Journal List > J Korean Soc Radiol > v.67(6) > 1087198

TOOLS
Jo, Choi, Jung, Yong, Park, Kim, Jang, and Cha: A Study on the Improvement of Safety Testing Standards and Methods for Mammography
Breast Radiology
Journal of the Korean Society of Radiology

Journal of the Korean Society of Radiology 2012; 67(6): 451-459.

Published online: 18 December 2012

DOI: https://doi.org/10.0000/jksr.2012.67.6.451

A Study on the Improvement of Safety Testing Standards and Methods for Mammography

Sangwon Jo, MD2, Seon Hyeong Choi, MD1, 2, Ah Young Jung, MD1, 3, Hwan Seok Yong, MD1, 4, Ji Koon Park, MD5, Do Wan Kim, MD1, Gi Won Jang, MD1, Sang Hoon Cha, MD1, 6

1Korean Institute for Accreditation of Medical Imaging, Seoul, Korea.

2Department of Radiology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.

3Department of Radiology, Hallym University College of Medicine, Kangnam Sacred Heart Hospital, Seoul, Korea.

4Department of Radiology, Korea University College of Medicine, Guro Hospital, Seoul, Korea.

5Industry-Academic Cooperation Foundation, International University of Korea, Jinju, Korea.

6Department of Radiology, Korea University College of Medicine, Ansan Hospital, Ansan, Korea.

Corresponding author: Seon Hyeong Choi, MD. Department of Radiology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul 110-746, Korea. Tel. 82-2-2001-1880, Fax. 82-2-2001-1881, seonhyeong.choi@samsung.com

Received 7 August 2012       Accepted 11 September 2012

Copyright © 2012 The Korean Society of Radiology

Abstract

Purpose

To establish the improved national safety testing standards and methods for mammography.

Materials and Methods

We investigated and compared the current status of mammographic equipment installation with the national and international safety and quality control programs and methods. We established and verified the draft for safety testing standards and methods.

Results

We propose that the investigations of the conductor system, hardware leakage radiation profile, illumination intensity test, comparison between X-ray and light photon exposure, X-ray dose exposure on the chest wall, compression equipment size, timing equipment, and the average effective radiation dose, should all be maintained as they are in the present state without any changes. However, the exposure radiation dose reproducibility, kVp and mAs, and the half value layer tests should be reconsidered and revised. Moreover, compression pressure and autonomic exposure control system (AEC) tests should be included as new criteria. Other parameter controls included in the phantom image analysis which overlap with total quality assurance should be excluded.

Conclusion

We recommend that AEC and compression pressure tests should be included as new criteria and the methods for the exposure radiation dose reproducibility, kVp, and mAs, and half value layer tests should be reconsidered and revised.

Keywords: Breast, Mammography, Mandatory Testing, X-Rays, Safety Management

Figures and Tables

Table 1
Comparison of Quality Control Check Lists in USA, EU and South Korea
jksr-67-451-i001

Note.-AEC = autonomic exposure control system, EU = European Union, HVL = half value layer, IR = image receptor

Table 2
Current Similar Check Lists between Safety Test & Quality Control for Mammography
jksr-67-451-i002

Note.-AEC = autonomic exposure control system, HVL = half value layer, IR = image receptor

Notes

This research was supported by a grant (11172KFDA525) from Korea Food & Drug Administration in 2011.

References

1. Medical Law. No.38.
2. Medical Law. No.37.
3. USA Food and Drug Administration. Compliance Guidance, The Mammography Quality Standards Act Final Regulations, Preparing For MQSA Inspections, Final. 1999.
4. Perry N, Broeders M, de Wolf C, Törnberg S, Holland R, von Karsa L. European guidelines for quality assurance in breast cancer screening and diagnosis 4th edition: the European Reference Organization for Quality Assured Breast Screening and Diagnostic Services. 2006.
5. NHS Cancer Screening Programmes. National Quality Assurance Coordinating Group for Radiography. Quality assurance guidelines for mammography including radiographic quality control. NHSBSP Publication No. 63. 2006. Sheffield, UK: NHS Cancer Screening Programmes.
6. NHS Cancer Screening Programmes. Commissioning and Routine Testing of Full Field Digital Mammography Systems. NHSBSP Equipment Report 0604, Version 3. 2009.
7. National Accreditation Standards. Quality Improvement Program, Breast Screen Australia. 2008.
8. Health Canada, Health Environments and Consumer Safety. Canadian Mammography Quality Guidelines. 2002. Ottawa, ON: Health Environments and Consumer Safety Branch, Health Canada.
9. International Atomic Energy Agency (IAEA). Quality Assurance Programme for Screen-Film Mammography: IAEA Human Health Series No. 2. 2009. International Atomic Energy Agency.
10. IEC. International standard, Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotatic devices, IEC 60601-2-45, 3.0 edi. 203. 2011.
11. General requirements for safety of medical electrical equipment. KSP 1005:02. 2002. Korean Standard.
12. general rules for medical X-ray equipment. KS A 4021:1997. 2007. Korean Standard.
13. Medical radiology-Terminology. KS A 4920:2001. 2011. Korean Standard.
14. Korean Institute for Accreditation of Medical Image. 2010. Korean Institute for Accreditation of Medical Image.
15. Services EROfQABSaD. EUREF. Euref type testing protocol, ver. 1.12. 2011.
16. Evaluation and routine testing in medical imaging departments - Part 2-10: Constancy tests - X-ray equipment for mammography. KS C IEC 61223-2-10:2003. 2008. Korean Standard.
TOOLS
Similar articles