• 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.

• Journal of agricultural medicine and community health
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• v.27 no.1
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• pp.115-123
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• 2002

Objective: The aim of this study was to evaluate the patterns of helicopter emergency medical services (HEMS) in Ullung Island. Methods : The authors reviewed the records from emergency room diaries and the lists of helicopter transfers in the Ullung Public Health Medical Center over the 5-year period from Jan 1, 1997 to Dec 31, 2001. Results : One hundred thirteen cases were transferred by helicopters in 88 flights. According to year, the number of flights was 13(14.8%) and the number of cases was 15(13.3%) in 1997; 17(19.3%) and 21(18.6%) in 1998; 18(20.5%) and 20(17.7%) in 1999; 17(19.3%) and 20(17.7%) in 2000; and 23(26.1%) and 37(32.7%) in 2001. According to the kind of helicopter, the number of flights was 46(52.3%) and the number of cases was 60(53.1%) by Maritime police; and 19(21.6%) and 28(25.1%) by 119 rescue. According to time zone, there were no night flights. According to sex and age, there were 75 male cases(66.4%) and 28 cases(28.3%) of patients aged sixty years and over. The number of flights was 11(12.5%) and the number of cases was 15(13.3%) in November; 10 flights(11.4%) and 14 cases(12.4%) in March; and 7 cases(8.0%) in each of September, October and April. The most common season of helicopter transfer cases was autumn. According to transfer area, there were 48 cases (42.5%) in Pohang city, Gyeonsangbukdo; 35(31.0%) in Gangnung city, Gangwondo; and 17(15.0%) in Daegu metropolitan city. According to condition, there were 27 cases(23.9%) of cerebro-vascular accident, 13(11.5%) of fracture and 11(9.7%) of head injury. According to admission department, there were 42 cases(37.2%) in Neurosurgery, 21(18.6%) in Internal Medicine and 13(11.5%) in Orthopedic Surgery. According tothe Korea Standard Classification of Disease(3-KSCD), circulatory systemic disease(IX) and injury, intoxication and others (XIX) were the two most frequent categories with 34 cases(30.1%) each, followed by digestive system disease (XI) with 23 cases(20.4%). Conclusions : HEMS in Ullung Island leave much to be desired. Helicopters cannot make a night flight and are not equipped with medical facilities. HEMS in islands such as Ullung Island are essential. We hope that night flights, equipment-monitoring systems for emergency patients in the helicopters, and a law related to HEMS in the island will all be established.

• The Korean Journal of Nuclear Medicine Technology
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• v.17 no.1
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• pp.67-70
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• 2013

Purpose: Surge in patients with hepatocellular carcinoma, hepatic artery chemical embolization is one of the effective interventional procedures. The PET/CT examination plays an important role in determining the presence of residual cancer cells and metastasis, and prognosis after embolization. The other hand, the hepatic artery chemical embolization of embolic material used lipiodol produced artifacts in the PET/CT examination, and these artifacts results in quantitative evaluation influence. This study, the radioactivity density and the percentage error was evaluated by the extent of the impact of lipiodol in the image of PET/CT. Materials and Methods: 1994 NEMA Phantom was acquired for 2 minutes and 30 seconds per bed after the Teflon, water and lipiodol filled, and these three inserts into the enough to mix the rest behind radioactive injection with $20{\pm}10MBq$. Phantom reconfigure with the iterative reconstruction method the number of iterations for two times by law, a subset of 20 errors. We set up region of interest at each area of the Teflon, water, lipiodol, insert artifact occurs between regions, and background and it was calculated and compared by the radioactivity density(kBq/ml) and the% Difference. Results: Radioactivity density of the each region of interest area with the teflon, water, lipiodol, insert artifact occurs between regions, background activity was $0.09{\pm}0.04$, $0.40{\pm}0.17$, $1.55{\pm}0.75$, $2.5{\pm}1.09$, $2.65{\pm}1.16 kBq/ml$ (P <0.05) and it was statistically significant results. Percentage error of lipiodol in each area was 118%, compared to the water compared with the background activity 52%, compared with a teflon was 180% of the difference. Conclusion: We found that the error due to under the influence of the attenuation correction when PET/CT scans after lipiodol injection performed, and the radioactivity density is higher than compared to other implants, lower than background. Applying the nonattenuation correction images, and after hepatic artery chemical embolization who underwent PET/CT imaging so that the test should be take the consideration to the extent of the impact of lipiodol be.

• The Journal of Korean Medical History
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• v.35 no.1
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• pp.45-57
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• 2022

This paper examines the positions and personnel of the Naeui system in the late Joseon Dynasty. First, the regulations of the Naeui system were investigated through the literature related to Naeuiwon. Next, the operation of the regulations, changes in the system, and causes were analyzed through the Seungjeongwon Diary (承政院日記). We discovered: 1) Naeuiwon's medical bureaucracy originally did not have a fixed number of positions, but gradually came into being with a quota regulation. Uiyagdongcham-ui (議藥同參醫) and Naechim-ui (內鍼醫) did not have a quota, but was initially set at 10 people, then expanded to 12 people. Originally, the royal physician had no fixed number, and in 1864 the first quota was 7 people. 2) 'Gyeom-eoui' and 'gachanaeui' served to expand Naeui's quota. After the mid-17th century, 'Gyeom-eoui' expanded the quota of royal physicians to secure a position for the medical bureaucracy of Naeuiwon. 'Gachanae' after King Jeongjo serves to add to the quota while obeying the provisions of the law. 3) The customary promotion of Naeuiwon's medical bureaucracy expanded and became stricter after the mid-19th century, during which special promotions became more frequent than in previous periods. As for the provision of appointment to the 6th class after 30 months, Uiyagdongcham-ui was established in 1686 and Naechim-ui was established in 1718, increasing the chance for customary promotion. In the case of Naeui, the regulation for the Secretary General to raise the degree of official rank has been strengthened since the Cheoljong era. However, special promotions were frequent in the mid-19th century because the number of high-ranking officers increased compared to the previous period. In conclusion, the Naeui system in the late Joseon Dynasty changed in the direction of strengthening their own privileges. The Naeuiwon's quota was increased and promotion was guaranteed through the system and customs. Since the mid-18th century, there have been some regulatory restrictions, but the framework has not changed. This is confirmed not only in the regulations of the documents related to the Naeuiwon, but also in the Seungjeongwon Diary. Naeuiwon's medical bureaucracy enjoyed superiority in promotion and status compared to other forms of technical bureaucracy.

• Clinical and Experimental Pediatrics
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• v.52 no.11
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• pp.1185-1193
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• 2009

An act of children's welfare was made in 1961 for the first time in Korea but it had been nothing but the name in view of practical impact to prevention of child abuse. Real undertakings of Child Abuse Prevention were commenced overtly since 2000 in Korea, when the law for children's welfare was revised to put protective settings for the victims and to establish criterion for children's safety. The history of Child Abuse Prevention is very short in Korea but the reporting cases increased very fast from 4,133 cases in 2001 up to 9,570 cases in 2008 with the enthusiastic activities from people of the associated organizations along with the national supports. But the portion reported by the mandated reporters such as teachers or doctors is still low compared to those of the developed countries. The National Child Protection Agency (NCPA) was founded in 2001 by the Ministry of Health and Welfare to prevent child abuse and to aid recovery of abused and neglected children including their families, through the cooperation of related organizations. NCPA refers reported cases of child abuse to appropriate local centers, operates a computer database system for case management, publicizes national reports of child abuse on a yearly basis and technically supports the Local Child Protection Agency (LCPA) by developing scales for assessment of child abuse and neglect and distributing programs for the education of mandatory reporters. LCPAs operate 24-hour telephone hotline, investigate and visit homes and provide in home services networking with local resources, and operate multidisciplinary teams for screening child abuse victims and supervising case management through multimodal systems. We summarized the present state of child abuse in Korea and reviewed the operating systems for child protection in this country. Through this article, we hope that medical peoples are to be informed on the seriousness of child abuse and to be able to devote themselves for the prevention of child abuse.

• Journal of Environmental Health Sciences
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• v.47 no.3
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• pp.193-204
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• 2021

Objectives: In January 2021, the former heads of the manufacturer SK Chemical and the vendor Aekyung were acquitted for manufacturing and selling humidifier disinfectant (HD) containing 5-chloro-2-methylisothiazol-3(2H)-one/2-methylisothiazol-3(2H)-one (CMIT/MIT). In this article, we analyzed the rationale used in this judgement in the light of scientific consideration. Methods: The sentencing document for the judgements was obtained from the Korea Supreme Court Service. In particular, the judgements made by the court related to the toxicological and individual association with HD perspectives were discussed based on scientific evidence. Results: The ruling stated that the necessary conditions for causality between CMIT/MIT and such diseases were not met based on the fact that asthma and lung damage were not found in the inhalation exposure animal experiments. The judgment overlooked the inevitable limitations of using animal experiments for verifying health effects in humans, which are often inconsistent with the observations in animals. Among 11 governmentaffirmed lung injury cases with CMIT/MIT usage, three patients' humidifier disinfectant-associated lung injury (HDLI) pathology proved that CMIT/MIT could cause lung injury similar to that caused by PHMG and PGH. In addition, five children showed decreased lung function related to damage caused by humidifier disinfectant exposure. Conclusions: We conclude that there is sufficient evidence supporting the assertion that HDs containing CMIT/MIT cause lung injuries, including asthma, contrary to the court's decision.

• The Korean Society of Law and Medicine
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• v.20 no.2
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• pp.173-206
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• 2019

This research examines the characteristic of regulation on Japanese clinical research in recent years. First, Japan has had a severe punishment policy on research misconduct like Korea, but, in recent days, Japan has changed the direction of research ethics policy from restriction to research publicness securement by educational training, in addition, Act of Clinical Research, effected April 2018, has recruited excellent researchers, and then integrated clinical research and medicine clinical trial through raising transparency of funding and integrating ethics screening by mandating announcement on funding information of clinical research. Second, Japan has integrated and organized ethics guideline from dual system that consists of ethics guideline on dynamic research(here after, referred to as 「dynamic guideline」) and ethics guideline on clinical research(here after, referred to as 「clinical guideline」) to ethics guideline on medical research aimed at human(here after, referred to as 「integrated guideline」), thus, it complements repetition and deficit of ethics guideline needed in clinical research and dynamic research, and it has risk evaluation system for protecting human subjects, and also it clarifies the concept of 「invasiveness」, a preliminary consideration of evaluation. 「Evaluation issue of risk and profit」, common contents of international regulation related clinical research, is the method to check whether the research is designed appropriately or not, this is the method for Institutional Review Board to decide whether the risk on human subjects could be justified, and also this is the important standard for future human subjects to participate in clinical trial. Therefore, it is meaningful to define 「invasiveness」 concept, a preliminary consideration of risk evaluation for human subjects. This research examines Japanese clinical trial focusing on change of awareness on prevention of research misconduct, efficiency improvement of research through research screening and integration of human subjects, and clarification and extension of range of 「invasiveness」 concept, a preliminary of risk evaluation to protect human subjects.

• The Journal of Korean Society for Radiation Therapy
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• v.18 no.1
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• pp.7-12
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• 2006

Purpose: This is for the purpose to help the bill related to technologists be systematic and unitary by carefully analyzing a legislation, an enforcement ordinance, and enforcement regulations in the connection with the radiological worker and the radiation workers from the law and regulations related to technologists. Materials and Methods: Concerning technologists, a legislation, an enforcement ordinance, and enforcement regulations for a sort of medical technician, regarding the radiological worker, the rules of diagnosis radiation equipment safety management, and concerning the radiation workers, atomic energy law, an enforcement ordinance and enforcement regulations were gathered, compared with one another, and analyzed. Results: Among technologists, in the case of working in the department of diagnosis radiation, the title 'Radiological Worker' is used by the Medical Service Law, and in the case of working in the department of radiation tumors or the one of nucleus medicine, the title 'Radiation Workers' is used by the Atomic Energy Law. Conclusion: Besides the technical term that is used by characteristic tasks, unification of the terms that can be used in common is necessary for sure. And when a legislation, an enforcement ordinance, enforcement regulations, and notification, things like that in the radiation field are amended, certainly they should be done by mutual agreement through negotiation between the organization related to radiation and the governmental organization.

• The Korean Society of Law and Medicine
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• v.18 no.2
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• pp.163-194
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• 2017

Coronary artery disease has increased in Korea as the country enters the aged society. It is well known that the incidence of coronary artery disease is related to aging, hypertension, diabetes, hyperlipidemia, and dietary habit. For effective treatment of significant coronary stenosis, close coordination between cardiac surgery and cardiology team is essential. Especially cardiologists' decision whether to do the stent placement or CABG is very important because the cardiologists usually start to consult the patients for their treatment. Recently, non-surgical interventions(that is stent placement) in cardiology field have dramatically increased as the national insurance system removed the limitation of the number of stents deployed. However, accidents are often caused by inappropriate use of stents, especially in patients with triple coronary disease or left main disease with heavy coronary calcifications. Another aspect of stent placement is to cope with an emergency case in the event of coronary rupture or pericardial tamponade during coronary interventions without cardiac surgeons. In the past two years, the Korea Consumer Agency (Consumer Dispute Coordination Committee) analyzed eight cases of medical dispute settlement. Only two hospitals were manned with both cardiologists and cardiac surgeons. Seven patients died of procedures of stenting and five patients died on the day of the procedure. Among the 8 cases, 5 cases showed 3 vessel disease and the rest of the cases had either severe calcification, complete occlusion or poor coronary antomies for stenting According to a 2017 national data registry of coronary stenting, less than 3 drug-eluting stents were implanted in 98% of all patients. In 2015, the number of stent procedures was 38,922, and approximately in 800 (2%) cases, more than four stents were used per patient. We emphasize that it is necessary to seriously consider the cost-benefit analysis between stent and CABG. The patient has the right to choose the right procedure by asking the liability of 'instruction explanation obligation'. He should be well informed of the pros and cons of both procedures to avoid overuse of stent. It can be solved by intimate discussion of individual cases with the cardiac surgeon and the patient. Unilateral dialogue with the patient, forceful restriction on the number of stenting, lack of surgeon's backup in difficult cases should all be avoided. It is also necessary to solve the problem not only at the hospital level, such as multidisciplinary integrated medical care, but also a nationwide solution such as expanding cardiac surgeons as essential personnel to public officials.

• Journal of Environmental Health Sciences
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• v.46 no.5
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• pp.565-575
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• 2020

Objective: South Korea still lacks systematic national poisoning data collection or a poison control center (PC). The objectives of this study are to provide estimates of poisoning incidents in South Korea and to stress the necessity of a national poisoning surveillance framework managed by a national PC. Method: The number of poisoning incidents was estimated based on the 2018 annual report of the American Association of Poison Control Centers' National Poison Data System (NPDS). Our estimation of poisoning data was classified according to age group, reason for poison exposure, and case management site. Results: Total poisoning cases estimated numbered 326,636, which is tantamount to 631 cases per 100 thousand. Poisoning cases among those younger than five years old accounted for 71.7% in the United States. Fatal poisoning cases were estimated to be 210.63 (95% CI: 199.70-222.15). Non-intentional poisoning cases (250,378 cases, 95% CI: 249,992-250,764, 76.7%) were estimated to be far higher than intentional cases (62,399 cases, 95% CI: 62,207-62,593, 19.1%). Conclusion: Our results can be used to suggest the necessity of producing national poisoning data and establishing a PC despite the uncertainty of estimation.