• 의료법학
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• 제15권2호
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• pp.63-89
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• 2014

In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

• 한국수학교육학회지시리즈A:수학교육
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• 제61권2호
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• pp.221-237
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• 2022

이 연구는 검정 도서로 전환된 초등학교 3~4학년 수학 교과용 도서를 선정하는 교사들의 의사결정을 조사하였다. 개별 학교에서 수학 교과용 도서 선정에 참여한 296명의 초등교사를 대상으로 설문을 실시하고, Shavelson과 Stern (1981)의 의사결정 모델에 따라 수학 교과용 도서와 관련한 이들의 신념, 도서를 평가하는 판단 기준으로서 도서 내·외적 요인, 최종적인 의사결정에 영향을 미치는 요인을 분석하였다. 결과를 토대로 (1) 평소 신념과 실제 교과서 선정 의사결정 요소가 상충하는 현상, (2) 다교과 수업 업무에서 기인하는 의사결정 요소, (3) 교과서의 다양성을 추구하는 이상적인 정책과 차별성 없는 교과서에 안주하는 학교 현장 간의 괴리 현상 등 새로운 교과서 발행제도에 대한 시사점을 논의하였다.

• 한국심리학회지 : 문화 및 사회문제
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• 제9권spc호
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• pp.57-73
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• 2003

본 논문은 운전자의 지각과 판단과정에 필요한 최소한의 시간적 여유마저 앗아가 버릴 수 있는 과속운전의 행동배경과 형성과정을 분석하여 과속행동의 사고 위험성을 확인해 보려고 한다. 과속운전의 주요 요인이 될 수 있다고 생각되는 서두름 행동의 구조와 의미를 고찰하여 과속행동과의 관련성을 탐색해 보고, 그리고 위험항상성이론(Risk homeostasis theory)을 중심으로 과속운전의 형성과정에 영향을 미치는 요인을 생각해 보았다. 운전행동은 이익이 발생하는 방향으로 이루어진다고 가정하고, 과속운전으로 얻을 수 있는 이익이 사회적으로 인정받게 되면 과속운전은 습관화될 있다. 운전자는 과속운전이 교통사고의 중요원인이라고 인식하지만, 습관화된 고속운전은 쉽게 변화되지 않음을 운전자 태도조사 결과가 보여주고 있다. 그리고, 서두름행동이 과속운전의 형성과 습관화에 미치는 영향을 규명하는 것이 과속운전행동 이해의 단서가 될 수 있다고 생각한다.

• 대한방사선기술학회지:방사선기술과학
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• 제39권4호
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• pp.651-660
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• 2016

최근 인구고령화로 인하여 치과진료 주요대상인 노인층의 검사가 꾸준히 증가하고 있다. 따라서 치과 진단용 엑스선장치 시장도 꾸준히 성장하고 있으며, 동시에 치과용엑스선장치의 허가 심사건수도 증가하고 있다. 의료기기 기술문서는 의료기기의 허가 심사 시 필수로 요구되는 자료이며, 해당 의료기기의 전반적인 항목을 기술해야 하는 만큼 작성자의 업무 이해도 및 전문성이 필요하다. 그러나 국내 의료기기 제조 수입 업체 대부분이 영세하여 의료기기 인 허가 관련 전문 인력의 확보가 쉽지 않아, 이로 인한 기술문서의 부정확한 작성이 증가하고 있다. 이에 따른 심사자의 민원 처리 지연과, 제품의 신속한 시장 진입의 어려움이 발생되고 있다. 특히 치과용구강외엑스선장치, 치과용구강내엑스선장치, 암형전산화단층엑스선촬영장치, 포터블엑스선 촬영장치(이하 치과용엑스선장치)는 식품의약품안전처 기준 규격이 최근에 제정되거나 부재한 품목으로, 의료기기 제조 수입업체에서 시험항목 설정 시 많은 어려움을 겪고 있기에, 개선된 규격이 반영된 치과용엑스선 장치 가이드라인(안)을 개발하여 관련 업체 및 심사자에게 도움을 주고자 한다. 본 연구를 위하여 첫째, 기술문서에 대한 개선된 제도 운영 조사 및 의료기기의 제도 적용에 따른 문서 작성 방법을 검토하였으며, 둘째, 품목별 시장현황을 조사하고, 국내 외 규격을 분석하였으며, 셋째, 기 허가된 제품의 기술문서를 분석하여 품목별 올바른 작성방법과 국제조화된 시험항목, 기준 및 방법을 도출하였다. 마지막으로, 산 연 관 전문가 협의체 회의를 통하여, 공정하고 전문성이 강화된 기술문서 작성 가이드라인(안)을 도출하였다.

• 한국정보전자통신기술학회논문지
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• 제9권5호
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• pp.478-495
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• 2016

기존의 도시계획은 내부 소수의 의사결정자들에 의해 이루어졌으나 스마트시티에서는 ICT 기술 진화를 통해 개인이 접할 수 있는 정보가 많아지고 채널이 다양화 되면서 다양한 방식으로 의사결정과정에 참여할 수 있게 되었다. 이에 본 연구에서는 스마트시티의 안전도시 계획 과정을 주민과 직간접으로 소통하는 협력적인 계획과정으로써 데이터 활용 방안을 제시하고자 한다. 이를 위해 WHO 국제안전도시 인증을 받은 일본의 마츠바라시(松原市)의 데이터의 내용과 활용을 국내와 비교하여 국제안전 도시의 승인을 준비하는 지역에서 주민참여 방안의 보조적 역할로 데이터의 활용성을 높이고자 한다.

• 지역사회간호학회지
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• 제15권1호
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• pp.122-131
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• 2004

Purpose: The purpose of the study is to explore the socio-psychological coping process and experiences of families before and after institutionalization by applying the Corbin and Strauss ground research method. Method: Data collection from 9 participants with elderly institutionalized dementia with approval from directors of the institute was done by in depth interviews during a seven month period from May, 2003 to December, 2003. Data analysis was done by repeated reading of the transcribed interviews, and 344 concepts and 39 subcategories were generated. Results: Family members of the dementia elderly experienced various degrees of exhaustion, physically, mentally, and socially. The degree of their exhaustion was related to the severity of the family member's symptoms, and length of the dementia. Coping strategies were effected by economic status, social support from blood related families or neighbors, depth of their relationship with elderly institutionalized dementia. They were even affected by the elderly family members institutionalization. Conclusion: After institutionalization participants felt some guilt from not assuming their responsibilities as children. On the other hand they regained privacy, freedom, security, and comfort, so that their life returned to normal. They even felt more comfort because their elderly were living in a safer environment, and received a better quality of care. Participants had better composure, so that they could even take care of neighbors in need. They hope that there is more governmental involvement in terms of subsidy and numbers of institutes. Findings of the study will be a ground for the development of a coping program for families with elderly institutionalized dementia. Further studies are recommended to explore types of family, and to develop programs for the families to help them interact with each other.

• 패션비즈니스
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• 제19권4호
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• pp.183-199
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• 2015

This study aimed to systematize the apparel vendor work processes and provide useful information to future employees of clothing export units by analyzing the processes of vendors' manufacturing tasks. A survey of 20 apparel vendors servicing mainly U.S. buyers was conducted on employees of overseas business departments working for more than five years. buyers. Based on the results, vendors mainly manufactured cut-and-sew knit products. Regarding the production method, OEM was used more frequently than ODM. Fourteen (70%) companies used the ODM method. This suggests that vendors are expanding their production method from OEM to ODM. In order to summarize the work of each business based on the clothing production process research results, buyers were in charge of planning products and the vendors were in charge of sampling. Production of materials and the approval of material tests were out sourced. Overseas factories of vendors were in charge of bulk (mass) production and garment finishing, as well as packaging and shipping the completed products. Even though the vendors' head offices do not directly produce clothes, they play a pivotal role in ensuring planning and management progress in clothing production. As buyers prefer direct contracts for cost reduction, the vendor additionally performs the role of an agent. Also, with the increase in ODM production ratio, the work area of the vendor is expanding. If Korean clothing exporters improve their global competitiveness by investing in the R&D of materials and design to enhance the ODM method, the development of Korea's clothing and export industry will benefit significantly.

• 약학회지
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• 제53권3호
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• pp.107-113
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• 2009

Since 2006, the Computerized Restricted Antibiotic Control Program (CRACP) has been incorporated to facilitate a more efficient approval process of vancomycin use at the Chonbuk National University Hospital. The purposes of the study were to evaluate proper use of vancomycin and to examine if there is any improvement when administering the CRACP. The use of vancomycin was retrospectively reviewed by a medical record review based on the American Society of Hospital Pharmacists (ASHP) criteria (i.e., indication, use of critical process indicators and use of outcome measurements) and compared before (Group I) and after the CRACP (Group II). Two hundred fifty six patient records were evaluated (138 in Group I and 118 in Group II). There was a statistically significant improvement in the report of justification for vancomycin use after CRACP (42.0% vs. 62.7%, p=0.001). Out of eight critical process indicators, two indicators (appropriate cultures prior to medication [68.8% vs. 85.6%, p=0.002] and serum vancomycin level measurement [0% vs. 7.6%, p=0.001]) were significantly improved after CRACP. The total incidence of adverse effects was decreased from 14.5% to 6.8%. In addition, there was a statistically significant difference in WBC count reduction within normal range (52.8% vs. 73.1%, p=0.024). The CRACP appears to be a promising approach to improve use of vacomycin in a hospital setting. However, further evaluation for the long-term period should be performed to confirm the performance of the program.

• 한국정보시스템학회지:정보시스템연구
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• 제12권1호
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• pp.159-175
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• 2003

During the early stage of radioactive disposal programs, important issues related with quality assurance of data sets, methodologies, R&D procedures are recognized as important ones. This paper focused on the development of web-based workflow standards for the QA procedures of the radioactive waste disposal programs. The flow of process was analyzed based on workflow concepts proposed by the Workflow Management Coalition (WfMC). QA system is based on the principles of T2R3. T2R3 Workflow was used to standardize and restructure the business and/or work process in the industry or organization. The WfMC has identified five functional interfaces to a workflow service as part of its standardization program. They are composed of process definition interface, worklist handler, application program interface, interface between workflows, and system management. The task flow and QA program were defined based on the workflow ideas. QA procedures for the R&D results of radiation disoposal were analyzed following the reference model of workflow. In addition, six program run list were created and implemented. The creation, revision, and approval of the test data were designed to be inplemented on the web environment. Through this system, R&D procedures such as planning, research, documentation, internal review and future independent peer review processes could be well organized and stored more systematically on the database and knowledge base. This will encourage the usage and data sharing between interested parties through it's clear and transparent workflow standards.

• 한국재난정보학회 논문집
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• 제9권1호
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• pp.50-55
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• 2013

자체방제계획서 검토기준과 검토서는 공정안전보고서, 안전성향상계획서 등 안전관리제도의 심사내용과 기준, 심사양식에 관한 고시 및 지침을 분석하였다. 심사 담당인력과의 인터뷰를 통해 심사과정에서 예상되는 문제점을 사전 파악하여 연구에 반영될 수 있도록 하였다. 또한 자체방제계획서 작성항목에 따라 서류검토 및 현장이행실태 등의 검토방법으로 나누어 제안하였다. 자체방제계획서 검토는 유해화학물질관리법에 규정되어 있으나, 실질적인 승인절차가 없어 성과가 미흡했던 "자체방제계획서 검토제도"를 활성화 시키고, 검토반 구성을 통한 업무의 전문성과 효율성을 제고하고자 본 연구를 수행하였다.