• 제목/요약/키워드: Establishment risk

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Biosafety Risk Control Strategies in Laboratory Animal Research

  • Shun-tai Weng;Qu-wen Li;Ya-dong Gao;Yu-feng Qiu
    • Safety and Health at Work
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    • 제15권1호
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    • pp.118-122
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    • 2024
  • To understand biosafety's current situation in laboratory animal research and risk factors affecting occupational health. Compliance surveys were conducted by questionnaire via Questionnaire Star (an application app on the Internet) in Chinese. Thirty-nine anonymous questionnaires were collected. The surveyed institution has established 24 types of ABSL (Animal Biosafety Laboratory) and biosafety management organizations and systems equipped with safety equipment. Our study also suggests that the principal of the laboratory establishment fails to perform supervision and inspection responsibilities, the inappropriate design of the animal biosafety laboratory, non-standardized personnel training and health management, non-strict waste management, and insufficient emergency management. The administrative department and work units should address certain safety and occupational health risks in laboratory animal research. The author proposes control strategies based on organizational guarantee, personnel management, emergency management, etc., to help prevent risks and ensure occupational health. Due to regional limitations and small sample size, the results may not be generalisable to all parts of the world. However, some of the key common issuesmay also be present in other regions, sowe believe that this research still has some relevance.

일회용 의료기기에 적용을 위한 ISO 14971:2019 분석과 Periodic Safety Update Report 작성 방법 - Medical Device Regulation 2017/745 요구사항 중심으로 (ISO14971:2019 Detailed Analysis and Periodic Safety Update Report Establishment Method for the Single Use Medical Device - Focusing on Medical Device Regulation 2017/745 requirements)

  • 박상민;류규하
    • 대한의용생체공학회:의공학회지
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    • 제44권1호
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    • pp.1-10
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    • 2023
  • With the announcement of MEDICAL DEVICE REGULATION 2017/745 (MDR) on April 5 2017, medical device manufacturers shall apply ISO 14971:2019 (3rd) revised in December 2019. However, there is not much related information and guidance available to medical device manufacturers, especially single use medical device. Risk management process basically follow 5 steps which are Risk Analysis, Risk Evaluation, Risk Control, Evaluation of overall residual risk and post-production activities. The purpose of this study is to provide a guidance of from risk analysis with Failure Mode and Effects Analysis (FMEA) table to overall residual risk evaluation for the single use medical device and to reflect it in a Periodic Safety Update Reports (PSUR) to satisfy with MDR requirements with single use medical device which are widely used and manufactured FDA class 2 or CE class IIb as examples. For this study, single use medical device manufacturer can adopt ISO 14971:2019 in accordance with MDR requirements and it can be extended to the PSUR. But there are still limitations to adopt to the all-single use medical device especially high class, private device and implantable device. So, Competent Authority (CA) shall publish more guidance for the single use medical device.

Potential Risk Factors for Breast Cancer in Pakistani Women

  • Bano, Raisa;Ismail, Muhammad;Nadeem, Aamer;Khan, Mohammad Haroon;Rashid, Hamid
    • Asian Pacific Journal of Cancer Prevention
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    • 제17권9호
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    • pp.4307-4312
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    • 2016
  • Background: Breast cancer is the most common female malignancy worldwide and its incidence is on the rise in Pakistan. The aim of this case-control study was to quantify the association of various risk factors with breast cancer risk among Pakistani women. Materials and Methods: A total of 2,246 women were studied, including 1,238 women with histologically confirmed breast cancer patients and age matched control subjects (N=1008) without breast cancer and other chronic diseases. Subjects were interviewed using a specifically designed questionnaire. Unconditional logistic regression was applied. Subsequent disease-specific mortality was also measured. Results: In this study, majority of the breast cancer patients (69.59%) were in age ranges of 40s and 50s. BMI greater than 25kg/m2 (OR=1.57; 95%CI, 1.26-1.90 and OR=1.60; 95%CI, 1.26-2.03), marital status of unmarried (OR=2.03; 95%CI, 1.69-2.44), lack of breast feeding, smoking (current or ever), lack of physical activity and post-menopausal status were found to have significant positive associations with breast cancer. It was also observed that increased parity reduced the disease risk. A larger number of cases (58.1%) had their right breast affected while 22.8% had other complications as well. Conclusions: This exploratory analysis indicated a number of risk factors to be associated with increased risk of breast cancer. It was also observed that mean age at diagnosis is a decade earlier than in western countries. It is hoped that our findings will facilitate establishment of adequate evidence-based awareness and preventive measures for Pakistani women.

농작업시 발생하는 화학적 및 생물학적 위험요인에 대한 유사노출작업군 설정 연구 (A Study on Establishment of Similar Expousre Groups(SEGs) for Chemical and Biological Risk Factors in Farm Work)

  • 이민지;신소정;김효철;허진영;안민지;김경란;김경수
    • 한국산업보건학회지
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    • 제30권3호
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    • pp.292-298
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    • 2020
  • Objectives: The aim of this research is to establish Similar Exposure Groups (SEGs) for chemical and biological risk factors that occur in farm work involving 24 tasks among 15 crops. Methods: To categorize SEGs, work type, work environment, and similar tasks for each crop were considered. After confirming the chemical risk factors (pesticides, inorganic dust-total dust and PM10, ammonia, and hydrogen sulfide) and biological factors (organic dust-total dust and PM10, and endotoxins) that occur in the crops and tasks, similar crops and tasks were selected as SEGs. Results: Among chemical risk factors, pesticides was selected for the SEGs, which was categorized by open field, greenhouse, fruit, and specialty crops. For inorganic dust, open field (plowing harrowing, seedling, planting, harvest, and sorting and packing) and specialty crops (plowing harrowing, seedling, planting, and harvest) were selected as SEGs. For ammonia and hydrogen sulfide, livestock (preparation of farm, management of nursery bed, feeding, shipment and manure treatment) were selected as SEGs. For biological risk factors such as organic dust (total dust, PM10) and endotoxins, open field (manure application), greenhouse (plowing harrowing, planting, manure application, and harvest), fruit (manure application), specialty crops (manure application, making furrows, mixing mushroom media, harvest, and sorting and packing), and livestock (preparation of farm, maintaining poultry litter, feeding, shipment and manure treatment) were selected as SEGs. Conclusions: To establish similar exposure groups in agriculture, it is important that the characteristics of each hazard factor are categorized by identifying risk factors occurring by tasks.

관개취약성 평가모형 및 군집분석을 활용한 용수공급 위험도 평가 (Water Supply Risk Assessment of Agricultural Reservoirs using Irrigation Vulnerability Model and Cluster Analysis)

  • 남원호;김태곤;홍은미
    • 한국농공학회논문집
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    • 제57권1호
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    • pp.59-67
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    • 2015
  • Because reservoirs that supply irrigation water play an important role in water resource management, it is necessary to evaluate the vulnerability of this particular water supply resource. The purpose of this study is to provide water supply risk maps of agricultural reservoirs in South Korea using irrigation vulnerability model and cluster analysis. To quantify water supply risk, irrigation vulnerability indices are estimated to evaluate the performance of the water supply on the agricultural reservoir system using a probability theory and reliability analysis. First, the irrigation vulnerability probabilities of 1,346 reservoirs managed by Korea Rural Community Corporation (KRC) were analyzed using meteorological data on 54 meteorological stations over the past 30 years (1981-2010). Second, using the K-mean method of non-hierarchical cluster analysis and pre-simulation approach, cluster analysis was applied to classify into three groups for characterizing irrigation vulnerability in reservoirs. The morphology index, watershed area, irrigated area, and ratio between watershed and irrigated area are selected as the clustering analysis parameters. It is suggested that the water supply risk map be utilized as a basis for the establishment of risk management measures, and could provide effective information for a reasonable decision making on drought risk mitigation.

인터넷전문은행의 지각된 혜택, 지각된 위험, 지속적 이용의도의 관계에서 신뢰의 매개효과 분석 (Relationship among perceived benefit, perceived risk and continuous use of user' Internet primary bank : The mediation effects of trust)

  • 정주원;조소연
    • 한국융합학회논문지
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    • 제9권12호
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    • pp.195-205
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    • 2018
  • 인터넷전문은행의 안정적인 구축과 성장을 위하여 인터넷전문은행의 지각된 위험, 지각된 혜택과 신뢰가 지속적 이용의도에 미치는 영향에 대해 파악하였다. 그리고 지각된 혜택, 지각된 위험과 지속적 이용의도의 관계에서 신뢰의 매개효과를 검증하였다. 온라인 설문조사를 통하여 최근 3개월 이내에 인터넷전문은행 이용경험이 있는 20-59세 457명이 연구대상자로 선정되었다. 주요 결과로 첫째, 지각된 혜택과 위험, 신뢰는 인터넷전문은행의 지속적 이용의도에 유의한 영향을 미치는 것으로 밝혀졌다. 둘째, 편이성과 기능적 위험은 지속적 이용의도간의 관계에서 신뢰의 부분매개효과가 검증되었으며, 매력성과 혁신성은 완전매개효과로 검증되었다. 인터넷전문은행은 지속적인 성장을 확보하기 위해 소비자의 주요 혜택을 늘리고 위험수준을 낮추어 신뢰를 견고하게 구축해 나가야 한다.

COVID-19가 건설프로젝트 리스크에 미치는 영향 (Study on the Risk Factors of Construction Projects since COVID-19)

  • 이재현;이성현;이동훈
    • 한국건설안전학회 논문집
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    • 제4권1호
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    • pp.1-8
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    • 2021
  • 현재 유행하고 있는 COVID-19는 '세계보건기구' 설립 이래 가장 많은 사망자가 발생한 대유행이다. 수많은 건설 프로젝트에도 상당한 영향을 미칠 것으로 예상된다. COVID-19가 건설업계를 강타한 이후, 그들이 감당해야 할 위험은 매년 줄어들었다. 그러나 COVID-19의 장기화로 인해 대기 지연, 자재 공급, 경제적 손실의 위험이 증가했다. 정확한 대책은 파악이 필요할 것이며 현재 건설사업 중 리스크가 더 큰 비중으로 완화될 수 있어야 한다. 따라서 이번 연구는 COVID-19로 인해 국내 건설사에 건설사업에 영향을 미친 위험요소를 분석하고 규명하는 것을 목적으로 한다. 이전 건설 프로젝트의 리스크를 바탕으로 조사, 가중치 부여 등을 통해 리스크 사례 연구, COVID-19 관련 리스크 등을 추출한다. 각 위험 요소는 AHP 분석 기법을 기반으로 계산된다. 이에 따라 COVID-19로 인해 건설공사 리스크 연구 결과가 달라질 것으로 예상된다. 그것은 현재 상황과 이후의 전염병 상황에 대처하기 위해 제시될 것이다.

병원의 재무구조에 영향을 미치는 요인 (Factors Affecting the Financial Structure of Hospitals in Korea)

  • 최만규;문옥륜;황인경
    • 보건행정학회지
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    • 제12권2호
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    • pp.43-75
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    • 2002
  • This study focuses on the factors that make the financial structure of hospitals in Korea different, and on recommended courses of action that could be very helpful to hospitals in maintaining a sound financial structure. Data used in this study were collected from 132 hospitals with complete general data of present conditions as well as financial statements. They were chosen from the 174 hospitals that passed the standardization audit undertaken by the Korean Hospital Association from 1996 to 2000 for the purpose of accrediting training hospitals. The dependent variable in this study is financial structure. It consists of liabilities as against total assets (total liabilities to total assets, short-term liabilities to total assets, long-term liabilities to total assets, short-term borrowings to total assets, long-term borrowings to total assets). The independent variables are ownership type, hospital type, location, whether or not a representative is a director of the hospital, the possibility of changing a hospital director, bed size, period of establishment, asset structure, profitability, growth, tax shields, business risk, competition. The factors that appear to have the strongest impact on the liabilities to total assets of all the hospitals sampled are ownership type, hospital type, profitability, tax shields, and business risk. It was found that not-for-profit private hospitals and for-profit private hospitals have more liabilities than public hospitals, and tertiary medical institutions have less liabilities than the secondary general hospitals. Moreover, hospitals earning more at the expense of high business risk have a distinct tendency to lower liabilities. Concerning the current ratio, it was found that factors such as ownership type, hospital type, period of establishment, asset structure, and business risk are the more significant variables. The current ratio of public hospitals is higher than that of both not-for-profit private hospitals and for-profit private hospitals, and the current ratio of tertiary medical institutions is higher than that of general hospitals. As business risk is higher in hospitals compared to other businesses, the current ratio becomes higher; this is because it is assumed that for fear of bankruptcy, hospitals lessen liabilities to total assets. On the other hand, as hospitals become older, the fixed assets to total assets become lower. It is remarkable that in hospitals, the factors affecting liabilities to total assets have an opposite regression coefficient sign against factors affecting current ratio. It brings out the same results borne out by the old financial theories and researches, in which a lot of the liabilities of hospitals are considered as the cause of worsening liquidity. Therefore, it is very important for hospitals to maintain a sound financial structure in order to survive using the rational acquisition and maintenance of capital.

전자기록의 장기보존전략을 위한 의사결정 절차에 관한 연구 (A Study on the establishment of criteria for selecting long-term preservation strategy of electronic records)

  • 최주호;차현철
    • 한국컴퓨터정보학회:학술대회논문집
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    • 한국컴퓨터정보학회 2017년도 제55차 동계학술대회논문집 25권1호
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    • pp.31-32
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    • 2017
  • 본 논문에서는 파일 포맷에 대한 위험요소 평가를 기반으로 해당 포맷에 대한 장기보존 방안을 제시하는 절차 및 시스템 구축에 필요한 아키텍처를 정의하였다. 파일포맷이 사양화된 경우 이를 재현할 수 있는 장기보존전략으로 마이그레이션과 에뮬레이션 방안이 제시되고 있는데 개별 포맷에 대한 위험도 평가를 통해 가장 적합한 보존전략을 선정하여 전자기록의 재현성을 부여하는 연구를 진행하였다.

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The Analysis of User Perception and Attitude Using SNS Data about Emergency Contraceptive Pills

  • 이성현
    • 인터넷정보학회논문지
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    • 제18권1호
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    • pp.143-152
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    • 2017
  • In order to ensure the right of self-determination of women, most of countries allow women to buy post-coital contraceptive pills or general medical supplies with ease. This study aims to analyze how ordinary people recognize and respond to post-coital contraceptive pills through collecting atypical data by using the keyword 'Contraception', rather than using the existing actual condition survey, such as questionnaire and interview, so that the results have been presented, which may be referred to for establishment of policies.