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

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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.

The Relationship between the Refractive Power and Nutrient Intake of the Growth Period in Accordance with the Income (소득에 따른 성장기 영양소 섭취와 굴절력과의 관계)

  • Ye, Ki-Hun;Lee, Wan-Seok
    • Journal of Korean Ophthalmic Optics Society
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    • v.18 no.2
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    • pp.213-229
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    • 2013
  • Purpose: The Nutrient intake during the growth period is a critical factor for the development of the vision. In this study, we have analyzed the nutrient that has a correlation with the decrease of induced visual impairment. In addition, we investigated visual acuity and correlation of the nutrient in the higher-income youth and low-income youth. Methods: We used the Korean National Health and Nutrition Examination Survey 2010 document. The Korean National Health and Nutrition Examination Survey didn't show the clear standard of carbohydrates and fats, so we used the data from the Ministry of Food and Drug Safety standards with each 330 g, 51 g. In order to compare the correlation of nutrients and refraction, Nutrients has been classified macronutrients(energy, dietary fiber, protein, carbohydrate, fat), fat-soluble vitamins (vitamin A), water-soluble vitamins (vitamin C, riboflavin, niacin), trace minerals (iron), minerals (calcium, phosphorus, sodium, potassium) and water. Results: We investigated the correlation between refraction and nutrients on average about 328 subjects belonging to the high-income group. The fat intake was $54.21{\pm}32.60$ g, and it was about 2~10 times less than the recommended daily intake (112-540 g). Refractive power and fat intake showed a statistically significant correlation (O.D:p=0.033, O.S:p=0.029). We investigated the correlation between refraction and nutrients on average about 309 subjects belonging to the lowincome group. The phosphorus showed higher ingested by the $1118.75{\pm}501.98$ mg, and the sodium showed intake more than three times recommended intake by the $3705.24{\pm}2089.42$ mg. In addition, unlike other macro mineral it showed that was a correlation on the refraction by the 0.031. Conclusions: A broad variety of taking nutrition and good eating habits at the time of growth seems to have an effects to the good growth and vision and the senescence inhibition of vision.ave an effect to the good growth, the good vision and the senescence inhibition of vision.

Assaying Mitochondrial COI Sequences and Their Molecular Studies in Hexapoda, PART I: From 2000 to 2009 (육각강에서 보고된 미토콘드리아 COI 염기서열과 이들을 이용한 분자 연구 논문 분석, 파트 I: 2000년~2009년)

  • Lee, Wonhoon;Park, Jongsun;Akimoto, Shin-Ichi;Kim, Sora;Kim, Yang-Su;Lee, Yerim;Kim, Kwang-Ho;Lee, Si Hyeock;Lee, Yong-Hwan;Lee, Seunghwan
    • Korean journal of applied entomology
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    • v.52 no.4
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    • pp.395-402
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    • 2013
  • Since 2000, a large number of molecular studies have been conducted in Hexapoda with generating large amount of mitochondrial sequences. In this study, to review mitochondrial COI sequences and their molecular studies reported in Hexapoda from 2000 to 2009, 488 molecular studies conducted based on 58,323 COI sequences were categorized according to 26 orders and the positions of COI sequences (5', 3', and entire regions). The numbers of molecular studies in which the three regions utilized varied largely among the 26 orders; however, seven orders showed preferred positions of COI sequences in the researches: Diptera and Orthoptera revealed the largest number of studies in the 5' region; while, Coleoptera, Phthiraptera, Odonata, Phasmatodea, and Psocoptera, showed the largest number of studies in the 3' region. From comparing 84 molecular studies published before 2000, we observed the possibilities that molecular studies in Coleoptera, Diptera, Phthiraptera, and Phasmatodea from 2000 to 2009 had been followed classical studies using the positions of COI sequences well-known until 1999. This study provides useful information to understand the overall trends in COI sequence usages as well as molecular studies conducted from 2000 to 2009 in Hexapoda.

Laboratory Diagnosis of Coronavirus Disease 19 (COVID-19) in Korea: Current Status, Limitation, and Challenges (국내 중증 급성 호흡기 증후군 코로나 바이러스의 검사실 내 진단: 현재, 한계점 그리고 직면한 과제)

  • Song, Gi Seon;Lee, You-Rim;Kim, Sungmin;Kim, Wontae;Choi, Jungwon;Yoo, Dahyeon;Yoo, Jungyoung;Jang, Kyung-Tae;Lee, Jaewang;Jun, Jin Hyun
    • Korean Journal of Clinical Laboratory Science
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    • v.52 no.3
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    • pp.284-295
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    • 2020
  • In December 2019, the first coronavirus disease- 2019 (COVID-19) patient was reported in Wuhan, Hubei Province, China. Since then, the number of patients who suffered severe acute respiratory syndrome caused by the novel Coronavirus (SARS-CoV-2 or 2019-nCoV) has increased dramatically in Korea. This new variant virus induces pulmonary diseases, including cough, sore throat, rhinorrhea, dyspnea, and pneumonia. Because SARS-CoV-2 is an RNA virus, real-time reverse-transcriptase PCR has been used widely to diagnose COVID-19. As the Korea Centers for Disease Prevention and Control (KCDC) and Ministry of Food & Drug Safety (MFDS) approved emergency use authorization, clinical specimens collected from COVID-19 patients and even healthy people have been clinically diagnosed by laboratory medicine. Based on a literature search, this paper reviews the epidemiology, symptoms, molecular diagnostics approved by KCDC, a current diagnosis of COVID-19 in the laboratories, the difference between molecular and serological diagnosis, and guidelines for clinical specimens. In addition, the Korean guidelines of biosafety for clinical laboratory scientists are evaluated to prevent healthcare-associated infection. The author's experience and lessons as clinical laboratory scientists will provide valuable insights to protect the domestic and international health community in this COVID-19 pandemic around the world.