Radiofrequency Identification

Radiofrequency Identification (RFID)

Description

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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.

Uses

RFID systems are used in many places. Some examples include: ?Stores, warehouses and shipping areas for inventory control ?Pharmacies or pharmaceutical distributors for pharmaceutical supply management

?Worksites for employee identification

?Transportation systems for fare collection (i.e. subway passes) and highway toll collection (i.e. EZ Pass)

RFID is a rapidly growing technology. It may soon be used more widely, in settings such as hospitals and retail stores.

Risks/Benefits

RFID technology has many applications for health care. For example, RFID can potentially improve patient safety by:

?Ensuring that patients receive the correct medications and medical devices

?Preventing the distribution of counterfeit drugs and medical devices

?Facilitating device recalls

The potential benefits of RFID to hospitals and healthcare facilities include:

?Managing assets such as hospital equipment

?Tracking patients

?Providing data for electronic medical records systems

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.

Information for Patients

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.

Information for Healthcare Professionals

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.

Research

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 Force, conducted laboratory tests of pacemaker and ICD reactions to RFID. In this study, the devices were exposed to emissions from RFID readers operating at three different frequencies and at various distances from the devices. Results of the study showed inappropriate reactions in some of the devices, including inhibited pacing and inappropriate delivery of ICD therapy.

In 2008, FDA conducted further laboratory testing to evaluate the response of implantable pacemakers and ICDs to RFID. During in-vitro testing, 15 pacemakers and 15 ICDs were exposed to passive RFID readers in three frequency bands: low frequency (134 kHz), high frequency (13.56 MHz) and ultra high frequency (915 MHz).

The results from this research confirmed the preliminary findings from the earlier study: significant effects were observed when pacemakers and ICDs were exposed to RFID readers, especially low frequency RFID readers. Conditions in the testing laboratory were created to mimic worst-case scenarios of proximity to RFID readers likely to affect the functioning of the devices tested. These scenarios do not mimic the real-life conditions most people with these implantable devices will encounter. Although in-vitro testing has demonstrated the potential for clinically significant reactions when pacemakers and ICDs are exposed to RFID readers at maximum power and at close range, FDA has not received any reports of RFID readers causing adverse events in pacemakers and ICDs outside of the laboratory.

FDA Actions

FDA continues to study RFID and its potential effects on medical devices. Specifically, FDA is taking the following steps:

?Investigating potential RFID effects on other critical care medical equipment (infusion pumps, AEDs, ventilators, pulse oximeters) and implantable neurostimulator devices.

?Working with manufacturers of susceptible devices to test their products for any adverse effects from RFID and to consider RFID

interference when developing new devices.

?Reaching out to the RFID industry to better understand, (1) where RFID is located, (2) what power levels and frequencies are being used where, and (3) how to best mitigate EMI to pacemakers and ICDs.

?Participating in and reviewing the development of RFID standards.

?Working with AAMI Cardiac Rhythm Management Devices EMC Task Force in developing an RFID exposure protocol for pacemakers and ICDs.

?Collaborating with other government agencies such as the Federal Communications Commission (FCC), the National Institute for

Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA) to better identify places where RFID readers are in use.

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.