• Physical Therapy Korea
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• v.29 no.3
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• pp.235-240
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• 2022

Background: A spinal extension and intensive rehabilitation program reduced the symptoms and pain of kyphosis, and improved function. Objects: This study aimed to demonstrate the effect of a spine extension device on the degree of thoracic kyphosis and extension angles, confirm reduction of the kyphosis angle and an increase in flexibility. Methods: Thirteen adults were enrolled in the experiment, using the spine extension device, which was set to passively extend the spine. The angle between the spinous process of the first thoracic vertebra and the spinous process of the twelfth thoracic vertebra was measured by dual inclinometer before and after using the spine extension device. Results: In the static posture, the thoracic kyphosis decreased after using the spine extension device in the thoracic extension posture, and there was a significant difference (p < 0.05); thoracic extension angle increased with statistical significance (p < 0.05). Conclusion: In this study, the thoracic kyphosis angle and thoracic extension angle of the subjects before and after using spine extension device was compared and analyzed, which proved that the spine extension device can effectively improve the mobility of spinal extension.

• The Korean Journal of Nuclear Medicine Technology
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• v.27 no.1
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• pp.23-28
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• 2023

Carbon materials are widely used in many areas of our lives. A fiber having a carbon content of 90% or more obtained by heating an organic fiber precursor is referred to as a "carbon fiber". Carbon fibers are currently used in the medical market to manufacture radiation transmission device parts, artificial joints, and medical aids, as many developments have been made to utilize carbon fibers' characteristics such as light weight, radiation permeability, biocompatibility, high strength, high heat resistance, thermal conductivity, and electrical conductivity. In order to maintain body temperature and increase immunity in long-lasting nuclear medical examination and treatment through the idea of convergence of carbon materials and radiation technology, the quality of medical services can be improved by utilizing carbon materials. We should be aware of the domestic carbon-based medical device industry and make efforts to contribute to the development of medical devices. As a radiation expert, we should try to use our skills and experience to find items that can be fused with medical devices to develop various nuclear medical examination fields and radiographic examination fields that can be widely applied. We should actively engage in future technology development and carbon material research to strengthen the global competitiveness of the domestic medical device industry and improve the quality of medical services.

• 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.

• Journal of Biomedical Engineering Research
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• v.40 no.5
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• pp.197-205
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• 2019

The existing Extracorporeal membrane oxygenation(ECMO) and Cardiopulmonary bypass system(CPB) have been developed and applied to various devices according to their respective indications. However, due to the complicated configuration and difficult usage method, it causes inconvenience to users and there is a risk of an accident. Therefore, smart all-in-one cardiopulmonary circulation device is being developed recently. The smart all-in-one cardiopulmonary assist device consists of a blood pump for cardiopulmonary bypass, a blood oxidizer for cardiopulmonary bypass, a blood circuit for cardiopulmonary bypass, and an artificial cardiopulmonary device. It is an integrated cardiopulmonary bypass device that can be used for a variety of purposes such as emergency, intraoperative, post-operative intensive care, and long-term cardiopulmonary assist, combined with CPB used in open heart surgery and ECMO used when patient's cardiopulmonary function does not work normally. The smart all-in-one cardiopulmonary assist device does not exist as a standard and international standard applicable to advanced medical devices. Therefore, in this study, we will refer to the International Standard for Blood Components, the International Standard for Blood, the Guideline for Blood Products, and prepare applicable performance and safety guidelines to help quality control of medical devices, and contribute to the improvement of the health of people. The guideline, which is the result of conducted a survey of the method of safety and performance test, is based on the principle of all-in-one cardiopulmonary aiding device, related domestic foreign standards, the status of domestic and foreign patents, related literature, blood pump(ISO 18242), blood oxygenator (ISO 7199), and blood circuit (ISO 15676) for cardiopulmonary bypass.The items on blood safety are as follows: American Society for Testing and Materials ASTM F1841-97R17), and in the 2010 Food and Drug Administration's Safety Assessment Guidelines for Medical Assisted Circulatory Devices. In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers / importers, testing inspectors, academia, etc. the final guideline was established through revision and supplementation process. Therefore, we propose guidelines for evaluating the safety and performance of smart all-in-one cardiopulmonary assist devices in line with growing technology.

• Journal of Biomedical Engineering Research
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• v.44 no.6
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• pp.363-376
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• 2023

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.The purpose of this study is to conduct a usability assessment to ensure that ergonomic design has been applied so that the ventilator central monitoring system can improve user satisfaction, efficiency, and safety. The rapid spread of COVID-19, which began in 2019, caused significant damage global medical system. In this situation, the need for a system to monitor multiple patients with ventilators was highlighted as a solution for various problems. Since medical device software is closely related to human life, ensuring their safety and satisfaction is important before their actual deployment in the field. In this study, a total of 21 participants consisting of respiratory staffs conducted usability test according to the use scenarios in the simulated use environment. Nine use scenarios were conducted to derive an average task success rate and opinions on user interface were collected through five-point Likert scale satisfaction evaluation and questionnaire. Participants conducted a total of nine use scenario tasks with an average success rate of 93% and five-point Likert scale satisfaction survey showed a high satisfaction result of 4.7 points on average. Users evaluated that the device would be useful for effectively managing multiple patients with ventilators. However, improvements are required for interfaces associated with task that do not exceed the threshold for task success rate. In addition, even medical devices with sufficient safety and efficiency cannot guarantee absolute safety, so it is suggested to continuously evaluate user feedback even after introducing them to the actual site.

• Nuclear Medicine and Molecular Imaging
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• v.41 no.1
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• pp.68-69
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• 2007

A 44-year-old female underwent three-phase bone scintigraphy for an evaluation of right hip joint pain. The blood-flow and blood-pool images show a pelvic blush with a photopenic center (doughnut) prior to bladder filling. On the three hour delayed image, the pelvic uptake disappeared. The scintigraphic findings indicated the possibility of an early pregnancy. However, plain radiography demonstrated an intrauterine device. A uterine doughnut developed as a result of photon attenuation of intrauterine device.

• Korean Journal of Digital Imaging in Medicine
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• v.10 no.2
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• pp.33-37
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• 2008

To keep the online medical records available to anyone without constraint of time and space, introducing EMR (Electronic medical record), which is a clinical support management system. The purpose of this study is to develop interface standard of clinical test device. Integration and sharing of medical information is faced with enormous obstacles because medical organizations and associated companies are separately developing the interface. I hope that multi-function management system with workstation concept is operated to efficiently transmit clinical device result data based on this study. Transfer of precise medical result data available for decision making will improve quality of health care service.

• Journal of the Korean Society for Precision Engineering
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• v.33 no.11
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• pp.937-941
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• 2016

Stand-alone cervical cage consists of a PEEK body, Ti plate, and screw, which are configured as a single-piece. Through a single operation, this implantable medical device is capable of completely fixing the cervical vertebral body. For example, instead of a plate, which is normally used, the intervertebral disc is removed and replaced with a cervical cage. It should be noted that in Korea, KFDA guidelines for a stand-alone cervical cage have not yet been suggested. Therefore, the aim of this study is to present the systematic study of the static compression test, static torsion test, dynamic compression test, and expulsion test. Further, the test method is designed to refer to the ASTM standard and relative literature.

• Journal of Acupuncture Research
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• v.32 no.4
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• pp.91-102
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• 2015

Objectives : The Oriental medical device industry is expected to continue to experience significant growth. It should increase its global market share rather than focusing on the domestic market. Countries around the world self-regulate their domestic market, so this study aims to aid in the development of a particular overseas market by introducing the U.S.(the largest market) medical device registration and approval process. Methods : For an understanding of the US medical device licensing process, we researched the relevant regulatory organization (FDA), the history, definition and classification of medical devices, the approval and 510(k) submission process related to substantial equivalence, IEC 60601-1 Edition 3, usability tests, and so on. Results : Medical devices in the United States are assigned to one of three regulatory classes: Class I, Class II and Class III, based on the level of control necessary to assure the safety and effectiveness of the device. If a company's device is classified as Class II and if it is not exempt, a 510k will be required for marketing. 1) A 510(k) is a premarket submission made to the FDA to demonstrate that the new device to be marketed is "substantially equivalent" to a legally marketed device (predicate device) 2) The IEC 60601-1 Edition 3 preparation process, which contains information related to usability, is expensive and time-consuming but a critical requirement. Conclusions : Although the U.S. market has high barriers to entry, access to this, large overseas market will encourage development of the Oriental medical device industry and commercial value enhancement is expected.

• The Journal of the Korean dental association
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• v.56 no.9
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• pp.479-490
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• 2018

3D printing technology supporting the specific patient medical services is actively being implemented in dentistry. The purpose of this study is to introduce the legal and institutional considerations to the medical practitioners in dentistry who must observe when they manufacture medical devices using 3D printers, and to provide a ways to activate and enhance their utilization in the domestic approval point of view for medical devices. Through the public data of government agencies and related organizations, the statutory system and compliance matters related to the manufacture of 3D printing medical devices have been examined and reviewed for the government's improvement efforts. Through the study, the government has been actively improving the system and making policy, but the active interest and participation of medical professionals and related workers are continually required to solve the problems which are scattered. 3D printing technology is expected to be more frequently utilized in the field of dentistry in near future. Therefore, it is essential to establish measures to improve the regulation through continuous cooperation with the related ministries with the long-term point of view enhancing smooth entry to the market for the medical devices by taking data from the continued research.