FDA updates guidance
On Radio Frequency Identification
The FDA has updated its guidance on Radio Frequency Identification (RFID), 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 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.
According to the FDA, RFID is a rapidly growing technology, and it may soon be used more widely in settings such as hospitals. RFID technology has many applications for health care, including:
- Ensuring that patients receive the correct medications and medical devices
- Preventing the distribution of counterfeit drugs and medical devices
- Facilitating device recalls
- Managing suc assets 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, the 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 described in the FDA RFID Guidance, previous studies have shown that 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 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.
Because this technology is continuing to develop and gain more widespread application, 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.
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FDA continues to study RFID and its potential effects on medical devices. As it becomes available, The StayAlert Administrator will publish additional notices on this topic.To stay current with regulatory compliance changes, subscribe to StayAlert! from MCN Healthcare.