• Title/Summary/Keyword: Documents of safety Management

Search Result 123, Processing Time 0.027 seconds

A Study on the Application of Systematic Literature Review for Post-Market Clinical Evaluation of Medical Devices: Focused on the Ophthalmic Electrosurgical system (시판 후 의료기기 임상평가를 위한 체계적 문헌고찰 활용 방안 연구: 안과용전기수술기 사례를 중심으로)

  • Kim, Byung Gwan;Choi, Young Sook;Kim, Mi Sun;Yang, Seok-Jo
    • Journal of Biomedical Engineering Research
    • /
    • v.41 no.1
    • /
    • pp.35-41
    • /
    • 2020
  • In this study, we examined whether the systematic literature review method used in the field of evidence-based medicine could be used for post-market clinical evaluation of medical devices by modifying them to fit the regulatory perspective of medical devices in Korea. For this purpose, systematic literature review was modified and applied to conduct a clinical literature survey on the ophthalmic electrosurgical system(Trabectome®, NeoMediX Corp) used for the treatment of glaucoma. A total of six documents were finally selected, and clinical safety and efficacy information on the indications of the ophthalmic electrosurgical system were effectively presented. In addition, general safety information and unexpected safety information could be distinguished through comparison with medical device adverse event reporting cases. The method used in this study is expected to be used in various ways throughout post-market medical device safety management system and for the purpose of regulation improvement, especially in the field of ophthalmic electrosurgical system.

Comparative Analysis of On-site Construction Management in Korea and Japan (건설현장 관리기술에 대한 한·일간 비교분석 예비연구)

  • Song, Sang-Hoon;Sohn, Jeon-Grak
    • Journal of the Korea Institute of Building Construction
    • /
    • v.10 no.6
    • /
    • pp.27-38
    • /
    • 2010
  • Considering the similarity in legislation and long-term industrial trend of Korea and Japan, continuous attention to the Japanese situation is useful for the development of a domestic construction strategy. In order to compare the current on-site construction management practice of the two countries and analyze the reasons for discrepancy, a literature review, expert interview, and site investigation were executed. A detailed survey of experts with experience in both countries revealed that overall, Korea's level of competitiveness is gaining on that of Japan. However, the Japanese construction industry was still evaluated as maintaining higher competitiveness, due mainly to comprehensive planning for operation, well-established design documents, and effective total quality safety environment management, all of which are combined with institutional support and a cooperative attitude by labor. Adjustments should be made for advanced technologies considering the attributes of a typical Japanese construction prior to establishing and implementing application strategies according to the suggestion of experts. Based on the results of this study, a benchmarking of Japanese strength should be conducted, and this is eventually expected to contribute to establishing green construction, enhancing safety, improving culture, and reinforcing the capabilities of participants.

Preparation and Management of the Input Data for the Safety Assessment of Low- and Intermediate-level Radioactive Waste Disposal Facility in Korea (중·저준위 방사성폐기물 처분시설 안전성평가를 위한 입력데이터 설정 및 관리에 대한 고찰)

  • Park, Jin Beak;Kim, Hyun-Joo;Lee, Dong-Hee
    • Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
    • /
    • v.12 no.4
    • /
    • pp.345-361
    • /
    • 2014
  • The systematic quality assurance activities on documents of the safety assessment are required for the safety case of the low- and intermediate-level radioactive waste disposal facility. In this paper, quality assurance system focused on the input data including the site characterization, groundwater flow, system design and monitoring are prepared and discussed. Rule for the input data selection is suggested and applied for the safety assessment which is based on the in-situ/experiment observations, final facility design and waste pileup plan, engineered barrier, field monitoring, recent biosphere, and radionuclide inventory. The reduction of data uncertainty will be expected to contribute to the safety of disposal facility further.

The Legal and the Official Management System Status of the Agricultural Disease, Injury, and Accidents of Korean (한국 농업인 업무상 재해에 대한 법적 행정적 지원체계 고찰)

  • Lee, Kyung-Suk;Choi, Jeong-Wha;Kim, Hyo-Cher;Kang, Tae-Sun
    • Journal of agricultural medicine and community health
    • /
    • v.31 no.3
    • /
    • pp.219-236
    • /
    • 2006
  • Objectives: To develop a model of a official management system for agricultural disease, injury and accidents, We analyzed current Korean status and management system about occupational injury and accident of farmers. Methods: For national management systems of industry safety and health and current status of occupational injuries and accidents of farmers, related literature such as books, theses, articles, and web documents were collected and analyzed. Results and Conclusion: The regulations of protecting occupational injury and accidents of farmers are suggested as follows: (1)insurance and compensation act for occupational injury and accident of farmers, (2)setting standards of occupational injuries and accidents of farmers, (3)mandating the usage of safety devices for agricultural vehicles and equipments, (4)reporting occupational injuries and accidents that occur among farmers, (5)registering pesticides and assessing safety usage, (6)implementing safety training, (7)supporting personal protective equipments and agricultural safe facilities etc.

  • PDF

The Identification of Emerging Technologies of Automotive Semiconductor

  • Daekyeong Nam;Gyunghyun Choi
    • KSII Transactions on Internet and Information Systems (TIIS)
    • /
    • v.17 no.2
    • /
    • pp.663-677
    • /
    • 2023
  • As the paradigm of future vehicles changes, the interest in automotive semiconductor, which plays a key role in realizing this, is increasing. Automotive semiconductors are the technology with very high entry barriers that require a lot of effort and time because it must secure technology readiness level and also consider safety and reliability. In this technology field, it is very important to develop new businesses and create opportunities through technology trend analysis. However, systematic analysis and application of automotive semiconductor technology trends are currently lacking. In this paper, U.S. registered patent documents related to automotive semiconductor were collected and investigated based on the patent's IPC. The main technology of automotive semiconductor was analyzed through topic modeling, and the technology path such as emerging technology was investigated through cosine similarity. We identified that those emerging technologies such as driving control for vehicle and AI service appeared. We observed that as time passed, both convergence and independence of automotive semiconductor technology proceeded simultaneously.

A Study on the Risk Assessment Technique of the Underground Space -Focused on Prevention Policy of Fire and Explosion- (지하공간의 위험성 평가수법에 관한 연구 -지하가 화재, 폭발 방재 대책 중심으로-)

  • 박종근;노삼규
    • Fire Science and Engineering
    • /
    • v.15 no.4
    • /
    • pp.64-70
    • /
    • 2001
  • This study suggests fire, explosion safety assessment items and risk assessment technique for underground shopping malls by extracting dangerous elements in the management stage through examination of related accidents, documents and present conditions. This will also suggest importance of seven items to be key indices for a counterplan by classifying characteristics and trends of the large scale, depth and complexity of underground shopping malls.

  • PDF

Tendency Analysis of Information System for Effectively Management of IMO Document (IMO문서의 효과적 관리를 위한 국내.외 정보시스템 동향 분석)

  • Jang, Woon-Jae;Jang, Seung-Do;Cho, Min-Chul
    • Journal of Korea Ship Safrty Technology Authority
    • /
    • s.33
    • /
    • pp.63-73
    • /
    • 2012
  • The Ministry of Land, Transport and Maritime Affairs(MLTM) constructed the IMO Korea homepage to owned jointly IMO information when establishing a international standard in about marine transport and the shipbuilding, in order to speak for the profit of Korea in IMO and it was double renewal since 2004. But the newly re-opened the IMO Korea homepage is also operated to the level which simply keeps IMO documents because of limited H/W sizes. This study investigated and analyzed the domestic and similar foreign homepages to provide effectively about the IMO informations At the result, these homepages were serviced to the meeting resultants using the various contents such as Semantic search, Thesaurus search, establishment of web accessible etc. Therefore, the existing IMO Korea homepage must be re-constructed as IMO Information Portal Site to provide better information.

  • PDF

CONTRIBUTION OF HANARO IRRADIATION TECHNOLOGIES TO NATIONAL NUCLEAR R&D

  • Choo, Kee Nam;Cho, Man Soon;Yang, Sung Woo;Park, Sang Jun
    • Nuclear Engineering and Technology
    • /
    • v.46 no.4
    • /
    • pp.501-512
    • /
    • 2014
  • HANARO is a multipurpose research reactor located at the Korea Atomic Energy Research Institute (KAERI). Since the commencement of its operation in 1995, various neutron irradiation facilities, such as rabbit irradiation facilities, fuel test loop (FTL) facilities, capsule irradiation facilities, and neutron transmutation doping (NTD) facilities, have been developed and actively utilized for various nuclear material irradiation tests requested by users from research institutes, universities, and industries. Most irradiation tests have been related to national R&D relevant to present nuclear power reactors such as the ageing management and safety evaluation of the components. Based on the accumulated experience as well as the sophisticated requirements of users, HANARO has recently supported national R&D projects relevant to new nuclear systems including the System-integrated Modular Advanced Reactor (SMART), research reactors, and future nuclear systems. This paper documents the current state and utilization of irradiation facilities in HANARO, and summarizes ongoing research efforts to deploy advanced irradiation technology.

Status Analysis of Children's Swimming Pool in Korea

  • SEO, Myung Seok;SEO, Won Jae
    • Journal of Sport and Applied Science
    • /
    • v.4 no.3
    • /
    • pp.23-28
    • /
    • 2020
  • Purpose: This study sought to explore current status of children's swimming pool in Korea and to generate insights regarding safety management of children's swimming pool. Research design, data, and methodology: The study reviewed literatures including documents of Ministry of Culture, Sports and Tourism and sport facility-related articles. Furthermore, the study collected additional statistics via search engines. Results: First, numbers of swimming pools have been dramatically increased since 2016 and Korea experienced an increase of 37% from 2010 to 2019. Of the 611 indoor swimming pools, most swimming pools are located in Gyeonggi province with 27.7% (n=169). Seoul and Gyeonggi-do have the highest proportion of swimming pools in Korea. Second, in types of swimming pools, 47.6%(n=291) was children's swimming pool which is the highest proportion in the nation. Children's swimming pools are also mostly located in Seoul and Gyeonggi province with 57%. Third, of 372 profit swimming pools, children's pools show the highest number with 78%(n=291). Conclusions: Children's swimming pools are picking up faster than the other types of swimming pool. Yet, safety-related studies are still lack. This provides motivations to produce managerial insights from academia and business sectors. Moreover, more studies of legal issues should be conducted. Implications were discussed.

A Research on Management System of Herbal Medicine in Common Use for Food and Medicine (식약공용 한약재의 관리 방안에 관한 연구)

  • Kweon, Kee-Tae
    • The Korea Journal of Herbology
    • /
    • v.27 no.2
    • /
    • pp.25-29
    • /
    • 2012
  • Objectives : This article reviews a solution preventing the illegal distribution of herbal medicine in common use for food and medicine and risks on public health by conducting safety management of food and medicine. Also, this article would like to contribute to improvement of public health treating diseases in compliance with accurate diagnosis and prescription of Oriental Medicine Doctor("OMD")'s. Methods : An approach in this research can be categorized into two : first, to examine the current administrative situation and problems of herbal medicine in common use for food and medicine based on policy documents of Ministry of Health and Welfare and Korea Food and Drug Adminstration("KFDA") and academic articles of the herbal medicine;second, to find reasonable administrative solutions to solve the problems. Solutions : A solution is to strengthen the management level of herbal medicine in common use for food and medicine by selecting 117 items as target items requiring concentrated management. In case herbal medicine is imported for food, KFDA strengthens the quality management level of herbal medicine by making use of inspection frequency at random, collecting and verifying herbal medicine on the market. However, KFDA decides to maintain current different quality specification system of food and medicine reflecting a civil complaint that quality specification of food and medicine should separately managed according to the purpose of use. Herbal medicine as medicine that is functioned as treating diseases and alleviating symptoms, unlike herbal medicine for food, can cure all kinds of diseases by recovering inner balance of human body, making use of other properties of herbal medicine. Medicine has its own properties. If a doctor uses properties of medicine appropriately, he cures diseases. If a doctor uses herbal medicine inappropriately. he may damage human body. Thus, whether side effects of medicine depend on a doctor who uses herbal medicine. Conclusions : All herbal medicine will be supplied into the market after strict safety control of manufacturers of herbal medicine according to the revised Pharmaceutical Affairs Act, beginning in April, 2012. Thus, people can take safer and more reliable herbal medicine through strengthening safety management of herbal medicine and improving quality and transparency in the distribution system. Herbal medicine should appropriately be prescribed by licensed OMD because herbal medicine is used to treat diseases and alleviate symptoms, unlike herbal medicine for food.