[关于植入式医疗器械 MR 安全标签变更数量和比例的调查]。

Nihon Hoshasen Gijutsu Gakkai zasshi Pub Date : 2024-02-20 Epub Date: 2023-12-19 DOI:10.6009/jjrt.2024-1424
Masaaki Fukunaga, Takayuki Miyazaki, Takashi Ogasahara, Shinji Osumi, Kazuki Kitagawa, Hitoshi Fujioka, Maiko Sekiguchi, Haruna Tanaka
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引用次数: 0

摘要

目的:本研究旨在调查植入式医疗器械(IMDs)磁共振(MR)安全信息标签变更项目的数量和百分比,并确认检查最新磁共振安全信息数据库(117 种类型和 10031 个项目)的重要性:我们调查了截至 2021 年 12 月和 2022 年 8 月 MR 安全信息数据库中 IMD 的 MR 安全标签变更数量和百分比:MR 安全性无标签的 IMD 从 4116 项(41.1%)减少到 859 项(8.6%)。MR 有条件的 IMD 从 4141 项(41.3%)增加到 5896 项(58.8%):由于许多 IMD 的 MR 安全性标签发生了变化,本研究表明,确认 IMD 的最新 MR 安全性信息非常重要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[Survey on the Number and Percentage of MR Safety Labeling Changed for Implantable Medical Devices].

Purpose: The purposes of this study were to investigate the number and percentage of items that changed magnetic resonance (MR) safety information labeling for implantable medical devices (IMDs) and to confirm the importance of checking the latest MR safety information database (117 types and 10031 items).

Methods: We investigated the number and percentage of MR safety labeling changed for IMDs in the MR safety information database as of December 2021 and August 2022.

Results: IMDs of MR Safety Unlabeled decreased from 4116 items (41.1%) to 859 items (8.6%). IMDs of MR Conditional increased from 4141 items (41.3%) to 5896 items (58.8%).

Conclusions: Since there have been changes in the MR safety labeling for many IMDs, this study shows that it is important to confirm the latest MR safety information for IMDs.

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