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Abstract 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.

Abstract 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.

Abstract 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.

Abstract 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.

Exploiting unlicensed spectrum bands for cellular communication is a rapidly embraced trend by industry stakeholders. Accordingly, the specifications of Long Term Evolution (LTE) were extended in Release 13 to allow unlicensed spectrum operation, also known as LTE-Licensed Assisted Access (LAA). LTE is widely adopted, and there is a potential for significant coexistence impact of LTE-LAA on users of unlicensed spectrum including wireless medical devices, whether adopters of the new technology or incumbents. Therefore, work was initiated to revise and update the American National Standards Institute (ANSI) C63.27 standard for evaluation of wireless coexistence. This paper details the experimental work conducted at the Electromagnetic Compatibility and Wireless Laboratory, U.S. Food and Drug Administration, to investigate the use of LAA signals for wireless coexistence testing. A software defined radio platform was deployed to generate realistic LAA signals and measure the wireless coexistence impact on the LAA communication link. The equipment under test (EUT) used IEEE 802.11ac as an example incumbent technology in the 5 GHz band. The standardized radiated anechoic chamber method was used for testing. Results highlight the mutual coexistence impact of LAA in the 5 GHz band and suggest that selecting an LAA signal with the maximum possible channel time occupancy and the highest possible modulation and coding scheme (MCS) yields the most impactful coexistence situation on both the EUT and the LAA system.

Wireless communication is an essential part of daily life for users globally with applications in medical devices, cellular phones, Internet of Things nodes, and others. Accordingly, there is a need to understand the patterns and properties of radio frequency spectrum use by acquiring accurate spectrum utilization measurements. However, the massive storage volume needed to execute spectrum surveys-especially when a fast sampling rate is used-is an impeding factor in terms of cost and ease-of-access. In this article, a probabilistic efficient storage algorithm (PESA) is proposed to facilitate high-accuracy, time-domain spectrum surveys conducted at a fast sample acquisition rate to detect sporadic spectrum occupancy patterns that could be on the order of microseconds. PESA divides the dynamic range of a monitoring equipment into bins-each represented by one component of a Gaussian mixture model (GMM). Windows of activity and inactivity in the measurements are established by comparing with a threshold and then indicators to the GMM component that best describes a window are recorded. Hence, reducing required storage volume. Results demonstrate that ≈ 99% reduction in storage volume is achievable while maintaining an accurate estimation of channel utilization and activity/inactivity periods. Furthermore, a Lab-VIEW implementation of PESA on a hardware platform was executed and used to survey Wi-Fi channel 1 in a healthcare environment for seven consecutive hours. Although more than 25 billion samples were observed, resulting data only occupied 96.28 megabytes.

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.

Integrating wireless technology in medical devices has proved beneficial for both patients and caregivers. However, the use of shared, unlicensed spectrum bands by both medical and non-medical wireless devices has raised concerns about wireless coexistence. The challenge of incorporating wireless communication into a medical device is to ensure reasonable medical device effectiveness and patient safety. Consequently, work to develop a standardized process to assess wireless coexistence, primarily for wireless medical devices, was carried by Subcommittee 7 of American National Standards Institute (ANSI)-accredited standards committee (ASC) C63 and the Wireless Working Group (SM-WG06) of the Association for the Advancement of Medical Instrumentation (AAMI). Both groups have recently released their respective documents. In this article, we discuss practical aspects of wireless coexistence testing-in the realm of ANSI C63.27 and AAMI TIR69-to help answer basic, yet important, questions such as what to test, how to test, and how to present results.