美国FDA对磁共振环境下的器械指南文件进行了更新

奥咨达 医疗器械创新网 2019-08-10




上周四,美国食品和药物管理局(FDA)发布了一份指南草案,该指南草案提供了最新的检测和标签指导建议,以评估医疗器械在磁共振(MR)环境下的安全性和兼容性。

 

这份由FDA器械和放射健康中心(CDRH)制定的26页指南草案一旦定稿,将取代2014年发布的一份最终指南(Establishing Safety and Compatibility ofPassive Implants in the Magnetic Resonance (MR) Environment)。

 

指南草案中的新建议超出了2014版指南文件中所提及的建议范围,特别是与减轻MR环境和器械标签特有的安全危害有关的建议。

 

指南更新内容与磁共振成像(MRI)系统所经历的技术变革相吻合,例如各类世界首创设备的新MRI兼容性说明。FDA表示:“核磁共振成像是专业医护人员在疾病诊断以及为某些程序提供指导方面的有力工具。”该指南草案涉及“更广泛的设备”,包括有源植入物和辅助医疗设备,并概述了“更清晰的标签”,旨在帮助“专业医护人员更好地了解潜在危害”。

 

该指南草案明确说明了是否以及如何处理各种危害(具体取决于器械类型),以及如何格式化评估以及应包含在上市前申请(premarketsubmissions)中的标签信息。CDRH写道:“适当测试和分析、科学原理和标签,例如有足够证据支持表明MR特定条件下安全(MR conditional)的标签……为MR环境特有的安全危害提供充分的缓解措施依据。

 

除了2014版指南文件中所讨论的磁感应位移力、磁感应扭矩、加热和图像伪影危害之外,新指南草案中所提出的建议还包括:采取措施降低梯度诱导变化和外部电势、纠正MR检查所产生的射频脉冲和器械故障。

 

CDRH针对更广泛的危害提出了缓解措施建议,旨在设法将进入磁共振环境的器械所带来的风险降至最低,这类风险包括组织损伤和图像损坏等。为了降低核磁共振室中使用的器械(而不是磁共振系统)成为飞射物体的可能性,CDRH建议将此类器械“永久固定”,以便不会被移至危险区域。

 

根据该指南草案,建议提供试验报告摘要和完整的试验报告(如适用)。指南草案还确定了应包含在这些报告摘要或完整报告中的信息。

 

更新部分提出了使用“患者医疗器械卡”的新建议,尽管多年来针对某些器械类型(如乳房植入物和助听器)一直要求使用植入物卡和患者卡。CDRH当前表示,针对范围内植入物和固定到患者身上或由患者随身携带的外部设备的患者标签,还应使用患者医疗器械卡,以便专业医护人员可以识别患者所使用的具体器械、器械的MRI安全状态以及MR特定条件下安全的器械所需条件。

 

2017年,美国FDA收到了关于患者受伤和死亡的严重不良事件报告,这引起了FDA对在MR环境中使用的植入式输注泵的关注,于是建议使用此类器械的患者及其医护人员应采用植入物卡。2017年5月,欧洲提出了使用植入卡的要求,就在同年8月份,澳大利亚也提出了同样的要求。此外,欧盟上个月还发布了关于植入物卡的指南文件。

 

该指南草案尤其强调要采纳自2014年以来发布的其他共识标准和FDA指南文件,其中包括ISO和IEC标准以及关于MR诊断器械方面的Q-提交(Q-submissions)和510(k)提交指南文件等。


英文原文


FDA Updates Guidance on Devices in the Magnetic Resonance Environment


Draft guidance issued on Thursday offers updated testing and labeling advice to assess the safety and compatibility of medical devices for the magnetic resonance (MR) environment.

 

Once finalized, the 26-page draft guidance from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) will supersede a final guidance issued in 2014. The recommendations in the new draft guidance go beyond those set forth in 2014, particularly as it relates to mitigating the safety hazards unique to the MR environment and device labeling.

 

Updates coincide with the technological changes that magnetic resonance imaging (MRI) systems have been witnessing, such as new MRI compatibility indications for first-of-its-kind devices. “MRIs are powerful tools for health care professionals to diagnose medical conditions & guide certain procedures,” the agency said. The draft guidance addresses “a broader range of devices,” including active implants and ancillary medical equipment, and it outlines “clearer labeling” with the goal of helping “health care professionals better consider potential hazards.”

 

The draft clarifies whether and how to address each hazard depending on the device type, as well as how to format assessments and labeling information that should be included inpremarket submissions. “Appropriate testing and analyses, scientific rationale,and labeling, such as well supported MR conditional labeling...form the basis of adequate mitigations for the unique safety hazards of the MR environment,”CDRH writes.

 

New recommendations include mitigation measures for gradient induced variation and extrinsic electrical potential, the rectification of radiofrequency pulses from MR exams and device malfunctions. This is in addition to magnetically induced displacement force, magnetically induced torque, heating and image artifacts hazards discussed in the 2014 guidance.

 

With recommendations formitigation measures across a wider range of hazards, CDRH seeks to help minimize the risks posed by devices that enter the MR environment. These include tissue damage and image corruption, among others. To mitigate the potential of a device used in the MRI room but not the MR system bore becoming a projectile, CDRH is proposing that such a device “be permanently secured so that it may not be moved into a hazardous area.”

 

The draft guidance newly proposes providing test report summaries and complete test reports, if applicable. It also identifies the information that should be included in such summaries or reports.

 

Updates make new recommendations for using a “patient medical device card,” though implant cards and patient cards have been a requirement on certain device types like breast implants and hearing aids for years. CDRH now says that patient labeling forin-scope implants and external devices fastened to or carried by patients should also include a patient medical device card so that the medical professional can identify the specific devices a patient has, the MRI safety status of the devices and the conditions for the safe use of MR Conditional devices.

 

FDA raised concerns in 2017 with implantable infusion pumps in the MR environment after receiving serious adverse events reports of patient injury and death, recommending patients with such devices and their caregivers use an implant card. The required inclusion of an implant card was introduced in Europe in May 2017, followed by Australiain August 2017. EU guidance on implant cards was posted last month.

 

The draft guidance also places greater emphasis on leveraging additional consensus standards and FDA guidances made available since 2014. These include ISO and IEC standards and guidances on Q-submissions, 510(k) submissions for MR diagnostic devices, among others.


【来源】RAPS

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