• Title/Summary/Keyword: Medical Device Safety Education

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A Study on the Cognizance of Hospital and oriental Hospital Workers for Medical Device Safety Information Monitoring (의료기기 안전성 정보 모니터링에 대한 한병병원 및 병원 종사자의 인지도 조사연구)

  • Kim, Ji Hyun;Nam, Ki Chang;Kim, Hojun;Nam, Yeon Gyo;Kim, You Jin;jo, Eun hye;Kwon, Bum Sun
    • Journal of Biomedical Engineering Research
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    • v.42 no.3
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    • pp.86-93
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    • 2021
  • Purpose: The purpose of this study is to find out the cognizance of medical device safety information (MDSI) monitoring in the hospital and oriental hospital workers, and the different aspect of MDSI between oriental medical devices and medical devices. Methods: The survey was performed both in the oriental medicine hospital and general hospital. The survey had 16 items; 2 items basic questions, 5 items in the awareness of MDSI, 5 items in the education of MDSI, 4 items in the necessity of defining oriental medical devices and differences between general and oriental medical devices. A total of 120 hospital worker were participated; 60 oriental medicine hospital workers and 60 general hospital workers. They had worked in the oriental medicine or general hospital associated with 'Medical Device Safety Monitoring Center, Dongguk University Ilsan Hospital' in 2019 and 2020. Results: The cognizance of MDSI was high both in oriental medicine hospital and general hospital workers and there were no significant differences between oriental medicine and general hospital workers. When we divided the hospital workers into the senior workers who had worked for over 3 years and junior workers for less than 3 years, the senior workers had higher awareness of MDSI than junior workers. However, the cognizance of education of MDSI was high which was not different between senior and junior workers. Both hospital workers thought that it was necessary to define oriental medicine device legally and the oriental medical device might have low risk and less side effect than medical device. Conclusion: The cognizance of MDSI was high and there was no significant differences between oriental medicine and general hospital workers. Because the senior hospital workers had higher recognition of MDSI, we need to provide the continuous education program for junior hospital workers. Although oriental medical device are thought to be safer than medical device, we need to have a legal definition.

A Study on the Development and Effectiveness of ISO13485:2016 Education Programs for Domestic Medical Device Manufacturers (국내 의료기기 제조업체의 ISO13485:2016 교육 프로그램 개발 및 교육 효과 연구)

  • Lee, Seul-Bi;Kang, Giho;Jang, Wonseuk;Kwon, Byeong-Ju
    • Journal of Korean Society for Quality Management
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    • v.50 no.3
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    • pp.503-515
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    • 2022
  • Purpose: As ISO 13485 was revised in 2016, the domestic GMP (Good Manufacturing Practice) system was also revised and implemented in 2019. However, there are many problems in the domestic medical device industry because most of the small and medium-sized enterprises lack human and material resources. Accordingly, this study was conducted to provide education programs for domestic medical device companies to induce information provision and improve the company's quality management ability. Methods: First, analyze existing education. Second, based on the revised GMP system, a survey paper was produced to investigate difficulties and problems experienced by companies. Third, a two-week survey was conducted on domestic medical device manufacturers, and a total of 77 companies responded to this survey. Fourth, educational program development was conducted based on the results of the survey. Results and Conclusion: The developed education program consists of a total of five sessions. In this study, the educational program developed by grasping the needs of the company through a survey consists of a total of five sessions. The first session consisted of theoretical education and the second to fifth sessions of practical education. Through the education program developed in this study, it is expected to contribute to the overall development of medical device quality by establishing a domestic medical device manufacturing environment that secures the safety and performance of domestic medical device companies.

Study of Radiation Safety Management of Veterinary Hospital in Korea (동물병원 방사선 안전관리체계에 대한 연구)

  • Chae, Soo-young;Choi, Ho-jung;Lee, Young-won
    • Journal of Veterinary Clinics
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    • v.37 no.1
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    • pp.15-22
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    • 2020
  • This study investigated the effectiveness of radiation safety rules in animal hospital and the awareness and behavior of veterinary radiation workers. With the questionnaires, the data was collected from randomly selected veterinarians in animal hospitals and animal medical imaging centers. Collected data were about radiation device, shielding device, regulations, safety management, education, knowledge, behavior and awareness. Frequency, correlation and multiple regression analysis were performed. The medical devices related with radiation in animal hospital were X-ray (59%), CT (15%), fluoroscopy (12%), mobile X-ray (12%) and others (2%). The number of people using radiation shielding device is high. The answers were low on knowing radiation related regulation and receiving radiation protection education. The group with higher knowledge and awareness shows positive correlation with safety behavior. The increase of use of the radiation related medical devices in veterinary hospital causes the increase of radiation exposure risk. This study suggests that radiation safety management system and policies need to be developed to protect radiation workers and give them correct information and consciousness.

Perception and Behavior Regarding the Safety of Medical Devices among Medical Personnel at a Tertiary Care Hospital (의료기기 안전에 관한 대학병원 의료인들의 인식과 행동에 관한 연구)

  • Lim, Ji-Hye;Kim, Kyu-Sung;Kim, Sae-Rom;Kim, Young-Soon;Lee, Hun-Jae
    • Journal of rehabilitation welfare engineering & assistive technology
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    • v.11 no.4
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    • pp.287-297
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    • 2017
  • This exploratory study aimed to explore the perception (knowledge and attitude) and behaviors of medical personnel regarding medical device safety and to identify the differences in results linked with the type of their task. A questionnaire was administered to medical personnel working at a tertiary care hospital with 900 beds in Incheon, Korea, and 220 completed questionnaires were used for analysis. The results revealed that the majority of the medical personnel perceived the potential risk involved in different types of medical devices they use and stated that they need training programs for safe use of medical devices. Concerning the perception regarding medical devices across different positions within the hospital, it was found that the residents had a low awareness about safety issues, although the medical services they handled involve high risks, thereby calling for safety training. Further nationwide studies are needed to improve the quality and validity of data and eventually to provide important information required by policy makers and academicians to manage medical device safety.

Analysis of Serious Game Elements of the Contents for Smart Device Based First-Aid Education (스마트 기기 기반 응급 처치 교육 콘텐츠의 기능성 게임 요소 분석 연구)

  • Suh, Dong-hee
    • Cartoon and Animation Studies
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    • s.47
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    • pp.273-294
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    • 2017
  • Korea has suffered numerous casualties due to a lot of accidents caused by safety insufficiency in recent years. Therefore, safety education is more important than ever before, and 'how to educate with what contents' is an important subject. Especially, experience education is effective rather than theoretical education because of the nature of safety education. However, it is not easy to design and develop these safety education programs. There is not much opportunity to access first-aid training, which is a part of safety education, unless it is compulsory to learn through public institutions. As a result, program utilization on safety education in Korea is still insufficient to what it should be. With that taken into account, this study proposed an effective serious game with fun and immersion for medical first-aid education. To do this, we analyzed five medical games through 20 cases of first-aid applications and elicited five factors that enhance the usability of serious games. With an analysis of five medical games, we selected one game to borrow the game rules, and applied the elicited five elements in the forms of level-up structure, iterative learning, compensation outcomes, competition system, and information transfer. The proposed medical education functional games should have 1) a character that plays a role of a patient, 2) a narrative flow that shows the situation, 3) the user should judge the situation and induce first aid. 4) compensation, levels, and simple repetition should be designed, and 5) information should be shared with the others in the given community. The results of this study is believed to contribute to enhance the medical emergency education in Korea.

Knowledge, Attitude, and Practice of Radiation Management among Radiation Generating Device Manufacturers and Medical Personnel (방사선 발생장치 제조업체 및 의료기관 종사자의 방사선 관리에 대한 지식, 태도 및 실천)

  • Kim, Kyu-Hwan;Bae, Seok-Hwan
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.22 no.2
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    • pp.418-426
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    • 2021
  • This study investigates the perception of radiation safety management in radiation generator manufacturing workers and medical institutions. The basic data obtained is further applied to improve active coping ability and safety levels. The knowledge and attitude practice score of radiation was found to be related to gender, age, marital status, occupation, position, current work period, total work period, radiation related work period, the manual available, defense facility maintenance, number of defense equipment, radiation safety education, special health examination, and recognition of radiation terms. In particular, the knowledge score of radiologists was highest among the radiation-related occupations (<0.05). Radiation safety management requires active defense endeavors to prevent radiation exposure, by both workers of radiation manufacturers and medical institutions. Moreover, institutional devices such as compliance with guidelines, periodic education, facility reinforcement, manual preparation, and special health checkups are required for efficient radiation safety management.

Survey on Usage of Korean Quantitative Ultrasound for Proposing Quantitative Ultrasound Quality Control Guideline (초음파골밀도측정기 정도관리 방안제시를 위한 한국 초음파골밀도 사용현황 조사)

  • Jeong, Yoon-Ji;Kim, Mi-Jeong;Lee, Seung-Youl;Lee, Tae-Hee;Seoung, Youl-Hun
    • Journal of radiological science and technology
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    • v.41 no.4
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    • pp.329-337
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    • 2018
  • This study was investigated quantitative ultrasound (QUS) usage in Korea for the QUS quality control guidelines. A total of 344 questionnaires collected from July 24th to August 25th 2017 were analyzed. Questionnaires were created through user interviews, expert group advice, literature review and field observation. As a result of the general characteristics of quantitative ultrasound holding amounted to 81.98% of clinic and 6.69% of hospitals. The main user was radio-logical technologists as 31.39%. The contact methods of the gel pad (balloon) were the most used at 56.68% and the scan region was 91.9% of calcaneus. The quantitative ultrasound quality control cycle was 67.37% when the abnormality was found in the equipment, and 63.66% when the accuracy control was implemented according to the manual. The phantoms of QUS were 34.30% of the manufacturer's own phantoms. User of QUS had never received education for quality control of quantitative ultrasound as 62.20%. This study was expected to be useful when creating detailed quality control guidelines in the future, as well as guidelines for the quality control of Korea's standard quantitative ultrasound.

Problems of the Radiation Safety Management System and Legal Improvement Plans in the Department of Radiological Science: Focusing on the survey of the head of the Department of Radiological Science (방사선(학)과 방사선 안전관리제도의 문제점과 법적 개선방안: 전국 방사선(학)과장 설문조사를 중심으로)

  • Hyun-Jung, Lee;Chang-Gyu, Kim;Man-Seok, Han;Cheol-Ha, Baek
    • Journal of the Korean Society of Radiology
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    • v.16 no.7
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    • pp.815-824
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    • 2022
  • The current radiation safety management system is also applied to radiation practices at universities. The application of the law raised concerns about poor radiation practice education and hindering the development of radiology. Accordingly, the Korean Radiology Professors Association needed to grasp the reality of the management system for radiation practice education at each university and the current radiation safety management system in the department of Radiological science. So, a survey was conducted on heads of radiological science departments across the country. Through the survey, it was found that the current application of the Nuclear Safety Act to radiation safety management in the department of Radiological science is excessively restrictive and not very effective. In addition, radiology practice education for the purpose of training health and medical professionals should be controlled by the Ministry of Health and Welfare and the Korea Centers for Disease Control, but there is a problem of being supervised by the Nuclear Safety and Security Commission. Therefore, in this study, as a legal improvement plan to solve this problem, first, a plan according to a partial amendment to the Higher Education Act, second, a plan to be supervised by the Ministry of Health and Welfare through the amendment of article 37 of the Medical Service Act, third, article 20-2 of the Enforcement Decree of the Medical Service Technologists Act was newly inserted to propose three measures to be supervised by the Ministry of Health and Welfare.

How to Sustain Smart Connected Hospital Services: An Experience from a Pilot Project on IoT-Based Healthcare Services

  • Park, Arum;Chang, Hyejung;Lee, Kyoung Jun
    • Healthcare Informatics Research
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    • v.24 no.4
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    • pp.387-393
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    • 2018
  • Objectives: This paper describes an experience of implementing seamless service trials online and offline by adopting Internet of Things (IoT) technology based on near-field communication (NFC) tags and Bluetooth low-energy (BLE) beacons. The services were provided for both patients and health professionals. Methods: The pilot services were implemented to enhance healthcare service quality, improve patient safety, and provide an effective business process to health professionals in a tertiary hospital in Seoul, Korea. The services to enhance healthcare service quality include healing tours, cancer information/education, psychological assessments, indoor navigation, and exercise volume checking. The services to improve patient safety are monitoring of high-risk inpatients and delivery of real-time health information in emergency situations. In addition, the services to provide an effective business process to health professionals include surveys and web services for patient management. Results: Considering the sustainability of the pilot services, we decided to pause navigation and patient monitoring services until the interference problem could be completely resolved because beacon signal interference significantly influences the quality of services. On the other hand, we had to continue to provide new wearable beacons to high-risk patients because of hygiene issues, so the cost increased over time and was much higher than expected. Conclusions: To make the smart connected hospital services sustainable, technical feasibility (e.g., beacon signal interference), economic feasibility (e.g., continuous provision of new necklace beacons), and organizational commitment and support (e.g., renewal of new alternative medical devices and infrastructure) are required.

Laser Application and Nursing in the Field of Gynecology

  • Kim, Kyunghee
    • Medical Lasers
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    • v.10 no.4
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    • pp.201-206
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    • 2021
  • The recent development of new surgical techniques using lasers has increased the opportunities for open surgery involving minimal manipulation and faster and more accurate removal of lesions. The increasing use of laser technology requires nurses to play an extensive role. As assistants, nurses play an important role in maintaining the efficacy and safety of the laser device. In addition, they are also responsible for providing pre-and post-operative care to patients. Therefore, nurses should be aware of how to proceed with operative laser treatment for all surgical procedures and the steps for maintaining safety prior to, during, and after laser treatment. This review provides in-depth knowledge for nurses undertaking continuing education on lasers and patient care in the field of gynecology.