Electromagnetic compatibility, means a medical device is compatible with (no interference is caused by) its electromagnetic environment and it does not emit levels of electromagnetic energy that cause electromagnetic interference in other devices in the vicinity. A medical device can be vulnerable to electromagnetic interference if the levels of electromagnetic energy in its environment exceed the electromagnetic immunity (resistance) to which the device was designed and tested. The different forms of electromagnetic energy that can cause electromagnetic interference are conducted, radiated, and electrostatic discharge. Electromagnetic interference problems with medical devices can be very complex, not only from the technical standpoint but also from the view of public health issues and solutions.
The FDA’s Center for Devices and Radiological Health (CDRH) has regulatory authority over several thousands of different kinds of medical devices, with thousands of manufacturers and variations of devices. CDRH has been at the forefront of examining medical device electromagnetic interference and providing solutions. Extensive laboratory testing by CDRH, and others, has revealed that many devices can be susceptible to problems caused by electromagnetic interference. CDRH has been investigating incidents of device electromagnetic interference and working on solutions (e.g., the 1979 draft EMC standard for medical devices), since the late 1960s, when there was concern for electromagnetic interference with cardiac pacemakers.
- Electromagnetic Compatibility (EMC) of Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- Wireless Medical Devices
- Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff
- Recommendations for EMC/EMI in Healthcare Facilities
- Coordination with FCC
- Electromagnetic Compatibility - Documents Available to Help Resolve Medical Device EMC Problems
- Electromagnetic Compatibility - EMC Working Group
- Medical Devices and EMI: The FDA Perspective
- Labeling for Electronic Anti-Theft Systems - Guidance for Industry