over the question of BIA interfering with their pacemakers, but did wonder if a pacemaker could interfere with the accuracy of a BIA measurement.3

Medical devices vary in specification and function. For your reference, RJL Systems Quantum BIA devices utilize a fixed 50 kHz signal, and conform to the requirements in ANSI/AAMI ES1 and IEC 60601-1:2005, for maximum allowable current applied to the patient.

RJL Sciences continues to advise individuals to consult with their physician regarding their particular electronic medical implant device.

1 Kyle U, et al., Bioelectrical impedance analysis—part II: utilization in clinical practice. Clinical Nutrition, 2004; 23, 1430-1453.

2 Buch E, Bradfield J, Larson T, Horwich T, Effect of bioimpedance body composition analysis on function of implanted cardiac devices, Pacing Clinical Electrophys, 2012 Jun; 35(6):681-4.

3 (12/18/2013) and (12/30/13)

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