Abstract
BackgroundThere have been concerns that Electromagnetic security systems such as walk-through metal detectors (WTMDs) can potentially cause electromagnetic interference (EMI) in certain active medical devices including implantable cardiac pacemakers and implantable neurostimulators. Incidents of EMI between WTMDs and active medical devices also known as personal medical electronic devices (PMED) continue to be reported. This paper reports on emission measurements of sample WTMDs and testing of 20 PMEDs in a WTMD simulation system.MethodsMagnetic fields from sample WTMD systems were characterized for emissions and exposure of certain PMEDs. A WTMD simulator system designed and evaluated by FDA in previous studies was used to mimic the PMED exposures to the waveform from sample WTMDs. The simulation system allows for controlled PMED exposure enabling careful study with adjustable magnetic field strengths and exposure duration, and provides flexibility for PMED exposure at elevated levels in order to study EMI effects on the PMED. The PMED samples consisted of six implantable cardiac pacemakers, six implantable cardioverter defibrillators (ICD), five implantable neurostimulators, and three insulin pumps. Each PMED was exposed in the simulator to the sample WTMD waveforms using methods based on appropriate consensus test standards for each of the device type.ResultsTesting the sample PMEDs using the WTMD simulator revealed EMI effects on two implantable pacemakers and one implantable neurostimulator for exposure field strength comparable to actual WTMD field strength. The observed effects were transient and the PMEDs returned to pre-exposure operation within a few seconds after removal from the simulated WTMD exposure fields. No EMI was observed for the sample ICDs or insulin pumps.ConclusionThe findings are consistent with earlier studies where certain sample PMEDs exhibited EMI effects. Clinical implications were not addressed in this study. Additional studies are needed to evaluate potential PMED EMI susceptibilities over a broader range of security systems.
Highlights
There have been concerns that Electromagnetic security systems such as walk-through metal detectors (WTMDs) can potentially cause electromagnetic interference (EMI) in certain active medical devices including implantable cardiac pacemakers and implantable neurostimulators
This paper describes magnetic field emission measurement from walk-through metal detector (WTMD) and electromagnetic compatibility (EMC) testing performed on active medical devices for electromagnetic emission from WTMD
The potential susceptibility to EMI effects in a selected group of contemporary sample personal medical electronic devices (PMED) was assessed for locations in and around three WTMDs
Summary
There have been concerns that Electromagnetic security systems such as walk-through metal detectors (WTMDs) can potentially cause electromagnetic interference (EMI) in certain active medical devices including implantable cardiac pacemakers and implantable neurostimulators. A number of different technologies such as metal detectors and electronic article surveillance (EAS, known as anti-theft) systems are often referred to as security systems These security systems use electromagnetic fields for detection of an object of metal and merchandise (EAS using special tags attached). Metal detectors typically operate at lower frequencies: 100 Hz to 10 kHz for WTMD and from 18 kHz to 1.8 MHz for hand-held metal detectors (HHMD) [2,3,4,5,6] In normal operation these security systems typically involve short exposure times [1] to the emissions from the system, but can have a range of exposure amplitudes depending on the orientation and location near the emitters
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