News | August 21, 2007

FDA Updates Guidance On Radio Frequency Identification

August 23, 2007 - The FDA has updated its guidance on Radio Frequency Identification (RFID), a tool for identifying and tracking items or people in hospitals.
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 of data. 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.
The FDA says RFID is a rapidly growing technology which will soon be used widely in hospitals. RFID technology has many applications for health care. It can be used to ensure patients receive the correct medications and medical devices, manage hospital equipment, track patients, and provide data for electronic medical records systems.
However, RFID emissions also have the potential to affect electronic medical devices. The FDA has not received any reports of injuries resulting from RFID, but preliminary FDA testing has shown some RFID emitters 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 described in the FDA RFID Guidance, previous studies have shown pacemakers and ICDs are susceptible to interference from radio frequency sources, such as portable radio transmitters, cell phones, antitheft systems, and metal detectors. In 2006, the 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 the 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.
Because this technology is continuing to develop and gain more widespread application, the FDA says it is important for healthcare professionals 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 whether RFID may have been a factor, such as when and where the episode occurred, what the patient was doing at the time and whether the problem resolved once the patient moved away from that environment.
According to the FDA, if RFID is suspected to be a factor, device interrogation may be helpful in correlating the episode to the exposure. Any suspected medical device malfunctions should be reported to MedWatch, the FDA's voluntary adverse-event reporting system.

For more information: www.fda.gov/cdrh/rfid/

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