• Korea Journal of Hospital Management
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• v.23 no.4
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• pp.15-25
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• 2018

Purposes: The objectives of this study present the direction of the criteria for the separately reimbursement of therapeutic medical device. Methodology: We summarized experts' opinion using Delphi survey and Analytic Hierarchy Process(AHP). 48 experts were gathered from Medical Insurance Review Nurses Association, medical device industry, academy and association, Medical Device Expert Evaluation Committee. Descriptive statistics, consistency index, content validity ratio were analyzed. Findings: Clinical utility, patient safety, infection control, cost-homogeneity, cost-effectiveness showed high feasibility and importance, but market contribution and functional utility showed low feasibility and importance in a relative sense. The results of functional utility differed between clinical and non-clinical experts. Measurability was low across the whole area. Among the criteria for the separately reimbursement of therapeutic medical device. Patient safety/infection control and clinical utility showed the highest relative importance values, analyzed using AHP. Practical Implications: Patient safety and infection control are needed to be considered as one of Value Assessment Criteria. It is important to find out how to improve the measurability of therapeutic medical device.

• Journal of Biomedical Engineering Research
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• v.44 no.5
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• pp.315-323
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• 2023

The objective of this study is to identify the selective application targets for reporting on details of supply of class 1 and 2 medical devices as part of the improvement of the reports on details of supply of medical device system, and to analyze its effectiveness. Therapeutic materials covered by health insurance and secondhand medical devices were chosen based on the transparency of health insurance coverage and the management of medical device distribution. As a result, approximately 85% of groups can be excluded from the reporting requirements compared to reporting all items under Class 1 and 2 medical devices. This is expected to enhance the efficiency of supply reporting tasks. Additionally, the information on supply details managed by the regulatory authority can be utilized for statistical analysis and periodic monitoring, serving as fundamental data for the development of medical device-related policies and research in the field of medical devices.

• Investigative Magnetic Resonance Imaging
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• v.25 no.4
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• pp.218-228
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• 2021

Due to their high degree of freedom to transfer and acquire light, fiber optics can be used in the presence of strong magnetic fields. Hence, optical sensing and imaging based on fiber optics can be integrated with magnetic resonance imaging (MRI) diagnostic systems to acquire valuable information on biological tissues and organs based on a magnetic field. In this article, we explored the combination of MRI and optical sensing/imaging techniques by classifying them into the following topics: 1) functional near-infrared spectroscopy with functional MRI for brain studies and brain disease diagnoses, 2) integration of fiber-optic molecular imaging and optogenetic stimulation with MRI, and 3) optical therapeutic applications with an MRI guidance system. Through these investigations, we believe that a combination of MRI and optical sensing/imaging techniques can be employed as both research methods for multidisciplinary studies and clinical diagnostic/therapeutic devices.

• The Journal of Korean Medicine
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• v.35 no.3
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• pp.103-115
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• 2014

Objectives: The purpose of this survey was to investigate the need for new medical devices based on opinions of members of the Korean medical society. Methods: We distributed two independent questionnaires sequentially over two-week intervals to 16,510 doctors via the Korean Medical Society, and received replies from 888 and 928 doctors, respectively. The survey was carried out through a web-based questionnaire system. The first questionnaire focused on demand for new diagnostic and therapeutic medical devices that are specific for Korean medicine (KM). In contrast, the second questionnaire focused on demand for new hybrid medical devices which are useful both in Western medicine (WM) and KM. Results: In purchase intention of Korean medical devices (KMDs), demand for diagnostic devices was greater than for therapeutic ones. Among diagnostic devices, the purchase intention of 'imaging devices' ranked the highest and was followed by 'musculoskeletal diagnostic devices'. Among therapeutic KMDs, the purchase intention of 'musculoskeletal treatment devices' ranked the highest, followed by 'cranial nerve rehabilitation devices'. In the purchase intention of hybrid medical devices that can be used both in WM and KM, 'ultrasonic-based medical device' ranked the highest, followed by 'MRI-based medical device'. Conclusions: There is increasing demand for clinically useful medical devices among Korean medical doctors. Within demand for new devices, hybrid devices that can be used in both WM and KM were most strongly desired. This survey will be useful in establishing strategic plans for the development of medical devices in KM. Keywords: Korean medicine, medical device, demand survey, questionnaire.

• Journal of Biomedical Engineering Research
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• v.31 no.2
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• pp.129-133
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• 2010

Intense pulsed light(IPL) is a photo-therapeutic medical device using xenon lamps with optical characteristics of incoherence, defocusing, and polychromatic. IPL has been recognized as a representative medical therapeutic device with growth of domestic skin care market. However, there is no standard regulation manual and guideline to evaluate the safety and performance of IPL. International Electrotechnical Commission(IEC) is being statued "Technical Report IEC TR 60825-16" which is a guidelines for the safe use of intense light source equipment on humans and animals. In this study, a standard Korea Food & Drug Administration (KFDA) regulation for the safety and performance of IPL was suggested by developing minimal evaluation methods for optical parameters of IPL such as output energy density, pulse mode, spot size, wavelength and uniformity of output light. We expect that this study may be a step to statue a standard regulation manual and guideline for IPLs used in domestic.

• Journal of Biomedical Engineering Research
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• v.36 no.5
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• pp.162-168
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• 2015

In this study, we suggested the performance and safety testing guideline for low intensity pulsed ultrasound (LIPUS) represented by the ultrasound fracture treatment device and cartilage treatment device and low intensity focused ultrasound (LIFU) represented by ultrasonic face lifting device. For these study, the international standards and management regulations of Korea, Japan and United State were analyzed. And the usefulness and applicability were evaluated by testing with commercial equipment and reflecting the views of the industry and experts. As a result of this study, the safety and performance test guidelines for low intensity therapeutic ultrasound device were proposed by presenting the 10 items for LIPUS and 12 items for LIFU. The suggested guidelines are considered a high utilization in the domestic testing and approval authorities. And they are also thought to be useful to new technology development.

• The Korean Journal of Emergency Medical Services
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• v.20 no.1
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• pp.7-15
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• 2016

Purpose: There are few studies on the quality of cardiopulmonary resuscitation (CPR) performed by a single rescuer using a bag-valve-mask device. The aim of this study is to compare CPR quality outcomes according to the rescuer's position or mask fixation grip method and to determine the optimal means of achieving therapeutic goals. Methods: The three CPR methods were defined as over-the-head, lateral-superior, and lateral-inferior, depending on the rescuer's position or mask fixation hand placement. CPR quality was estimated for 83 paramedic students who performed 5 minutes of CPR in a randomized sequence on a manikin using each of the three methods. Results: The over-the-head method showed no advantage for cardiac compression and ventilation quality, but minimized the rescuer's fatigue score. Conclusion: In contrast to previous studies or prevailing beliefs, the lateral-superior position is optimal for achieving therapeutic goals with moderate or minimal rescuer fatigue.

• The Journal of Korean Medicine
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• v.34 no.1
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• pp.69-79
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• 2013

Objectives: The aim of this survey was to investigate utilization, intended use, problems with and demand for medical devices by surveying members of the traditional Korean medical society. Methods: We distributed questionnaires to 13,957 traditional Korean medical doctors via e-mail, and received replies from 1,225. The questionnaire consisted of 4 multiple-choice questions for survey respondent information, 8 multiple-choice questions about the status of medical devices utilizing, and a short answer question about the demand for medical devices. Results: Use of medical devices in traditional Korean medical clinics is common. Diagnostic medical devices are mainly used to assess the patient's condition and to establish a close rapport with clients. In case of therapeutic medical devices, they are usually used for secondary treatment. Issues with traditional Korean medical devices currently in use were ineligibility for national health insurance, low reliability, uncertain validity, and high price. In development of traditional Korean medical equipment, the need for diagnostic medical devices was greater than for therapeutic, and the need for the recording and analysis of medical image data and visualization of medical information was great. Conclusions: There is growing demand for facilitating the development and commercialization of traditional Korean medical devices. To satisfy this demand, research on evaluation indicators that reflect functional and structural clinical information and how to clinically assess the indicators should proceed.

• Radiation Oncology Journal
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• v.12 no.2
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• pp.191-199
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• 1994

Purpose : This study was undertaken to show the clinical results of combined radiotherapy and hyperthermia in primary hepatoma Materials and Methods : Between December 1989 and March 1993, 50 patients with hepatomas were treated by combined radiotherapy and hyperthermia. Among them, we analyzed retrospectively 33 patients who received the complete course of treatment. The ages of the patients ranged from 36 to 75(mean age: 55.5 years). Twenty-six patients ($78.8\%$) were men, and 7 ($21.2\%$ were women. According to Child's classification, nine patients ($27.3{\%}$) were A group, 9 ($27.3\%$) were B group, 15 ($45.4\%$) were C group. Radiation therapy was done by a 6 MV and 15 MV linear accelerator. Patients were treated with daily fractions of 150-180 cCy to doses of 2550 cGy -4950 cGy (median : 3000 cGy). Local hyperthermia was done by 8 MHZ RF capacitive heating device (Cancermia. Green Cross Co., Korea), 50-60 min/session, 1-2 sessions/wk, and 8.5 sessions (median number)/patient. We analyzed the prognostic factors including age, sex, tumor type, Child's classification, $\alpha$-fetoprotein, liver cirrhosis, ascites, portal vein invasion, esophageal varix, number of hyperthermia, chemotherapy, total bilirubin level, Karnofsky perfomance status. Results : The overall 1-year survival was $24.2\%$, with a mean survival of 10months. Of 33 patients, tumor regression (PR+MR) was seen in $30.4\%$, no response was seen in $52.2\%,\;17.4\%$ patient was progressed. In patients who had tumor regression, the overall 1-year survival was $42.1\%$ with a mean survival of 14 months. Factors influencing the survival were sex (p=0.05), tumor type (p=0.0248), Child's classification (p=0.0001), liver cirrhosis (p=0.0108), ascites (p=0.0009), and Karnofsky perfomance status (p=0.0028). Complications developed in 28 patients, including 18 hot pain,5 fat necrosis, 3 transient fever, 2 nausea and vomiting. Conclusion : In this study, the results suggests that combined radiotherauy and hyperthermia may improve the survival rate of hepatoma.

• Journal of Biomedical Engineering Research
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• v.44 no.6
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• pp.428-442
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• 2023

In this study, we have a goal to develop usability evaluation guidelines for heuristic-based artificial intelligence-based Software as a Medical Device (SaMD) in the medical field. We conducted a gap analysis between medical hardware (H/W) and non-medical software (S/W) based on ten heuristic principles. Through severity assessments, we identified 69 evaluation domains and 112 evaluation criteria aligned with the ten heuristic principles. Subsequently, we categorized each evaluation domain into five types, including user safety, data integrity, regulatory compliance, patient therapeutic effectiveness, and user convenience. We proposed usability evaluation guidelines that apply the newly derived heuristic-based Software as a Medical Device (SaMD) evaluation factors to the risk management process. In the discussion, we also have proposed the potential applications of the research findings and directions for future research. We have emphasized the importance of the judicious application of AI technology in the medical field and the evaluation of usability evaluation and offered valuable guidelines for various stakeholders, including medical device manufacturers, healthcare professionals, and regulatory authorities.