植入性医疗器械在磁共振成像检查中的应用现状调研及临床建议

Application of implantable medical devices in magnetic resonance imaging examination and clinical recommendations

目的了解植入性医疗器械在磁共振成像(magnetic resonance imaging,MRI)检查中的应用现状并提出临床建议。材料与方法本研究为横断面调查研究,采用方便取样法。依托中华医学会放射学分会护理学组,于2023年2月至3月通过问卷星对从事影像护理工作的护士发放电子调查问卷。本研究对可兼容植入性医疗器械的MRI检查临床应用情况、植入物材料、磁场场强、植入时长以及扫描时间的限定条件进行现状调查。数据收集完成后输入Excel 2016软件进行数据分析,计数资料采用频数、百分比(%)进行描述性统计分析。结果共有28个省、自治区、直辖市227家医院影像科护士填写有效问卷。对9类植入性医疗器械的临床应用调查显示,75.00%以上的医院检查前要求患者或家属签字,81.01%的医院要求植入可兼容起搏器的临床医师签字,77.85%的医院要求携带说明书。其中人工关节、心脏支架、骨科内固定物行MRI检查的允许或部分允许医院数最多,分别占比为87.22%、86.79%和81.05%。电子人工耳蜗行MRI检查的允许或部分允许医院数最少,占比为31.28%。除输液港外,其他8类植入性医疗器械医院要求扫描磁场≤1.5 T的占比在64.71%~83.15%之间。限制植入时间>3周的占比在63.01%~92.96%之间。限制扫描时间≤15 min的占比为28.32%~39.44%。结论目前国内各医院对9类植入性医疗器械的临床应用及临床适应条件存在不同。建立全国统一性、同质性的临床安全评估及临床应用标准对影像科护士的临床安全筛查和判断有一定的指导意义。

Objective:To investigate the application status of implantable medical devices in magnetic resonance imaging(MRI)examination and put forward clinical suggestions.Materials and Methods:This study was a cross-sectional investigation,using convenient sampling method.Relying on the Nursing Group of Radiology Society of Chinese Medical Association,an electronic questionnaire was distributed to nurses engaged in imaging nursing from February to March 2023 by asking questions.In this study,the clinical application of MRI examination of compatible,implant material devices,implant materials,magnetic field strength,implantation time and scanning time were investigated.After data collection,Excel 2016 software was used for data analysis.Frequency and percentage(%)were used for descriptive statistical analysis of counting data.Results:A total of 227 hospitals in 28 provinces,autonomous regions and municipalities directly under the Central Government have filled in valid questionnaires.The investigation on the clinical application of nine types of implantable medical devices showed that more than 75.00%hospitals require the signature of patients or their families before examination,81.01%hospitals require the signature of clinicians who implant compatible pacemakers,and 77.85%hospitals require to carry instructions.Among them,artificial joints,cardiac stents and orthopedic internal fixators were the most allowed or partially allowed hospitals,accounting for 87.22%,86.79%and 81.05%,respectively.The number of hospitals allowed or partially allowed for MRI examination of cochlear implant was the least,accounting for 31.28%.Except for the infusion port,the proportion of other eight types of implantable medical device hospitals requiring scanning magnetic field≤1.5 T was between 64.71%and 83.15%.The proportion of limited implantation time>3 weeks was between 63.01%and 92.96%.The proportion of limited scanning time≤15 min was between 28.32%and 39.44%.Conclusions:At present,there were different clinical applications and clinical adaptation conditions of nine types of implantable medical devices in domestic hospitals.Establishing a unified and homogeneous clinical safety assessment and clinical application standard in China has certain guiding significance for clinical safety screening and judgment of nurses in imaging department.