A new method to improve RF safety of implantable medical devices using inductive coupling at 3.0 T MRI.

OBJECTIVE: To enhance RF safety when implantable medical devices are located within the body coil but outside the imaging region by using a secondary resonator (SR) to reduce electric fields, the corresponding specific absorption rate (SAR), and temperature change during MRI. MATERIALS AND METHODS: This study was conducted using numerical simulations with an American Society for Testing and Materials (ASTM) phantom and adult human models of Ella and Duke from Virtual Family Models, along with corresponding experimental results of temperature change obtained using the ASTM phantom. The circular SR was designed with an inner diameter of 150 mm and a width of 6 mm. Experimental measurements were carried out using a 3 T Medical Implant Test System (MITS) body coil, electromagnetic (EM) field mapping probes, and an ASTM phantom. RESULTS: The magnitudes of B1+ (|B1+|) and SAR1g were reduced by 15.2% and 5.85% within the volume of interest (VoI) of an ASTM phantom, when a SR that generates opposing electromagnetic fields was utilized. Likewise, the Δ|B1+| and ΔSAR1g were reduced by up to 56.7% and 57.5% within the VoI of an Ella model containing a copper rod when an opposing SR was used. CONCLUSION: A novel method employing the designed SR, which generates opposing magnetic fields to partially shield a sample, has been proposed to mitigate the risk of induced-RF heating at the VoI through numerical simulations and corresponding experiments under various conditions at 3.0 T.

Comparison of SAR distribution of hip and knee implantable devices in 1.5T conventional cylindrical-bore and 1.2T open-bore vertical MRI systems.

PURPOSE: There is increasing use of open-bore vertical MR systems that consist of two planar RF coils. A recent study showed that the RF-induced heating of a neuromodulation device was much lower in the open-bore system at the brain and the chest imaging landmarks. This study focused on the hip and knee implants and compared the specific absorption rate (SAR) distribution in human models in a 1.2T open-bore coil with that of a 1.5T conventional birdcage coil. METHODS: Computational modeling results were compared against the measurement values using a saline phantom. The differences in RF exposure were examined between a 1.2T open-bore coil and a 1.5T conventional birdcage coil using SAR in an anatomical human model. RESULTS: Modeling setups were validated. The body placed closed to the coil elements led to high SAR values in the birdcage system compared with the open-bore system. CONCLUSION: Our computational modeling showed that the 1.2T planar system demonstrated a lower intensity of SAR distribution adjacent to hip and knee implants compared with the 1.5T conventional birdcage system.

A Multi-Frequency 3D Printed Hand Phantom for Electromagnetic Measurements.

It has been shown that the presence of a hand holding a wireless handset (cell phone) can influence antenna efficiency and the measurement of specific absorption rate (SAR) and electromagnetic compatibility. Head phantoms, used in handset compliance testing to estimate SAR in the head, have achieved low cost and multi-frequency use. Head phantoms typically consist of a thin plastic shell, open on the top, holding a tissue simulating fluid. The specific simulant fluid used is determined by the radio frequency of the test. IEC 62209-1 has recipes, using safe nontoxic materials, for all the required frequency bands. Thus, head phantoms can be reused at different frequencies simply by changing the tissue simulating fluid. However, standards have not adopted the use of hand phantoms because SAR limits in limbs are less restrictive than the head, the tissue depth in a hand is insufficient to make accurate measurements with current electric field probes, and the cost of a solid hand phantom is limited to a single frequency band. Our goal was to determine whether 3D printing techniques would allow the construction of a hand phantom with the same utility as existing head phantoms. We developed this phantom based on computer simulations to determine how much human anatomy needed to be included in the phantom to obtain results consistent with actual use. Electric field scans of a handset alone, and held by the hand phantom, were performed. Comparison of handset scans using the phantom and human subjects was planned, but not performed due to Covid-19 restrictions and subsequent changes in priorities. We feel a fluid-filled 3D printed hand phantom is viable and practical. The 3D print files are available on GitHub.

Static magnetic field measurements of smart phones and watches and applicability to triggering magnet modes in implantable pacemakers and implantable cardioverter-defibrillators.

BACKGROUND: Implantable pacemakers and implantable cardioverter-defibrillators (ICDs) are designed to include a "magnet mode" feature that can be activated from magnets stronger than 10 G. This feature is designed to be used when a patient is undergoing a procedure where electromagnetic interference is possible, or anytime suspension of tachycardia detection and therapy is needed. A publication in Heart Rhythm demonstrates an iPhone 12 triggering the magnet mode of a Medtronic ICD. OBJECTIVE: The purpose of this study is to determine the separation distance between consumer electronic devices that may create magnetic interference, including cell phones and smart watches, and implantable pacemakers and ICDs where magnet mode can be triggered. METHODS: The static magnetic fields of the iPhone 12 models and Apple Watch were measured at several planes in 1 cm resolution using an FW Bell 5180 Gauss Meter with STD18-0404 Transverse probe (unidirectional probe). RESULTS: All iPhone 12 and Apple Watch 6 models tested have static magnetic fields significantly greater than 10 G in close proximity (1-11 mm), which attenuates to below 10 G between 11 and 20 mm. CONCLUSION: The findings of this study support the US Food and Drug Administration recommendation that patients keep any consumer electronic devices that may create magnetic interference, including cell phones and smart watches, at least 6 inches away from implanted medical devices, in particular pacemakers and cardiac defibrillators.

A Case Study of Medical Device Wireless Coexistence Evaluation.

This article aims to provide a narrative for addressing wireless coexistence in medical devices to help medical device developers, test engineers, and regulatory affairs personnel throughout the device life cycle. Accordingly, we present a case-study covering the coexistence evaluation process including the risk analysis of the wireless functionality of a hypothetical medical device, determining the corresponding risk category, specification of the device functional wireless performance (FWP), wireless coexistence testing, and measurement of the intended/untended signal ratio. Also, we propose a simple method for translating the test outcome into user recommendations for minimum/maximum separation distances between the device, its intended companion, and the source of unintended signals.

An outlook on wireless coexistence with focus on medical devices.

The use of shared and unlicensed radio spectrum has been the impetus of innovative and widely used technologies (e.g., Wi-Fi, Bluetooth, and others)-driving the scene of ubiquitous connectivity for devices, sensors, and peripherals in an encompassing Internet of Things (IoT). However, coexisting technologies operating in unlicensed bands need to share limited spectrum resources while attempting to offer desired performance. This could prove challenging as channel access is not guaranteed, which raises concerns for wireless coexistence in sensitive applications like medical devices. In this article, we provide a brief review of topics forming the current stage of wireless coexistence in research, industry, and regulatory circles. We present the standardization activities for the evaluation of wireless coexistence, and recent advancements of unlicensed spectrum technologies such as Wi-Fi, Bluetooth, and Long Term Evolution (LTE) in unlicensed bands, along with proposed evaluation methods.

Personal medical electronic devices and walk-through metal detector security systems: assessing electromagnetic interference effects.

BACKGROUND: 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. 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. METHODS: Magnetic 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. RESULTS: Testing 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. CONCLUSION: The 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.

A novel method to decrease electric field and SAR using an external high dielectric sleeve at 3 T head MRI: numerical and experimental results.

Materials with high dielectric constant (HDC) have been used in high field MRI to decrease specific absorption rate (SAR), increase magnetic field intensity, and increase signal-to-noise ratio. In previous studies, the HDC materials were placed inside the RF coil decreasing the space available. This study describes an alternative approach that considers an HDC-based sleeve placed outside the RF coil. The effects of an HDC on the electromagnetic (EM) field were studied using numerical simulations with a coil unloaded and loaded with a human head model. In addition, experimental EM measurements at 128 MHz were performed inside a custom-made head coil, fitted with a distilled water sleeve. The numerical simulations showed up to 40% decrease in maximum 10 g-avg. SAR on the surface of the head model with an HDC material of barium titanate. Experimental measurements also showed up to 20% decrease of maximum electric field using an HDC material of distilled water. The proposed method can be incorporated in the design of high field transmit RF coils.

Feasibility results of an electromagnetic compatibility test protocol to evaluate medical devices to radio frequency identification exposure.

BACKGROUND: The use of radio frequency identification (RFID) systems in healthcare is increasing, and concerns for electromagnetic compatibility (EMC) pose one of the biggest obstacles for widespread adoption. Numerous studies have demonstrated that RFID systems can interfere with medical devices; however, the majority of past studies relied on time-consuming and burdensome test schemes based on ad hoc test methods applied to individual RFID systems. METHODS: This paper presents the results of using an RFID simulator that allows for faster evaluation of RFID-medical device EMC against a library of RFID test signals at various field strengths. RESULTS: The results of these tests demonstrate the feasibility and adequacy of simulator testing and can be used to support its incorporation into applicable consensus standards. CONCLUSIONS: This work can aid the medical device community in better assessing the risks associated with medical device exposure to RFID.

Adhoc electromagnetic compatibility testing of non-implantable medical devices and radio frequency identification.

BACKGROUND: The use of radiofrequency identification (RFID) in healthcare is increasing and concerns for electromagnetic compatibility (EMC) pose one of the biggest obstacles for widespread adoption. Numerous studies have documented that RFID can interfere with medical devices. The majority of past studies have concentrated on implantable medical devices such as implantable pacemakers and implantable cardioverter defibrillators (ICDs). This study examined EMC between RFID systems and non-implantable medical devices. METHODS: Medical devices 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 three syringe pumps, three infusion pumps, four automatic external defibrillators (AEDs), and one ventilator. The testing procedure is modified from American National Standards Institute (ANSI) C63.18, Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio-Frequency Transmitters. RESULTS: For syringe pumps, we observed electromagnetic interference (EMI) during 13 of 60 experiments (22%) at a maximum distance of 59 cm. For infusion pumps, we observed EMI during 10 of 60 experiments (17%) at a maximum distance of 136 cm. For AEDs, we observed EMI during 18 of 75 experiments (24%) at a maximum distance of 51 cm. The majority of the EMI observed was classified as probably clinically significant or left the device inoperable. No EMI was observed for all medical devices tested during exposure to 433 MHz (two readers, one active tag) or 2.4 GHz RFID (two readers). CONCLUSION: Testing confirms that RFID has the ability to interfere with critical medical equipment. Hospital staff should be aware of the potential for medical device EMI caused by RFID systems and should be encouraged to perform on-site RF immunity tests prior to RFID system deployment or prior to placing new medical devices in an RFID environment. The methods presented in this paper are time-consuming and burdensome and suggest the need for standard test methods for assessing the immunity of medical devices to RFID systems.

Analysis of induced electrical currents from magnetic field coupling inside implantable neurostimulator leads.

BACKGROUND: Over the last decade, the number of neurostimulator systems implanted in patients has been rapidly growing. Nearly 50, 000 neurostimulators are implanted worldwide annually. The most common type of implantable neurostimulators is indicated for pain relief. At the same time, commercial use of other electromagnetic technologies is expanding, making electromagnetic interference (EMI) of neurostimulator function an issue of concern. Typically reported sources of neurostimulator EMI include security systems, metal detectors and wireless equipment. When near such sources, patients with implanted neurostimulators have reported adverse events such as shock, pain, and increased stimulation. In recent in vitro studies, radio frequency identification (RFID) technology has been shown to inhibit the stimulation pulse of an implantable neurostimulator system during low frequency exposure at close distances. This could potentially be due to induced electrical currents inside the implantable neurostimulator leads that are caused by magnetic field coupling from the low frequency identification system. METHODS: To systematically address the concerns posed by EMI, we developed a test platform to assess the interference from coupled magnetic fields on implantable neurostimulator systems. To measure interference, we recorded the output of one implantable neurostimulator, programmed for best therapy threshold settings, when in close proximity to an operating low frequency RFID emitter. The output contained electrical potentials from the neurostimulator system and those induced by EMI from the RFID emitter. We also recorded the output of the same neurostimulator system programmed for best therapy threshold settings without RFID interference. Using the Spatially Extended Nonlinear Node (SENN) model, we compared threshold factors of spinal cord fiber excitation for both recorded outputs. RESULTS: The electric current induced by low frequency RFID emitter was not significant to have a noticeable effect on electrical stimulation. CONCLUSIONS: We demonstrated a method for analyzing effects of coupled magnetic field interference on implantable neurostimulator system and its electrodes which could be used by device manufacturers during the design and testing phases of the development process.

Electromagnetic compatibility of implantable neurostimulators to RFID emitters.

BACKGROUND: The objective of this study is to investigate electromagnetic compatibility (EMC) of implantable neurostimulators with the emissions from radio frequency identification (RFID) emitters. METHODS: Six active implantable neurostimulators with lead systems were tested for susceptibility to electromagnetic fields generated by 22 RFID emitters. These medical devices have been approved for marketing in the U.S. for a number of intended uses that include: epilepsy, depression, incontinence, Parkinsonian tremor and pain relief. Each RFID emitter had one of the following carrier frequencies: 125 kHz, 134 kHz, 13.56 MHz, 433 MHz, 915 MHz and 2.45 GHz. RESULTS: The test results showed the output of one of the implantable neurostimulators was inhibited by 134 kHz RFID emitter at separation distances of 10 cm or less. The output of the same implantable neurostimulator was also inhibited by another 134 kHz RFID emitter at separation distances of 10 cm or less and also showed inconsistent pulsing rate at a separation distance of 15 cm. Both effects occurred during and lasted through out the duration of the exposure. CONCLUSIONS: The clinical significance of the effects was assessed by a clinician at the U.S. Food and Drug Administration. The effects were determined to be clinically significant only if they occurred for extended period of time. There were no observed effects from the other 5 implantable neurostimulators or during exposures from other RFID emitters.

In vitro tests reveal sample radiofrequency identification readers inducing clinically significant electromagnetic interference to implantable pacemakers and implantable cardioverter-defibrillators.

BACKGROUND: The use of radiofrequency identification (RFID) systems is expanding and highlights the need to address electromagnetic interference (EMI) to implantable pacemakers and implantable cardioverter-defibrillators (ICDs). OBJECTIVE: This study sought to examine the electromagnetic compatibility (EMC) between RFID readers and implantable pacemakers or ICDs. METHODS: During in vitro testing, 15 implantable pacemakers and 15 ICDs were exposed to 13 passive RFID readers in 3 frequency bands: 134 kHz (low frequency [LF]), 13.56 MHz (high frequency [HF]), and 915 MHz (ultra high frequency [UHF]). RESULTS: While being exposed to LF RFID, a reaction was observed for 67% of all pacemaker tests (maximum distance 60 cm) and 47% of all ICD tests (maximum distance 40 cm). During HF RFID exposure, a reaction was observed for 6% of all pacemaker tests (maximum distance 22.5 cm) and 1% of all ICD tests (maximum distance 7.5 cm). For both pacemakers and ICDs, no reactions were observed during exposure to UHF RFID or continuous-wave RFID. Pacemakers and ICDs were most susceptible to modulated LF RFID readers. CONCLUSION: Although there is in vitro testing evidence for concern for implantable pacemaker and ICD EMI at LF and HF, the FDA has not received any incident reports of pacemaker or ICD EMI caused by any RFID system. We do not believe the current situation reveals an urgent public health risk.

The Virtual Family--development of surface-based anatomical models of two adults and two children for dosimetric simulations.

The objective of this study was to develop anatomically correct whole body human models of an adult male (34 years old), an adult female (26 years old) and two children (an 11-year-old girl and a six-year-old boy) for the optimized evaluation of electromagnetic exposure. These four models are referred to as the Virtual Family. They are based on high resolution magnetic resonance (MR) images of healthy volunteers. More than 80 different tissue types were distinguished during the segmentation. To improve the accuracy and the effectiveness of the segmentation, a novel semi-automated tool was used to analyze and segment the data. All tissues and organs were reconstructed as three-dimensional (3D) unstructured triangulated surface objects, yielding high precision images of individual features of the body. This greatly enhances the meshing flexibility and the accuracy with respect to thin tissue layers and small organs in comparison with the traditional voxel-based representation of anatomical models. Conformal computational techniques were also applied. The techniques and tools developed in this study can be used to more effectively develop future models and further improve the accuracy of the models for various applications. For research purposes, the four models are provided for free to the scientific community.