• 보건행정학회지
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• 제28권3호
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• pp.301-307
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• 2018

The development of transport is being easily shared with people all over the world. It is necessary to appropriately and effectively revise the domestic quarantine law because the fatal infectious diseases are at risk of being easily shared. Today, Korea has an advanced quarantine system approved by World Health Organization, but it maintains partnerships with related ministries (Ministry of Foreign Affairs, Ministry of Justice, local medical institutions) and to introduce new medical technology (electronic quarantine) is important. And since the prevention of quarantine infectious diseases and prevention of the spread, in order to maintain international cooperation with the International Health Regulations, the quarantine law and the system should be amended and improved effectively and it is also a way to prepare for the outbreak of new quarantine infectious diseases. In the past, Korea has experienced great confusion during the past outbreak of swine flu and Middle East respiratory syndrome coronavirus. To prevent similar cases from recurring in the past, the revision of the quarantine law and the improvement of the system should be done to cope with the changing environment (new infections, increased number of overseas travelers, etc.).

• 대한수의학회지
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• 제54권3호
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• pp.151-157
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• 2014

A nationwide survey on radiation safety management in Korean animal hospitals was conducted. By 2013, 53 radiation generators were registered as veterinary medical devices (41 X-ray generators and 12 computed tomography scanners). Additionally there were six approved laboratories for radiation equipment and protection facility, and five approved laboratories for radiation exposure of employees, respectively. By March 2013, 2,030 out of 3,829 animal hospitals operated radiation-generating devices. Among these devices, 389 (19.2%) out of 2,030 were not labeled with the model name and 746 (36.7%) were not labeled with production dates. Thus, most veterinary X-ray generators were outdated (42.6%) and needed replacements. When periodic inspections of 2,018 animal hospitals were performed after revision of the Veterinarians Act in 2011, the hospitals were found to be equipped with appropriate radiation generators and protection facilities. Among 2,545 employees exposed to radiation at the hospitals, 93.9% were veterinarians, 4.3% were animal nurse technicians, and 18% held other positions. Among 169 employees supervised by administrators, none of those had a weekly maximum operating load that exceeded $10mA{\cdot}min$. This study suggests that the radiation safety management system of animal hospitals was general good.

• 한국어병학회지
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• 제32권2호
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• pp.123-127
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• 2019

In this study, white spots appearing in carapace of imported white leg shrimp Litopenaeus vannamei were observed by macroscopic and microscopic examination. White spots due to white spot disease showed two types, white spots with a regular circular shape ranging from 0.4 mm to 1.7 mm and white spots with an irregular shape ranging from 0.05 mm to 2 mm. White spots due to other causes showed four types that appeared as crystalized materials in range of 100 ㎛ around the tegumental gland, as polygonal inorganic deposits ranging from 58 ㎛ to 188 ㎛, as Linear inorganic deposits ranging from 0.8 mm to 9 mm, as brownish spots ranging from 0.1 mm to 0.4 mm, and brownish spots containing melanin ranging from 0.1 mm to 2 mm. As a result, white spots occurred in imported white leg shrimp Litopenaeus vannamei were divide two type, due to white spot disease or other causes, for quarantine works.

• 한국임상수의학회지
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• 제35권4호
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• pp.119-125
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• 2018

In vitro diagnostic veterinary medical reagents (IVDVMRs) were diverted the medical devices from medicine by the revision of the pharmaceutical affairs act enforcement regulations in 2015 in Korea. It classified into class I-IV according to risks of individual and public health. However, good manufacturing practices requirements on IVDVMRs were exempted from the current system. The registration of IVDVMRs by the Animal and Plant Quarantine Agency has gradually increased since 2012, and total of 584 products from 68 companies were registered from 1978 to 2017. Most of these items are clinical immunochemistry (infection disease), clinical immunochemistry (non-infection disease), molecular genetics, endocrinology, blood gas analysis, clinical microbiology, toxin, heavy metal and drug of abuse, other etc. The market size of IVDVMRs reported from the Korea Animal Health Products Association was estimated to be approximately 51.9 billion won in 2017. The domestic consumption and the export sales were approximately 31.2 and 20.7 billion won, respectively. They are increasing 23.9% (CAGR) in domestic consumption and 40.4% (CAGR) in export from 2011 to 2017.

• 대한수의학회지
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• 제55권2호
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• pp.97-103
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• 2015

In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.

• 대한수의학회지
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• 제57권2호
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• pp.71-78
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• 2017

Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications for veterinary medical devices in Korea based on data obtained through analyses of those medical devices. General standards for electromechanical, electromagnetic, and biological safety and individual standards for 76 electric and 70 general medical device products have been established by the Korean Ministry of Food and Drug Safety. However, the first standards and specifications for veterinary medical devices were established in March 2000 for two products (disposable needle and syringe). Similar to the large number of standards for medical devices, there have been general standards for safety and individual standards for 72 veterinary medical devices (27 electric medical devices, 12 non-electric medical devices, 10 medical supplies, and 23 other types) established since 2014. These new standards considered, among other aspects, the devices' applications, usage characteristics, and industrial environment. To date, the establishment of standards and specifications for veterinary medical devices remains limited. This study suggests that improvements should be made to the regulation of general and individual standards associated with various veterinary medical instruments, supplies, and in vitro diagnostic medical reagents.

• 대한수의학회지
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• 제46권4호
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• pp.295-304
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• 2006

Residual materials such as veterinary drugs, environmental contaminants, and pesticides are affecting food safety. High resolution techniques and quality controls are needed to analyze these materials from part per million to part per trillion quantities in food. In order to achieve quality results, standardized methods and techniques are required. Our laboratories were prepared to obtain a certificate of accreditation for ISO/IEC 17025 in the analytical criteria of animal drugs, dioxins, pesticides, and heavy metals. ISO together with IEC has built a strategic partnership with the World Trade Organization with the common goal of promoting a free and fair global trading system. ISO collaborates with the United Nations Organization and its specialized agencies and commissions, particularly those involved in the harmonization of regulations and public policies including the World Health Organization and CODEX Alimentarius for food safety measurement, management and traceability. Our goal was to have high quality analysts, proper analytical methods, good laboratory facilities, and safety systems within guidelines of ISO/IEC 17025. All staff members took requirement exams. We applied proficiency tests in the analysis of veterinary drugs (nitrofuran metabolites, sulfonamide and tetracyclines), dioxins, organophosphorus pesticides, and heavy metals (Cd, Pb, As) to the Food Analysis Performance Assessment Scheme (FAPAS) at Central Science Laboratory, Department for Environment Food and Rural Affairs (DEFRA), England. The results were very satisfactory. All documents were prepared, including system management, laboratory management, standard operational procedures for testing, reporting, and more. The criteria encompassed the requirements of ISO/IEC 17025:1999. Finally, the Korea Laboratory Accreditation Scheme (KOLAS) accredited our testing laboratories in accordance with the provisions of Article 23 of the National Standards Act. The accreditation will give us the benefit of becoming a regional reference laboratory in Asia.

• 한국임상수의학회지
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• 제32권1호
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• pp.85-90
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• 2015

In this study, we investigated the number of categories of veterinary medical devices registered by Animal and Plant Quarantine Agency (QIA) by 2013. We also analyzed the sales of the veterinary medical devices reported from Korea Animal Health Product Association (KAHPA) from 2011 to 2013. The registration rate of veterinary medical devices has sharply increased since 2008, and a total of 495 categories from 141 companies were registered by the end of 2013. The multi-frequency products registered for companion animals were ultrasound imaging system, x-ray system, microchip & reader, telemetry system transmitter, and hematology analyzer. The veterinary medical devices for farm animals include marker, artificial insemination catheter, injector, and ultrasound imaging system. Of these products, the multi-frequency products dominated on the veterinary medical devices market. The market size of 223 (45.0%) veterinary medical devices was estimated to be approximately 20.6 billion Won in 2013; the proportion of domestic products and imports was 56% to 44%; the proportion of domestic demand and export was 82% to 18%, respectively. This study suggested that the registration and sales of the veterinary medical devices have gradually increased as the demand of health care services got bigger in Korea.

• Mycobiology
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• 제40권3호
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• pp.205-207
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• 2012

A fungus detected from the importing seeds of Papaver rhoeas under plant quarantine inspection in Korea was identified as Brachycladium penicillatum Corda. It differed in morphological characteristics from a similar species, B. papaveris, which was known to form no macroconidiophores and no microsclerotia. Since the first interception in 2006, this fungus has frequently been found from importing seeds of Papaver spp. It was detected from 31 out of 282 seed consignments imported from 2006 to 2011. To prevent its introduction to Korea, the seed consignments infested by B. penicillatum were destroyed or reshipped.

• 한국항행학회논문지
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• 제22권2호
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• pp.173-178
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• 2018

2015년 5월 첫 중동호흡기증후군 사례가 발생하여 환자 186명, 사망자 38명이 발생하고 16,693명을 격리하였다. 정부에서는 MERS 감염의 확산을 차단하기 위하여 확진 또는 의심환자와 접촉한 사람에 대한 모니터링을 시행하였다. 관리 담당자는 자가격리자에 대해 최대 잠복기인 14일 동안 1일 2회 감시를 실시하여 격리 준수 여부 등을 확인하였다. 그러나 격리대상자가 폭발적으로 증가하면서 관리 인력의 한계로 거주지 이탈자 발생 등의 문제가 발생하였다. 또한 관리자들은 하루에 두세번 전화로만 상태를 체크하다 보니 자가 격리 생활 수칙은 유명무실해졌으며 격리자들이 무단으로 외출할 경우 이를 통제하기란 사실상 불가능하다고 인정했다. 이에 본 논문에서는 자가격리장치 및 본인 인증 방법을 제안하고 검증하였다. 검증결과 본 논문에서 제안한 방법은 추후 자가격리장치 및 본인인증방법으로 사용되는데 전혀 문제가 없을 것으로 판단된다.