Ha, Tae-Sung;Ahn, Cheol;Jung, Pyeong-Hwan;Cho, Jeong-Hee;Lee, Jong-Seok;Lee, Hye-Nam;Yoo, Beong-Gyu
Journal of radiological science and technology
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v.33
no.4
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pp.387-394
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2010
In the field of healthcare, the conventional sterilization treatments have been replaced by irradiation methods which are in accordance with internationally well established quality standards. The quality control in radiation sterilization assures that the absorbed dose of the irradiated material is in agreement with its requirements and standards. The electron beam irradiation requires technical assessments of more process parameters than gamma irradiation does. Korea has witnessed wide uses of electron accelerators since early 2000 but there hasn't been research experiences relating to quality system in accordance with international standards. The new large scale e-beam irradiation system with the specification of 10 MeV, 8 kW was installed and operated in 2008 by Seoul Radiology Services Co. It consists of the electron accelerator, product handling system, safety, documentation and control subsystems into an integrated system to meet the requirement of the Good Manufacturing Practice such as process quality assurance and management of product tracking records. To implement the international standard such as EN ISO11137, it is necessary to understand the purposes aimed in the standard and carry out the tests following the procedures required. This study presented the specification of the e-beam facility and showed what its design requirements and features are. The test results on a variety of process parameters were presented and validated it they are within the required limits.
Park, Junhyun;Ho, YeJi;Lee, Duck Hee;Choi, Jaesoon
Journal of Biomedical Engineering Research
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v.40
no.5
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pp.215-221
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2019
The respiratory medical device is a medical device that delivers optimal oxygen or a certain amount of humidification to a patient by delivering artificial respiration to a patient through a machine when the patient has lost the ability to breathe spontaneously. These include respirators for use in chronic obstructive pulmonary disease and anesthesia or emergency situations, and positive airway pressure devices for treating sleep apnea, and as the population of COPD (chronic obstructive pulmonary disease) and elderly people worldwide surge, the market for the respiratory medical devices it is getting bigger. As the demand for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, the boundaries between the items are blurred due to the purpose, intended use, and method of use overlapping similar items in a respiratory medical device. In addition, for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, in this study, we propose clear classification criteria for the respiratory medical devices according to the purpose, intended use, and method of use and provide safety and performance evaluation guidelines for those items to help quality control of the medical devices. And to contribute to the rapid regulating and improvement of public health. This study investigated the safety and performance test methods through the principles of the respiratory medical device, national and international standards, domestic and international licensing status, and related literature surveys. The results of this study are derived from the safety and performance test items in the individual ventilator(ISO 80601-2-72), the International Standard for positive airway pressure device (ISO 80601-2-70), The safety and performance of humidifiers (ISO 80601-2-74) and the safety evaluation items related to home healthcare environment (IEC 60601-1-11), In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers and importers, certified test inspection institutions, academia, etc., the final guidelines were established through revision and supplementation. Therefore, in this study, we propose guidelines for evaluating the safety and performance of the respiratory medical device in accordance with growing technology development.
Objective : This study aimed to develop prototypes of "smart stacking cones" by combining ICT to evaluate and train the upper extremity function and dual task performance in patients with central nervous system impairment, and to identify the complementary point to the completion of the device through a usability test. Methods : This prototype comprised of a hardware and software system that enabled the evaluation and training of patients and the management of data obtained from patients' performance. Specific measurement variables were established so that patient performance could be measured correctly. Based on the measurement variables, a the prototype included a 'single task evaluation modes', 'dual task evaluation mode', 'single task training mode', and 'dual task training modes'. Additionally, a usability test was conducted to assess clinical applicability and overall satisfaction for the prototype. Results : The results of the usability test were generally found to be appropriate. The 'content adequacy' in the usability test was the area with the highest level of adequacy and the lowest level of inadequacy. Additionally, overall 'satisfaction' in the usability test was the area with the highest appropriate and inappropriate levels. Hence, the overall satisfaction results were unstable. Conclusion : Future studies should be conducted to identify the clinical effectiveness of the device by applying an upgraded smart stacking cone to an actual patient group.
Kim, Sun Hee;Kim, Kwang kee;Jeong, Won Mee;Lee, Jeong Weon
재활복지
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v.17
no.4
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pp.401-420
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2013
This study was performed to investigate the impact of the Neurocognitive Rehabilitation Therapy on the upper limb function recovery of patients with stroke and their abilities to perform daily activities and to provide basic data for a long-term treatment. A total of 30 patients with hemiplegia that occurred due to stroke were recruited as subjects of the present study, and 15 patients were randomly assigned to a Neurocognitive Rehabilitation Therapy group and a conventional treatment group, respectively. And, tests were performed over four weeks, five times a week, and 30 minutes a session. Manual Function Test(MFT), Fugl-Meyer Assessment Scale(FMA), and Korean-Modified Bathel Index(K-MBI) were used to measure the degree of the functional recovery before and after the experiment. According to the data of this study, in the upper limb function test, the Neurocognitive Rehabilitation Therapy group showed significant increase of the measurement values of MFT and FMA(p <.05), and when the difference between the two groups were compared, the upper limb function showed a statistically significant difference. In the daily activity performance test, only the Neurocognitive Rehabilitation Therapy group showed a significant improvement of K-MBI value(p <.05). Based on the results of the present study, it was demonstrated that the Neurocognitive Rehabilitation Therapy was effective in enhancing the upper limb functions and daily activity performance of patients with stroke.
The purpose of this study is to check the extent to which "instruction of physician or dentist" defined in the Medical Service Technologists, etc. Act is applied in relation to radiography examination procedures for radiological technologists. In addition, it is intended to present basic data on the requirement to revise the Medical Service Technologists, etc. Act in the radiological technologist's duty area and scope of work, The subjects of this study were radiological technologists with license, and the response data were collected after sending the questionnaire link written on the online questionnaire form. The final number of respondents were 1,018, and the response rate was 6.8%. Most of the negative responses were "I have never received 'instruction' for radiologic examination by a physician or dentist, including a radiologist in a medical environment." There were a high perception that "the professionalism in radiation examination on radiological technologists are higher than that of a physician or dentist." They answered that the current continuing education has a great impact on maintaining and continuing professionalism and learning new knowledge in the radiology field. In addition, the radiological technologists provide a very high level of education in areas related to radiography procedure ethics such as patient care, patient safety, and patient privacy protection, as well as specialized fields such as radiation-related examination methods, radiography examination dose, and patient exposure dose. Radiological technologists replied that they were receiving it consistently. In conclusion, in the current medical environment, the 'instruction' of a physician or dentist cannot be seen as being realistically performed. The phrase 'instruction' of a physician or dentist as defined in the Medical Service Technologists, etc. Act is considered inappropriate in respect of the fact that the state recognizes the qualifications of the medical service technologist through a license. It is thought that revision to a new term suitable for the current medical environment is necessary.
Objectives : Practice-Based Research Networks (PBRNs), collaborations of practitioners and academic researchers, have provided platforms for conducting research to address clinical questions generated from daily routine care. This review aimed to critically analyse articles from PBRNs that are related to complementary and integrative medicine (CIM) and to suggest future directions for a PBRN which is appropriate for Korean Medicine (KM). Methods : PubMed, PBRN registries in Agency for Healthcare Research and Quality and relevant PBRN websites were searched up to November 2019 for research articles from PBRNs that focused on CIM regardless of study design. Methodological quality of the included studies was assessed. The included studies were read in full, classified and summarised according to their topics. Results : A total of 51 articles published from 1998 through 2020 were included in this review. They were categorised into three principal themes based on research questions and findings: health services research (embracing researches examining characteristics of patients and CIM practitioners/practices, and communication between patients and practitioners); effectiveness and safety of CIM practices/interventions; and feasibility studies of instruments and interventions in PBRN settings. The study designs varied including surveys (n=30), prospective observational studies (n=6), 2ndary analyses of existing studies (n=7), protocols (n=7), retrospective chart review (n=1) and qualitative study (n=1). Quality of the included studies greatly varied. Conclusions : PBRNs can serve as a feasible platform for conducting practice-relevant research on KM and CIM. Considering growing demands on evidence-base for routine practice of KM amid various stakeholders, a PBRN in KM community and further researches nested within PBRN designs are warranted.
Objective : This study aimed to verify the effectiveness of ICT-Living Lab-based programs to promote the health of elderly residents in small and medium-sized cities, thus, providing basic data for solving the health and quality of life problems faced by modern society. Methods : The tow-month program included 14 elderly individuals visiting senior center located in W City, from October to November 2019. The program was organized by consulting four senior experts and one ICT expert. The program consisted of 10 min for advance assessment, 10 min for preparation activities, 30 min for main activities, and 10 min for finishing, and 60 min for eight sessions over two months, once a week. Results : EQ-5D increased from 0.76 to 0.84, compared to pre-assessment(p=.009*). EQ-VAS scores increased from 36.43 to 65.71 (p=.001*). MMSE-DS increased from 21.21 to 24.14 (p=.000*). SGDS-K decreased from 3.36 to 3.21, but this was not statistically significant (p=.854). Conclusion : The ICT·Living Lab-based program could be used as a basic material for future research as one of the ways to improve health and quality of life by preventing and addressing the problems faced by the elderly in modern society.
Medical information is variously generated not only from medical devices but also from electronic devices. Recently, related convergence technologies from big data collection in healthcare to medical AI products for patient's condition analysis are rapidly increasing. However, there are difficulties in applying them because of independent developmental procedures. In this paper, we propose an intelligent hospital information system (iHIS) model to simplify and integrate research, development and application of medical AI technology. The proposed model includes (1) real-time patient data management, (2) specialized data management for medical AI development, and (3) real-time monitoring for patient. Using this, real-time biometric data collection and medical AI specialized data generation from patient monitoring devices, as well as specific AI applications of camera-based patient gait analysis and brain MRA-based cerebrovascular disease analysis will be introduced. Based on the proposed model, it is expected that it will be used to improve the HIS by increasing security of data management and improving practical use through consistent interface platformization.
A guideline for determining the optimal catheter length according to the patient's physique during tunnel-type dialysis catheter insertion used in renal failure patients is presented, and the maintenance of the function of the dialysis catheter is evaluated. From October 1, 2015 to February 31, 2016, a total of 110 (male : female = 73 : 37) patients who underwent tunnel-type dialysis catheterization performed at our hospital were treated without using guidelines. The group was divided into A group, and the group treated using the guideline into B group. Results were analyzed statistically using SPSS 20.0. As a result of the dialysis catheter insertion procedure according to the use of guidelines, the function maintenance rate of group A was 81.8%, and the function maintenance rate of group B was 96.3%. In the case of tunnel dialysis catheter procedure, the function maintenance effect was statistically significant in the group treated using the guideline compared to the group not using it (p<0.05). It can be said that it is more effective when information on the patient's underlying disease is reflected in addition to the use of guidelines.
The purpose of this study was to identify the influencing factors of subjective health status among the subjects of the 7th year 3 (2018) National Health and Nutrition Examination Survey, and to help provide programs for improving subjective health status in the future. Data from the 7th Korea National Health and Nutrition Examination Survey(2018) were used. Variables were age, gender, age, subjective health status, subjective body shape recognition, weight change over the past year, usual stress level, walking days per week, and strength training days per week. The higher the number of walking days per week, the lower the usual stress perception level. As the number of strength training days per week increased, the level of stress perception was lower (p<.001). The subjects' subjective health status was found to have a negative effect on their usual stress perception (β=-.759), subjective body shape (β=.111), age (β=.421), and number of days walking per week. (β=.968). Based on this study, it is intended to provide basic data for preparing programs to help improve stress perception and subjective health status in the future.
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