Frequency and impact of incorrect data when assessing MR safety for patients with active implants.

Abstract

Problem: An active implant is a medical device that includes a power source and provides diverse therapies to patients. Active implants are a source of risk to patients undergoing magnetic resonance (MR) imaging. Institutions develop workflows to ensure devices are assessed for MR safety and scanned using acceptable acquisition parameters. Low data integrity can result in incorrect assessments and increased patient risk.

Approach and intervention: The rate of data integrity issues and their causes were not known at our institution. Between March 2020 and April 2023, a survey was distributed for each MR implant case recording the information used to assess MR safety of the implanted device. The leading cause of data integrity loss was incorrect vendor manual for the implant. A list of links to implant vendor manual repositories was added to our workflow in December of 2021 with instructions to always find the most recent version of the device manual.

Outcomes: 749 patient records were reviewed by MR safety experts. Data integrity issues, i.e., a lack of complete and/or correct patient and implant information, occurred in 16% of cases and could impact MR safety (assessment or scanning) in 47% of those cases. A missing or incorrect manual was the leading cause of data integrity loss (78%). The incorrect manual problem initially worsened between October 2021 and March 2022 due to increased surveillance leading to more incorrect manuals being detected. The rate improved by August 2022 and remained high through March of 2023. Reducing the difficulty of finding implant vendor manuals by providing a list of links to vendor manual repositories along with guidance to pull the most recent manual version is an effective strategy to improve data integrity in MR safety workflows.