• Journal of the Korea Academia-Industrial cooperation Society
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• v.19 no.6
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• pp.382-390
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• 2018

This study developed a model to evaluate the quality management system of a medical device manufacturing company, and applied it to medical device manufacturers to understand the impact on business performance in response to international regulations and industry's change. This study prepared preliminary items, defined four (4) major factors (Plan-Do-Check-Act) that consist of the evaluation layers and items per category according to prior research review and expert interview, and calculated the weight and importance using AHP. The study results showed that responsibility & authority and quality objective in Planning Category, product-related requirement and R&D in Doing Category, Measuring and monitoring in Check Category, and review of meeting Regulatory and regulation in Action Category are relatively more important factors. The evaluation model developed based on the calculated weight and importance to business performance was applied to medical device manufacturers to investigate and analyze the implementation level of QMS and its impact on business performance according to each category. Most medical device manufacturers to be studied showed a reasonable level of QMS and effective business performance. Almost all the evaluation layers and items in the four (4) factors had a significant influence on business performance. Although the medical device quality management system is aimed mainly at license acquisition, it is important that management environment factors not related directly to licensing and authorization are important to business performance, and it is effective when these factors are integrated and operated within and outside the manufacturer.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.41-52
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• 2023

With the international change in the medical device market owing to the development of innovative medical engineering and the use of various raw materials, a systematic and rational medical device classification system is needed to safely manage newly developed medical devices. This study aims to improve the domestic medical device classification system by proposing product establishment and segmentation. It is based on medical device products from the United States and Europe that are only available in foreign systems and are more subdivided than domestic products. This study analyzes and compares the domestic and foreign medical device classification systems by examining laws, guidelines, and analysis reports in Korea, the United States, and Europe. In accordance with product establishment and segmentation criteria, products subject to improvement are presented. This study contributes to safely managing medical devices that do not fit with the current classification system and to solving the confusion caused by the lack of international harmony in product classification systems.

• Journal of Information Technology Services
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• v.22 no.4
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• pp.21-35
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• 2023

Software as Medical Devices (SaMD) is a growing category of medical devices that are composed of software to perform one or more medical purposes. SaMD is less likely to cause physical harm compared to conventional medical devices, particularly medical electrical equipments, and may be more vulnerable to privacy issues. This difference was acknowledged and resulted in introducing new regulation guidance specifically for cybersecurity of SaMD. It guides stakeholders of SaMD what to consider in what context in terms of cybersecurity. This study examines the current guidance of how cybersecurity is considered for SaMD by analyzing current medical device standards, then suggest which concept or details beyond current medical device standards may be applicable through analysis of international standards documents published for software in general.

• International journal of advanced smart convergence
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• v.11 no.1
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• pp.111-116
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• 2022

After COVID-19, the number of people with sleep disorders around the world is increasing. In particular, in the flow of the 4th industrial revolution, the differentiation of types and characteristics of the sleep industry is accelerating. Therefore, in this study, the characteristics of each type of sleep-related industry were reclassified from an industrial point of view, and based on this, an attempt was made to review the classification system that can help companies develop sleep products and improve related national systems. Based on the 10th standard industry classification, we compared input cost, value, and usability and analyzed common characteristics, treatments, and preventive effects based on this. A comprehensive taxonomy using matrix analysis was reviewed. As a result, in terms of cost (A), the most common sleeping products are general mattresses and general bedding. It is an IOT device (auxiliary device), and the value aspect (B, B/D) included sleep cafe, bedding rental and management service, and sleep consulting. In terms of utility (A/B), a total of 6 product groups including sleep aids (health functional foods) belong to this category, and in terms of treatment (A/C), a total of 3 product groups including sleep clinics (medical services) belong to this category. As for the product group (A/D) with both properties, it was found that non-insurance sleep treatment medical devices, sleep-related over-the-counter drugs, and some sleep monitoring applications belong to this category. Ultimately, it was found that the sleep industry classification enables the most active product development and composition according to the relative relationship between cost and utility, and treatment and utility. appeared to be necessary.

• Journal of Periodontal and Implant Science
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• v.51 no.1
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• pp.30-39
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• 2021

Purpose: The present study was undertaken to examine whether periodontal probe visibility (PV) accurately reflects gingival thickness (GT) and to identify factors affecting PV using cluster and multivariate analyses. Methods: The clinical characteristics of the maxillary central incisors (n=90 subjects) were examined. Clinical photographs, sex, PV, probing depth, gingival width, papilla height, GT as measured with an ultrasonic device, and the ratio of crown width to crown length were recorded. Multivariate analysis, using multinomial baseline-category logistic regression, was used to identify factors predictive of PV. Cluster analysis was used to identify gingival biotypes. Results: In the multivariate analysis, sex was the only significant predictor of PV (odds ratio, 6.48). Two clusters of subjects were created based on morphometric parameters. The mean GT among cluster A subjects was significantly lower than that among cluster B subjects (P=0.015). No significant difference was found between cluster A and B subjects in terms of PV score (P=0.583). Conclusions: Periodontal PV was not associated with GT as measured directly using an ultrasonic device. Sex was a highly significant predictor of periodontal PV. GT was found to be correlated with morphological characteristics of the periodontium.

• Journal of Physiology & Pathology in Korean Medicine
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• v.20 no.5
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• pp.1102-1110
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• 2006

Sambyun(三變) is standard classification for nine palace. Through sambyun you can define new meaning of 'self' in three perspective ways. First 'self' could mean desire, emotion and memory which are ontological values. second, 'self' could mean id, ego, and superego which are practical values. Third 'self' could mean unconscious, preconscious and conscious which are epistemological values. Samjae(三才) is method that analyze things base on common features. Sa sang is method that analyze things base on difference. They both are device that searching for reason. If you put one's mind in center to observe the universe creativity of great absolute and symmetry distinction of yingyang produces jeung(情), supreme intelligence(神), and soul(魂魄). With these facts identity of the heaven(天), earth(地) and man(人) which is named samjae(三才) generates symbols of independent sasang(四象). And also, sasang generates relations between five element(五行), six energy(六氣). From ten shen(十神) relation comes seven feelings(七情) of man which creates a category of the eight trigrams(八卦) for divination and unification of nine palace(九宮). All these process are united.

• Asian Pacific Journal of Cancer Prevention
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• v.16 no.5
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• pp.1715-1718
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• 2015

Background: Magnetic resonance imaging of breast, reported to be a high sensitivity of 94% to 100%, is the most sensitive method for detection of breast cancer. The purpose of this study was to investigate our clinical experience in MRI-guided breast lesion wire localization in Chinese women. Materials and Methods: A total of 44 patients with 46 lesions undergoing MRI-guided breast lesion localization were prospectively entered into this study between November 2013 and September 2014. Samples were collected using a 1.5-T magnet with a special MR biopsy positioning frame device. We evaluated clinical lesion characteristics on pre-biopsy MRI, pathologic results, and dynamic curve type baseline analysis. Results: Of the total of 46 wire localization excision biopsied lesions carried out in 44 female patients, pathology revealed fourteen malignancies (14/46, 30.4%) and thirty-two benign lesions (32/46, 69.6%). All lesions were successfully localized followed by excision biopsy and assessed for morphologic features highly suggestive of malignancy according to the American College of Radiology Breast Imaging Reporting and Data System (BI-RADS) category of MRI (C4a=18, C4b=17, C4c=8,C5=3). Of 46 lesions, 37 were masses and 9 were non-mass enhancement lesions. Thirty-two lesions showed a continuous kinetics curve, 11 were plateau and 3 were washout. Conclusions: Our study showed success in MRI-guided breast lesion wire localization with a satisfactory cancer diagnosis rate of 30.4%. MRI-guided wire localization breast lesion open biopsy is a safe and effective tool for the workup of suspicious lesions seen on breast MRI alone without major complications. This may contribute to increasing the diagnosis rate of early breast cancer and improve the prognosis in Chinese women.

• Asian Oncology Nursing
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• v.11 no.1
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• pp.1-8
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• 2011

Purpose: The purpose of this study was to identify the types of venous access devices (VAD) for cancer patients and investigate the factors related to the insertions of central venous catheter (CVC) in cancer patients. Methods: The subjects were 379 cancer patients. A retrospective review of all patients who were discharged from a cancer unit from November 1st to 21st in 2008 was done using a structured questionnaire. Results: A total of 82 CVC (21.6%) was inserted among 379 patients for administering anticancer therapy. There were statistically significant differences in age, length of stay (LOS), cumulative LOS, medical department, history of CVC insertion, cancer category, and albumin level between patients using peripheral intravenous (IV) catheters and CVC. In addition, factors influencing the use of CVC were LOS (odds ratio [OR]=0.286, confidence interval [CI]=1.043-1.124), history of CVC insertion (OR=3.920, CI=0.128-0.637), albumin level (OR=1.010, CI=1.879-8.179), cumulative LOS (OR=1.010, CI=1.001-1.018), and hematological diseases (OR=4.863, CI=2.162-10.925). Conclusion: We found that central venous catheterization for anticancer therapy was minimal even though CVC was safe and effective device for IV access. It is necessary to develop a strategy to use VADs efficiently and timely for cancer patients.

• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.209-244
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• 2020

TMS and tDCS are non-invasive devices that treat the diseases of patients or individual users, and manage or improve their health by applying stimulation to a brain through magnetism and electricity. The effect and safety of these devices have proved to be valid in several diseases, but research in this area is still much going on. Despite increasing cases of their application, legislations directly regulating TMS and tDCS are hard to find. Legal regulation regarding TMS and tDCS in the United States, Germany and Japan reveals that while TMS has been approved as a medical device with a moderate risk, tDCS has not yet earned approval as a medical device. However, the recent FDA guidance, European MDR changes, recalls in the US, and relevant legal provisions of Germany and Japan, as well as recommendations from expert groups all show signs of tDCS growing closer to getting approved as a medical device. Of course, safety and efficacy of tDCS can still be regulated as a general product instead of as a medical device. Considering multiple potential impacts on a human brain, however, the need for independent regulation is urgent. South Korea also lacks legal provisions explicitly regulating TMS and tDCS, but they fall into the category of the grade 3 medical devices according to the notifications of the Korean Ministry of Food and Drug Safety. And safety and efficacy of TMS are to be evaluated in compliance with the US FDA guidance. But no specific guidelines exist for tDCS yet. Given that tDCS devices are used in some hospitals in reality, and also at home by individual buyers, such a regulatory gap must quickly be addressed. In a longer term, legal system needs to be in place capable of independently regulating non-invasive brain stimulating devices.

• Archives of Plastic Surgery
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• v.46 no.4
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• pp.303-310
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• 2019

Background Prosthetic hands with a myoelectric interface have recently received interest within the broader category of hand prostheses, but their high cost is a major barrier to use. Modern three-dimensional (3D) printing technology has enabled more widespread development and cost-effectiveness in the field of prostheses. The objective of the present study was to evaluate the clinical impact of a low-cost 3D-printed myoelectric-interface prosthetic hand on patients' daily life. Methods A prospective review of all upper-arm transradial amputation amputees who used 3D-printed myoelectric interface prostheses (Mark V) between January 2016 and August 2017 was conducted. The functional outcomes of prosthesis usage over a 3-month follow-up period were measured using a validated method (Orthotics Prosthetics User Survey-Upper Extremity Functional Status [OPUS-UEFS]). In addition, the correlation between the length of the amputated radius and changes in OPUS-UEFS scores was analyzed. Results Ten patients were included in the study. After use of the 3D-printed myoelectric single electromyography channel prosthesis for 3 months, the average OPUS-UEFS score significantly increased from 45.50 to 60.10. The Spearman correlation coefficient (r) of the correlation between radius length and OPUS-UEFS at the 3rd month of prosthetic use was 0.815. Conclusions This low-cost 3D-printed myoelectric-interface prosthetic hand with a single reliable myoelectrical signal shows the potential to positively impact amputees' quality of life through daily usage. The emergence of a low-cost 3D-printed myoelectric prosthesis could lead to new market trends, with such a device gaining popularity via reduced production costs and increased market demand.