• 제목/요약/키워드: medical administration

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의료기기 허가.기술문서 원자재 작성 가이드라인 개발 (The Development for guideline of raw matrials on technical document of Medical Device)

  • 박기정;유규하;이성희;이창형;정진백;이재근;허찬회;김형범;최민용;김용우;황상연;정재훈;구자중;홍혜경;임경택;강세구;곽지영
    • 대한의용생체공학회:의공학회지
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    • 제31권6호
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    • pp.434-437
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    • 2010
  • For approval of medical devices manufactured or imported, submission of technical documents as well as the application form is required. The manufacturer (or importer) should properly identify the raw materials the applied product is made of and the manufacturing processes the product undergoes before it is shipped in the application form. In the technical documents, scientific data to evaluate the efficacy, safety, and quality of the applied product that has been described in the application form should be provided. Therefore, identifying the raw materials that were used for the parts of the applied product and describing the physical and chemical characteristics of the raw materials are quite important and essential in ensuring the efficacy, safety, and quality of the applied product. To describe the physical and chemical characteristics of the raw materials correctively, the applicant is required to have broad knowledge in the scientific fields such as chemical, polymer, metal, and ceramic science and engineering. But most of the applicant are not experts in these fields, so that the description in the application form often includes wrong and improper descriptions. Thus, we developed a guideline which explains the raw materials for medical devices, show the their examples. The purpose of this description guideline is to help the applicant properly completing the "Raw materials or constituents and their volumes" part in the application form.

명대(明代) 의정사(醫政史)에 관한 연구 (A Study of the History of Medical Administration in Ming(明) Dynasty)

  • 김기욱;박현국;김정호
    • 대한한의학원전학회지
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    • 제20권2호
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    • pp.201-230
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    • 2007
  • Basic summary of the medical administration : First of all Ming dynasty was at its last stage of dynastic era that the politics reached absolute autocracy. The influence of centralized power lead to systematical medical administration management system that was generally formed around Tai Yi Yuan(太醫院). Criticizing treatments via shamanism with supernatural powers and advent of strengthening medical concepts were steps toward a new phase. Medical education in regional areas showed drastic development and preventative medicine on epidemics as well as relief work succeeded to a certain amount. Overall Ming(明) dynasty has somewhat of a growth in some areas keeping the basics of Tang(唐) Song(宋) and Yuan(元)'s medical administration, however basically, unique contribution was not shown much. But on the other hand, measures such as common medical system, reserving incompetent doctors, positioning medical officers by the amount of contributions, paying salary with medicine instead of currency brought losses on medical development.

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Medication Errors in Chemotherapy Preparation and Administration: a Survey Conducted among Oncology Nurses in Turkey

  • Ulas, Arife;Silay, Kamile;Akinci, Sema;Dede, Didem Sener;Akinci, Muhammed Bulent;Sendur, Mehmet Ali Nahit;Cubukcu, Erdem;Coskun, Hasan Senol;Degirmenci, Mustafa;Utkan, Gungor;Ozdemir, Nuriye;Isikdogan, Abdurrahman;Buyukcelik, Abdullah;Inanc, Mevlude;Bilici, Ahmet;Odabasi, Hatice;Cihan, Sener;Avci, Nilufer;Yalcin, Bulent
    • Asian Pacific Journal of Cancer Prevention
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    • 제16권5호
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    • pp.1699-1705
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    • 2015
  • Background: Medication errors in oncology may cause severe clinical problems due to low therapeutic indices and high toxicity of chemotherapeutic agents. We aimed to investigate unintentional medication errors and underlying factors during chemotherapy preparation and administration based on a systematic survey conducted to reflect oncology nurses experience. Materials and Methods: This study was conducted in 18 adult chemotherapy units with volunteer participation of 206 nurses. A survey developed by primary investigators and medication errors (MAEs) defined preventable errors during prescription of medication, ordering, preparation or administration. The survey consisted of 4 parts: demographic features of nurses; workload of chemotherapy units; errors and their estimated monthly number during chemotherapy preparation and administration; and evaluation of the possible factors responsible from ME. The survey was conducted by face to face interview and data analyses were performed with descriptive statistics. Chi-square or Fisher exact tests were used for a comparative analysis of categorical data. Results: Some 83.4% of the 210 nurses reported one or more than one error during chemotherapy preparation and administration. Prescribing or ordering wrong doses by physicians (65.7%) and noncompliance with administration sequences during chemotherapy administration (50.5%) were the most common errors. The most common estimated average monthly error was not following the administration sequence of the chemotherapeutic agents (4.1 times/month, range 1-20). The most important underlying reasons for medication errors were heavy workload (49.7%) and insufficient number of staff (36.5%). Conclusions: Our findings suggest that the probability of medication error is very high during chemotherapy preparation and administration, the most common involving prescribing and ordering errors. Further studies must address the strategies to minimize medication error in chemotherapy receiving patients, determine sufficient protective measures and establishing multistep control mechanisms.

의료용 소프트웨어생명주기 프로세스 분석 (A Analysis of Medical Device Software Life Cycle Processes)

  • 최민용;강영규;허찬회;이정림;박기정;박해대;이인수;김혁주
    • 한국정보처리학회:학술대회논문집
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    • 한국정보처리학회 2006년도 추계학술발표대회
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    • pp.571-574
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    • 2006
  • 2006년 5월 국제전기기술위원회(International Electrotechnical Commission, IEC) TC62(의료용전기기기기술위원회) SC62A(의료용전기기기 공통특성에 관한 세부분과위원회)에서 의료기기 소프트웨어의 생명주기 프로세스에 관한 국제규격인 IEC 62304, Ed.1을 제정하였다. 전체 내용은 크게 일반적인 요구사항(General requirements)과 소프트웨어 개발과 유지보수에 대한 프로세스(Software development & maintenance process)로 구성되어 있다. 그리고 소프트웨어 개발과 유지보수 프로세스가 진행되는 동안에 기본적으로 확보되어야 하는 소프트웨어 위험관리와 형상관리에 대한 프로세스 Software risk management & configuration management process)를 규정하고, 또한 문제 발생 시 이를 해결하기 위한 소프트웨어 문제 해결 프로세스(Software problem resolution process)를 규정하고 있다. 이는 기존의 정보통신 분야에서 사용되던 소프트웨어 생명주기 프로세스인 ISO/IEC 12207 규격과 외형상 많은 차이를 나타내고 있다. 이에 본 논문에서는 의료기기 소프트웨어의 생명주기 프로세스에 관한 국제규격인 IEC 652304를 분석하여 실제 의료용 소프트웨어 개발 및 유지보수 작업들이 어떠한 방식으로 이루어지는지를 분석하고, 또한 기존의 소프트웨어 생명주기 프로세스인 ISO/IEC 12207 규격과의 차이점을 비교 분석하여 본 규격에 대한 근본적인 활용 방안을 모색하고자 한다.

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Usefulness of medical review in the insurance claims

  • Lee, Eui-Kwan;Hwang, Jin-Sup;Lee, Sin-Hyung
    • 보험의학회지
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    • 제28권1_2호
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    • pp.31-35
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    • 2009
  • Background : Many of internists have been working for insurance industry. Insurance medicine is use of medical knowledge for insurance industry. There is social role of insurance medicine in terms of soundness of insurance administration. Recently social role of internists also have been being watched. Although theme of insurance medicine is medical risk selection, insurance claims administration also needs medical experts'opinion. There are not any corroborative study of medical consulting for insurance claims. Among insurance industry, someone called this medical review of insurance claims as 'medical claims review'. Aim : To investigate usefulness of medical review of insurance claims. Design : Questionnaire survey with claim staffs in one of insurance claim adjustment company in Korea. Methods : 265 claim staffs were divided into 4 groups and conducted survey using a questionnaire of 20 questions. Utility score, job satisfaction score, and difficult factors of claims administration were measured. Results : Utility score and job satisfaction score are highest in medical claims review group. The most difficult in claim administration to claim staffs was demonstrated to medical knowledge. Conclusion : Medical review of insurance claims is proved to be worthy. Document-based consulting method, namely medical claims review, is more useful than telephone-based simple query among claim staffs...Subjects of the medical claims review are medical record and it's principle is independent medical examination with evidence-based approach, it also has role of protecting fraud of insurance claims. Two main question types of medical claims review are verification and advice.

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KFDA Postal Dose Audit System

  • Lim, Chun-Il;Ahn, Ji-Young;Lee, Hyun-Koo;Jeong, Hee-Kyo;Oh, Heon-Jin
    • 한국의학물리학회:학술대회논문집
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    • 한국의학물리학회 2006년도 제33회 추계학술대회 발표논문집
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    • pp.12-12
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    • 2006
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료(遼).금(金).원대(元代)의 의정사(醫政史)에 관한 연구 (A Study of the History of Medical Administration for Liao(遼).Jin(金).Yuan(元) Dynasty)

  • 김기욱;박현국
    • 대한한의학원전학회지
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    • 제20권1호
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    • pp.17-37
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    • 2007
  • Basic summary of the medical administration: First of all, Liao Jin Yuan dynasties had broad cultural exchange between north and south that the two traditional medical administrations were closely linked which later formed a system that united as one. Establishment of governmental medical office and governmental medical education organization was the very first attempt in the history of the medical administration. The measure on promoting the social level of medical doctors has an important meaning on the growth of the medical field. Medical policy on prisoners was done under the new condition brought on from experience. Medicine not of China was broadly interchanged, medicine from Arab was spread throughout China, and the department on skeletal injuries and the dietary treatments had major development. At this era, under a overall expansion of politics, economy, culture and medicine, scholastic dispute on medicine triggered medical expansion.

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청대(淸代) 의정사(醫政史)에 관한 연구 (A Study of the History of Medical Administration in Qing(淸) Dynasty)

  • 김기욱;박현국
    • 대한한의학원전학회지
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    • 제20권3호
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    • pp.79-99
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    • 2007
  • Basic summary of the medical administration : Due to Qing dynasty being the last of the dynastic era, it revealed overall extreme political traits in politics, economy, phenomenon, and cultural aspects. Few emperors of the early Qing dynasty adopted appeasement policy that mitigated ironies to a certain extent and showed growth in various business related fields. Even the medical administration had freshness during that period. United medical administrative system was generally formed, chicken pox was effectively prevented, shamanistic treatment was banned, medical journals were complied by the government, medical relief was more intensely done. However, actions on restoring Ming dynasty and against Qing dynasty as well as the reform power grew against Qing government threatening it. The drastically grown forces from the western region damaged Qing dynasty that the governors had to adopt despotic measures in politics, economy and culture. Social chaos began to arise, economy stagnated and weakened that the medical field also dwindled to the point where it could not be restored to the original point. The era of Qing dynasty was the period that had scientific culture at its fast growing pace, but for Chinese medicine, by contrary, due to autocracy and other factors, was faced with barriers in the medical development.

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Systematic Review on the efficiency of prefilled syringe : To administer medication for cardiac arrest patient

  • Yoon, Byoung Gil;Park, Jung Hee;Kim, Young Seo
    • International Journal of Advanced Culture Technology
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    • 제10권4호
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    • pp.23-244
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    • 2022
  • The Pulpose of this systematic review is aimed to establish the procedure of the injection with saftey and efficiency in the pre-hospital cardiac arrest patient performing the cardiopulmonary resuscitation (CPR), compared with traditional medication administration using Ampoule and medication administration with Prefilled Syringe. Databases were searched for CPR, heart arrest, resuscitation, Pre-filled Syringe, and Ampoule by the electronic data research including Pubmed, EMBASE and Cochran Library of Konyang University Library: 4 articles were selected by three co-authors using EndNote X20 and Covidence (Covidence.org) and were systematically reviewed. The Result of this study, the medication administration using Pre-fillled Syringe improves the safety of patients and Emergency medical workers by reducing the error in administration dose and administering the drug in safe than the medication adminisrtaion using Ampoule, also, contributes to the increment of survival rate of cardiac arrest and severe patients by decreasing the administration time that prevents the delay of medication administration.

부산·경남지역 의무기록사 직무분석 (A Study on the Job Description of Medical Record Administrator in Busan and Gyeongnam)

  • 정미영;김혜숙;김경나
    • 보건의료산업학회지
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    • 제6권4호
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    • pp.61-72
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    • 2012
  • The purpose of this study was to propose how to improve and develop the college curriculum of medical record administration, satisfying requirements from hospitals having medical record administrators. For the purpose, this researcher surveyed medical record administrators serving at hospitals located in Busan, Changwon, Masan and Jinju. Finally analyzed were responses from 100 medical recorders. The frequency of searching medical records to support information use was statistically different among hospitals according to the number of sick beds(p=.041), or $3.16{\pm}1.75$ for fewer than 300 sick beds, $4.28{\pm}2.42$ for 300 to 500 and $4.86{\pm}3.18$ for more than 500. The college course that was regarded as most important by most of the surveyed medical record administrators, or 53(37.2%) was medical terminology, followed by statistics by 36 of the respondents(18.5%) and EMR, 25(12.8%) in order. To make EMR truly effective requires reforming the university curriculum of medical record administration and giving more attention and more supports to training for better computerization, realizing that medical record administrators serve as a true manager of health and medical information, not a person who just paper-based medical information. In addition to managing health and medical information, medical record administrators are expected to have more roles in the future, for example, providing high-quality clinic knowledge and medical information that are necessary for efficient hospital management and medical research to survive competition.