Radio Frequency Identification (RFID) is a tool for identifying and tracking items or people. In an RFID system, a small memory-storage chip (tag) is placed on an item. RFID readers (emitters) send out radio waves to detect tags and read their data.
RFID tags can store a range of information from a serial number to several pages. Readers may be mobile so that they can be carried by hand, or they may be mounted on a post or overhead. Reader systems can also be built into the architecture of a cabinet, room or building.
RFID systems are used in many places. Some examples include:
RFID is a rapidly growing technology. It may soon be used more widely, in settings such as hospitals and retail stores.
RFID technology has many applications for health care. For example, RFID can potentially improve patient safety by:
The potential benefits of RFID to hospitals and healthcare facilities include:
However, RFID emissions also have the potential to affect electronic medical devices. To date, FDA has received no reports of injuries resulting from RFID. But preliminary FDA testing has shown that some RFID emitters potentially could slow the rate of pacemakers or cause implantable cardioverter defibrillators (ICDs) to deliver inappropriate shocks. Other electronic medical devices could also react inappropriately in the presence of RFID.
As RFID becomes more widely used, it is important to be aware of the potential for reactions between RFID and medical devices. As a general rule, if you are in an environment where RFID systems may be in place, such as those listed on this fact sheet, be aware of any changes in how you feel. If you begin to experience symptoms that might indicate that your device is not working properly, leave the immediate area, and call your doctor if you do not begin to feel better. Your doctor can advise you if you need to take any further actions.
FDA has received no confirmed reports of ICDs or pacemakers reacting to RFID through any of its reporting or postmarket surveillance mechanisms. FDA continues to monitor this developing technology and potential interactions with medical devices, including pacemakers and ICDs.
Because this technology is continuing to develop and gain more widespread application, it is important to keep in mind the potential for reactions with pacemakers, ICDs, and other electronic medical devices. Physicians should keep informed about the environments where RFID systems are used. If a patient experiences a problem with a device, ask questions that will help determine if RFID may have been a factor, such as when and where the episode occurred, what the patient was doing at the time, and whether or not the problem resolved once the patient moved away from that environment. If you suspect that RFID was a factor, device interrogation may be helpful in correlating the episode to the exposure. Report any suspected medical device malfunctions to MedWatch, FDA’s voluntary adverse event reporting system.
Previous studies have shown that pacemakers and ICDs are susceptible to interference from radio frequency sources such as portable radio transmitters, cell phones, anti-theft systems, and metal detectors (see CDRH References on Electromagnetic Compatibility). In 2006, FDA, in collaboration with the AAMI Cardiac Rhythm Management Devices EMC Task Group, conducted laboratory tests of pacemaker and ICD reactions to RFID. Five medical device manufacturers and five RFID companies provided equipment for this study. The devices were exposed to emissions from RFID readers operating at three different frequencies and at various distances from the devices.
Preliminary findings showed inappropriate reactions in some of the devices. Reactions included inhibited pacing and inappropriate delivery of ICD therapy.
FDA continues to study RFID and its potential effects on medical devices. As it becomes available, FDA will communicate new information to the public through its website, the news media and other channels.
Updated May 2, 2007
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