• 한국산학기술학회논문지
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• 제19권6호
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• pp.382-390
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• 2018

본 연구에서는 국제기준 및 산업환경 변화에 따른 의료기기 품질경영 평가모델, 즉 의료기기 제조기업의 품질경영시스템의 인허가와 상시점검에 필요한 평가기준의 구성요소를 도출하고, 이를 평가도구로 의료기기 제조기업에 적용하여 실행수준의 평가 및 경영성과에 미치는 영향을 검증하였다. 본 연구에서는 선행연구 검토, 전문가 면담조사에 따라 예비항목을 마련하고, 기획, 실시, 점검, 조치 등 4개 영역의 요인으로 대분류 항목을 정의한 후, 각각의 평가계층과 평가항목을 구성하였으며, AHP에 의한 가중치와 중요도를 산출하였다. 그 결과, 기획 요인에서는 책임의 명확화와 품질관리 목표설정의 항목, 실시 요인에서는 개별제품을 중심으로 한 요구사항의 관리 및 설계 개발 프로세스의 관리에 관한 평가항목, 점검 요인에서는 정보의 측정 분석에 대한 관리항목, 조치 요인에서는 인증기준 및 법규, 규제에 대한 검토항목이 상대적으로 중요하게 나타났다. 이에 도출된 평가모델을 평가도구로 삼아 의료기기 제조기업에 적용함으로써, 품질경영 실행수준의 평가와 경영성과에 미치는 영향을 조사 분석하였다. 연구대상 의료기기 제조기업들은 비교적 양호한 수준의 품질경영 실행수준을 보이고 있고, 이를 통해 일정수준의 경영성과를 얻고 있는 것으로 나타났다. 또한, 각 요인과 평가계층들이 대부분 경영성과에 유의한 영향을 미치는 것으로 분석되었다. 특히 의료기기 품질경영시스템은 인허가 취득이 주목적이지만, 인허가와 직접적인 관련이 없는 경영환경적 요소들이 중요하며, 기업 내 외부에서 이러한 요소들이 연계성을 갖고 통합적으로 운영되는 것이 효과적이라는 점을 알 수 있었다.

• 대한의용생체공학회:의공학회지
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• 제44권1호
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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.

• 한국IT서비스학회지
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• 제22권4호
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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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• 제11권1호
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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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• 제51권1호
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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.

• 동의생리병리학회지
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• 제20권5호
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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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• 제16권5호
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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.

• 종양간호연구
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• 제11권1호
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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.

• 의료법학
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• 제21권2호
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• pp.209-244
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• 2020

TMS와 tDCS는 자기와 전류를 통하여 뇌에 자극을 가함으로서 환자나 개별 이용자의 질병을 치료하고, 이외에도 건강을 관리하거나 증진시킬 수 있는 비침습적 기기를 말한다. 이들 기기의 효과와 안전성은 몇몇 질병에서 입증되고 있으나, 아직도 이에 대한 연구는 진행 중이다. 점차 증가하고 있는 이들 기기의 활용도에 비해 TMS와 tDCS를 직접 규율하는 입법례를 찾기는 어렵다. 미국, 독일, 일본의 TMS와 tDCS에 대한 법적 규율을 살펴보면, TMS는 중등도의 위해도를 가진 의료기기로 승인되어 있는 반면, tDCS는 아직 의료기기로 승인된 상태는 아니다. 하지만, 최근 FDA 가이드집이나 유럽 MDR 규정의 변화, 미국의 리콜사례, 독일과 일본의 관련 법 규정, 전문가 그룹의 제언 등을 검토하면, tDCS도 조만간 의료기기로 승인되어 규율될 것으로 보인다. 물론, tDCS를 의료기기가 아닌 일반제품으로 보더라도 다른 법률과 제도를 통하여 제품의 안전성과 효과를 규제할 수는 있다. 그러나 이 기기가 인간의 뇌에 미칠 수 있는 여러 영향을 고려할 때, 이를 독자적으로 규율할 필요성이 크다. 우리도 TMS와 tDCS를 규율하는 명시적 법률은 없으나, 이 두 기기는 식약처 고시에 따라 3등급 의료기기로 판정된다. 그리고 TMS는 가이드 라인에 따라 미국 FDA 지침에 의해 안전성과 성능을 평가하도록 하고 있다. 하지만, tDCS는 아직 이에 대한 구체적 지침은 존재하지 않는다. tDCS 기기가 일부 병원에서, 그리고 개별 구매자를 통하여 가정에서 사용되고 있는 현실을 고려하면, 이러한 규제의 공백은 신속히 보완되어야 한다. 장기적으로는 비침습적 뇌자극기기를 독자적으로 규율할 수 있는 법적 시스템의 정비가 필요하다.

• Archives of Plastic Surgery
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• 제46권4호
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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.