• Title/Summary/Keyword: Approval standard

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Bone graft materials and its intended use (임상가를 위한 특집 1 - 뼈이식재 족보 바로 알고 사용하기)

  • Lee, Jeong-Keun
    • The Journal of the Korean dental association
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    • v.48 no.4
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    • pp.256-262
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    • 2010
  • bone grafting is indicated in the case of bony defects and is classified into autograft, allograft, and xenograft. Synthetic bone graft is contrasted with these three categories in that it has a different donor source. Autograft is most prominent as it is known as a gold standard of all grafting procedures. Its principles and practices are well established via accumulated informations and clinical experiences, which imposes no regulations or restrictions in its clinical use. On the other hand, other bone graft procedures are under tight control for the safety and effectiveness of each product. Food and Drug Administration of the United States has a system in which the information on the approvals and clearances of bone graft materials on their internet homepage. All the bone graft materials that are under the regulations of the United States are classified into the category of medical devices, which includes allogenic bone, xenogenic bone, and synthetic bone graft materials. Each bone graft material has its own indication and the FDA approvals and clearances of medical devices contain the item of "intended use" to specify the indications of each bone graft materials. US dentists, as users of the specific bone graft materials, are provided with adequate information on the approved materials they are to utilize. As an user of these materials, Korean dentists are less provided with the information on the bone graft materials they want to use. Medical providers of the bone graft materials have to be able to provide their users with the essential information such as the intended use of the regulatory approval. Dentists must also be active in gathering informations on the material of their interest, and the system must be built in which both of the medical providers and users of bone graft materials can be satisfied in providing and getting the information, respectively.

The Effect of Clinical Dental Hygienist's Moral Sensitivity and Psychological Well-Being on Job Engagement

  • Han, Ye-Seul;Kim, Young-Im
    • Journal of dental hygiene science
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    • v.20 no.1
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    • pp.51-58
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    • 2020
  • Background: The present study aimed to provide basic data to establish a foundation for efficient operation of the organization by identifying the effects of factors related to moral sensitivity and psychological well-being on job engagement of clinical dental hygienists. Methods: This cross-sectional survey consisted of self-administration questionnaires. After the approval by the Institutional Review Board, a survey was conducted from September 2019 to November 2019, targeting dental hygienists with clinical experience of 1 year or more. A total of 189 questionnaires were analyzed using SPSS 18.0 for Windows. The data were analyzed using average standard deviation, t-test, one-way analysis of variance, Scheffe test, Pearson's correlation analysis, and multiple regression analysis. Results: According to job-related characteristics, higher job engagement was associated with more amount of clinical experience, less turnover intention, higher positions, and occasional job fatigue. Job engagement was improved by increasing moral sensitivity and psychological well-being of clinical dental hygienists. The factors affecting job engagement revealed that along with clinical career, the sub-areas of job engagement, namely turnover intention, moral sensitivity, and psychological well-being had statistically significant influence on job engagement and the explanatory power of the model was approximately 44.8%. Conclusion: Joy of working as a clinical dental hygienist, clinical career, turnover intention, moral sensitivity, and psychological well-being were confirmed as influencing factors that affected job engagement of clinical dental hygienists. It is necessary to establish an effective plan to improve job engagement by increasing moral sensitivity and psychological well-being of clinical dental hygienists.

Analysis on Facilities & Basic Equipment of School Foodservice Safety in Pohang area (포항지역 학교급식의 안전성을 위한 학교 급식 조리실의 기본 시설.설비 조사)

  • Yun, Mi-Yeon;Lee, In-Suk
    • Journal of the Korean Dietetic Association
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    • v.12 no.3
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    • pp.264-276
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    • 2006
  • The purpose of this study was to propose HACCP system implementation properly and to secure the food safety of school foodservices in Pohang city since the proper facilities and equipment should be key factors in food safety and production. So this study was designed to evaluate existing equipment in food production area, receiving and dining area, and employee facilities. Questionnaire was mailed to 107 school foodservice dietitians in Pohang area and 97 were responded (90.7% response rate). Approximately sixty percent of foodservices were not available separate receiving or polluted area, fifty one percent were installed screen door for insecticidal and temperature and humidity control, and these environmental conditions were hard to keep kitchen dry and sanitary condition. Usually public schools were better equipped than private schools. Forty three percent of school foodservice had initial use of non-foodservice, opened before 1994, and thirty three percent of elementary school foodservice. Among employee facilities, hand washing sanitation stand was prepared seventy nine percent (78.9%) of school foodservices. Dietitians chose outworn equipment and facilities (30.9%), difficulties of maintaining standard temperature and humidity for foodservice (20.6%), lacking separate receiving or polluted area (13.4%), indirect contamination of water hoss (10.3%), and lacking employee facilities (10.3%) as critical points to correct in school foodservice. Therefore governmental regulating agencies must review and approval of plans prior to new construction or extensive remodeling of school foodservice facilities. In addition to these requirement, plan must be set-up step by step to implement HACCP system properly.

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Substrate reduction therapy as a new treatment option for patients with Gaucher disease type 1: A review of literatures

  • Sohn, Young Bae;Yoo, Han-Wook
    • Journal of Genetic Medicine
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    • v.13 no.2
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    • pp.59-64
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    • 2016
  • Gaucher disease type 1 (GD1) is an inherited lysosomal storage disorder caused by deficiency of acid ${\beta}$-glucosidase. The diminished enzyme activity leads to the accumulation of substrates and results in multi-systemic manifestations including hepatosplenomegaly, anemia, thrombocytopenia, and bone diseases. Enzyme replacement therapy (ERT) by infusion of recombinant protein has been the standard treatment for over 20 years. Despite the successful long-term treatment with ERT, several unmet needs remain in the treatment of GD1 such as severe pulmonary and skeletal manifestations. Substrate reduction therapy (SRT) reduces the accumulation of substrates by inhibiting their biosynthesis. Eliglustat, a new oral SRT, was approved in United States and Europe as a first-line therapy for treating adult patients with GD1 who have compatible CYP2D6 metabolism phenotypes. Although eliglustat is not yet available in Korea, introduction and summary of this new treatment modality are provided in this paper by review of literatures. Despite the fact that there are only limited studies to draw resolute conclusions, the current data demonstrated that eliglustat is not inferior to ERT in terms of its clinical efficacy. The approval of eligustat enables eligible adult GD1 patients to have the option of oral therapy although it still needs further studies on long-term outcomes. The individual patient should be assessed carefully for the choice of treatment modality when eliglustat becomes available in Korea. Furthermore, the clinical guidelines for Korean patients with GD1 regarding the use of eliglustat needs to be developed in near future.

Do Obese Children Exhibit Distinguishable Behaviours from Normal Weight Children?-Based on Literature Review (비만어린이와 정상체중 어린이의 행동 특성에 관한 문헌적 고찰)

  • Baek, Seol-Hyang
    • Korean Journal of Community Nutrition
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    • v.13 no.3
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    • pp.386-395
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    • 2008
  • Since obesity has been a crucial issue regarding children's health in Korea, numerous studies have been conducted. However, it is difficult to locate studies that can help researchers and/or medical professionals who want to study behavioral differences between obese and normal weight (non-obese) children. The collected literature about obese childrens behaviors were accumulated by performing 'key word' searches from several web engines: 'obesity' 'children obesity' 'behavior' 'habit' 'eating behavior or habit' 'exercise' 'physical activity' and 'daily behavior'. The information was extracted and the behaviors were reviewed utilizing 30 papers that revealed any differences from normal weight children with at least p .05 level of significance. According to those studies, the obese children tended to skip meals more often as a method of losing weight. They also have an increased appetite, eat larger portions and rarely leave food on their plates. The obese children prefer to eat high fat, high calorie foods and eat faster than their normal weight counterparts. Also, the children usually eat alone and eat at irregular meal times. Beside the behaviors related to the standard three meals a day, obese children have high preferences for snacking. The children reported that with pocket money they usually eat certain types of snacks without parent approval. The children stated that they exercise more on a regular basis. However, when asked about their participation they were not likely to engage actively. Meanwhile, they tend to spend free time doing sedentary activities such as watching TV or playing on the computer. Since these studies used self -reported questionnaires with a small sample, size there may be difficulty in forming a basis about obese children's behaviors. Nevertheless, these findings are in accordance with other studies conducted in local as well as western countries. In conclusion, obese children have different daily behaviors or routines from normal weight children. It is recommended that altering these behavioral patterns to match those of normal weight children should be encouraged.

The Study for Performance TestㆍVerification Standard, Form approval procedure(draft) of OSBA (생물정화제제의 성능시험ㆍ검정기준, 형식승인절차(안) 등에 관한 연구)

  • Chung Jin-Won;Yoon Joo-yong;Shin Jae-Rouk;Kim Han-Gyu
    • Journal of the Korean Society for Marine Environment & Energy
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    • v.6 no.2
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    • pp.16-27
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    • 2003
  • For the last decade, some 400 small and large oil spill accidents have occurred every year. Such accident blow a serious damage to the marine resource and ecosystem, which can't be estimated in terms of economic and environmental losses. The physical/chemical methods used currently may be effective at the initial stage of accidents, but they can't serve to remove the spilled oil completely. Moreover, the dispersant may lead to a secondary contamination detrimental to the lives inhabiting wet lands, beaches and tidal zone. Thus, a new decomposing technology Is required for the environmentally sensitive areas. Bioremediation is the active use of biological techniques to mitigate the consequences of a spill using biological processes and refers both of stimulation of pollutant biodegradation and/or to enhance ecosystem recovery Bioremediation is an economically attractive method for the clean-up of oil-contaminated area. Bioremediation has been demonstrated to be an effective oil spill countermeasure for use in cobble, sand beach, salt marsh, and mud flat environment.

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The effect of dental hygienist's work environment on job satisfaction and organizational commitment (일부 치과위생사의 근무환경이 직무만족과 조직몰입에 미치는 영향)

  • Kim, Nam-Suk;Yoon, Na-Na;Kim, Ye-Hwang;Park, Jeong-Hee;Kim, Hye-Jin;Lee, Jung-Hwa
    • Journal of Korean society of Dental Hygiene
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    • v.18 no.2
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    • pp.153-164
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    • 2018
  • Objectives: The purpose of this study is to analyze the descriptive correlation of the commission intended to provide effective working practices to enhance job satisfaction and organizational engagement by examining the work environment of the dental hygienist. Methods: After the IRB approval, the subjects were dental hygienists working for dental hospitals and clinics in Busan from May 1st to May 31th of 2017. And the final 153 questionnaires were analyzed to SPSS 23.0 for windows, SPSS Inc. Chicago, IL. USA. The data was analyzed using average standard deviation, t-test, one-way ANOVA and multiple regression analysis. Results: The average working environment of the subjects was found to be $3.37{\pm}0.53$ points with the average job satisfaction of the subjects of $3.29{\pm}0.50$ points and the average organizational commitment of the subjects of $3.25{\pm}0.59$ points. As the working conditions of the working environment are higher, it revealed that the higher the working environment, the better the job satisfaction. Conclusions: In conclusion, this study showed that the ability to support managers' abilities, leadership, and dental hygienists is the most influential factor in job satisfaction and organizational involvement. Also, hospital administrators are encouraged to provide excellent work and leadership skills to enhance both the quality of work and that of work ethic.

A Study on the Self-Prevention Plan System (자체방제계획서 검토기준 마련 연구)

  • Kim, Sungbum;Noh, Hyeran;Lee, Jinseon;Kim, Jungmin;Ahn, Seungyoung;Seok, Kwangseol
    • Journal of the Society of Disaster Information
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    • v.9 no.1
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    • pp.50-55
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    • 2013
  • Self-Prevention Plan Review Report and Review Standards Process Safety Management(PSM), Safety Management System(SMS), including the contents of the safety management system audit standards, notices and guidelines on the screening form and were analyzed. Were expected through the interview and screening personnel in the screening process to identify problems prior research so that it can be reflected in the. Also divided into methods such as document review and on-site implementation status of the review written Emergency Preparedness Plan depending on the item proposed. Toxic Chemicals Control Act(TCCA) Self-Prevention Plan Review Regulations. However, the substantial approval process, and do not enable the system performance lacked Self-Prevention Plan Review. Review half configuration to enhance the professionalism and efficiency of the work of this research was performed.

Development of Wide Prestressed Concrete Sleeper for Asphalt Concrete Track (아스팔트 콘크리트 궤도용 광폭 PSC침목 개발)

  • Bae, Young-Hoon;Lee, Seong-Hyeok;Kim, Eung-Rok
    • Journal of the Korea institute for structural maintenance and inspection
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    • v.22 no.2
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    • pp.34-42
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    • 2018
  • In order to minimize the deformation of asphalt concrete track(ACT) and ensure the structural safety, a wide type concrete sleeper is necessary to distribute vehicle loading and reduce the exposure of the asphalt roadbed. In this research, the wide prestressed concrete(PSC) sleeper for ACT was developed through the shape design and the structural safety was reviewed using finite element analysis. Furthermore, static test, dynamic test and fatigue test were carried out according to EN13230-2 to verify the design appropriateness of the wide PSC sleepers for ACT. The performance test showed that the developed wide PSC sleeper for ACT meets all the performance requirements by European standard.

The Research on Compression Image Quality of Full Field Digital Mammography on PACS Environment (PACS환경에서 Full Field Digital Mammography 영상의 압축 화질평가에 관한 연구)

  • Jeong, Jaeho;Kim, Eunsoo
    • Journal of the Korean Society of Radiology
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    • v.8 no.4
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    • pp.147-153
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    • 2014
  • We tried to assessment about characteristics of image through quantitative evaluation method and qualitative evaluation method in Full Field Digital Mammography. It satisfied an approval standard of ten score regardless of compression ratio measuring detection score after compressing and appling an algorithm of JPEG2000 orJPEG compression targeting ACR accreditation phantom. Also, it was apparent that when we selected and compressed the image of real fine lesion and measured a change of diagnosis ability magnifing over 50 percent after compressing over 20:1 ratio, it had a strong influence on diagnosis ability. We realized that the difference between the original image according to compression ratio measuring a quantitative evaluation which is PSNR,RMSE,MAE and SSIM was relatively allowable.