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Study Finds RFID Readers May Affect Pacemakers, But Pose No Urgent Risk

The U.S. Food and Drug Administration, in collaboration with major implantable pacemaker and ICD manufacturers, demonstrated the effects of RF emissions from RFID readers on implantable cardiac devices.
By Mary Catherine O'Connor
Jan 08, 2010A study published this month in a medical journal shows that while interrogators of passive RFID tags do cause some electromagnetic interference to implantable pacemakers and implantable cardioverter-defibrillators (ICDs), the devices pose no urgent health risks. However, the study's authors believe that the "continued proliferation of RFID without taking implantable pacemaker and ICD EMC into consideration could potentially cause clinically significant events for patients."

The research was conducted by the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health, which is responsible for regulating companies that manufacture medical devices sold in the United States, as well as for regulating radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions. This research was supported by the Cardiac Rhythm Management Devices (CRMD) Electromagnetic Compatibility (EMC) Task Force of the Association for the Advancement of Medical Instrumentation, a nonprofit organization that works to advance the safety of medical devices through standards development and information-sharing.

The study, conducted in a laboratory, involved exposing 15 implantable pacemakers and 15 ICDs to an interrogation field. Each device manufacturer provided an engineer for testing its own implantable devices. The group employed 13 RFID readers from six different manufacturers in three frequency bands: 134 kHz low-frequency (LF), 13.56 MHz high-frequency (HF) and 915 MHz ultrahigh-frequency (UHF). There were five LF, six HF and two UHF readers. Each device was turned on, and proper operation was verified.

The study's findings were peer-reviewed and published in the January 2010 edition of HeartRhythm Journal, the official journal of the Heart Rhythm Society and the Cardiac Electrophysiology Society The findings show that the readers in the LF band produced the most significant reaction; 67 percent of all pacemakers tested showed EMI interference from these devices at a maximum distance of 60 centimeters (24 inches) between the interrogator and the pacemaker. And 47 percent of all ICDs tested showed interference at a maximum distance of 40 centimeters (16 inches). During HF exposure, an adverse reaction was observed for 6 percent of all pacemaker tests when the maximum distance was 22.5 centimeters (9 inches), and 1 percent of all ICD tests when the maximum distance was 7.5 centimeters (3 inches). But the UHF readers produced no measurable reaction from either the pacemakers or the ICDs. When EMI occurred, the signals emitted by the ICDs and pacemakers were altered, resulting in a variety of reactions from the medical devices, including pacing inhibition, inappropriate pacing, noise reversion mode, changed pacing rates, inappropriate delivery of antitachycardia pacing, inappropriate high-voltage shocks and device programming change.

Seth Seidman, a research electrical engineer for the Center for Devices of Radiological Health, and the report's lead author, notes that while individuals outfitted with pacemakers or ICDs are not commonly exposed to RFID readers in clinical settings, the growing number of medical applications using RFID technology may mean that in the future, such exposure will increase during patient care. To mitigate pacemaker and ICD electromagnetic interference from RFID interrogators, the FDA is working with manufacturers of potentially susceptible devices, in order to test the potential adverse effects of radio frequency identification, and to take those potential effects into account when developing devices.

USER COMMENTS

david frenkel 2010-01-20 07:04:05 PM
Study Finds RFID Readers May Affect Pacemakers From a scientific point of view the results of this study would be very difficult to duplicate without knowing which manufacturers products were used. Any valid scientific research is peer reviewed and the results have to be able to be replicated by another scientific organization. Given the pace of scientific advancement in medical devices this study was done with equipment that are probably already outdated.
Craig Harmon 2010-01-22 08:46:31 AM
President & CEO Au contraire mon ami! It is arguable that the Hokkaido study may have used dated pacemakers, ICDs, and readers, but the FDA study used the most current of what could be procured. If the FDA had published the list of the equipment they used, everyone who was not tested would probably issue a press release noting that the FDA did not say there was a problem with their equipment, only their competitors. The FDA, the Association for Advancement of Medical Instrumentation (AAMI), and the RFID Experts Group (REG) have been working on the development of test protocols that can be used by RF emitter and medical device companies to insure that there is minimal EMI. At a recent meeting between the REG, the FDA, and AAMI, the Chief of Surgical Electrophysiology at the University of Miami Medical Center stood up and asked quite bluntly, "So what is the RFID industry doing about this? You know there is a problem, so what are you doing?" The REG test protocols are being developed by Georgia Tech Research Institute, MET Labs, the REG, AAMI, and the FDA. We could certainly use funding, as GTRI and MET Labs are presently donating their time, causing the development to be slowed. We need to develop solutions, this is an issue that can be solved but it needs attention and not posturing. Craig K. Harmon craig.harmon@qed.org
Mary Catherine O'Connor 2010-01-26 06:09:45 PM
hardware makers D. Frenkel: while reporting the story I did request that information but was not provided the information, because of the reasons Mr. Harmon pointed out in his comment.

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