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Study Finds RFID Readers May Affect Pacemakers, But Pose No Urgent Risk
Furthermore, the study reports that the "RFID industry should also take note with regard to medical device [electromagnetic compatibility]. With so many promising health-care applications for RFID, it is inevitable that RFID and medical devices will increasingly function in close proximity."
The report goes on to note that signals from LF readers are a "near-perfect source to cause EMI for implantable pacemakers and ICDs," because the "low carrier frequency allows the signal to enter the implant, bypassing commonly used feed-through filters."
Despite these clinical findings, the FDA indicates it has not received any reports of adverse incidents caused by electromagnetic interference emitted by any RFID system. And while it does not believe that individuals who have an implanted pacemaker or ICD are at significant risk for those devices to malfunction due to interference from RFID readers, the agency does recommend that these individuals not linger near RFID readers, as a precaution.
This newly published study, initiated in 2008, confirms preliminary findings from a 2006 study entitled "Electromagnetic Compatibility of Pacemakers and Implantable Cardiac Defibrillators Exposed to RFID Readers," that Seidman presented at the fifth RFID Academic Convocation, which was held in conjunction with RFID Journal LIVE! 2007. A complete copy of the study can be downloaded from HeartRhythm Journal's Web site.
Recommendations for future testing, the authors say, would include "extending each distance test dwell time from 10 to 20 seconds, creating a more anatomical torso simulator, grading each distance for clinical significance as opposed to each test, modifying the pulse repetition rate of RFID readers outside the physiological band, and modifying the modulation depth of each RFID reader."
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The report goes on to note that signals from LF readers are a "near-perfect source to cause EMI for implantable pacemakers and ICDs," because the "low carrier frequency allows the signal to enter the implant, bypassing commonly used feed-through filters."
Despite these clinical findings, the FDA indicates it has not received any reports of adverse incidents caused by electromagnetic interference emitted by any RFID system. And while it does not believe that individuals who have an implanted pacemaker or ICD are at significant risk for those devices to malfunction due to interference from RFID readers, the agency does recommend that these individuals not linger near RFID readers, as a precaution.
Recommendations for future testing, the authors say, would include "extending each distance test dwell time from 10 to 20 seconds, creating a more anatomical torso simulator, grading each distance for clinical significance as opposed to each test, modifying the pulse repetition rate of RFID readers outside the physiological band, and modifying the modulation depth of each RFID reader."
READERS' COMMENTS
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.
Posted By: D. Frenkel 1/20/2010 at 6:04:05 PM
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
Posted By: C. Harmon 1/22/2010 at 7:46:31 AM
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.
Posted By: M. Oconnor 1/26/2010 at 5:09:45 PM