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质量保证监管执法对乳腺摄影系统性能的影响:来自台湾大规模调查的证据。

Effects of quality assurance regulatory enforcement on performance of mammography systems: evidence from large-scale surveys in Taiwan.

机构信息

Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital at Linkou, 5 Fushing St, Kweishan, Taoyuan 333, Taiwan.

出版信息

AJR Am J Roentgenol. 2013 Aug;201(2):W307-12. doi: 10.2214/AJR.12.9614.

Abstract

OBJECTIVE

The Standards for Medical Exposure Quality Assurance in mammography systems were enacted on July 1, 2008, in Taiwan. This study aimed to evaluate the trends in performance of mammography units before and after the regulation started on the basis of annual on-site surveys from 2008 to 2010.

MATERIALS AND METHODS

On-site measurements were conducted on 215, 205, and 209 mammography units in 2008, 2009, and 2010, respectively, which accounted for more than 95% of all units in Taiwan. Phantom image quality, average glandular dose (AGD), and half-value layer were evaluated on all systems. Processor conditions, compression conditions, radiation output, and computed radiography exposure indicators were assessed on units participating in mammography screening in 2008 and on all units in the later years. Evaluations of maximum compression force and automatic exposure control reproducibility were added into the protocol from 2009 onward.

RESULTS

Mean phantom scores were improved significantly from 2008 to 2009 (11.63 ± 1.30 vs 12.31 ± 0.94, p < 0.05) and remained stable for 2010 (12.35 ± 0.87). Mean AGDs were 1.48 ± 0.47, 1.38 ± 0.41, and 1.37 ± 0.42 mGy over the 3 years, with a significant reduction from 2008 to 2009 (p < 0.05). For film-screen mammography systems, variations of sensitometric curves were greatly reduced in 2009 and 2010 when compared with 2008. Passing rates were increased after the regulation took effect in almost all aspects.

CONCLUSION

Results from large-scale on-site surveys showed an overall improvement in performance after quality assurance in mammography was enforced in Taiwan.

摘要

目的

2008 年 7 月 1 日,台湾颁布了《乳腺摄影系统医用照射质量保证标准》。本研究旨在通过 2008 年至 2010 年的年度现场调查,评估该法规实施前后乳腺摄影设备的性能变化趋势。

材料与方法

2008、2009 和 2010 年分别对 215、205 和 209 台乳腺摄影设备进行了现场测量,占台湾所有设备的 95%以上。对所有系统进行了图像质量、平均腺体剂量(AGD)和半价层的评估。对参加 2008 年乳腺摄影筛查的设备和之后所有设备进行了处理器条件、压缩条件、辐射输出和计算机放射摄影曝光指标的评估。从 2009 年开始,协议中增加了最大压缩力和自动曝光控制重复性的评估。

结果

2008 年至 2009 年,平均图像质量评分显著提高(11.63 ± 1.30 对 12.31 ± 0.94,p < 0.05),2010 年保持稳定(12.35 ± 0.87)。3 年间,AGD 均值分别为 1.48 ± 0.47、1.38 ± 0.41 和 1.37 ± 0.42 mGy,2008 年至 2009 年明显降低(p < 0.05)。对于屏片乳腺摄影系统,2009 年和 2010 年与 2008 年相比,感光曲线的变化大大减少。法规实施后,几乎所有方面的通过率都有所提高。

结论

大规模现场调查结果显示,台湾实施乳腺摄影质量保证后,整体性能得到了提高。

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