• Title/Summary/Keyword: Medical Device Management

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Regulatory System of Quasi-drugs in Korea (우리나라 의약외품 허가심사제도 고찰 및 개선 방안)

  • Sohn, Hyun-Soon;Shin, Hyun-Taek;Song, In-Sook;Jun, Hyo-Jung
    • Korean Journal of Clinical Pharmacy
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    • v.16 no.2
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    • pp.123-130
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    • 2006
  • The study was aimed to recommend the ways for improving regulatory system of quasi-drugs in governmental authority by comparing with other countries. According to the regulations, the scope of quasi-drugs includes 3 categories of 1) the health aids made of textile, rubber and paper, 2) the health aids which have very minimal effects or no any effects on humans, and 3) disinfectants and pesticides. In US, these quasi-drugs in Korea are classified into 5 categories of medical device, cosmetics, OTC drugs, dietary supplements and pesticides. To improve quasi-drugs administration in Korea, it is concluded that several measures should be implemented : 1) establish clear criteria for classifying into quasi-drugs and more detailed guidelines on designation of quasi-drugs, 2) reform current regulations to meet 3-categories characteristics, supplement detailed guidelines on quasi-drugs administration for effective application process, and update relevant regulations for efficacy, safety and quality, 3) update quasi-drug monographs, 4) re-evaluate current classification of individual quasi-drugs, 5) develop comprehensive list by ingredients, 6) reform post-marketing management system for safety and quality, 7) strengthen the review agency function by increasing the number of experts, 8) develop the database for quasi-drugs for effective information management.

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Channel Grade Method of multi-mode mobile device for avoiding Interference at WPAN (WPAN에서 간섭을 피하기 위한 멀티모드 단말기 채널등급 방법)

  • Jung, Sungwon;Kum, Donghyun;Choi, Seungwon
    • Journal of Korea Society of Digital Industry and Information Management
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    • v.11 no.3
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    • pp.91-98
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    • 2015
  • There is a new evolution in technological advancement taking place called the Internet of Things (IoT), The IoT enables physical world objects in our surrounding to be connected to the Internet. ISM (Industrial Scientific Medical) band that is 2.4GHz band authorized free of charge is being widely used for smart devices. Accordingly studies have been continuously conducted on the possibility of coexistence among nodes using ISM band. In particular, the interference of IEEE 802.11b based Wi-Fi devices using overlapping channel during communication among IEEE 802.15.4 based wireless sensor nodes suitable for low-power, low-speed communication using ISM band. Because serious network performance deterioration of wireless sensor networks. In this paper, we will propose an algorithm that identifies the possibility of using more accurate channels by mixing utilization of interference signal and RSSI (Received Signal Strength Indicator) Min/Max/Activity of Interference signal by wireless sensor nodes. In addition, it will verify our algorithm by using OPNET Network verification simulator.

Community Health Center Digital Transition (마을 건강센터 디지털 전환)

  • Han, Jeong-won;Han, June-Sik
    • Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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    • 2022.10a
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    • pp.514-516
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    • 2022
  • Busan Metropolitan City runs Community Health Center which aims to health care service based on the community, besides the established health medical service towards people with low-income. 71 centers are run in 2021, therefore, this papear explores the way of digital transition of these centers. Digital Technologies possibly adopted inside the centers are: First, smart devices to advance the management system of chronical diseases based on health index; Second, IoT with mobile tech to manage health index; Third, AI Robot to care lone elderly people and to warn the emergency.

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The Effect of Consultant Competency on Consulting Performance, Customer Satisfaction, and Intention to Renew Contract: Focused on CSV Consulting in the GMP Industry (컨설턴트 역량이 컨설팅 성과, 고객만족, 재계약 의도에 미치는 영향에 대한 연구: GMP 산업의 CSV 컨설팅을 중심으로)

  • Dae-Hyun Park;Dong-Hyun Baek
    • Journal of Korean Society of Industrial and Systems Engineering
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    • v.46 no.4
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    • pp.74-92
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    • 2023
  • The computer system validation consulting industry is growing as domestic GMP companies' overseas exports or advancements increase, and computer system validation has been mandatory in Korea since the 2010s, but domestic CSV consulting companies are small in size and have a short history, revealing many shortcomings in terms of service quality and customer satisfaction when conducting consulting. Research related to consulting has been mainly focused on management consulting and IT consulting, and research related to computer system validation is very insufficient. This study confirmed the effect of consultant competency and service quality on consulting performance, customer satisfaction, and intention to renew contract when performing computer system validation through empirical research on food, pharmaceutical, cosmetics, and medical device companies, which are representative companies in the GMP industry. As a result, it was confirmed that consultant competency and service quality had a significant effect on consulting performance, customer satisfaction, and intention to renew contract. In addition, it was confirmed that the reputation and expertise of consulting companies had a moderating effect on the relationship between consultant competency and consulting performance.

Role of endoscopic duodenojejunal bypass liner in obesity management and glycemic control

  • Willian Ferreira Igi;Victor Lira de Oliveira;Ayah Matar;Diogo Turiani Hourneaux de Moura
    • Clinical Endoscopy
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    • v.57 no.3
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    • pp.309-316
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    • 2024
  • The treatment of obesity and its comorbidities ranges from clinical management involving lifestyle changes and medications to bariatric and metabolic surgery. Various endoscopic bariatric and metabolic therapies recently emerged to address an important therapeutic gap by offering a less invasive alternative to surgery that is more effective than conservative therapies. This article comprehensively reviews the technical aspects, mechanism of action, outcomes, and future perspectives of one of the most promising endoscopic bariatric and metabolic therapies, named duodenojejunal bypass liner. The duodenojejunal bypass liner mimics the mechanism of Roux-en-Y gastric bypass by preventing food contact with the duodenum and proximal jejunum, thereby initiating a series of hormonal changes that lead to delayed gastric emptying and malabsorptive effects. These physiological changes result in significant weight loss and improved metabolic control, leading to better glycemic levels, preventing dyslipidemia and non-alcoholic fatty liver disease, and mitigating cardiovascular risk. However, concern exists regarding the safety profile of this device due to the reported high rates of severe adverse events, particularly liver abscesses. Ongoing technical changes aiming to reduce adverse events are being evaluated in clinical trials and may provide more reliable data to support its routine use in clinical practice.

Fluoroscopic the equipment study in accordance with the entrance surface dose study of patients and practitioners (투시 검사 시 장비에 따른 환자와 시술자의 입사표면선량 연구)

  • Yang, Hae-Doo;Hong, Seon-Sook;Seong, Min-Sook;Ha, Dong-Yoon
    • Korean Journal of Digital Imaging in Medicine
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    • v.15 no.2
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    • pp.13-18
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    • 2013
  • Purpose : Fluoroscopy equipment, depending on the type of changes that occur in the patient's position ESD and study the patient's scatter ray of ESD Practitioners considered a comparative analysis was to evaluate the correct dose. Materials and Methods : HITACHI four overtube type TU-8000 Flat Detector and Under tube C-Arm Philips' Multi Diagnost Eleva with Flat Detector type were measured by. Each devices is a measure of the patient's esd randophantom position in tabel unfors Xi multi funtion then fixed to the abdomen fluoroscopy and 10 seconds, spot was measured three times, practitioners of the incident surface dose by considering the patient's scatter ray of the table for each device in the average human stomach 21cm thickness acrylic phantom ($25cm{\times}25cm$) Place the practitioner position after position randophantom unfors Xi multi funtion in the thyroid and stomach 1 minute by a fixed one-time fluoroscopy and measured. Results : 10 seconds and the patient perspective of the c-arm ESD 1.2 times smaller on the AP and oblique measurements were measured in the 6-13 times smaller. spot positions to changes in the measured three times on the AP of the abdomen, ESD is 18 times smaller c-arm measurements and the oblique measurement was 19-30 times smaller. And 1 minute at practitioners fluoroscopy esd in the thyroid 2.12 times the c-arm, chest 1.75 times less the dose was measured. On the AP, depending on the device, but the lack of dose difference oblique positions of the two devices depending on changes in the area due to changes in both the AP than on the dose increased, the difference in dose between the two devices, the maximum difference was approximately 27 times. Conclusion : Fluoroscopic equipment at the time of inspection in accordance with changes in dose according to the patient and the patient's positions changes, because the area of the scatter ray considering the change of dose measurements be made, and study of the equipment according to the characteristics of the efficiency and the exposure of the patient and practitioner is considered smooth study equipment manufacturers that can be done is to build the system and think that is also important. Various fluoroscopy when you check future changes in many factors of change in dose for the equipment in the laboratory system by considering the scatter ray radiation shielding for the management to take advantage of reckless undertube have been utilized as more exposure Reduction activities can help is considered as the direction.

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A Study on Modeling of Watering Control status by Regions Using the Measurement Device of the Ministry of Root Environment (근권 환경부 측정장치를 이용한 지역별 관수제어 모델링 연구)

  • Jeong, Jin-Hyoung;Jo, Jae-Hyun;Kim, Seung-Hun;Choi, Ahnryul;Lee, Sang-Sik
    • The Journal of Korea Institute of Information, Electronics, and Communication Technology
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    • v.14 no.2
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    • pp.168-174
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    • 2021
  • According to the World Agricultural Productivity Report, the current annual average growth rate of agriculture is 1.63%, which is lower than 1.73% to support the world's 10 billion people, which is growing by 2050. The demand for food, feed, and bioenergy is not growing enough to continue to meet the demand, and it is predicting a future food shortage. The purpose of this study was to create a regional irrigation control model for the purpose of reducing the production cost of crops, increasing production, and improving quality, and presenting a model that can give advice to farmers who start farming in the region. The irrigation control modeling presented in this study means to represent the change of medium weight·supply liquid·drainage amount due to changes in the root zone environment according to the passage of time and climate in a graph model. For water control modeling, we collected data on the change in the amount of the root zone environment and the weight of the badge·supply amount·drainage amount from March to June in Nonsan, Buyeo, and Yesan regions in Chungnam Province through the measuring device of the Ministry of Environment in the root region. We set up the parameters for derivation and derived an irrigation control model that can confirm the change in weight·supply liquid·drainage amount over time through the parameters.

Private Blockchain and Biometric Authentication-based Chronic Disease Management Telemedicine System for Smart Healthcare (스마트 헬스케어를 위한 프라이빗 블록체인과 생체인증기반의 만성질환관리 원격의료시스템)

  • Young-Ae Han;Hyeok Kang;Keun-Ho Lee
    • Journal of Internet of Things and Convergence
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    • v.9 no.1
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    • pp.33-39
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    • 2023
  • As the number of people with chronic diseases increases due to an aging society, it is urgent to prevent and manage their diseases. Although biometric authentication methods and Telemedicine Systems have been introduced to solve these problems, it is difficult to solve the security problem of medical information and personal authentication. Since smart healthcare includes personal medical information of subjects, the security of personal information is the most important field. Therefore, in this paper, we tried to propose a Telemedicine System using a smart wearable device ECG in the form of a wristband and face personal authentication in a private blockchain environment. This system targets various medical personnel and patients with chronic diseases in all regions, and uses a private blockchain that can increase data integrity and transparency, ECG and face authentication that are difficult to forge and alter and have high personal identification to provide a system with high security and reliability. composed. Through this, it is intended to contribute to increasing the efficiency of chronic disease management by focusing on disease prevention and health management for patients with chronic diseases at home.

Comparison of Electrodermal Activity between Hypertensive and Non-hypertensive Subject in Health Screening Population (건강검진자 대상 고혈압 유무에 따른 피부전기활동성 비교 연구)

  • Kim, Young Eun;Kim, Chul;Yea, Sang Jun;Yang, Chang Sop;Song, Mi Young
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.27 no.6
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    • pp.847-852
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    • 2013
  • The aim of this study was to investigate the difference of electrodermal activity between the hypertensive and non-hypertensive subjects. A total 161 subjects who visited a hospital for health check ups from August 2011 through November 2011 and from September 2012 through November 2012 were included in this study. We divided the subjects into two groups by blood pressure, hypertension group(81 patients) and non-hypertension group(180 subject). Then we compared electrodermal activity between two groups by using the autonomic bioelectric response device model CP-6000A. The data was analyzed by independent t-test and logistic regression. In this study, there was a significant difference in electrodermal activity(the mean absolute value of positive, negative pulse conductivity) between hypertensive and normotensive group in t-test and electrodermal activity showed the significant influence on the prevalence risk of hypertension with age, body mass index and dyslipidema in binominal logistic regression. In conclusion, hypertensive patients had high level of electrodermal activity compared with normotensive subjects and this finding suggests that electrodermal activity which is explained excess tendency in Korean traditional medicine could be used for diagnosis in hypertension patients at Korean traditional medical clinic.

Preliminary study of Korean orthodontic residents' current concepts and knowledge of cleft lip and palate management

  • Cho, Il-Sik;Shin, Hyo-Keun;Baek, Seung-Hak
    • The korean journal of orthodontics
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    • v.42 no.3
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    • pp.100-109
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    • 2012
  • Objective: A national survey was conducted to assess orthodontic residents' current concepts and knowledge of cleft lip and palate (CLP) management in Korea. Methods: A questionnaire consisting of 7 categories and 36 question items was distributed to 16 senior chief residents of orthodontic department at 11 dental university hospitals and 5 medical university hospitals in Korea. All respondents completed the questionnaires and returned them. Results: All of the respondents reported that they belonged to an interdisciplinary team. Nineteen percent indicated that they use presurgical infant orthopedic (PSIO) appliances. The percentage of respondents who reported they were 'unsure' about the methods about for cleft repair operation method was relatively high. Eighty-six percent reported that the orthodontic treatment was started at the deciduous or mixed dentition. Various answers were given regarding the amount of maxillary expansion for alveolar bone graft and the estimates of spontaneous or forced eruption of the upper canine. Sixty-seven percent reported use of a rapid maxillary expansion appliance as an anchorage device for maxillary protraction with a facemask. There was consensus among respondents regarding daily wearing time, duration of treatment, and amount of orthopedic force. Various estimates were given for the relapse percentage after maxillary advancement distraction osteogenesis (MADO). Most respondents did not have sufficient experience with MADO. Conclusions: These findings suggest that education about the concepts and methods of PSIO and surgical repair, consensus regarding orthodontic management protocols, and additional MADO experience are needed in order to improve the quality of CLP management in Korean orthodontic residents.