• Title/Summary/Keyword: Ministry of Food and Drug Safety

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An Analysis of the Research Trends in Safety Education for Home Economics Education (가정과 안전교육의 연구 동향 분석)

  • Kim, Nam Eun
    • Journal of Korean Home Economics Education Association
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    • v.28 no.3
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    • pp.47-63
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    • 2016
  • The purpose of this study is to suggest the basic information for diverse and balanced research and development in this field with understanding research trends related to safety education in home economics. In order to so, this study makes population and sampling by targeting cases which refer to 'safety' on 15 papers of academic journals related to home economics registered in the National Research Foundation from 2001 to 2015, 244 papers related to safety education area and 179 master doctorate thesis by searching keyword as 'safety'. Analysis contents are research trends of papers related to safety education by year and by subject and research trends of safety education by area and by research method. As a result of the study, first, the number of research papers related to safety education by year on home economics curriculum repeated increase and decrease and there have been consistent studies conducted on safety education with 14-52 papers per every year and yearly average 28.2 papers. On the other hand, the most number of studies conducted in 2015 with 52 papers which are twice as much of 26 papers in 2014. This seems to be affected by the announcement of safety comprehensive countermeasures from government and the emphasis of safety subject on 2015 curriculum revision of the Ministry of Education. Second, with regards to research trends by topic, 137 papers are related to safety education (29%), 336 papers are related to safety actual condition (71%). Accidents and recognition had a greater percentage in a paper before 2009 (74.4%) and studies are increased after 2009 (from 21 papers to 53 papers) in terms of development or evaluation of safety education program, development of education materials, development of education method etc. Subject area dealt with the most on the research of safety actual condition is regarding safety accidents or effective variables (23.2%). Subject regarding the variables are researches related to factors influencing family violence, internet addiction, spouse violence, willingness to purchase unsafe food, age harassment, or suicidal attempt etc. Next, researches related to safety recognition (13.9%), safety knowledge and attitude (7.4%), safety behaviors (6.3%), safety consciousness (2.3%) show in sequence. Subject area dealt with the most on the researches regarding safety education is development and evaluation of safety education program (11%) and this appears the most in 2015 by year (21.5%). Third, with regards to eight areas of safety education, there are 143 papers regarding public safety (33.8%), 106 papers regarding violence and personal safety (25.1%), 93 papers regarding general subject on safety or whole safety area (22%) and 58 papers regarding drug and internet addiction (13.7%) in sequence. And there is no paper related to first aid and 1 paper is related to occupational safety (0.2%). Occupational safety area is less researched nevertheless its included in home economic curriculum as relative chapter. First aid does not directly correlate with home economics curriculum but should be studied in preparation for accident which could happen in practical class. Forth, with regards to research trends by research method, quantitative research (89.1%) is mostly used and both research study (70.4%) and experimental research (18.7%) are used the most frequently. In particular, researches on the actual condition of safety education and experimental studies for effectiveness verification take most of research method. As qualitative studies, there are phenomenological study (3.1%) and case study (3.1%) related to actual conditions of safety accidents. 10 papers (2.4%) are mixture of quantitative and qualitative research and some research conducted research study and experimental research at the same time (0.9%). With regards to subject of study, human environments (87.5%) are more than physical environments (12.5) and students (48.4%) are more than teachers and school parents (20.6%). As the subject of physical environments, school (6.5%) is the most but home environment is none. As a result of the study, research for the development of evaluation tool for evaluating safety education, occupational safety and lifelong education should be conducted from this time forward. In addition, the object of study shall be expanded to both human environments in terms of entire life and physical environments for home. An in-depth qualitative research should be needed by observing and meeting with each student.

Non-invasive Brain Stimulation and its Legal Regulation - Devices using Techniques of TMS and tDCS - (비침습적 뇌자극기술과 법적 규제 - TMS와 tDCS기술을 이용한 기기를 중심으로 -)

  • Choi, Min-Young
    • The Korean Society of Law and Medicine
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    • v.21 no.2
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    • pp.209-244
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    • 2020
  • TMS and tDCS are non-invasive devices that treat the diseases of patients or individual users, and manage or improve their health by applying stimulation to a brain through magnetism and electricity. The effect and safety of these devices have proved to be valid in several diseases, but research in this area is still much going on. Despite increasing cases of their application, legislations directly regulating TMS and tDCS are hard to find. Legal regulation regarding TMS and tDCS in the United States, Germany and Japan reveals that while TMS has been approved as a medical device with a moderate risk, tDCS has not yet earned approval as a medical device. However, the recent FDA guidance, European MDR changes, recalls in the US, and relevant legal provisions of Germany and Japan, as well as recommendations from expert groups all show signs of tDCS growing closer to getting approved as a medical device. Of course, safety and efficacy of tDCS can still be regulated as a general product instead of as a medical device. Considering multiple potential impacts on a human brain, however, the need for independent regulation is urgent. South Korea also lacks legal provisions explicitly regulating TMS and tDCS, but they fall into the category of the grade 3 medical devices according to the notifications of the Korean Ministry of Food and Drug Safety. And safety and efficacy of TMS are to be evaluated in compliance with the US FDA guidance. But no specific guidelines exist for tDCS yet. Given that tDCS devices are used in some hospitals in reality, and also at home by individual buyers, such a regulatory gap must quickly be addressed. In a longer term, legal system needs to be in place capable of independently regulating non-invasive brain stimulating devices.

New Functional Properties of Passion Fruit Extract on Skin (패션 프룻 추출물이 피부에 미치는 새로운 기능적 효과)

  • Jeong, Mi Suk;Kim, Soon-Rae;Han, Chang Woo;Kim, Hyeon Jin;Jang, Se Bok
    • Journal of Life Science
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    • v.32 no.2
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    • pp.101-107
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    • 2022
  • In this research, the anti-inflammatory, antioxidant, antiaging, and skin whitening properties of pulp and seed extracts of passion fruit were studied. The result of the primary skin irritation test using a skin-attached patch determined the skin irritation index to be 0.00 for the passion fruit extract. In addition, RAW 264.7 macrophages produce NO by stimulation of lipopolysaccharides, and the application of extracts to this resulted in significantly lower NOs, confirming the excellent anti-inflammatory properties of passion fruit extracts. The 2,2-diphenyl-1-picrylhydrazyl test further confirmed that the passion fruit extract exhibits a good 2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonate radical scavenging ability of 5.11% and strong antioxidant properties. The presence of collagen type I in the skin is a measure of aging and various skin diseases. The results obtained from the analysis of the activity of human procollagen I alpha 1 confirmed that the passion fruit extract reduces the synthesis of procollagen. In addition, the skin whitening property of the passion fruit extract was confirmed by the melanin inhibition test, and a sample was obtained that contained more than 2% of arbutin, a whitening agent approved by the Ministry of Food and Drug Safety, which is generally present in the form of a white powder and is used as a functional ingredient. This confirms that the whitening efficacy of the passion fruit extract obtained from nature contributes to the development of functional raw materials for cosmetics and food.

Development of smart education-based teaching and learning plans and a smart textbook for 'healthy diet and meal plans' unit in 「Technology·Home Economics」 (중학교 「기술·가정」의 '건강한 식생활과 식사 구성' 단원에 적용한 스마트 교수·학습 과정안과 교재 개발)

  • Choi, Song Eun;Chae, Jung-Hyun
    • Journal of Korean Home Economics Education Association
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    • v.26 no.4
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    • pp.85-114
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    • 2014
  • The main purpose of this study was to develop teaching and learning plans and a smart textbook for food and nutrition education in Home Economics focusing on 'healthy diet and meal plans' unit in "Technology home Economics" textbooks for 7th graders to evaluate the effectiveness of the instruction conducted with the smart textbook. The content of the study to achieve the purpose is as follows: First, design a smart education-based teaching and learning curriculum for food and nutrition education in Home Economics, focusing on 'healthy diet and meal plans' unit. Second, develop a smart textbook for food and nutrition education based on the teaching and learning curriculum, using a smart content authoring tool. Third, evaluate the effectiveness of the instruction after applying the curriculum in real classroom situations. The results of this study were as follows: First, teaching and learning plans and materials were developed for two units, 'issues regarding teenagers' diet' and 'implementation of a healthy and balanced diet', under 'teenagers' life'. The first unit, 'issues regarding teenagers' diet', dealt with topics such as teenagers' dietary behaviors, nutrition, and health. Learning objectives for this unit were to help students identify and evaluate their own dietary behaviors. The second unit, 'implementation of a healthy and balanced diet', encouraged students to diagnose problems with their diet and plan nutrient rich meals. The objectives for this unit were to help students implement a healthy and balanced diet by providing them with nutrition and dietary guidelines for Koreans, sample meal plans, and guidelines for developing healthy eating habits for teenagers. In order to develop a teaching and learning plans to achieve these objectives, teaching and learning materials including inquiry tasks, materials for group activities, multimedia, applications and various pop-up learning materials were developed. Second, a smart textbook using DocZoom, which was a smart content authoring tool was developed. The textbook dealt with issues regarding teenagers' diet and implementation of a healthy and balanced diet. Multimedia material used in the textbook come from the Ministry of Food and Drug Safety's food and nutrition education web sites and other sources. To develop student-oriented material, relevant video clips were added to the smart textbook to motivate students and enhance their interest in the course. Third, the outcome of this study indicated that the instruction using teaching and learning plans and learning materials with the smart textbook was effective for enhancing students' interest in Home Economics classes (t-value=-3.99, p<.001), creating enthusiasm for learning(t-value = -2.61, p<.05), encouraging self-directed and independent learning(t-value = -4.77, p<.001), and improving students' interest in food and nutrition courses(t-value = -3.83, p<.001). The students' evaluation of the instruction were as follows: the instruction using teaching and learning plans and learning materials with smart textbooks, instead of paper textbooks, helped them save time looking for learning materials; students evaluated that it was easier for them to see and understand video clips and charts. In addition, most students answered that instruction with smart textbooks were more fun and convenient, and they agreed that the courses enhanced their learning experience.

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The Association of Blood Concentrations of Healvy Metals and Blood Pressure in Residents Living Near Janghang Copper Smelter in Korea (제련소 주변 지역 주민들의 혈중 중금속 농도와 혈압과의 관련성)

  • Eom, Sang-Yong;Yim, Dong-Hyuk;Moon, Sun-In;Ochirpurev, Bolormaa;Choi, Young-Sook;Park, Choong-Hee;Kim, Guen-Bae;Yu, Seung-Do;Choi, Byung-Sun;Park, Jung-Duck;Kim, Yong-Dae;Kim, Heon
    • Journal of agricultural medicine and community health
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    • v.42 no.1
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    • pp.13-23
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    • 2017
  • Objectives: This study was conducted to evaluate a relationship between the blood concentrations of toxic metals and the blood pressure in people living near the copper smelter. Methods: The study included 570 adults living within 4km of the smelter. We compared systolic and diastolic blood pressure between tertiary groups for blood cadmium, mercury and lead levels, respectively. Multiple regression analysis was performed to identify risk factors affecting systolic and diastolic blood pressures. Results: In male subjects, there is a significant difference in the mean of systolic and diastolic blood pressure between tertiary groups of blood cadmium and mercury levels, but in women, there was no significant difference in the mean systolic and diastolic blood pressures in all tertiary groups of heavy metals. The results of multiple regression analysis showed that age, BMI, and cadmium concentration in men were risk factors for blood pressure. In women, age and BMI, drinking and smoking, and blood mercury were significantly influenced to blood pressure. Conclusions: Residents living near the Janghang smelter showed high concentrations of blood lead and cadmium, suggesting that they were exposed to high concentrations of heavy metals released from the smelter in the past. Such exposure may have caused some blood pressure increase. Especially, the concentration of cadmium in the case of men and the concentration of mercury in blood in the case of women were found to be significantly related to the increase of blood pressure. The local population should be advised to make efforts to reduce exposure to environmental contaminants, in order to minimize cardiovascular disease, and to pay close attention to any health problems possibly related to toxic metal exposure.

Exposure and Risk Assessments of Multimedia of Arsenic in the Environment (환경 중 비소의 매체통합 노출평가 및 위해성평가 연구)

  • Sim, Ki-Tae;Kim, Dong-Hoon;Lee, Jaewoo;Lee, Chae-Hong;Park, Soyeon;Seok, Kwang-Seol;Kim, Younghee
    • Journal of Environmental Impact Assessment
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    • v.28 no.2
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    • pp.152-168
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    • 2019
  • The element arsenic, which is abundant in the Earth's crust, is used for various industrial purposes including materials for disease treatment and household goods. Various human activities, such as the disposal of soil waste, metal mining and smelting, and combustion of fossil fuels, have caused the pollution of the environment with arsenic. Recently, guidelines for arsenic in rice have been adopted by the Korean ministry of food and drug safety to prevent health risks based on rice consumption. Because of the exposure to arsenic and its accumulation in the human body through various channels, such as air inhalation, skin contact, ingestion of drinking water, and food consumption, integrated multimedia risk assessment is required to adopt appropriate risk management policies. Therefore, integrated human health risk assessment was carried out in this study using integrated exposure assessment based on multimedia (e.g., air, water, and soil) and multi-route (e.g., oral, inhalation, and dermal) scenarios. The results show that oral uptake via drinking water is the most common pathway of arsenic into the human body, accounting for 57%-96% of the total arsenic exposure. Among various age groups, the highest exposures to arsenic were observed in infants because the body weight of infants is low and the surface areas of infant bodies are large. Based on the results of the exposure assessment, the cancer and non-cancer risks were calculated. The cancer risk for CTE and RME is in the range of 2.3E-05 to 6.7E-05 and thus is negligible because it does not exceed the cancer probability of 1.0E-04 for all age groups. On the other hand, the cancer risk for RME varies from 6.4E-05 to 1.8E-04 and from 1.3E-04 to 1.8E-04 for infants and preschool children, exceeding the excess cancer risk of 1.0E-04. The non-cancer risks range from 5.4E-02 to 1.9E-01 and from 1.5E-01 to 6.8E-01, respectively. They do not exceed the hazard index 1 for all scenarios and all ages.

Evaluation of Commercial Complementary DNA Synthesis Kits for Detecting Human Papillomavirus (인유두종바이러스 검출을 위한 상용화된 cDNA 합성 키트의 평가)

  • Yu, Kwangmin;Park, Sunyoung;Chang, Yunhee;Hwang, Dasom;Kim, Geehyuk;Kim, Jungho;Kim, Sunghyun;Kim, Eun-Joong;Lee, Dongsup
    • Korean Journal of Clinical Laboratory Science
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    • v.51 no.3
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    • pp.309-315
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    • 2019
  • Cervical cancer is the fourth most common malignant neoplasm in women worldwide. Most cases of cervical cancer are caused by an infection by the human papillomavirus. Molecular diagnostic methods have emerged to detect the HPV for sensitivity, specificity, and objectivity. In particular, real-time PCR has been introduced to acquire a more sensitive target DNA or RNA. RNA extraction and complementary DNA synthesis are proceeded before performing real-time PCR targeting RNA. To identify an adequate and sensitive cDNA synthesis kit, this study evaluated the two commonly used kits for cDNA synthesis. The results show that the $R^2$ and efficiency (%) of the two cDNA synthesis kits were similar in the cervical cancer cell lines. On the other hand, the Takara kit compared to Invitrogen kit showed P<0.001 in the $10^2$ and $10^3$ SiHa cell count. The Takara kit compared to the Invitrogen kit showed P<0.001 in the $10^1$ and $10^2$ HeLa cell count. Furthermore, 8, 4, 2, 1, and 0.5 ml of forty exfoliated cell samples were used to compare the cDNA synthesis kits. The Takara kit compared to the Invitrogen kit showed P<0.01 in 8, 4, and 1 ml and P<0.05 in 0.5 mL. The study was performed to identify the most appropriate cDNA synthesis kit and suggests that a cDNA synthesis kit could affect the real-time PCR results.

A Study on Heavy Metal Concentrations of Oxidized Hair Coloring Products in Korea Market (한국에서 유통 중인 산화형 염모제의 중금속 농도에 관한 연구)

  • Choi, Chae Man;Hong, Mi Sun;Lee, Yun Jung;Kim, Hwa Soon;Kim, Hyun Jung;Kim, Jung Hun;Chae, Young Zoo
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.39 no.3
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    • pp.241-249
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    • 2013
  • This study was aimed to provide the fundamental data about oxidized hair color products. For this reason, we collected 125 oxidized hair color products, which were distributed in domestic market from January to October, 2012, and measured the heavy metal concentrations of lead, arsenic, cadmium, chromium, manganese, nickel, copper in the samples. Results were compared by domestic, foreign, henna, type and color. The average metal concentrations were as follows; 0.211 ${\mu}g/g$ for lead, 0.008 ${\mu}g/g$ for cadmium, 0.051 ${\mu}g/g$ for arsenic, 0.954 ${\mu}g/g$ for chromium, 6.250 ${\mu}g/g$ for manganese, 0.591 ${\mu}g/g$ for nickel and 0.544 ${\mu}g/g$ for copper. In case of lead and arsenic, the concentrations were much less than the regulated amount (20 ${\mu}g/g$ and 10 ${\mu}g/g$, respectively) suggested by MFDS (Ministry of Food and Drug Safety). In henna (p < 0.05), the concentrations were significantly higher than those of other domestic and foreign oxidized hair color products as follows; 1.264 ${\mu}g/g$ for lead, 0.267 ${\mu}g/g$ for arsenic, 0.025 ${\mu}g/g$ for cadmium, 4.055 ${\mu}g/g$ for chromium, 72.044 ${\mu}g/g$ for manganese, 3.076 ${\mu}g/g$ for nickel and 4.640 ${\mu}g/g$ for copper. Statistically, it showed that the heavy metal concentrations were quite different for the different types of hair color products. The cream and liquid type products had the highest average concentration in chromium (0.708 ${\mu}g/g$, 0.478 ${\mu}g/g$, respectively). On the other hand, powder type products showed the highest concentration in manganese (60.041 ${\mu}g/g$). In addition, the concentrations of heavy metals and the color of products are not quite correlated. It was shown that average concentrations of lead and chromium were higher for yellow, chromium for red and pink, manganese for brown and black, and nickel for green.

Analyze Technologies and Trends in Commercialized Radiology Artificial Intelligence Medical Device (상용화된 영상의학 인공지능 의료기기의 기술 및 동향 분석)

  • Chang-Hwa Han
    • Journal of the Korean Society of Radiology
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    • v.17 no.6
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    • pp.881-887
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    • 2023
  • This study aims to analyze the development and current trends of AI-based medical imaging devices commercialized in South Korea. As of September 30, 2023, there were a total of 186 AI-based medical devices licensed, certified, and reported to the Korean Ministry of Food and Drug Safety, of which 138 were related to imaging. The study comprehensively examined the yearly approval trends, equipment types, application areas, and key functions from 2018 to 2023. The study found that the number of AI medical devices started from four products in 2018 and grew steadily until 2023, with a sharp increase after 2020. This can be attributed to the interaction between the advancement of AI technology and the increasing demand in the medical field. By equipment, AI medical devices were developed in the order of CT, X-ray, and MR, which reflects the characteristics and clinical importance of the images of each equipment. This study found that the development of AI medical devices for specific areas such as the thorax, cranial nerves, and musculoskeletal system is active, and the main functions are medical image analysis, detection and diagnosis assistance, and image transmission. These results suggest that AI's pattern recognition and data analysis capabilities are playing an important role in the medical imaging field. In addition, this study examined the number of Korean products that have received international certifications, particularly the US FDA and European CE. The results show that many products have been certified by both organizations, indicating that Korean AI medical devices are in line with international standards and are competitive in the global market. By analyzing the impact of AI technology on medical imaging and its potential for development, this study provides important implications for future research and development directions. However, challenges such as regulatory aspects, data quality and accessibility, and clinical validity are also pointed out, requiring continued research and improvement on these issues.

The Evaluation and Development of Head and Neck Radiation Protective Device for Chest Radiography in 10 Years Children (소아(10세) 흉부 방사선촬영에서의 두경부 방사선 방어기구 개발 및 평가)

  • Lee, Jun Ho;Lim, Hyun Soo;Lee, Seung Yeol
    • Journal of Radiation Protection and Research
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    • v.40 no.2
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    • pp.118-123
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    • 2015
  • The frequency of diagnostic radiation examinations in medical institutions has recently increased to 220 million cases in 2011, and the annual exposure dose per capita was 1.4 mSv, 51% and 35% respectively, compared to those in 2007. The number of chest radiography was found to be 27.59% of them, the highest frequency of normal radiography. In this study, we developed a shielding device to minimize radiation exposure by shielding areas of the body which are unnecessary for image interpretation, during the chest radiography. And in order to verify its usefulness, we also measured the difference in entrance surface dose (ESD) and the absorbed dose, before and after using the device, by using an international standard pediatric (10 years) phantom and a glass dosimeter. In addition, we calculated the effective dose by using a Monte Carlo simulation-based program (PCXMC 2.0.1) and evaluated the reduction ratio indirectly by comparing lifetime attributable risk of cancer incidence (LAR). When using the protective device, the ESD decreased by 86.36% on average, nasal cavity $0.55{\mu}Sv$ (74.06%), thyroid $1.43{\mu}Sv$ (95.15%), oesophagus $6.35{\mu}Sv$ (78.42%) respectively, and the depth dose decreased by 72.30% on average, the cervical spine(upper spine) $1.23{\mu}Sv$ (89.73%), salivary gland $0.5{\mu}Sv$ (92.31%), oesophagus $3.85{\mu}Sv$ (59.39%), thyroid $2.02{\mu}Sv$ (73.53%), thoracic vertebrae(middle spine) $5.68{\mu}Sv$ (54.01%) respectively, so that we could verify the usefulness of the shielding mechanism. In addition, the effective dose decreased by 11.76% from $8.33{\mu}Sv$ to $7.35{\mu}Sv$ before and after wearing the device, and in LAR assessment, we found that thyroid cancer decreased to male 0.14 people (95.12%) and female 0.77 people (95.16%) per one million 10-year old children, and general cancers decreased to male 0.14 people (11.70%) and female 0.25 people (11.70%). Although diagnostic radiation examinations are necessary for healthcare such as the treatment of diseases, based on the ALARA concept, we should strive to optimize medical radiation by using this shielding device actively in the areas of the body unnecessary for the diagnosis.