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