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2021年5月份，F(xiàn)DA發(fā)布了一則MR相關(guān)的指南終版，提供了FDA關(guān)于在MR環(huán)境下評(píng)估醫(yī)療器械安全性和兼容性的測(cè)試建議，以及醫(yī)療器械標(biāo)簽中磁共振成像（MRI）安全信息的推薦格式。此指南取代了2014版的MR指南"Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment"。

 

與2014版指南相比，此指南最大的變化在于以下幾點(diǎn)：

 

適用產(chǎn)品范圍更廣了：

 

       之前僅適用于無源植入類器械，現(xiàn)在適用于所有預(yù)期進(jìn)入MR環(huán)境的醫(yī)療

 

       器械，包括所有植入醫(yī)療器械、固定在患者身上或由患者攜帶的醫(yī)療器

 

       械（例如，外部胰島素泵、脈搏血氧儀）、在臨床護(hù)理期間合理預(yù)計(jì)會(huì)

 

       進(jìn)入MR環(huán)境的醫(yī)療設(shè)備，以及所有打算進(jìn)入MR環(huán)境的醫(yī)療器械。

 

       這意味著很多醫(yī)療器的械都要考慮這個(gè)指南的要求了，整個(gè)設(shè)計(jì)開發(fā)過

 

       程中都要注意符合這個(gè)指南的要求。

 

MR相關(guān)labeling的要求更具體了：

 

       要求所有產(chǎn)品labelling上的MR labeling都要清晰易懂，且能夠在制造商

 

       網(wǎng)站上和/或通過電話獲取到。不能使用MR Compatible這個(gè)標(biāo)識(shí)，因?yàn)?/span>

 

       這個(gè)標(biāo)識(shí)容易造成誤解，且已經(jīng)被廢棄了。

 

針對(duì)這個(gè)指南，F(xiàn)DA在6.24舉辦了一場(chǎng)網(wǎng)絡(luò)研討會(huì)，大家可以在之前文章中找到相關(guān)通知：

 

【FDA會(huì)議通知】2021.06.24 Webinar - 醫(yī)療器械在MR環(huán)境下的安全所進(jìn)行的測(cè)試和標(biāo)記

 

此研討會(huì)相關(guān)的信息分享給大家：

 

1、醫(yī)療器械與磁共振環(huán)境的相互作用，概述如下圖：

 

 

2、指南發(fā)展背景：

 

• Standardization of testing for passive implants

 

– American Society for Testing and Materials (ASTM) Test Standards

 

• Evolution of the Passive Implant Guidance

 

– “Establishing Safety and Compatibility of Passive Implants in the

 

Magnetic Resonance (MR) Environment,” dated December 11, 2014

 

• Safety testing for active implantable medical devices in the MR environment

 

– Covered currently by the ongoing ISO (International Organization for

 

Standardization)/TS (Technical Specification) 10974

 

• Identification of a need for a comprehensive guidance

 

• Draft guidance issued for comment August 2, 2019: “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment”

 

3、Relevant FDA Recognized Consensus Standards

 

• ASTM F2052: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment

 

• ASTM F2119: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

 

• ASTM F2182: Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging

 

• ASTM F2213: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

 

• ASTM F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

 

• IEC 60601-2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

 

• ISO/TS 10974: Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

 

4、重要術(shù)語：

 

•磁共振（MR）環(huán)境（Magnetic Resonance (MR) environment）

 

–“磁共振磁體周圍空間的三維體積，包含法拉第屏蔽體積和0.50 mT磁場(chǎng)輪廓（5高斯（G）線）。這里指的是醫(yī)療器械可能因暴露于磁共振設(shè)備和附件產(chǎn)生的電磁場(chǎng)而造成危險(xiǎn)的區(qū)域。

 

•磁共振（MR）系統(tǒng)（Magnetic Resonance (MR) System）

 

MR設(shè)備的集合，附件，包括顯示、控制、能源供應(yīng)和受控訪問區(qū)域（如提供）”的裝置

 

•MR安全（MR Safe）

 

–“暴露在任何MR環(huán)境中不會(huì)造成已知危害的醫(yī)療設(shè)備。MR-Safe醫(yī)療器械由不導(dǎo)電、非金屬和非磁性的材料組成。

 

•MR條件性（MR Conditional）

 

–“在規(guī)定條件下，包括靜態(tài)磁場(chǎng)、時(shí)變梯度磁場(chǎng)和射頻場(chǎng)條件下，在MR環(huán)境中證明安全的醫(yī)療器械。”

 

•MR不安全（MR Unsafe）

 

–“對(duì)MR環(huán)境中的患者、醫(yī)務(wù)人員或其他人員造成不可接受風(fēng)險(xiǎn)的醫(yī)療設(shè)備”

 

5、MR環(huán)境中醫(yī)療器械需解決的危害

 

• Magnetically induced displacement force (ASTM F2052)

 

• Magnetically induced torque (ASTM 2213)

 

• Heating (ASTM F2182, ISO/TS 10974)

 

• Gradient induced vibration (ISO/TS 10974)

 

• Gradient induced electrical potential (unintended tissue stimulation) (ISO/TS 10974)

 

• Rectification of radiofrequency pulses (unintended tissue stimulation) (ISO/TS 10974)

 

• Medical device malfunction (ISO/TS 10974)

 

• Extent of image artifact (ASTM F2119)

 

6、Reporting Results的要求

 

• Test report summaries, and if applicable, complete test reports should:

 

– List the hazard addressed by the test

 

– List the test equipment used

 

– Include results and all report elements as defined in the consensus  standard.

 

• For the computational modeling report, follow the FDA Guidance: Reporting of Computational Modeling Studies in Medical Device Submissions .

 

• When ASTM F2182 is used, scale the values for °C/(V/m) or in °C/(W/kg) to a temperature increase (in °C) for the exposure conditions specified in the MR Conditional labeling.

 

• Provide a written narrative or a tabulated summary, including a narrative discussion of the results/conclusions

 

• See also the FDA guidance: Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions

 

Example of a Tabular Test Summary

 

 

7、MRI Safety Labeling的要求

 

The labeling should include:

 

• Sufficient information for a health care professional to determine whether a device can safely enter the MR environment

 

• A separate section of your labeling entitled “MRI Safety Information.”

 

• Based on assessments, MR Safe, MR Unsafe, or MR Conditional

 

• The appropriate symbol from ASTM F2503 and/or the corresponding term in the labeling

 

• A patient medical device card with MRI safety information

 

The MRI safety information should be readily accessible on the manufacturer’s website and/or by telephone.

 

 

對(duì)于MR Conditional的設(shè)備，還有較多l(xiāng)abeling的要求，大家可以細(xì)讀指南要求了解更詳細(xì)的要求。

 

Example MR Conditional labeling for a passive medical device

 

 

還有一類labeling，為Safety in MRI Not Evaluated的labeling，要求如下：

 

The labeling should include the following information:

 

“The <insert medical device name> has not been evaluated for safety in the MR environment. It has not been tested for heating or unwanted movement in the MR environment. The safety of <insert medical device name> in the MR environment is unknown. Performing an MR exam on a person who has this medical device may result in injury or device malfunction.”

 

Safety in MRI Not Evaluated的labeling的適用范圍如下：

 

適用于預(yù)期在MR環(huán)境中使用的數(shù)量非常有限的醫(yī)療設(shè)備，例如某些無源植入物：

 

–以前沒有提供任何關(guān)于MRI安全性的信息

 

–沒有因暴露于MR環(huán)境而導(dǎo)致的已知不良事件

 

不適合標(biāo)為Safety in MRI Not Evaluated的器械：

 

–通常被標(biāo)記為MR Conditional或MR Unsafe

 

–新型的器械

 

–含有鐵磁性材料

 

–有源類醫(yī)療器械

 

–部分植入的器械