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(Database last updated on Mar 27, 2024)
| ID Number | 1069 | |
| Study Type | Engineering & Physics | |
| Model | Mobile phone exposure [900, 1800 MHz (CW, GSM)] to pacemakers and analysis of electromagnetic interference. | |
| Details | Several models of pacemakers [PM MINIOR 100 (Sorin Biomedica, Italy) were exposed to 900 or 1800 MHz (CW, GSM, TACS) RF. The authors report various effects of signals on the pacemakers including desensitizing / sensitizing and pulse inhibition. CW RF signals did not alter the response of the sensing amplifier, while GSM RF signals were demodulated and resulted in artifacts (in models using a block capacitor) that may be mistaken for the patients heartbeat. In subsequent studies, the authors report that exposure of several pacemaker models (using a saline trunk simulator) to analog mobile phone technology caused interference with more models (10 of 25) and to a greater extent than TACS technology and included pacemaker desensitizing / sensitizing and pulse inhibition during incoming call and throughout ringing and in certain models resulted in skipping beats before resuming normal pacing. A recent report suggests newer pacemakers are more immune and less vulnerable to such EMI events. AUTHORS' ABSTRACT: Mattei et al. 2016 (IEEE #6349): The purpose of this study is to perform provocative testing for the assessment of the electromagnetic interference (EMI) of radiofrequency identification (RFID) and near field communication (NFC) readers on implantable pacemakers (PMs). Ten PMs were exposed to the electromagnetic field generated by an RFID/NFC reader emulator, in the LF (125 kHz), HF and NCF (13.56 MHz), and UHF (900 MHz) bands. Provocative tests were performed by increasing the field strength beyond the maximum levels allowed for commercial devices. PMs were affected by EMI for all three frequency bands. For the LF RFID, 2/10 PMs when exposed to magnetic field levels typical of commercial devices (100 A/m) and 9/10 PMs at a magnetic field of 500 A/m. For the HF RFID and NFC, 3/10 PMs when exposed to output power levels of magnetic field typical of commercial devices (4 W), and 7/10 PMs at 10 W. For the UHF RFID, 2/10 at output power lever of 2 W, and increasing the output power level up to 20 W did not caused EMI in the other PMs. For the PMs evaluated, the provocative tests performed in this study revealed that the safety margin is narrow in the LF and HF/NFC bands, whereas a fair margin exists in the UHF band. |
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| Findings | Not Applicable to Bioeffects | |
| Status | Completed With Publication | |
| Principal Investigator | Istituto Superiore di Santi, Rome, Italy | |
| Funding Agency | FDA, USA | |
| Country | ITALY | |
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