Electromagnetic Compatibility Testing of Implantable Neurostimulators Exposed to Metal Detectors
Seth J Seidman*, Wolfgang Kainz, Jon Casamento, Donald Witters
Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), 10903 New Hampshire Ave, Silver Spring, MD20910, USA
This paper presents results of electromagnetic compatibility (EMC) testing of three implantable neurostimulators exposed to the magnetic fields emitted from several walk-through and hand-held metal detectors. The motivation behind this testing comes from numerous adverse event reports involving active implantable medical devices (AIMDs) and security systems that have been received by the Food and Drug Administration (FDA). EMC testing was performed using three neurostimulators exposed to the emissions from 12 walk-through metal detectors (WTMDs) and 32 hand-held metal detectors (HHMDs). Emission measurements were performed on all HHMDs and WTMDs and summary data is presented. Results from the EMC testing indicate possible electromagnetic interference (EMI) between one of the neurostimulators and one WTMD and indicate that EMI between the three neurostimulators and HHMDs is unlikely. The results suggest that worst case situations for EMC testing are hard to predict and testing all major medical device modes and setting parameters are necessary to understand and characterize the EMC of AIMDs.
Keywords: EMC, EMI, metal detectors, implantable neurostimulators..
open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.
* Address correspondence to this author at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), 10903 New Hampshire Ave, Silver Spring, MD 20910, USA; Tel: 301-796-2477; Fax: 301-796-9927; E-mail: firstname.lastname@example.org