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B 型超声设备质量控制规程的制定与实施。

Development and implementation of a quality control protocol for B-mode ultrasound equipment.

机构信息

Konstantopoulio Hospital, Nea Ionia, 142 33, Athens, Greece.

Medical Phyiscs Unit, Konstantopoulio Hospital, Nea Ionia, 142 33, Athens, Greece.

出版信息

J Ultrasound. 2022 Jun;25(2):155-165. doi: 10.1007/s40477-021-00579-7. Epub 2021 Apr 8.

Abstract

PURPOSE

Quality assurance (QA) of ultrasound (US) equipment is currently required in only a few countries around the world. In Greece, no national or other norms exist for regulating the use of US equipment. However, to obtain accreditation for the radiology department of a Greek hospital, the establishment and implementation of a quality control (QC) protocol and a QA programme for US equipment was required.

MATERIALS AND METHODS

A literature review regarding US QC/QA procedures was performed. The information collected was used as a guide to create a QC/QA protocol and to obtain an appropriate US QC phantom. Drafting and testing of the initial protocol lasted 6 months. Its final version was implemented for 18 months in two US systems and five US transducers.

RESULTS

The QC tests included in the protocol evaluate mechanical and electrical safety, image display, uniformity, penetration depth, distance accuracy, greyscale display, anechoic object imaging, geometric distortion, and axial/lateral resolution. The only QC test that failed was the test for uniformity since intense non-uniformities were observed that led to the replacement of two linear transducers.

CONCLUSION

US imaging is considered safe and, where appropriate, is preferred over imaging modalities that use ionizing radiation. However, the lack of QC/QA implies that US image quality is not routinely monitored. Therefore, the possibility of malfunctions that may go undetected and lead to wrong diagnosis cannot be excluded. A QC/QΑ programme can contribute to the elimination of such errors and ensure that performance is maintained over time.

摘要

目的

目前,全球只有少数几个国家需要对超声(US)设备进行质量保证(QA)。在希腊,没有关于规范 US 设备使用的国家或其他规范。然而,为了获得希腊医院放射科的认证,需要为 US 设备建立和实施质量控制(QC)协议和 QA 计划。

材料和方法

对 US QC/QA 程序进行了文献回顾。收集到的信息被用作创建 QC/QA 协议和获取适当的 US QC 体模的指南。初始协议的起草和测试持续了 6 个月。其最终版本在两个 US 系统和五个 US 换能器中实施了 18 个月。

结果

协议中包含的 QC 测试评估机械和电气安全、图像显示、均匀性、穿透深度、距离精度、灰度显示、无声物体成像、几何失真和轴向/侧向分辨率。唯一失败的 QC 测试是均匀性测试,因为观察到强烈的不均匀性,导致两个线性换能器被更换。

结论

US 成像被认为是安全的,并且在适当的情况下,优于使用电离辐射的成像方式。然而,缺乏 QC/QA 意味着 US 图像质量没有得到常规监测。因此,不能排除可能未被发现并导致错误诊断的故障的可能性。QC/QΑ 计划有助于消除此类错误,并确保性能随时间保持。

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本文引用的文献

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A simple uniformity test for ultrasound phased arrays.一种用于超声相控阵的简单均匀性测试方法。
Phys Med. 2016 Sep;32(9):1162-6. doi: 10.1016/j.ejmp.2016.08.011. Epub 2016 Aug 18.
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Ultrasound Med Biol. 2011 Aug;37(8):1350-7. doi: 10.1016/j.ultrasmedbio.2011.05.007. Epub 2011 Jun 16.
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Quality assurance in diagnostic ultrasound.诊断超声中的质量保证。
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