• Title/Summary/Keyword: Safety Management of Medical Equipments

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Development of Device Management and Safety Diagnosis Manual for Electrical Stimulating Swallowing-Assist Equipments (전기적 자극방식 삼킴 보조 치료기의 장비관리/안전진단 매뉴얼 개발)

  • Heo, S.Y.;Choi, B.G.;Rhee, G.M.
    • Journal of rehabilitation welfare engineering & assistive technology
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    • v.8 no.2
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    • pp.79-88
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    • 2014
  • In Republic of Korea, there are considerable vulnerability in electrical stimulating swallowing-assist equipments even though they are professional medical equipments and have high penetration rate with heavy frequency of use. Therefore, in this article, we developed Device Management and Safety Diagnosis Manual for Electrical Stimulating Swallowing-Assist Equipments system. For achieving this, we collected and analysed international standard data from international organizations like International Electrotechnical Commission(IEC). After literature reviews, we build maintenance worksheet and equipment procedure manual for electrical stimulating swallowing-assist equipments according to evidences we collected. These manual and protocol would be used as standard process and contribute to sustain accuracy, effectiveness of the devices, also decrease failure rate and assist to save medical documents.

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A Study on Enforcement Effects of Radiation Safety Control Regulations for Diagnostic X-ray Equipments (진단용 방사선안전관리 현황에 관한 연구)

  • Sung, Mo-Il;Park, Myeong-Hwan;Kwon, Duk-Moon;Lee, Joon-Il
    • Journal of radiological science and technology
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    • v.22 no.1
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    • pp.73-78
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    • 1999
  • The purposes of this study are to analyze the realities after enforcements of safety control regulations for diagnostic X-ray equipments and to suggest means for an improvement of low radiation safety control. A questionnaire survey for medical radiologic technologists was carried out to determine enforcement effects of the safety control regulations. The results of analysis from the survey are as follows. That is, most of the respondents realized the importance of the radiation safety control system, but about a half of them revealed that the regulations were not well observed in accordance with their purposes. Only 43.9% of the respondents took an active part in quality control and safety control of radiation. And respondents responsibility, sex, age, and knowledge for safety control were important indicators for observations of the regulations. Trainings for the safety control regulations are needed to ensure safety control and proper usage of diagnostic X-ray equipments. And management of organizations using diagnostic X-ray equipments have to understand and stress the importance of radiation safety control system.

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Amendment of the Inspection Standard for Diagnostic Radiation Equipment Applying IEC 60601-1-3: Medical Electrical Equipment - Part 1-3: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment (KS C IEC60601-1-3: 의료용 전기기기-제1-3부: 기본 안전 및 필수 성능에 관한 일반 요구사항-보조표준: 진단용 X선 장치의 방사선 방어를 적용한 진단용 방사선 발생장치의 검사기준 개선안)

  • Park, Hye-Min;Kim, Jung-Min;Kim, Jung-Su;Kim, Seong-Ok;Choi, Young-Min
    • Journal of radiological science and technology
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    • v.41 no.5
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    • pp.493-504
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    • 2018
  • The diagnostic radiation equipment is managed in accordance with the "Rules for Safety Management of Diagnostic Radiation Equipment" enacted in 1995. The equipments should be inspected before use and every three years after use in accordance with the [Appendix 1] of the same rule. The inspection standard has been maintained without particular revision since enacted. But, over the past two decades new types of equipments have been manufactured and used. So, it is necessary to revise [Appendix 1] by making inspection items and inspection standards. In this study, we revised the classification system of equipments and reviewed international standards of IEC 60601 series, IEC 61223 series and AAPM TG 18 On-line Report No.03. And identified the problem of current inspection standards. Through this, we revised, deleted and added the inspection items and inspection standard of each equipment to meet the domestic circumstances. As a result of the study, we reorganized the classification system of equipment which are current classified as 5 classes into 22 classes as X-ray system etc. (7 classes), CT system etc. (5 classes) and Dental X-ray system etc. (10 classes). And then, we developed 70 inspection items for 6 types of equipments according to the reorganized classification system of equipments. The inspection items and inspection standards derived from this study have been proposed to the KCDC and will be applied to the revision of the Rule's [Appendix 1]. Therefore, we expect to be used as reference materials for domestic medical center, inspection institutions, and equipment manufacturing import companies.

A Study on the Activation·Specification of 119 Rescue & Care in JeJu (제주도 119구조·구급대의 활성화 및 전문화 방안)

  • Koh, Jae-Moon;Kim, Tae-Min;Kim, Hyo-Sik;Lee, Young-A
    • The Korean Journal of Emergency Medical Services
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    • v.6 no.1
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    • pp.153-168
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    • 2002
  • Since 1992, conventional fire fighting businesses have been converted into a metropolitan autonomous fire fighting system to be ready for a variety of disasters. However, the corresponding investment has been overlapped due to the non-integration of businesses to prevent any potential disasters, and a series of collaborative systems have been not functioning so well. In the meantime, our fire fighting sector has been trying to set up its own clean and faithful position by abolishing any inconvenient system or outsourcing private sectors, and expanded its work scope from conventional fire fighting even to rescue and emergency works. While focusing on handling disaster, the fire fighting sector has been widely trusted and reliable throughtout our nation. Moreover, our fire fighting sector has secured nation wide mobile organizations, technical personnel by field, special equipments and independent communication network. In addition, the fire fighting sector has knowledges, expertise and capabilities required for managing disasters, while in charge of almost every disaster management works including fire, explosion, collapse, disaster and flood. It becomes an organization for comprehensive disaster management under an absolute national trust, which is based on the system for prevention, preparation and countermeasure against a variety of disasters. Thus, our fire fighting sector must make many efforts and try to modernize conventional education and training. The ways to facilitate rescue and emergency works may include the nurture of technical fire fighting personnel along with modernized equipments, the reinforcement of rescue and emergency education, the facilitation of operating civil defense corps, the facilitation of operating volunteer fire fighting corps, the better arrangement of 119 briefing room for public healthcare in provincial offices, the sterilization of rescue instruments and equipments the better repair education for emergency rescue member, the establishment of regional emergency assistant system and the expansion of fire fighting personnel and equipments. In terms of reinforcing the functions and services of rescue 119 and emergency corps, we must review the following considerations: Building up security system along with operational expansion, building up a system for emergency medical treatment, building up a comprehensive information management system for rescue and emergency, constructing a provincial safety museum and so forth. For the ways to better the works of rescue 119 we can review the following considerations : Improving the education for fire fighting training corps under Jeju Provincial Fire and Disaster Management Department, providing rescue members with more opportunities for clinical practices, enhancing the morale of rescue members, installing a comprehensive briefing room for emergency rescue members, building up medical networks along with reasonable policies for information service, operating the consulting system for rescue 119 and so on. If these requirements are met, it is expected that the fire fighting departments in Jeju province can cope with every accident and disaster a little more rapidly and quickly in compliance with local needs, so that they can keep their own position as a public fire fighting organization which may be trusted by the public.

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A Study on the Safety of Electromagnetic Wave of Medical Imaging System (의료영상장치의 전자파 안전에 대한 연구)

  • Seon, Jong-Ryul;Lee, Won-Jeong;Rhim, Jae-Dong
    • Journal of the Korea Safety Management & Science
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    • v.12 no.4
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    • pp.67-72
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    • 2010
  • This study was done to provide basic data on the safety of professionals in medical imaging system by measuring the electromagnetic waves generated in the medical imaging system being used in medical organization. The studied medical imaging systems were general X-ray system, computed tomography(CT), ultrasonographic(USG) system, magnetic resonance imaging(MRI), PET-CT and fluoroscopic(R/F) system, and through these devices, electric field and magnetic field were measured and analyzed. As a result of the analysis, the measured values classified by the medical organizations were not much significant, but in the measurement by the medical imaging systems, there were high hazard elements in the sequential order of electric field PET-CT($17.7{\pm}22.9$)v/m, CT($10.3{\pm}8.7$)v/m, general X-ray system($8.8{\pm}8.8$)v/m, magnetic field general X-ray system($5.06{\pm}8.26$)mG, CT($2.71{\pm}4.53$)mG and PET-CT($0.74{\pm}0.34$)mG, the systems that adopted X-ray as main ray source, and the more aged the medical imaging systems, the greater the effects of electro-magnetic waves($10.6{\pm}15.93v/m$ for 5 years or more, $6.14{\pm}5.60v/m$ for 5 years or less). The effects of electromagnetic waves on medical imaging systems or facilities were not much when the notification of ministry of knowledge economy is considered, but in the overall perspective considering all the equipments and facility of the medical organization, such effects were significant. It is determined that sustainable safety managements of electric field and magnetic field must be done during process from medical imaging system installation to maintenance to rule out such factors.

A Study on the Safety of Electromagnetic Wave of Medical Imaging System (의료영상장치의 전자파 안전에 대한 연구)

  • Seon, Jong-Ryul;Lee, Won-Jeong;Rhim, Jae-Dong
    • Proceedings of the Safety Management and Science Conference
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    • 2010.11a
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    • pp.103-112
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    • 2010
  • This study was done to provide basic data on the safety of professionals in medical imaging system by measuring the electromagnetic waves generated in the medical imaging system being used in medical organization. The studied medical imaging systems were general X-ray system, computed tomography(CT), ultrasonographic system, magnetic resonance imaging(MRI), PET-CT and fluoroscopic system, and through these devices, electric field and magnetic field were measured and analyzed. As a result of the analysis, the measured values classified by the medical organizations were not much significant, but in the measurement by the medical imaging systems, there were high hazard elements in the sequential order of electric field PET-CT($17.7{\pm}22.9$)v/m, CT($10.3{\pm}8.7$)v/m, general X-ray system ($8.8{\pm}8.8$)v/m, magnetic field general X-ray system($5.06{\pm}8.26$)mG, CT($2.71{\pm}4.53$)mG and PET-CT($0.74{\pm}0.34$)mG, the systems that adopted X-ray as main ray source, and the more aged the medical imaging systems, the greater the effects of electro-magnetic waves($10.6{\pm}15.93v/m$ for 5 years or more, $6.14{\pm}5.60v/m$ for 5 years or less). The effects of electromagnetic waves on medical imaging systems or facilities were not much when the notification of ministry of knowledge economy is considered, but in the overall perspective considering all the equipments and facility of the medical organization, such effects were significant. It is determined that sustainable safety managements of electric field and magnetic field must be done during process from medical imaging system installation to maintenance to rule out such factors.

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A study on the system improvement policy according to the status analysis of medical device control system in Korea (국내 의료기기관리제도의 현황분석에 따른 정책적 제도개선 방안에 관한 연구)

  • Lee, Kyung-Man;Baek, Nak-Ki;Seo, Jong-Hyun
    • Journal of the Korea Safety Management & Science
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    • v.12 no.3
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    • pp.37-52
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    • 2010
  • This study is aimed at proposing the national policy for medical device control system in Korea as deeply analysed the present status of the system. On 1979, Korean government had started to inspect 24 kinds of the medical devices such as X-ray diagnostic equipments, medical sterilizer and etc. mostly imported from advanced countries which USA, Germany and Japan for the first time according to the Pharmaceutical Affairs Law. However medical devices were becoming consideration as an important partner of diagnosis, curing and alleviation of diseases by medical doctors and also much important keeping the health at home. Furthermore medical devices industry can be designated as a national growth engine industry. So it is necessary not only to harmonize to international standards but also the harmonization of the system including pre-market application and post-market surveillance, is strongly needed by the Korea Food and Drugs Administration(KFDA).

International Standards of Electrical Equipments for Medical Practice (의료용 전기기기에 대한 국제표준 현황)

  • Lee, Tae-Bum
    • The Korean Journal of Health Service Management
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    • v.7 no.3
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    • pp.203-212
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    • 2013
  • Medical devices separated by a committee of the International Electrotechnical Commission IEC TC (Technical Committee) 62 medical electrical equipment being promoted by the International standards. Actually, a lot of standards were existed, but many national and international standards for medical devices were lacking in practical standards that can be applied to their development. Most international standards were focused in electrical and mechanical safety of medical devices. Therefore, there were few practical standards which contain essential performance evaluation. Although medical device regulations do not enforce a fixed lifecycle model, activities are presented in a sequential manner, thus hinting at a waterfall process. Meanwhile, for a decade or more, software teams have benefitted from agile development methods. Several medical device manufacturers have adopted agile practices while keeping development in compliance with regulations, but conflicts arise and decisions have to be taken in favor of agility or formality. However, if there are new practical standards of medical devices, it must be possible to promote the medical devices industry in their nation. To do this, there is a need to develop a new standard could apply to the international market through the analysis of the medical device related technology. Consequently, new standards such as NP (New proposal) or NWIP (New Work Item Proposal) should be developed through international standardization of medical device technology.

A Study on the Natural Disaster Response Policy in Korea (재해방지정책의 개선방안에 관한 고찰 - 자연재해를 중심으로 -)

  • Kim, Jae-Pil;Kang, Soon-Min
    • The Korean Journal of Emergency Medical Services
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    • v.5 no.1
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    • pp.89-97
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    • 2001
  • Recently, natural disasters happened to the Korea frequently. Disaster in the present society has been changed and increased it impacts and extent of danger as the society develops. So, Korean people feel uneasy about the unpredictable disaster. Therefore the capability of administration system, and cooperation and support between related organization become more necessary. This study aims to find out better ways of disaster management system which can protect people's lives and fortune from all sort of national disasters. To research policy reform, it is necessary to analyze disaster response organization(national disaster prevention countermeasures headquarters and so on), interorganizational relationship, law system etc. Especially, in this study, role appreciation of government was analyzed to get the rational policy reform measure. Suggestion : First, it is necessary Establishing a consolidated organization for disaster managing and united response organization is necessary such as Federal Emergency Management Agency(FEMA) which controls an over all aspects of disaster management. And it is necessary to develop Integrated Administrative Control System based on comprehensive plan. When the accidents happen, it needs to be many equipments and various specialized personnel. So, to manage a large scale of disaster, it is necessary to have interorganizational network system which many specialized organization including volunteer group are integrated. Also, as soon as the natural disaster happen, many professionals and volunteers are distributed to the spots of disaster in the right man in the right place. Finally, All the citizens have to keep safety rules, and also to take a safe action in ordinary daily life.

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