• 대한수의학회지
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• 제55권2호
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• pp.97-103
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• 2015

In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.

• 한국산업경영시스템학회:학술대회논문집
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• 한국산업경영시스템학회 2002년도 춘계학술대회
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• pp.421-426
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• 2002

• Korean Journal of Radiology
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• 제24권10호
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• pp.1038-1041
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• 2023

• 대한의용생체공학회:의공학회지
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• 제38권6호
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• pp.321-329
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• 2017

This paper presents a bone metastasis Detection algorithm on abdominal computed tomography images for early detection using fully convolutional neural networks. The images were taken from patients with various cancers (such as lung cancer, breast cancer, colorectal cancer, etc), and thus the locations of those lesions were varied. To overcome the lack of data, we augmented the data by adjusting the brightness of the images or flipping the images. Before the augmentation, when 70% of the whole data were used in the pre-test, we could obtain the pixel-wise sensitivity of 18.75%, the specificity of 99.97% on the average of test dataset. With the augmentation, we could obtain the sensitivity of 30.65%, the specificity of 99.96%. The increase in sensitivity shows that the augmentation was effective. In the result obtained by using the whole data, the sensitivity of 38.62%, the specificity of 99.94% and the accuracy of 99.81% in the pixel-wise. lesion-wise sensitivity is 88.89% while the false alarm per case is 0.5. The results of this study did not reach the level that could substitute for the clinician. However, it may be helpful for radiologists when it can be used as a screening tool.

• 한국인공지능학회지
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• 제11권2호
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• pp.39-44
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• 2023

The creativity of thesis is that the significance of cyber security challenges in blockchain. The variety of enterprises, including those in the medical market, are the targets of cyberattacks. Hospitals and clinics are only two examples of medical facilities that are easy targets for cybercriminals, along with IoT-based medical devices like pacemakers. Cyberattacks in the medical field not only put patients' lives in danger but also have the potential to expose private and sensitive information. Reviewing and looking at the present and historical flaws and vulnerabilities in the blockchain-based IoT and medical institutions' equipment is crucial as they are sensitive, relevant, and of a medical character. This study aims to investigate recent and current weaknesses in medical equipment, of blockchain-based IoT, and institutions. Medical security systems are becoming increasingly crucial in blockchain-based IoT medical devices and digital adoption more broadly. It is gaining importance as a standalone medical device. Currently the use of software in medical market is growing exponentially and many countries have already set guidelines for quality control. The achievements of the thesis are medical equipment of blockchain-based IoT no longer exist in a vacuum, thanks to technical improvements and the emergence of electronic health records (EHRs). Increased EHR use among providers, as well as the demand for integration and connection technologies to improve clinical workflow, patient care solutions, and overall hospital operations, will fuel significant growth in the blockchain-based IoT market for linked medical devices. The need for blockchain technology and IoT-based medical device to enhance their health IT infrastructure and design and development techniques will only get louder in the future. Blockchain technology will be essential in the future of cybersecurity, because blockchain technology can be significantly improved with the cybersecurity adoption of IoT devices, i.e., via remote monitoring, reducing waiting time for emergency rooms, track assets, etc. This paper sheds the light on the benefits of the blockchain-based IoT market.

• 한국임상수의학회지
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• 제35권1호
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• pp.1-6
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• 2018

This study reviewed the regulatory safety management system for prevention of side effects of veterinary medical devices in Korea based on data obtained through analyses of those medical devices. In order to ensure the safety of medical devices, Ministry of Food and Drug Safety has established the management system include licensing, test inspection (134 designated clinical trial agencies) and post management. In addition, it was introduce the good manufacture practice (GMP) certification system and device tracking requirements. In contrast, it is necessary to establish regulations for side effects report and awareness on veterinary medical devices in Korea. The center for veterinary medicine of FDA in the United States has been operated side effects reporting system of veterinary medical devices from user, manufactures and distributor. Due to increase the use of various kinds of veterinary medical devices for animals, it should be required to improve regulation related to the licensing procedures, GMP system, and the side effects reporting system in our country.

• 보건행정학회지
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• 제26권1호
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• pp.63-70
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• 2016

Background: Selective health benefit was introduced for decreasing economic burden of patients. Medical devices with economic uncertainty have been covered as selective health benefit by National Health Insurance since December 2013. We aimed to analyze impact of selective health benefit to medical expenditure and provider behavior focused on electrosurgery (ultrasonic shears, electrothermal bipolar vessel sealers) for gastric cancer patients covered since December 2014. Methods: We used the National Health Insurance claims data of 2,698 patients underwent gastric cancer surgery between August 2014 and March 2015. Medical cost and patient sharing per inpatient day were analyzed to verify that covering electrosurgery increased medical expenditure and changed provider behavior from open surgery to endoscopic or laparoscopic surgery. Additionally, we analyzed the claim rate of medical device or goods relating gastric endoscopic and laparoscopic surgery. Results: Medical cost and patient sharing per inpatient day were increased after covering electosurgery as selective health benefit (39,724/1,421 won). However, there were no medical expenditure increases after adjusting claim of electosurgery and patient sharing was decreased 1,057 won especially. The coverage of selective health benefit did not increase the claim rate of medical device or goods related endoscopic or laparoscopic surgery, either. Conclusion: Covering electosurgery decreased patient economic burden and did not change of provider behavior. Expanding selective health benefit is needed to decrease economic burden of severe patients. Further study should evaluate the long term effect with accumulated data.

• 품질경영학회지
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• 제41권4호
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• pp.659-672
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• 2013

Purpose: The purpose of this study was to estimate life time of halogen lamps and acceleration factors using accelerated life test. Methods: Voltage was selected as an accelerating variable through the technical review about failure mechanism. The test was performed at 14.5V, 15.5V and 16.5 for 4,471 hours. It was assumed that the lifetime of Halogen lamps follow Weibull distribution and the inverse power life-stress relationship models. Results: Mean lifetimes of pin and screw types were 19,477 hours and 6,056 hours, respectively. In addition, acceleration factor of two items are calculated as 4.8 and 2.2 based on 15.5V, respectively. Conclusion: The life-stress relationship, acceleration factor, and MTTF at design condition are estimated by analyzing the accelerated life test data. These results suggest that voltage was very important factor to accelerate life time in the case of halogen lamps and the life time of pin type is three times longer than screw type lamps.

• 벤처창업연구
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• 제7권1호
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• pp.67-72
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• 2012

본 연구는 국내 벤처기업에서 세계 최초로 제조된 요실금 치료기기의 유럽시장 진출을 위하여 국내외 의료기기 시장의 환경변화에 대하여 서술하고 요실금과 치료방법, 그리고 신제품의 특성 및 유럽 요실금 치료기기 시장을 분석하여 유럽시장 진출 방안을 제시하였다. 그 결론으로 국내 의료기기 벤처기업에서 세계 최초로 개발된 요실금 치료기기를 유럽시장에 판매하기 위해서는 다음과 같은 전략이 필요하다. 첫째, 시장침투수준을 증가시키기 위하여 국내 업체는 유럽에서 개최되는 관련 학회 및 전시회 참가 등을 통하여 유럽의 가정의와 비뇨기과 의사들에게 국내에서 개발된 요실금 치료 장비에 대한 인식을 높이는 전략이 필요하다. 둘째, 개성 있는 독특한 제품임과 치료방법의 제시, 그리고 감염률을 줄일 수 있는 비용-효과적인 제품이라는 점의 강조가 필요하다. 셋째, 요실금 치료기기 시장의 경쟁이 심화되고 있는 상황에서 국내의 요실금 치료기기 제조업체는 품질을 확보하면서 가격을 낮출 수 있는 방법 모색을 통하여 품질과 배송, 그리고 가격의 일관성을 제시하여야 할 것으로 연구되었다.

• 재활복지공학회논문지
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• 제8권2호
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• pp.79-88
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• 2014

국내에서 전기적 자극방식 삼킴 보조 치료기는 높은 보급률과 사용빈도를 가진 전문 의료기기임에도 불구하고 기기에 대한 관리체계가 전무하여 유지 보수의 측면에 있어서도 매우 큰 취약성을 노출해 왔다. 이에 본 연구는 전기적 자극방식 삼킴 보조 치료기의 장비관리 및 안전진단 매뉴얼 개발에 목적을 두고 프로그램을 개발하였다. 이를 위하여 국제전기기술위원회(International Electrotechnical Commission, IEC)등의 기관에서 공시한 표준화된 프로그램 수집과 문헌고찰을 통해 매뉴얼 개발의 근거를 마련하고, 프로토콜을 개발하여 제시하였다. 완성된 알고리즘과 프로토콜, 지표 등의 자료를 전문가 및 현장 실무자의 자문을 통하여 수정 및 보완하고 유지보수 워크시트(Maintenance Worksheet)의 5지표 18항목, 삼킴 보조 전자 의료기기 장비관리/안전진단 절차 매뉴얼(Equipment Procedure Manual)에서 4개 지표 32항목으로 구성된 점검 매뉴얼을 최종적으로 완성하였다. 완성된 지표는 장비의 고장률을 줄이고 의료기록 문서화의 체계성 제고에 도움을 줄 것이며, 의료서비스의 효율성, 적절성을 유지하는데 기여할 수 있을 것이라 생각된다.