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U.S. Department of Health and Human Services

About FDA

Electromagnetic Compatibility (EMC) of Medical Devices

Description: CDRH/OSEL’s Division of Physics (DP) provides test and analytic data about malfunctions due to a lack of EMC of medical devices. Malfunctions can be caused by a wide range of electromagnetic field emitting devices, from cellular phones to airport security. By proactively identifying the susceptibility of devices to new and emerging sources of radiofrequency interference, OSEL enables manufacturers and users to prevent and avoid malfunctions.

Accomplishment: The project was successfully completed as follows:

  • Automatic External Defibrillators (AEDs) Related to RFID Exposures: AEDs were exposed to 19 different RFID readers and one RFID active tag. The RFID systems used covered 5 different frequency bands: 125-134 KHz (low frequency [LF]); 13.56 MHz (high frequency [HF]); 433 MHz; 915 MHz (ultra high frequency [UHF]) and 2.4 GHz. We tested 4 AEDs and developed an internal report of findings.
  • Hearing Aid/Cell Phone Compatibility: With our collaborators from Gallaudet University we have completed our GTEM measurements of interference susceptibility for representative hearing aids. A report has been prepared for the IEEE C63.19 standards committee proposing a new method of GTEM measurement that increases accuracy and repeatability while decreasing total test time.
  • Body-worn and Implanted Medical Devices Related to Airport Body Scanners: A system was developed to simulate the emissions from the advanced imaging technology (AIT) millimeter wave (mmW) security system. Novel test methods were developed to simulate the human body and configuration of the medical devices being examined, and were used to perform testing on a range of personal electronic medical devices (PMEDs), including implantable cardiac pacemakers and defibrillators, implantable neurostimulators, and body worn insulin pumps. No effects on the function of any of these devices were observed. Findings and assessments were provided to DHS/TSA in a detailed report.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Complete study on malfunctions related to Radiofrequency Identification (RFID) systems emitters.

6/30/2011

Completed 6/30/2011

1. Perform EMC testing on selected critical medical devices using RFID systems as emitters.

3/31/2011

Completed 3/31/2011

2. Submit a journal paper on RFID effects on implantable neurostimulators.

6/30/2011

Completed 6/30/2011

B. Complete study on malfunctions of Automatic External Defibrillators (AEDs) related to RFID exposures.

6/30/2011

Completed 6/30/2011

1. Perform EMC tests of AEDs to worst-case RFID exposures.

3/30/2011

Completed 3/30/2011

2. Document findings of EMC tests of AEDs in an internal report or draft paper submitted to a peer reviewed journal.

6/30/2011

Completed 6/30/2011

C. Complete study on hearing aid/cell phone compatibility.

10/31/2011

Completed 1/15/2012

1. Validate GTEM measurement procedures from IEEE C63.19 standard using representative hearing aids.

4/30/2011

Completed 4/15/2011

2. Document GTEM/hearing aid findings in an internal report or peer reviewed journal publication.

10/31/2011

Completed 1/15/2012

D. Complete study on malfunctions of body-worn and implanted medical devices related to airport body scanners.

10/31/2011

Completed 4/4/2011

1. Develop test systems for evaluating potential effects of airport body scanners on body-worn and implanted medical devices.

2/28/2011

Completed 2/28/2011

2. Test effects of emissions from one scanner on a range of devices. Write a report on the results for Department of Homeland Security (DHS) / Transportation Security Administration (TSA).

10/31/2011

Completed 4/4/2011

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.