Health care personnel employed by facilities that are subject to Reporting Adverse Events (Medical Devices) requirements should follow the reporting procedures established by their facilities. If you suspect a problem, we encourage you to file a voluntary report through MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with RFID. 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.Working with the Association for Automatic Identification and Mobility (AIM) to develop a way to test medical devices for their vulnerability to EMI from RFID systems.Participating in and reviewing the development of RFID standards to better understand RFID’s potential to affect medical devices and to mitigate potential EMI.Working with the RFID industry to better understand, where RFID can be found, what power levels and frequencies are being used in different locations, and how to best mitigate potential EMI with pacemakers and ICDs.Working with manufacturers of potentially susceptible medical devices to test their products for any adverse effects from RFID and encouraging them to consider RFID interference when developing new devices.The FDA has taken steps to study RFID and its potential effects on medical devices including: Report any suspected medical device malfunctions to MedWatch, FDA’s voluntary adverse event reporting system. If you suspect that RFID was a factor, device interrogation might be helpful in correlating the episode to the exposure. If a patient experiences a problem with a device, ask questions that will help determine if RFID might 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. Physicians should stay informed about the use of RFID systems. Information for Health Care Professionalsīecause this technology continues to evolve and is more widely used, it is important to keep in mind its potential for interference with pacemakers, implantable cardioverter defibrillators (ICDs), and other electronic medical devices. EMI is a degradation of the performance of equipment or systems (such as medical devices) caused by an electromagnetic disturbance. However, there is concern about the potential hazard of electromagnetic interference (EMI) to electronic medical devices from radio frequency transmitters like RFID. The FDA is not aware of any adverse events associated with RFID.
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