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. RESULTS: The proposed methodology was validated by comparing the SAR obtained from the PM lead TF with experimental measurements: a maximum difference of 2.2 dB was observed. It was also shown that the estimation of the TF cannot be considered independent with the lead trajectory: a variation of the SAR estimation up to 3.4 dB was observed. CONCLUSION: For the three PM lead tested, the error in the SAR estimation is within the uncertainty level of SAR measurements (± 2 dB). Additionally, the estimation of the TF using the reciprocity principle is influenced by the particular lead trajectory adopted, even if the consequent variability in the SAR estimation is still close to the uncertainty level of SAR measurements.