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U.S. Department of Health and Human Services

About FDA

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Research Project: Radio Frequency Identification (RFID)

FDA engineers are investigating the effects that radio frequency identification (RFID) readers may have on medical devices.  RFID technology is rapidly gaining wide use in medical and non-medical applications. RFID technology is used in hospitals to track and trace both medical equipment and patients.  RFID is more susceptible to interference issues than traditional EMC given the application of RFID devices directly on medical equipment.  RFID readers are also commonly hidden in the architecture of buildings so that their location is not as readily visible.  As part of the FDA’s Unique Device Identification initiative, the FDA promotes the use of RFID in devices, drugs, and blood products to prevent counterfeiting and assist in product recalls.  Through collaboration with medical device manufacturers, FDA scientists have recently looked at the electromagnetic interference susceptibility of 15 pacemakers and 15 ICDs caused by exposure to 13 RFID readers, concluded that low frequency RFID readers may pose the greatest risk to pacemakers and ICDs.  Many of the effects seen are clinically significant, such as a pacemaker not pacing or an ICD sending out a high voltage shock to the patient.  While FDA has seen these effects in laboratory bench testing, no adverse reports have been reported to the FDA as of this reporting (September 2010).  RFID has many promising uses in health care and the single biggest obstacle is EMC.  Through laboratory testing, standards development, education, and collaboration FDA hopes to mitigate these risks.

 


An FDA engineer measures electromagnetic fields from
an RFID system using a computer-controlled robotic arm.