Experience with a Continuous Education Program for Clinical, Regulatory and Quality Affairs in Northwestern Switzerland.

The European Medical Device and In-Vitro Diagnostic Medical Device industry is currently facing a highly challenging situation, as applied regulations have changed significantly over the last year. To cope with this, a novel continuing education program for employees from these sectors provides knowledge and hands-on experience in clinical, regulatory and quality affairs. Since 2020 two classes have been successfully completed at the University of Applied Sciences and Arts Northwestern Switzerland: this paper describes the concept and content, the students, and the benefits both for participants and their employers.

A combined computational and experimental approach to assess the transfer function of real pacemaker leads for MR radiofrequency-induced heating.

Objective: To propose and validate a variation of the classic techniques for the estimation of the transfer function (TF) of a real pacemaker (PM) lead.

Methods: The TF of three commercially available PM leads was measured by combining data from experimental measurements and numerical simulations generated by three sources: a) the experimental local SAR at the tip of the PM lead (single measurement point) exposed to a 64 MHz birdcage body coil; b) the experimental current distribution along the PM lead, obtained by directly injecting a 64 MHz signal inside the lead; c) the electric field (E-field) simulated with a computational model of the 64 MHz birdcage body coil adopted in the experimental measurement performed in a). The effect of the lead trajectory on the estimation of the TF was also estimated.

Radio-Frequency Safety Assessment of Stents in Blood Vessels During Magnetic Resonance Imaging.

The purpose of this study was to investigate the need for high-resolution detailed anatomical modeling to correctly estimate radio-frequency (RF) safety during magnetic resonance imaging (MRI). RF-induced heating near metallic implanted devices depends on the electric field tangential to the device ( ). and specific absorption rate (SAR) were analyzed in blood vessels of an anatomical model to understand if a standard gel phantom accurately represents the potential heating in tissues due to passive vascular implants such as stents.

A numerical investigation on the effect of RF coil feed variability on global and local electromagnetic field exposure in human body models at 64 MHz.

Purpose: This study aims to investigate how the positions of the feeding sources of the transmit radiofrequency (RF) coil, field orientation direction with respect to the patient, and patient dimensions affect the global and local electromagnetic exposure in human body models.

Methods: Three RF coil models were implemented, namely a specific two-source (S2) feed and two multisource feed configurations: generic 32-source (G32) and hybrid 16-source (H16). Thirty-two feeding conditions were studied for the S2, whereas two were studied for the G32 and H16.

Effects of tuning conditions on near field of MRI transmit birdcage coil at 64 MHz.

This study investigates how the tuning conditions of a 64 MHz / 1.5 T radio frequency (RF) birdcage coil modeled with an RF circuit and 3D electromagnetic co-simulation affect the electric and magnetic near-field distribution. Four models were implemented with different tuning conditions and difference between numerical results and measurements was evaluated.

RF induced energy for partially implanted catheters: a computational study.

Magnetic Resonance Imaging (MRI) is a radiological imaging technique widely used in clinical practice. MRI has been proposed to guide the catheters for interventional procedures, such as cardiac ablation. However, there are risks associated with this procedure, such as RF-induced heating of tissue near the catheters.

Time resolved dosimetry of human brain exposed to low frequency pulsed magnetic fields.

An accurate dosimetry is a key issue to understanding brain stimulation and related interaction mechanisms with neuronal tissues at the basis of the increasing amount of literature revealing the effects on human brain induced by low-level, low frequency pulsed magnetic fields (PMFs). Most literature on brain dosimetry estimates the maximum E field value reached inside the tissue without considering its time pattern or tissue dispersivity. Nevertheless a time-resolved dosimetry, accounting for dispersive tissues behavior, becomes necessary considering that the threshold for an effect onset may vary depending on the pulse waveform and that tissues may filter the applied stimulatory fields altering the predicted stimulatory waveform's size and shape.

High dielectric material in MRI: Numerical assessment of the reduction of the induced local power on implanted cardiac leads.

High dielectric materials (HDM) have been proposed in magnetic resonance imaging (MRI) to increase the signal-to-noise ratio (SNR) of the images acquired while reducing the radiofrequency (RF) absorption in tissue. The aim of this study is to assess the potential merit of using HDM to reduce power induced at the tip of an endocardial lead in patients undergoing MRI. Numerical simulations were performed using a commercial finite-differences time-domain (FDTD) software to model the RF field generated by a birdcage body coil at 64 MHz on a human body model.

Assessing the Electromagnetic Fields Generated By a Radiofrequency MRI Body Coil at 64 MHz: Defeaturing Versus Accuracy.

Goal: This study aims at a systematic assessment of five computational models of a birdcage coil for magnetic resonance imaging (MRI) with respect to accuracy and computational cost.

Methods: The models were implemented using the same geometrical model and numerical algorithm, but different driving methods (i.e.