体外测试显示，样本射频识别读取器对植入式心脏起搏器和植入式除颤复律器产生具有临床意义的电磁干扰。
In vitro tests reveal sample radiofrequency identification readers inducing clinically significant electromagnetic interference to implantable pacemakers and implantable cardioverter-defibrillators.
机构信息
U.S. Food and Drug Administration, Silver Spring, MD, USA.
出版信息
Heart Rhythm. 2010 Jan;7(1):99-107. doi: 10.1016/j.hrthm.2009.09.071. Epub 2009 Oct 12.
BACKGROUND
The use of radiofrequency identification (RFID) systems is expanding and highlights the need to address electromagnetic interference (EMI) to implantable pacemakers and implantable cardioverter-defibrillators (ICDs).
OBJECTIVE
This study sought to examine the electromagnetic compatibility (EMC) between RFID readers and implantable pacemakers or ICDs.
METHODS
During in vitro testing, 15 implantable pacemakers and 15 ICDs were exposed to 13 passive RFID readers in 3 frequency bands: 134 kHz (low frequency [LF]), 13.56 MHz (high frequency [HF]), and 915 MHz (ultra high frequency [UHF]).
RESULTS
While being exposed to LF RFID, a reaction was observed for 67% of all pacemaker tests (maximum distance 60 cm) and 47% of all ICD tests (maximum distance 40 cm). During HF RFID exposure, a reaction was observed for 6% of all pacemaker tests (maximum distance 22.5 cm) and 1% of all ICD tests (maximum distance 7.5 cm). For both pacemakers and ICDs, no reactions were observed during exposure to UHF RFID or continuous-wave RFID. Pacemakers and ICDs were most susceptible to modulated LF RFID readers.
CONCLUSION
Although there is in vitro testing evidence for concern for implantable pacemaker and ICD EMI at LF and HF, the FDA has not received any incident reports of pacemaker or ICD EMI caused by any RFID system. We do not believe the current situation reveals an urgent public health risk.
背景
射频识别（RFID）系统的使用正在不断扩大，这凸显了需要解决对植入式起搏器和植入式心律转复除颤器（ICD）的电磁干扰（EMI）问题。
目的
本研究旨在检查 RFID 读写器与植入式起搏器或 ICD 之间的电磁兼容性（EMC）。
方法
在体外测试中，将 15 个植入式起搏器和 15 个 ICD 暴露于 3 个频带的 13 个无源 RFID 读写器中：134 kHz（低频 [LF]）、13.56 MHz（高频 [HF]）和 915 MHz（超高频 [UHF]）。
结果
在 LF RFID 暴露期间，观察到所有起搏器测试（最大距离 60 cm）的 67%和所有 ICD 测试（最大距离 40 cm）的 47%有反应。在 HF RFID 暴露期间，观察到所有起搏器测试（最大距离 22.5 cm）的 6%和所有 ICD 测试（最大距离 7.5 cm）的 1%有反应。对于起搏器和 ICD，在 UHF RFID 或连续波 RFID 暴露期间均未观察到反应。起搏器和 ICD 最容易受到调制 LF RFID 读写器的影响。
结论
尽管有体外测试证据表明对植入式起搏器和 ICD 的 EMI 在 LF 和 HF 频段存在担忧，但 FDA 尚未收到任何因任何 RFID 系统导致起搏器或 ICD EMI 的事件报告。我们认为目前的情况并未揭示出迫切的公共健康风险。
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