대한방사선기술학회지:방사선기술과학 (Journal of radiological science and technology)

  • 제44권3호
  • /
  • Pages.261-267
  • /
  • 2021
  • /
  • 2288-3509(pISSN)
  • /
  • 2384-1168(eISSN)
대한방사선과학회 (Korean Society of Radiological Science)
권호 표지
DOI QR코드

DOI QR Code

이동형 전산화단층촬영장치의 기본 안전 및 필수 성능 기준을 마련하기 위한 연구

A Study on Establishment of Basic Safety and Essential Performance Criteria of Mobile Computed Tomography

  • 김은혜 (고려대학교 보건안전융합과학과) ;
  • 박혜민 (고려대학교 보건안전융합과학과) ;
  • 김정민 (고려대학교 보건안전융합과학과)
  • 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)
  • 투고 : 2021.06.08
  • 심사 : 2021.06.28
  • 발행 : 2021.06.30
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

As the number of Coronavirus Disease-19 (COVID-19) patients increases in a global pandemic situation, the usefulness of mobile computed tomography (CT) is gaining attention. Currently, mobile CT follows the basic safety and essential performance evaluation criteria of whole-body or limited-view X-ray CT in order to obtain device approval and evaluation in the Republic of Korea. Unlike stationary CT, mobile CT is not operated in shielded areas but rather areas such as intensive care units, operating rooms, or isolation rooms. Therefore, it requires a different basic safety and essential performance evaluation standard than stationary CT. In this study, four derived basic safety evaluation criteria related to electrical, mechanical, and radiation safety were included (dose indication test, protection against stray radiation, safety measures against excessive X-rays, half-value layer measurement); and seven essential performance evaluation criteria were included (tube voltage accuracy, mAs accuracy, radiation dose reproducibility, CT number of water, noise, uniformity, and spatial resolution); total eleven basic safety and essential performance evaluation criteria were selected. This study aims to establish appropriate basic safety and essential performance evaluation criteria for simultaneously obtaining images with diagnostic value and reducing the exposure of nearby patients, medical staff, and radiologic technologists during the use of mobile CT.

키워드

과제정보

This work was supported by the Korea Medical Device Development Fund grant funded by the Korean government (the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, the Ministry of Health and Welfare, the Ministry of Food and Drug Safety) (Project Number: KMDF_PR_20200901_0262).

참고문헌

  1. Rubin DG. Computed tomography: Revolutionizing the practice of medicine for 40 years. Radiology. 2014;273(25):S45-74. https://doi.org/10.1148/radiol.14141356
  2. Waydhas C. Equipment review: Intrahospital transport of critically ill patients. Crit Care. 1999;3:R83. https://doi.org/10.1186/cc362
  3. Temsah MH, Al-Sohime F, Alhaboob A, Al-Eyadhy A, Aljamaan F., et al. Adverse events experienced with intrahospital transfer of critically ill patients. Medicine. 2021;100(18):e25810. https://doi.org/10.1097/MD.0000000000025810
  4. Coronavirus Disease (COVID-19) Pandemic. World Health Organization website. [Accessed June 02, 2021]. https://www.who.int/emergencies/diseases/novel-coronavirus-2019. Published 2021.
  5. Rubin DG, Ryerson JC, Haramati LB, Tomiyama N, Wells YA, Leung NA, et al. Radiology department preparedness for COVID-19: Radiology scientific expert review panel. Radiology. 2020;296(2):E106-12. https://doi.org/10.1148/radiol.2020200988
  6. Shin HH, Lee JH, Kim KH, Kim BJ, Park HM. Application of mobile hospital computed tomography in a state-designated medical institution under the coronavirus disease 2019 (COVID-19) Situation by Example. JRST. 2020;43(2):71-7.
  7. Ministry of Health and Welfare. Guidance for temporary use of mobile CT in isolation wards for COVID-19 response. Seoul, Republic of Korea; 2020.
  8. Ministry of Health and Welfare. Rules on the safety management of diagnostic radiation generating devices. No. 777. 2021.
  9. Food and Drug Administration. Enforcement policy for imaging systems during the coronavirus disease 2019 (COVID-19) public health emergency. FDA-2020-D-1138 2020.
  10. Ministry of Food and Drug Safety. Regulations on medical device item and classification. Ministry of Food and Drug Safety Notice No. 2021-24
  11. Food and Drug Administration. Computed tomography x-ray system. FDA-892.1750
  12. Ministry of Health, Labor and Welfare. Basic requiremetns conformity checklist: standard for whole-body X-ray CT diagnostic equipment. MHLW-No. 112.
  13. International Electrotechnical Commission IEC 60601-2-44:2009 Medical electrical equipmentPart 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography. 2009.
  14. International Electrotechnical Commission IEC 61223-3-5:2019 Evaluation and routine testing in medical imaging departments- Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment. 2019.
  15. International Electrotechnical Commission IEC 60601-1-3:2021 Medical electrical equipment-Part 1-3: General requirements for basic safety and essential performance- Collateral Standard: Radiation protection in diagnostic X-ray equipment. 2021.
  16. International Electrotechnical Commission IEC 60601-2-54:2009 Medical electrical equipment-Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. 2009.
  17. Ministry of Health and Welfare. Rules on the installation and operation of special medical equipment. No. 672, Article 5(2) 2019.
  18. Ministry of Food and Drug Safety. Medical device standard: attached table 2, appliance equipment 49 whole body X-ray computed tomography system. 2001.
  19. 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. JRST. 2019;42(2):105-11.
  20. 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.
  21. 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.
  22. Mollura JD, Culp PM, Lungren PM. Radiology in global health: strategies, implementation, and applications. Second edition. Springer; 2019.