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CALCE student invited to present at the FDA's Electromagnetic Compatibility
Working Group

Mehdi Kohani, a PhD candidate at CALCE, was invited by the Electromagnetic Compatibility (EMC) Working Group at the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) to give a lecture on his research on evaluating electrostatic discharge (ESD) immunity standards for medical devices.

The EMC working group was particularly interested in two recent publications by Kohani and his advisor, Prof. Michael Pecht, on analyzing the FDA's medical device malfunction reports related to ESD (published in IEEE Access) and on evaluating ESD characteristics of wearable devices (published in IEEE Transactions on Electromagnetic Compatibility).

Kohani's findings reinforced the working group’s mission to enhance electromagnetic safety of electrically powered medical devices. His research showed that adverse event reports due to ESD are underreported in the literature, and the reason may be lack of sufficient ESD immunity standards.

Kohani also presented his research findings on the characterization of ESD events in wearable medical applications, for which he collaborated with a group of researchers at the EMC lab at the Missouri University of Science and Technology under the supervision of Prof. David Pommerenke. His study showed the test configuration used in the IEC 61000-4-2 standard setup for ESD immunity of medical devices does not provide sufficient immunity for wearable medical devices.

Kohani suggested improvements for improving the current ESD immunity standard by establishing separate ESD testing methods for wearable medical devices using anatomically correct human body models called “phantoms,” which imitate the electrical impedance of the body, in place of the current ESD gun test method specified in IEC 61000-4-2.

More details of Kohani's research findings are provided in his article.

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