MRI safety management in patients with cardiac implantable electronic devices: Utilizing failure mode and effects analysis for risk optimization

Abstract

Introduction Cardiac Implantable Electronic Devices (CIEDs) are increasing in prevalence. Exposing patients with CIEDs to MRI can lead to adverse outcomes. This has led certain radiology departments to not accept MRI referrals related to patients with CIEDs. Patients with MR-conditional CIEDs can be safely scanned under specific conditions. Our institution has accepted such referrals since 2014. The aim of this study was to systematically identify and reduce risk in our CIED-MRI protocol using Failure Mode and Effects Analysis (FMEA). Methods A multidisciplinary FMEA team was assembled and included senior stakeholders from the CIED-MRI protocol. A process map was constructed followed by risk analysis and scoring. Targeted interventions were formulated and implemented, high-risk failure modes were prioritized. A new process map and protocol were drafted and repeat risk analysis performed. Monitoring and re-evaluation of the CIED-MRI pathway were instigated at departmental QA meetings. Results Interventions included direct CIED characterisation using wireless technology pre-MRI, CIED programming and reprogramming in the MRI suite before and immediately after MRI reducing device downtime and continuous patient monitoring during MRI by a cardiac physiologist. The cumulative risk priority number decreased from 1190 pre FMEA to 492 post FMEA. Discussion Despite the risk of exposing CIEDs to the MR environment, patients with MR-conditional CIEDs can be safely scanned with appropriate multidisciplinary support. We found FMEA an indispensable tool in identifying and minimizing risk with no adverse events recorded since FMEA recommendations were implemented.

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“…cardiac pacemaker and electrode). [94][95][96][97][98][99][100] MR unsafe corresponds to materials that are dangerous in MR environments, such as surgical scissors and forceps. [101][102][103][104] Preventing eddy current-induced complications in the patient Consideration must be given to eddy currents, which are generated in nearby conductors, including the largest eddy current generated in an MR scanner, which is a shield panel placed inside the gradient coil, which is part of the MR scanner, and when there is ferrous, eddy current is not the only cause of heat generation but also there is so-called antenna effect and current inflow.…”

“…cardiac pacemaker and electrode). 94 – 100 MR unsafe corresponds to materials that are dangerous in MR environments, such as surgical scissors and forceps. 101 – 104 …”

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