• Title/Summary/Keyword: Safety management institution

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Development of Regulation System for Off-Label Drug Use (의약품 허가외사용 관리 체계 발전 방안)

  • Lee, Iyn-Hyang;Seo, Mikyeong;Lee, Young Sook;Kye, Seunghee;Kim, Hyunah;Lee, Sukhyang
    • YAKHAK HOEJI
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    • v.58 no.2
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    • pp.112-124
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    • 2014
  • This study aimed to develop a regulation system for off-label drug use to secure the safe use of marketed drugs. We searched governmental documents for national and global regulating systems of off-label drug uses and a body of academic literature to explore current regulating trends. We included European Union, United Kingdom, United States of America, Australia and Japan, and critically reviewed the regulation of off-label drug use in four issues, which were a regulatory structure, safety control before and after off-label use, and information management. The findings of the present investigation called for several measures in off-label drug uses: enhancing prescribers' self-regulation, providing up-to-date information to prescribers for evidence-based practice and to patients for their informed consent, making evidence with scientific rigor, building an official registering process for off-label use in good quality and extending the role of pharmaceutical industry in pharmacovigilance. At last, we proposed a new system so as to regulate and evaluate off-label drug uses both at national and institutional level. In the new system, we suggested a clear-cut definition for clinical evidence that applicants would submit. We newly introduced an official 'Off-Label Drug Use Report' to evaluate the safety and clinical efficacy of a given off-label drug use. In addition, we developed an algorism of the regulation of off-label drug use within an institution to help set up the culture of evidence-based practices in off-label drug uses.

Review and Improvement of Alternative Medical Dispute Resolution Through Case Studies (사례연구를 통한 소송이외의 의료분쟁 해결방안의 검토와 개선방안)

  • Kang, Eui Sung;Kim, Jang Mook;Sung, Dong Hyo;Mok, Nam Hee
    • Korea Journal of Hospital Management
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    • v.18 no.3
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    • pp.106-125
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    • 2013
  • Medical litigation, as a method of resolving medical disputes, has been a huge burden on both the patient and medical institution as it is both costly and time-consuming. The Korea Medical Dispute Mediation and Arbitration Agency has created a dispute mediation process as a method of alternative dispute resolution(ADR). Being in its early stage of implementation, there are still areas requiring improvement as some functions overlap with the Korea Consumer Agency's damage redress and mediation process. This study examines the problems of existing practices in medical litigation while reviewing the mediation process of the two agencies from legal/administrative aspects, and provides an in-depth analysis of the situation through case studies and interviews. While the Korea Medical Dispute Mediation and Arbitration Agency offers many advantages in resolving medical disputes, there must be a distinct division of roles and mutual cooperation with the Korea Consumer Agency. Considering the increasing amount of compensation in medical disputes, medical professionals are being requested to carry medical malpractice insurance. However, this has yet to become a general trend in the medical field despite the growing social demand. As such, the coverage of medical malpractice insurance should be expanded to prevent medical accidents from escalating into medical disputes, thus acting as a social safety net. This study seeks to examine the methods of medical dispute resolution and to allow institutional provisions to reduce the social costs arising from such disputes.

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Guideline on Acceptance Test and Commissioning of High-Precision External Radiation Therapy Equipment

  • Kim, Juhye;Shin, Dong Oh;Choi, Sang Hyoun;Min, Soonki;Kwon, Nahye;Jung, Unjung;Kim, Dong Wook
    • Progress in Medical Physics
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    • v.29 no.4
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    • pp.123-136
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    • 2018
  • The complex dose distribution and dose transfer characteristics of intensity-modulated radiotherapy increase the importance of precise beam data measurement and review in the acceptance inspection and preparation stages. In this study, we propose a process map for the introduction and installation of high-precision radiotherapy devices and present items and guidelines for risk management at the acceptance test procedure (ATP) and commissioning stages. Based on the ATP of the Varian and Elekta linear accelerators, the ATP items were checked step by step and compared with the quality assurance (QA) test items of the AAPM TG-142 described for the medical accelerator QA. Based on the commissioning procedure, dose quality control protocol, and mechanical quality control protocol presented at international conferences, step-by-step check items and commissioning guidelines were derived. The risk management items at each stage were (1) 21 ionization chamber performance test items and 9 electrometer, cable, and connector inspection items related to the dosimetry system; (2) 34 mechanical and dose-checking items during ATP, 22 multileaf collimator (MLC) items, and 36 imaging system items; and (3) 28 items in the measurement preparation stage and 32 items in the measurement stage after commissioning. Because the items presented in these guidelines are limited in terms of special treatment, items and practitioners can be modified to reflect the clinical needs of the institution. During the system installation, it is recommended that at least two clinically qualified medical physicists (CQMP) perform a double check in compliance with the two-person rule. We expect that this result will be useful as a radiation safety management tool that can prevent radiation accidents at each stage during the introduction of radiotherapy and the system installation process.

The Effects of Recognition of Material Safety Data Sheets in Dental Hygienist (치과위생사의 물질안전보건자료 인식에 대한 융복합 연구)

  • Oh, Na-Rae;Kim, Hae-Kyoung;Cho, Min-Jeong
    • Journal of Digital Convergence
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    • v.15 no.2
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    • pp.215-223
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    • 2017
  • This research conducted a survey targeting 238 dental employees in Daegu Gyeongbuk region in order to improve awareness on danger risk of dental materials henceforth by analyzing the awareness on material safety health data (MSDSs) and working environment characteristics that influence thereon. Accordingly, the average score of importance per item based on material safety health data(MSDSs) appeared $3.98{\pm}0.59$, and the highest item appeared 'danger risk', and the average score of necessity in improvement appeared $4.34{\pm}0.57$. Average score of necessity in improvement appeared higher as the career increased, and difference in importance per item showed higher score in the target who worked in the dentist (p<0.01). This research expects that the employees of dentist hospital secure safety on chemical substances of dental materials and pay more attention on chemical substance material of dental material and the material safety health data (MSDSs) that explains this, in order to improve quality of working environment, also, the researcher wishes that concrete policy and institution would be prepared for the safety of dentist hospital employees' working environment safety.

A Study on utilization of 3-Dimension GIS for Disaster Prevention on Urban Safety and Disaster Paradigm (도시안전패러다임을 고려한 방재분야 3차원 공간정보 활용방안 연구)

  • Park, Young-Jin;Yeon, Kyung-Hwan
    • Proceedings of the Korean Association of Geographic Inforamtion Studies Conference
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    • 2008.10a
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    • pp.136-141
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    • 2008
  • The rapid development of the information technology has passed over the implementation of the virtual reality. It is realizing information services that are form of the globalization, based on the Internet. In addition, the effort to apply IT to public administration for public services has been made. The remarkable development of computer hardware has overcome the limit of the information distribution and emerged for practical use in various fields such as public institution, underground facilities management, tourism industry development etc. However, the practical use of Virtual Reality with Three-Dimensional GIS on disaster management by Korea National Emergency Management Agency is very much low. Therefore, this studies focus on how to use 3-Dimensional GIS for the purpose of fire disaster prevention. The studies also discussed, through understanding of the limitations of 2-Dimensional GIS, the establishment of basis for fire prevention technology development and its utilization among those ubiquitous city paradigms, which have become so much issues these days.

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A Survey on the Awareness and Performance of Infection Management of Workers in long-term Care Institutions (장기요양 기관 종사자들의 감염관리에 대한 인지도 및 수행도 연구)

  • Park, Mi-Jin;Moon, Heakyung
    • Journal of the Korean Applied Science and Technology
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    • v.38 no.6
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    • pp.1393-1404
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    • 2021
  • The current study was conducted to understand the status of infection management through a survey on the status of awareness and performance of infection management and to improve efficient infection management and education programs of workers in long-term care institutions. The subjects of the study were 134 workers at 35 long-term care institutions in the C region, and data were collected from July 12 to 30, 2021. They agree to participate in research self reported structured questionnaire by SPSS program ver. 22.0. As a result of the study, the subject's awareness of infection management appeared to be a difference in accordance with occupation (F=3.181, p=.032) and education experience (F=6.372, p=.013). Also, factors influencing the subject's performance of infection management were occupation (F=3.972, p=.010) and education experience (F=4.403, p=.038). The relationship between awareness of infection management and performance resilience fined out a significantly positive correlation (r=.919, p<.001). As a result, for patient safety in long-term care institutions in the COVID-19 pandemic situation, it is very important for workers not only to recognize the importance of infection management but also to directly perform infection management activities. To this end, regardless of the size of the institution, it is necessary to prepare a systematic and continuous curriculum by occupation and educational topic, and to legally strengthen the evaluation system to improve the quality of the infection management system.

A Survey on the Sanitary Management in Food Service Institutions (집단급식소의 위생관리에 대한 실태 조사)

  • Soh, Gowan-Soon;Kim, Yong-Suk;Shin, Dong-Hwa
    • Journal of Food Hygiene and Safety
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    • v.22 no.1
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    • pp.63-75
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    • 2007
  • A survey on sanitary management at 98 food service institutions located in Jeollabuk-Do were conducted. Food service institutions included 13 hospitals, 38 schools, 40 enterprises, and 7 others. The sterilization in boiling water was used for disinfection of tableware, spoon and chopsticks, and dish towel. Cooking kit, refrigerator, chopping board, and knife were sterilized with disinfectant. Frequency of sanitary training program on employees was 56.1% for 1 time/month, 12.2% for 2-3 times/month, and 11.3% for 1 time/week. Preparing ratio of defrosting, warehouse and rest room, and washing and sterilization diary were 73.8, 60.5, and 54.5%, respectively. However, checking ratio of environments (9.5%), personal sanitation (10.8%), and sanitary training program diary(8.4%) were low. Major obstacle factors on the introduction of Hazard analysis critical control point (HACCP) system into food service institutions were lack of equipment and facilities (54.1%) and lack of understanding and data on HACCP system (17.3%). Therefore, in order to reduce the outbreak of food-borne diseases increasing frequency, we estimated that the introduction of sanitary management system and the conversion of dietician' perception on sanitary managements in food service institutions were needed.

Salvage Transoral Robotic Surgery for Recurrent or Residual Head and Neck Squamous Cell Carcinoma: A Single Institution Experience

  • Dabas, Surender;Dewan, Abhinav;Ranjan, Reetesh;Dewan, Ajay Kumar;Shukla, Himanshu;Sinha, Rupal
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.17
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    • pp.7627-7632
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    • 2015
  • Background: The present study was conducted to evaluate the technical feasibility, safety and adequacy of surgical margins with salvage transoral robotic surgery (TORS) for recurrent or residual head and neck squamous cell carcinoma patients. Materials and Methods: Thirty patients who underwent salvage TORS using the 'DaVinci' robot were enrolled in the study and data related to their surgical time, complications and functional outcome were recorded. Results: The feasibility of salvage TORS in our study was observed to be 100%. Positive margins were encountered in only 6.7% of patients. Mean blood loss was 23.3 ml with no patient requiring blood transfusion. Postoperative complications in the form of primary haemorrhage requiring active surgical intervention occurred in 13.3%. Oral feeding could be started as early as the 3rd postoperative day in a few patients, with nasogastric tubes being removed on the 12th postoperative day. Long term gastrostomy tube dependency was seen in 10% cases. Median survival of patients was 19 months. Conclusions: Salvage TORS is a safe, effective and feasible option in the management of treatment failure cases. It offers an alternative surgical approach with unexpected benefits in terms of tracheostomy tube use, Ryle's tube and gastrostomy dependence.

A Study on the Ship Ability Evaluation Criteria for Training-only ship through Ship Space Analysis (선박공간분석을 통한 실습전용선박의 선박능력 평가 기준에 관한 연구)

  • Park, Kitae
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.28 no.1
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    • pp.100-106
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    • 2022
  • Ships are built according to the purpose and operated with individual goals. Operational goals are reflected in the design of the ships and become the main criterion for determining the required ship ability. In general, cargo ships and passenger ships are objectively evaluated in terms of the operation part of the ship and the capacity part of the cargo or passenger, centering on their transportation ability. In consideration of the required ship ability, the built ship can expect effects such as economic feasibility and eco-friendliness in addition to basic characteristics such as stability. Accordingly, the concept of ship ability is expected to be effectively used in the field of training-only ship management by each institution, which plays a pivotal role in training ship-officers. In this study, the basic direction was verified for the ship ability evaluation criteria of training-only ships through the analysis of the internal space of two training-only ships of the Korea Institute of Maritime and Fisheries Technology, which were recently built with a time lag. In the process of building training-only ship or general-purpose training ship, the possibility of using the ship ability standards in securing budget and designing was derived.

Effective Customer Risk Management at the Nuclear Medicine Department: Risk Managemont MOT Development Application and Producing Public Relations Film (핵의학과 내에서의 효과적인 고객위험관리: 위험관리 응대 MOT 개발적용 및 홍보동영상 제작)

  • Ham, Jong-Hum;Hwang, Jae-Bong;Kim, Joon-Ho;Lee, Gui-Won
    • The Korean Journal of Nuclear Medicine Technology
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    • v.13 no.3
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    • pp.110-122
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    • 2009
  • Purpose: Nowadays, A medical institution assesment could get more interest about a quality of medical services from many hospitals that developed the active activities for improving medical services. Also, there is an other additional issue which is the patients risk management. Uijeongbu ST. Mary's hospital Nuclear Medicine department has been changed many work process after PET-CT introduction and renovation of its place since 2008. Therefore, modified structure and the way of existing work process have contained risk factors. The purpose of this study would be the appropriate risk management process while imaging examination process, the removal risk factors and improved activities through the analysis risk factors. Materials and Methods: Nuclear Medicine department new process should analysis through many-sided, Firstly, make and trained risk management manual after then apply an actual work. Result analysis showed the number of risk accident occurrence that comparing the last year and after the improved activities. Secondly, producing risk management public relations film has been showed an applicable patient after then the customer service measurement checked for a hundred patient by questionnaire. Lastly, Risk factors were eliminated through the facilities participation improving activities which could change for the better risk factors. Results: The number of safety accident occurrence(medication error, fall and collision) were checked as zero after the improving activities both PET-CT and gamma camera examination. The results of questionnaire showed as follows; 74% marked as understanding of the test process and 81% checked "satisfaction" after the public relations film showing. The question "Did you consider about the risk factors?", both PET-CT and gamma camera checked as 94% and 89% respectively. Customer risk management could be accomplished effectively through the improving activities at the nuclear medicine department. Conclusions: The study would be an opportunity that spread risk factors were systematically showed and analyzied. Also, It showed the possibility of the minimized safety accident and its feedback, if application of the response manuel that could be a standard of radiology technician's work method to react safety accident. It was the more effective that visual material could be easy to approach as a methodology of risk factors. As far as I have concerned that It could help the safety and convenience through continuous and detailed activities that offer to patients.

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