Advisory: Electromagnetic
Interference in Telemedicine
July 1998
The Federal Joint Working Group on Telemedicine (JWGT) is charged with assessing the role of the Federal government in telemedicine and coordinating telemedicine activities across Federal cabinet agencies. Part of the charge involves developing specific actions to overcome barriers to the effective use of telemedicine technologies. One such barrier is Electromagnetic Interference (EMI).
EMI can disrupt the normal function of electrically powered medical devices, or the communications link, within a telemedicine system. EMI can and has produced serious adverse consequences for patient and medical device users.
In a recent Advisory, the U.S. Food and Drug Administration (FDA) warned about the potential impact of EMI disrupting the function of medical telemetry systems, thereby compromising the safe and effective use of these systems. The FDA Advisory cannot be ignored.
Recent events such as interference from digital television transmission (DTV) with certain telemetry systems have prompted the JWGT to issue the following recommendations to minimize the risks posed by EMI. A few simple steps can help to reduce the potential for patient risk from EMI with these systems:
- Make electromagnetic compatibility (EMC) an integral part of the design, construction, testing, and management of all medical devices and equipment within the telemedicine system. This includes policies and procedures to address EMC.
- Educate all staff and patients about the risks of EMI and the policies for EMC.
- Assess the medical facility and telemedicine system for sources of electromagnetic energy (e.g., AC power grid, radio transmitters, electrostatic electricity), and manage these sources as much as possible to minimize EMI.
- Develop procedures to report, and appropriately deal with, EMI incidents. Incidents involving patient injury and death due to medical device malfunction should be reported through the MedWatch program at 1-800-FDA-1088.
- Where appropriate, perform in-house testing of all devices to assess their EMC,
- using the ANSI-recommended practice C63.18 for ad hoc EMC testing of medical devices.
More detailed information about EMI/EMC can be found in the Association for the Advancement of Medical Instrumentation Technical Information Report AAMI TIR No.18-1997.
The JWGT strongly encourages you to review your current or planned telemedicine systems to address the EMI/EMC issues. For more information concerning this issue please contact the following Web sites:
- Joint Statement of the Federal Communications Commission and the Food and Drug Administration Regarding Avoidance of Interference Between Digital Television and Medical Telemetry Devices
- CDRH Medical Device Electromagnetic Compatibility Program
- Health Care and the FCC: Digital TV and Medical Telemetry Devices
References
Guidance on Electromagnetic Compatibility of Medical Devices For Clinical/Biomedical Engineers- part 1: Radiated Radio-Frequency Electromagnetic Energy, AAMI TIR No. 18-1997. Available from the Association for the Advancement of Medical Instrumentation (AAMI) 3330 Washington Blvd. Suite 400, Arlington, VA 22201-4598, (703) 525-4890 or (800) 332-2264, http://www.aami.org
American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio-Frequency Transmitters, ANSI C63.18-1997. Available from the Institute for Electrical and Electronic Engineers (IEEE) 345 East 47th Street, New York, NY 10017, 1-800 678-4333, http://standards.ieee.org
FDA Public Health Advisory: Interference Between Digital TV Transmissions and Medical Telemetry Systems, at http://www.fda.gov/cdrh/dtvalert.html
"Medical Devices and EMI: The FDA Perspective," Don Witters, Center for Devices and Radiological Health, U.S. Food and Drug Administration, ITEM Update, 1995.
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