• 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.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.

• Journal of Radiation Protection and Research
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• v.25 no.1
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• pp.31-36
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• 2000

In radiotherapy, it may happen to radiate surrounding normal tissue because of inconsistent field size by changing patient position during treatment. We are going to analyze errors reduced by using immobilization device with Electonic portal imaging device(EPID) in this study. We had treated the twenty-one patients in pelvic region with 10 MV X-ray from Aug. 1998 to Aug. 1999 at Chungnam National University Hospital. All patients were treated at supine position during treatment. They were separated to two groups, 11 patients without device and 10 patients with immobilization device. We used styrofoam for immobilization device and measured the errors of anterior direction for x, y axis and lateral direction for z, y axis from simulation film to EPID image using matching technique. For no immobilization device group, the mean deviation values of x axis and y axis are 0.19 mm. 0.48 mm, respectively and the standard deviations of systematic deviation are 2.38 mm, 2.19 mm, respectively and of random deviation for x axis and y axis are 1.92 mm. 1.29 mm, respectively. The mean deviation values of z axis and y axis are -3.61 mm. 2.07 mm, respectively and the standard deviations of systematic deviation are 3.20 mm, 2.29 mm, respectively and of random deviation for z axis and y axis are 2.73 mm. 1.62 mm, respectively. For immobilization device group, the mean deviation values of x axis and y axis are 0.71 mm. -1.07 mm, respectively and the standard deviations of systematic deviation are 1.80 mm, 2.26 mm, respectively and of random deviation for x axis and y axis are 1.56 mm. 1.27 mm, respectively. The mean deviation values of z axis and y axis are -1.76 mm. 1.08 mm, respectively and the standard deviations of systematic deviation are 1.87 mm, 2.83 mm, respectively and of random deviation for x axis and y axis are 1.68 mm, 1.65 mm, respectively. Because of reducing random and systematic error using immobilization device, we had obtained good reproducibility of patient setup during treatment so that we recommend the use of immobilization device in pelvic region of radiation treatment.

• 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.

• Journal of Biomedical Engineering Research
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• v.30 no.1
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• pp.23-33
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• 2009

It can be used easily to reduce rehabilitation and treatment time if diagnostic and therapeutic devices are attached to cloth or body. Therefore we developed neuromuscular wearable ultra-miniature lighting modules which can improve the neuromuscular function and verified its clinical effectiveness. The system is based on the ultra-miniature lighting treatment module and there are two types of systems. One of them is designed as an attached type and the other type is combined with clothing. The wearable ultra-miniature lighting module is composed of controller (battery, MCU, bidirectional transmitter and receiver), cable, treatment medium generating device and other peripheral devices. To verify the clinical effectiveness of this device, we observed the difference of the strength of a muscle before and after 650nm and 25mW laser irradiation on the reflex point for 1 to 4 seconds. Among 48 patients having the degenerative osteoarthritis, the muscle strength before and after irradiation of laser was $21.8{\pm}7.99$ and $27.3{\pm}8.43$. According to the result, the muscle strength after treatment was significantly increased (p<0.01). To whom having difficulty in visiting to OPD(Out-Patient Department), doctors medically examine the patients and find the therapeutic point, attachment of this wearable ultra-miniature lighting module can function as self treatment (treating instrument) and treatment assist at home. If doctor can remotely control the patient and take part in treatment, the therapeutic device could contribute to prevention and care 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.

• 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.

• 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.

• Radiation Oncology Journal
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• v.10 no.1
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• pp.101-105
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• 1992

Authors performed a stereotactic radiosurgery with multiple noncoplanar convergent photon beams of linear accelerator (NELAC-1018 18 MeV, NEC) using a specially designed Yeungnam localization device for two patients with recurrent glioblastoma multiforme. One patient had 2 cm sized and the other 4 cm sized mass on the CT images. After single session of treatment with 15 and 20 Gy, headache was improved in a few days after radiosurgery with no remarkable untoward reactions. Our experience with these two patients were encouraging and we found that our localization device, which is easily adjustable and inexpensive, could be a valuable tool for stereotactic radiosurgery particularly in the treatment of recurrent brain tumor.

• Applied Science and Convergence Technology
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• v.25 no.6
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• pp.103-107
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• 2016

The use of nanovesicles (NVs) has contributed to nanotechnology in the development of new concept medicine to compete with diseases of deleterious and infectious to human health. Due to their properties of size, morphology, and biocompatibility NVs have great impact on public health especially in the development of new therapeutic and prophylaxis approaches in addition to the device for biosensors to diagnose human diseases. Recent data also strongly suggest that NVs are regarded as innovative materials in developing for vaccines and diagnostic tools. In this review, we focus on the basic concepts and recent applications of NVs to utilize or engineer them as therapeutic materials.