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A Study on the Establishment and Operation of a Regulatory Response Framework in connection with the Regulatory Strength of the Licensing Policy for New Medical Devices -Focusing on the Application of FMEA- (의료기기 신제품의 인허가정책 규제강도에 연계한 규제대응 프레임워크 수립 및 운영에 관한 연구 - FMEA 적용을 중심으로 -)

  • Kim, Gyosu;Ru, Gyuha;Kim, Yeonhee
    • Journal of Technology Innovation
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    • v.28 no.4
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    • pp.1-26
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    • 2020
  • Due to the spread of Corona 19 around the world, Infectious Disease Medicine and New Medical Devices such as Diagnostic Agent are being rapidly developed and launched, and for the fast supply and demand of these, each country has eased import regulations or has implemented policies for fast approval(NIDS, 2020). On the other hand, New Developed Medical Devices that are not related to New Infectious Diseases, they are still entering the market through strict licensing and licensing regulations, such as delay and cancellation in the test inspection process, etc. Therefore, This Study specialized in the government-managed laws encountered when New Medical Devices enter the market, derive Factors influencing the Strength of Regulations, analyzes the Strength of Regulations, and proposes a Regulatory Response Framework. The Research Method was conducted by Literature Research, was applied by Failure Mode and Effects Analysis(FMEA) Method, Expert Interview(1st): Idea Collection, Expert Interview(2nd): Validation, and Priority through the Application Process of FMEA Method. A Method of Quantifying the Intensity of Regulation was proposed by multiplying the Impact of the Influencing Factors for each stage of regulation and the Burden Impact for each type of Regulatory Affairs to find the Importance of the Regulatory Factors and multiplying the Severity of the Regulatory Impact. The Implications are that major overseas countries and the Korean government are actively responding with Special Regulatory Policies and Mitigation Policies for fast licensing of New Developed Medical Devices in accordance with Corona 19. It is expected that the direction for improvement of regulations and measures to respond to regulations will be implemented so that a more proactive and preemptive response to the regulatory process of the licensing policy for New Devices can be achieved.

Changes and Comparative Analysis of Job-offer, Job-search and Small and Medium-sized Companies Before and after the Corona Era (코로나 시대 이전과 이후의 구인·구직 및 중소기업의 변화 및 비교분석)

  • Kim, Youn Su;Chang, In Hong;Song, Kwang Yoon
    • Journal of Integrative Natural Science
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    • v.14 no.1
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    • pp.11-20
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    • 2021
  • On November 17, 2019, an infectious disease with symptoms of pneumonia, called the Wuhan virus at the time, occurred in Wuhan, China. Since then, the name has been changed to COVID-19, and the virus has spread all over the world, and the WHO has declared the highest warning level for infectious diseases, "Pandemic". The coronavirus has also caused great confusion in South Korea. This resulted in large infected people.The first confirmed cases occurred on January 20, 2020, and the number of infected patients is steadily increasing after experiencing several waves, and many corona confirmed cases are also occurring in 2021 after the year. As the whole world enters a pandemic, walls are created between people and people, companies and businesses, and countries and countries, and all growth stops or declines, including human relationships, domestic companies and industries, and foreign industries. As a result, society in general is experiencing a lot of stagnation. Among them, small and medium-sized enterprises (SMEs), which are the basis of all growth in Korea, and youth who are trying to contribute to the national development by entering society, are struggling to find jobs. Even before the coronavirus outbreak, the difficulty of job hunting and the prospect of small and medium-sized businesses were not very good. In this situation, as the country's overall economic situation is poor, the vitality of SMEs has decreased a lot, the prospects are not good, so jobs are reduced, and there are many difficulties due to reluctance to hire new employees. In this study, with 2019 before the corona era and 2020 after the corona era, we compare SMEs before and after the corona era and overall job search and job search activities through average difference analysis, and whether they are affecting through correlation analysis. Through this, it suggests a direction to increase job search through corporate and government policies after raising the prospects of SMEs first.

Autopoietic Machinery and the Emergence of Third-Order Cybernetics (자기생산 기계 시스템과 3차 사이버네틱스의 등장)

  • Lee, Sungbum
    • Cross-Cultural Studies
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    • v.52
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    • pp.277-312
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    • 2018
  • First-order cybernetics during the 1940s and 1950s aimed for control of an observed system, while second-order cybernetics during the mid-1970s aspired to address the mechanism of an observing system. The former pursues an objective, subjectless, approach to a system, whereas the latter prefers a subjective, personal approach to a system. Second-order observation must be noted since a human observer is a living system that has its unique cognition. Maturana and Varela place the autopoiesis of this biological system at the core of second-order cybernetics. They contend that an autpoietic system maintains, transforms and produces itself. Technoscientific recreation of biological autopoiesis opens up to a new step in cybernetics: what I describe as third-order cybernetics. The formation of technoscientific autopoiesis overlaps with the Fourth Industrial Revolution or what Erik Brynjolfsson and Andrew McAfee call the Second Machine Age. It leads to a radical shift from human centrism to posthumanity whereby humanity is mechanized, and machinery is biologized. In two versions of the novel Demon Seed, American novelist Dean Koontz explores the significance of technoscientific autopoiesis. The 1973 version dramatizes two kinds of observers: the technophobic human observer and the technology-friendly machine observer Proteus. As the story concludes, the former dominates the latter with the result that an anthropocentric position still works. The 1997 version, however, reveals the victory of the techno-friendly narrator Proteus over the anthropocentric narrator. Losing his narrational position, the technophobic human narrator of the story disappears. In the 1997 version, Proteus becomes the subject of desire in luring divorcee Susan. He longs to flaunt his male egomaniac. His achievement of male identity is a sign of technological autopoiesis characteristic of third-order cybernetics. To display self-producing capabilities integral to the autonomy of machinery, Koontz's novel demonstrates that Proteus manipulates Susan's egg to produce a human-machine mixture. Koontz's demon child, problematically enough, implicates the future of eugenics in an era of technological autopoiesis. Proteus creates a crossbreed of humanity and machinery to engineer a perfect body and mind. He fixes incurable or intractable diseases through genetic modifications. Proteus transfers a vast amount of digital information to his offspring's brain, which enables the demon child to achieve state-of-the-art intelligence. His technological editing of human genes and consciousness leads to digital standardization through unanimous spread of the best qualities of humanity. He gathers distinguished human genes and mental status much like collecting luxury brands. Accordingly, Proteus's child-making project ultimately moves towards technologically-controlled eugenics. Pointedly, it disturbs the classical ideal of liberal humanism celebrating a human being as the master of his or her nature.

Antibiotics Susceptability of Streptococcus pneumoniae Isolated from Single Tertiary Childrens' Hospital Since 2014 and Choice of Appropriate Empirical Antibiotics (최근 4년간 국내 단일 의료기관을 내원한 소아청소년에서 분리된 폐구균의 항생제 감수성 양상 분석)

  • Jung, Jiwon;Yoo, Ree Nar;Sung, Hungseop;Kim, Mina;Lee, Jina
    • Pediatric Infection and Vaccine
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    • v.26 no.1
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    • pp.1-10
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    • 2019
  • Purpose: We investigated the distribution and antimicrobial resistance of pneumococcal isolates from hospitalized children at Asan Medical Center for recent 4 years, and aimed to recommend proper choice of empirical antibiotics for pneumococcal infection. Methods: From March 2014 to May 2018, children admitted to Asan Medical Center Childrens' Hospital with pneumococcal infection were subjected for evaluation of minimal inhibitory concentration (MIC) for ${\beta}-lactams$ and macrolide antibiotics. Patient's age, underlying disease, gender were retrospectively collected. Using Monte Carlo simulation model and MIC from our study, we predicted the rate of treatment success with amoxicillin treatment. Results: Sixty-three isolates were analyzed including 20.6% (n=13) of invasive isolates, and 79.4% (n=50) of non-invasive isolates; median age were 3.3 years old, and 87.3% of the pneumococcal infections occurred to children with underlying disease. Overall susceptibility rate was 49.2%, 68.2%, and 74.6% for amoxicillin, parenteral penicillin, and cefotaxime respectively. 23.8% and 9.5% of the isolates showed high resistance for amoxicillin, and cefotaxime. Only 4.8% (n=3) were susceptible to erythromycin. Monte Carlo simulation model revealed the likelihood of treatment success was 46.0% at the dosage of 90 mg/kg/day of amoxicillin. Conclusions: Recent pneumococcal isolates from pediatric patients with underlying disease revealed high resistance for amoxicillin and cefotaxime, and high resistance for erythromycin. Prudent choice of antibiotics based on the local data of resistance cannot be emphasized enough, especially in high risk patients with underlying disease, and timely vaccination should be implemented for prevention of the spread of resistant strains.

Childhood Tuberculosis Contact Investigation and Treatment of Latent Tuberculosis Infection: a Single Center Study, 2014-2017 (소아청소년 결핵 접촉자 검진 및 잠복결핵감염의 치료 현황: 2014-2017 단일 기관 연구)

  • Hwang, Woo Jin;Lee, Go Un;Kim, So Hyun;Cho, Eun Young
    • Pediatric Infection and Vaccine
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    • v.26 no.1
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    • pp.32-41
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    • 2019
  • Purpose: In order to prevent tuberculosis transmission early, it is important to diagnose and treat tuberculosis infection by investigating people who have contact with patients with active tuberculosis. Methods: From July 2014 to June 2017, the intrafamilial childhood contacts of the patients who were diagnosed with active tuberculosis at Chungnam National University Hospital were investigated for the presence of tuberculosis infection. We also retrospectively analyzed the treatment status of children treated with latent tuberculosis infection (LTBI) during the same period. Results: Among the 269 children who had intrafamilial contact with active tuberculosis patient, 20 (7.4%) did not receive any screening. At the first screening, one (0.4%) was diagnosed with pulmonary tuberculosis, seven (2.8%) had a previous history of tuberculosis infection, and 42 patients (16.9%) were diagnosed with LTBI. At the second screening, 29 patients (11.6%) were diagnosed with LTBI, and 61 patients did not finish the investigation. Only 188 (69.9%) out of 269 patients completed the investigation. Ninety patients received treatment for LTBI and 83 patients (92.2%) completed the treatment, of which 18 patients had side effects such as rash, fatigue, and gastrointestinal symptoms. However, there were no serious side effects requiring treatment discontinuation. Conclusions: The completion rate of childhood tuberculosis contact investigation was low, but the completion rate of LTBI treatment was high in children without serious side effects. In order to prevent and manage the spread of tuberculosis, active private-public partnership efforts and education of the patient and guardian are needed.

A Study on the Development Plan for Promotion of Advanced Disaster-Safety Awareness (선진 재난안전의식의 활성화를 위한 방안 연구)

  • Lee, Jong-hyun;Kim, Mi-ra;Ko, Jae-chul
    • Journal of the Society of Disaster Information
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    • v.17 no.3
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    • pp.415-426
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    • 2021
  • Purpose: The purpose of this study is to create the deveopment plan for promotion of advanced disaster-safety awareness, which is noted as a major factor in the large disaster. Method: This study is to conduct theoretical review with regard to disaster management and safety awareness. Consciousness surveys on safety awareness and previous disaster case was analyzed to derive the cause of the disaster, and the development plan for promotion of advanced disaster-safety awareness was suggested. Result: In the survey on the public's sense of safety on the disaster management evaluation, 'Response' stage was well performed, but the 'Recovery' stage was not. Especially, it was found that disaster safety education at the 'Prevention' stage was very lacking. In the survey on the public's safety awareness, the awareness level of the evacuation facility was very low, information on infectious diseases and collapse accident was insufficient. Especially, it has been found that the awareness on safety regulation in daily life is very insufficient. Through the case study on previous disaster(COVID-19, Fire in Miryang Sejong Hospital, Forest fire in the east coas at 2004'), it was derived that the lack of safety awareness(such as safety insensitivity) was the main factor of the expansion of the damage scale. Conclusion: The development plan for promotion of advanced disaster-safety awareness are as follow. First, it is necessary to spread the safety culture movement through the expansion of safety education and safety promotion. Second, disaster confrontation training for the public should be implemented to improve the effectiveness of disaster response. Finally, it is necessary to change the individual awareness on safety. When these factors are implemented systematically, advanced disaster-safety awareness can be promoted. Ultimately, disaster accidents in our society can be reduced.

Qualitative Study on Experiences of Responding to COVID-19 of Therapists in Long-term Care Hospitals (요양병원 치료사의 코로나19 대응 경험에 대한 질적 연구)

  • Bae, Won-Jin;Park, Ju-Young
    • Journal of Korea Entertainment Industry Association
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    • v.15 no.4
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    • pp.337-347
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    • 2021
  • This study is a qualitative study conducted to provide basic data for therapists working in long-term care hospitals to improve their countermeasure strategies for new infectious diseases and improvement of the treatment room infection management system, and to help therapists understand their infection management work. Colaizzi's phenomenological research method was applied as the research method. Telephone interviews were conducted with nine occupational therapists and physical therapists working in nursing hospitals. The contents of the interview were recorded with the consent of the study subjects, and additional confirmation was received by email. The recorded content was analyzed after transcription, and the meaning and nature of the experience coping with COVID-19 were described. The content was organized into 6 themes, 17 main meaning and 49 meaning units. In accordance with the COVID-19 situation, the infection control system has been strengthened by reinforcing infection control education in nursing hospitals, practicing infection control, and supervising infection control outside business hours. It was found that the treatment environment was changed due to the restriction of treatment activities by practicing distancing in the treatment room, adjusting rest and meal times during working hours, and strengthening infection control. In addition, the therapist's role has been expanded and the paradigm of treatment has changed, such as considering the untact intervention, and they have experienced cohort quarantine, pre-tested for COVID-19, vaccinations, and side effects from COVID-19. However, due to the infection work, the therapist's work burden is increased, and the person is experiencing fear, depression, and work stress from the spread of COVID-19. They were also aware of the need for nursing hospital care personnel support, such as guaranteeing rest after vaccination and providing infection control tools and equipment. The results of this study are expected to be used as basic data for human and physical support for the development of infectious disease response strategy programs in nursing hospital treatment rooms and for infection control in nursing hospitals.

A Study on Changes in Consumption Behavior due to the Risk of the COVID-19 Pandemic (COVID-19 팬데믹 위험으로 인한 소비행동의 변화 연구)

  • Oh, Jong-chul;Lee, Yu-sun;Kim, Jae-hong
    • Journal of Venture Innovation
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    • v.5 no.2
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    • pp.49-66
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    • 2022
  • This study intends to examine how the perception of covid-19 risk affects consumers' consumption behavior based on previous studies in a situation where the spread of covid-19 is prolonged. This study demonstrates how consumers' perception of covid-19 risk affects online and offline consumption behavior through the perceived severity, perceived vulnerability, coping effectiveness, and self-efficacy of the revised protective motivation theory (Rogers, 1983). We want to test it through analysis. In order to achieve the purpose of this study, consumers living in Seoul and Gyeonggi Province who have purchased within the past 3 months were selected as a sample. In addition, variable data such as risk perception of covid-19, perceived severity, perceived vulnerability, coping effectiveness, self-efficacy, online purchase attitude and purchase intention, offline purchase attitude and purchase intention were collected through the questionnaire.A total of 363 copies of valid responses were tested to test the hypothesis of the relationship between variables through the covariance structure model. The analysis results of this study were first, that covid-19 risk perception had a significant positive (+) effect on perceived severity, perceived vulnerability, and coping effectiveness. Second, perceived severity and perceived vulnerability were found to have a significant positive (+) effect on offline purchasing attitude. Third, perceived severity, perceived vulnerability, coping plan effectiveness, and self-efficacy were all found to have significant positive (+) effects on online purchase attitude. Finally, it was found that offline purchase attitude and online purchase attitude had a significant positive (+) effect on offline purchase intention and online purchase intention, respectively. Also, it was found that online purchase attitude had a negative (-) effect on offline purchase intention. The results of this analysis will provide meaningful implications for the establishment of strategies for distribution channels according to the social risk of infectious diseases.

Antioxidant Activity of Native Korean Halophyte Extracts and Their Anti-biofilmActivity against Acinetobacter baumannii (한국 자생 염생식물 추출물의 항산화 활성 및 다재내성 Acinetobacter baumannii에 대한 항생물막 활성)

  • Eun Seong Lee;Jeong Woo Park;Ki Hwan Moon;Youngwan Seo
    • Journal of Life Science
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    • v.33 no.12
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    • pp.1015-1024
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    • 2023
  • Antibiotics have greatly contributed to the treatment and prevention of bacterial diseases in humans, animals, and fish. However, antibiotic misuse has led to the emergence and spread of multidrug-resistant bacteria. In addition to antibiotic discovery research, efforts are being made to combat such multidrug-resistant bacteria using antimicrobial agents, antioxidants, host immune enhancement, probiotics, and bacteriophages, as well as various symptomatic therapies. To discover novel bioactive compounds, it is crucial to adopt approaches that incorporate fresh ideas, new targets, innovative techniques, and untapped resources. Halophytes are plants that grow in high-salt soils and are known to adapt to salt-induced stress through unique metabolic processes that produce secondary metabolites. This study aimed to investigate the effects of extracts of halophytes native to Korea on oxidative stress and to determine whether they exert inhibitory activity against biofilms, which are major pathogenic factors of infectious bacteria. The Acinetobacter baumannii strain ATCC 17978, a representative drug-resistant bacterium, was used to measure anti-biofilm activity. The results showed that Aster spathulifolius, Carex kobomugi, Rosa rugosa, and Asparagus cochinchiensis exerted strong antioxidant and anti-biofilm effects without affecting bacterial growth itself. The halophytes used in this study are promising candidates for the development of pharmaceutical agents with antioxidant and antimicrobial properties.

COVID-19 Rapid Antigen Test Results in Preschool and School (March 2 to May 1, 2022) (유치원·학교 구성원의 코로나19 신속항원검사 결과(2022년 3월 2일부터 5월 1일까지))

  • Gowoon Yun;Young-Joon Park;Eun Jung Jang;Sangeun Lee;Ryu Kyung Kim;Heegwon Jeong;Jin Gwack
    • Pediatric Infection and Vaccine
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    • v.31 no.1
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    • pp.113-121
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    • 2024
  • Purpose: In response to the surge in coronavirus disease 2019 (COVID-19) omicron variant cases, we have implemented preemptive testing for preschool and school. The purpose is to quickly detect COVID-19 cases using a rapid antigen test (RAT) kit so that normal school activities can continue. Methods: The results entered in The Healthcare Self-Test App were merged with the information on the status of confirmed cases in the COVID-19 Information Management System by Korea Disease Control and Prevention Agency (KDCA) for preschool and school of students and staffs March 2 to May 1, 2022 to analyze the RAT positive rate and positive predictive value of RAT. Results: In preschool and school 19,458,575 people were tested, weekly RAT positive rate ranged from 1.10% to 5.90%, positive predictive value of RAT ranged from 86.42% to 93.18%. By status, RAT positive rate ranged from 1.13% to 6.16% for students, 0.99% to 3.93% for staffs, positive predictive value of RAT ranged from 87.19% to 94.03% for students, 77.55% to 83.10% for staffs. RAT positive rate by symptoms ranged from 76.32% to 88.02% for those with symptoms and 0.34% to 1.11% for those without symptoms. As a result of preschool and school RAT, 943,342 confirmed cases were preemptively detected, before infection spread in preschool and school. Conclusions: RAT was well utilized to detect confirmed cases at an early stage, reducing the risk of transmission to minimize the educational gap in preschool and school. To compensate for the limitations of RAT, further research should continue to reevaluate the performance of RAT as new strains of viruses continue to emerge. We will have to come up with various ways to utilize it, such as performing periodic and repeated RAT and parallel polymerase chain reaction.