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http://dx.doi.org/10.17946/JRST.2022.45.2.127

A Study on Establishment of Essential Performance Evaluation Criteria for C-arm Computed Tomography  

Kim, Eun-Hye (Dept. Health Safety Convergence Science, Korea University)
Park, Hye-Min (Dept. Health Safety Convergence Science, Korea University)
Kim, Jung-Min (Dept. Health Safety Convergence Science, Korea University)
Publication Information
Journal of radiological science and technology / v.45, no.2, 2022 , pp. 127-134 More about this Journal
Abstract
In order to overcome the image quality limitations of the conventional C-arm, a flat panel detector (FPD) is used to enhance spatial resolution, detective quantum efficiency, frame rate, and dynamic range. Three-dimensional (3D) visualized information can be obtained from C-arm computed tomography (CT) equipped with an FPD, which can reduce patient discomfort and provide various medical information to health care providers by conducting procedures in the interventional procedure room without moving the patient to the CT scan room. Unlike a conventional C-arm device, a C-arm CT requires different basic safety and essential performance evaluation criteria; therefore, in this study, basic safety and essential performance evaluation criteria to protect patients, medical staff, and radiologists were derived based on International Electrotechnical Commission (IEC) standards, the Ministry of Food and Drug Safety (MFDS) standards in Korea, and the rules on the installation and operation of special medical equipment in Korea. As a result of the study, six basic safety evaluation criteria related to electrical and mechanical radiation safety (leakage current, collision protection, emergency stopping device, overheating, recovery management, and ingress of water or particulate matter into medical electrical (ME) equipment and ME systems: footswitches) and 14 essential performance evaluation criteria (accuracy of tube voltage, accuracy of tube current, accuracy of loading time, accuracy of current time product, reproducibility of radiation output, linearity and consistency in radiography, half layer value in X-ray equipment, focal size and collimator, relationship between X-ray field and image reception area, consistency of light irradiation versus X-ray irradiation, performance of the mechanical device, focal spot to skin distance accuracy, image quality evaluation, and technical characteristic of cone-beam computed tomography) were selected for a total of 20 criteria.
Keywords
C-arm CT; Basic safety; Essential performance; Evaluation criteria; Radiation protection;
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Times Cited By KSCI : 2  (Citation Analysis)
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1 Wallace MJ, Kuo MD, Glaiberman C, et al. Three-dimensional C-arm cone-beam CT: Applications in the interventional suite. J Vasc Interv Radiol. 2009;20(7):S523-37.   DOI
2 Fahrig R, Dixon R, Payne T, Morin RL, Ganguly A, Strobel N. Dose and image quality for a cone-beam C-arm CT system. Med Phys. 2006;33(12):4541-50.   DOI
3 Orth RC, Wallace MJ, Kuo MD. Technology Assessment Committee of the Society of Interventional Radiology. C-arm cone-beam CT: General principles and technical considerations for use in interventional radiology. J Vasc Interv Radiol. 2009;20(7):S538-44.   DOI
4 Hirota S, Nakao N, Yamamoto S, et al. Cone-beam CT with flat-panel-detector digital angiography system: Early experience in abdominal interventional procedures. Cardiovasc Intervent Radiol. 2006;29(6):1034-8.   DOI
5 Baba R, Konno Y, Ueda K, Ikeda S. Comparison of flat-panel detector and image-intensifier detector for cone-beam CT. Comput Med Imaging Graph. 2002;26(3):153-8.   DOI
6 Ning R, Chen B, Yu R, Conover D, Tang X, Ning Y. Flat panel detector-based cone-beam volume CT angiography imaging: System evaluation. IEEE Trans Med Imaging. 2000;19(9):949-963.   DOI
7 Akpek S, Brunner T, Benndorf G, Strother C. Three-dimensional imaging and cone beam volume CT in C-arm angiography with flat panel detector. Diagn Interv Radiol. 2005;11(1):10-3.
8 International Electrotechnical Commission. IEC 60601-2-43 Medical electrical equipment-Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures. Geneva, Switzerland; 2010.
9 Ministry of Health, Labor and Welfare. Basic requirements conformity checklist: Standard for whole-body X-ray CT diagnostic equipment. MHLW-No. 112.
10 Siewerdsen JH, Moseley DJ, Burch S, et al. Volume CT with a flat-panel detector on a mobile, isocentric C-arm: Pre-clinical investigation in guidance of minimally invasive surgery. Med Phys. 2005;32(1):241-54.   DOI
11 Food and Drug Administration. Computed tomography x-ray system. FDA-892.1750.
12 International Electrotechnical Commission. IEC 60601-2-44 Medical electrical equipment-Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography. Geneva, Switzerland; 2016.
13 International Electrotechnical Commission. IEC 60601-1-3 Medical electrical equipment-Part 1-3: General requirements for basic safety and essential performance-Collateral Standard: Radiation protection in diagnostic X-ray equipment. Geneva, Switzerland; 2008.
14 Ministry of Food and Drug Safety. Regulations on medical device item and classification. Ministry of Food and Drug Safety Notice No. 2021-24.
15 Ministry of Food and Drug Safety. Medical device standard: Attached table 2, appliance equipment 8 diagnostic X-ray system; 2021.
16 Kim EH, Park HM, Kim JM. A study on establishment of basic safety and essential performance criteria of mobile computed tomography. J. Radiol. Sci. Technol. 2021;44(3):261-7.   DOI
17 Ministry of Health and Welfare. Rules on the installation and operation of special medical equipment. Ministry of Health and Welfare No. 817; 2021.
18 Mollura JD, Culp PM, Lungren PM. Radiology in global health: Strategies, implementation, and applications. 2nd ed. Springer; 2019.
19 Intergency Working Group on Medicla Radiation U.S. Environmental Protection Agency. Radiation protection guidance diagnostic and interventional X-ray procedures. Federal Guidance Report No. 14.
20 Choi MH, Jang JS, Lee KB. A Study on the Indirect Radiation Exposure of the Medical Personnel Who is Responsible for Patient Safety in CT Examination. J. Radiol. Sci. Technol. 2019;42(2):105-11.   DOI
21 International Electrotechnical Commission. IEC 60601-2-54 Medical electrical equipment-Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. Geneva, Switzerland; 2018.
22 International Atomic Energy Agency. Radiation protection and safety in medical uses of ionizing radiation: IAEA safety standards for protection people and the environment. IAEA-DS399.
23 International Electrotechnical Commission. IEC 61223-3-5, Ed 1.0. Evaluation and routine testing in medical imaging departments-Part 3-5: Acceptance and constancy tests-Imaging performance of computed tomography X-ray equipment. Geneva, Switzerland; 2019.