The FDA, in collaboration with major implantable pacemaker and ICD manufacturers, demonstrated the effects of emissions from radiofrequency identification device (RFID) readers on common implantable cardiac devices. Based on research in the January issue of the Heart Rhythm Journal, the observed effects may cause increasing complications as RFID use expands in the medical device field.
Seth J. Seidman, MS, research electrical engineer for the FDA’s Center for Devices of Radiological Health, and colleagues examined the electromagnetic interference susceptibility of 15 pacemakers and 15 ICDs caused by exposure to 13 RFID readers during June 2008 to August 2008. The researchers found that low-frequency RFID readers may pose the greatest risk to pacemakers and ICDs.
While contemporary pacemakers and ICDs use filters to minimize susceptibility to higher-frequency signals, the authors noted that there is limited filtering of low-frequency signals due to the design constraints of both pacemakers and ICDs.
“We do not believe the current situation reveals an urgent public health risk,” Seidman and colleagues wrote. “However, we are concerned that the continued proliferation of RFID without taking electromagnetic interference into consideration could cause clinically significant events for patients.”
Reactions from pacemakers and ICDs include pacing inhibition, inappropriate pacing, noise reversion mode, changed pacing rates, inappropriate delivery of anti-tachycardia pacing, inappropriate high-voltage shocks and device programming change. Although in vitro testing demonstrated the potential for pacemaker and ICD interference, the FDA has not received any incident reports of electromagnetic interference caused by any RFID system.
While clinical exposure to RFID readers is uncommon, the authors noted that advances in medical applications using RFID may lead to increased use in patient care. They also commented on the “potential advantages of RFID in healthcare,” which “seem promising,” and the FDA is promoting RFID as a technology to reduce counterfeit drugs in the supply chain.
To mitigate pacemaker and ICD electromagnetic interference from RFID readers, the researchers encouraged implant manufacturers and the RFID industry to work to develop industry requirements and design future devices “appropriately.”