• Journal of the Korean Society of Safety
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• v.27 no.2
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• pp.92-97
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• 2012

Risk management is the process that helps to identify hazards, analyze them, and then to create an action plan to avoid and mitigate these hazards. The main objective of risk management in product development and manufacturing is to provide safe and efficient products without spending too many resources. Medical device manufacturers also face enormous risks - regulatory, legal, and financial - based on their products and processes, and the concepts of risk management are particularly important because any single failure may result in serious damages to body or loss of life. In this regard, a set of guidelines for the application of risk management to medical devices has been issued by ISO and specified in the document ISO 14971 Medical devices - Application of risk management to medical devices. The main objective of this study is to investigate the application of risk management to dental implant development and manufacturing processes based on ISO 14971. A general risk management process is first introduced, and the application of ISO 14971 to dental implants is further investigated.

• Journal of radiological science and technology
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• v.47 no.3
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• pp.183-195
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• 2024

Additional functional upgrades to the large-area compton camera (LACC) measurement device that can provide characteristics evaluation information (nuclear species and radioactivity) and two-dimensional or three-dimensional distribution imaging information of radioactive materials existing in surface or internal of concrete structures are required in terms of work stability and efficiency in order to apply to actual decommissioning sites such as nuclear power plants or medical cyclotron facilities by using this measurement device. To this purpose, the technology that allows radiation workers to intuitively and visually check the distribution of radioactive materials in advance by matching the two-dimensional distribution imaging information of radioactive materials obtained through the LACC measurement device and visual imaging of the measurement zone (10 m × 5 m) was developed. In addition, the separate system that can automatically adjust the position (height) in units of the measurement area size (0.7 m × 0.3 m × 0.8 m) of the LACC measurement device was developed and the integrated management system for characteristics evaluation information and two-dimensional or three-dimensional distribution imaging information obtained per unit of measurement for radioactive materials was developed. These functional upgrades related to LACC measurement device can improve work efficiency and safety when measuring radioactivity of concrete structures and enable the establishment of appropriate decommissioning strategies using radioactivity measurement information for decommissioning nuclear power plants or medical cyclotron facilities.

• Proceedings of the KSME Conference
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• 2008.11a
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• pp.1419-1426
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• 2008

Fulminant hepatic failure is a clinical syndrome associated with a high mortality rate. Orthotopic liver transplantation is the only clinically proven effective treatment for patients with end-stage liver disease who do not respond to medical management. A major limitation of this treatment modality is the scarcity of donor organs available, resulting in patients dying while waiting for a donor liver. An extracorporeal bioartificial liver (BAL) device containing viable hepatocytes has the potential to provide temporary hepatic support to liver failure patients, serving as a bridge to transplantation while awaiting a suitable donor. In some patients, providing temporary hepatic support may be sufficient to allow adequate regeneration of the host liver, thereby eliminating the need for a liver transplant. Although the BAL device is a promising technology for the treatment of liver failure, there are several technical challenges that must be overcome in order to develop systems with sufficient processing capacity and of manageable size. In this overview, the authors describe the critical issues involved in developing a BAL device. They also discuss their experiences in hepatocyte culture optimization within the context of a microchannel flat-plate BAL device.

• Journal of Veterinary Clinics
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• v.39 no.1
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• pp.9-15
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• 2022

As more veterinary clinics become specialized with the growth of the companion animal market, an increasing number of veterinary clinics perform orthopedic surgery and use orthopedic products, some of which are defective and have side effects. Thus, the present study aimed to prepare fundamental data for the revision and development of manufacturing standards for these products in order to prevent their side effects. We conducted a survey targeting veterinary clinics as consumers and medical device companies as suppliers. Veterinary clinics were surveyed via offline and online methods; 320 clinics that offered orthopedic surgery and approximately 4,000 veterinary clinics that were registered in the Korean Veterinary Medical Association were targeted, and 153 veterinary clinics responded to the survey. The survey for medical device companies, was performed online, targeting 29 companies; 14 companies responded. The number of side effects of orthopedic products was higher in animal orthopedic products than in those for human use. Many consumers tended to suspect that side effects were caused by product defects. To resolve side effects after using orthopedic products, consumers mostly underwent reoperation. Meanwhile, some severe cases proceeded to legal disputes. Similarly, medical device companies, or the suppliers, responded that most side effects occurred in veterinary orthopedic products and that product defects and mistakes in use were the causes. As for most of the follow-up actions for side effects, these companies either reported the issue to those in charge or analyzed and resolved the issues themselves. Therefore, to develop quality products, suppliers should be provided with clear standards for the production, and information disclosure and a report system for side effects should be particularly established to gain consumers' trust regarding the safety of these products.

• Journal of Biomedical Engineering Research
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• v.43 no.4
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• pp.199-213
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• 2022

EN ISO 14971:2012 a risk management standard approved and applied as a European standard in 2012, will be adopted and applied as ISO 14971:2019 published in December 2019, ISO/TR 24971(Guidance) published in June 2020 from May 2022. After that, it is applied to IVDD surveillance and IVDR new and conversion, and the manufacturer is already preparing for application or is starting preparation for application. In addition, 98/78/EEC IVDD applied from 1998 will also be applied as REGULATION (EU) 2017/746 IVDR from May 2022. In particular, in IVDR, the requirements for post-marketing investigations such as Post Market Surveillance (PMS), Summary of safety and performance(SSP), Periodic Safety Update Report(PSUR) and Post Market Performance Follow Up(PMPF), which were not required in the existing IVDD, increased, and the contents were also specified. This study focused on ISO14971:2019 among these strengthened and newly applied regulations, and tried to present a detailed analysis and application plan of Post Market Surveillance (PMS) required by 2017/746 IVDR.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.19 no.11
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• pp.157-165
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• 2018

Companies conduct R&D for continuous development and enhancement of corporate value, and obtain patents as an intangible asset resulting from this process. This study screened 103 medical device firms whose R&D information, patent information, and management performance information were all published to determine how R&D activities and patents affect corporate operational performance. The number of patents, R&D costs, company type and Inno-Biz of the company were set as independent variables, and the companies' sales, intangible assets, operating profit ratios, net profit margins, corporate ratings and profit-related financial ratios were used as dependent variables. The results confirmed that R&D expenditure had negative (-) effects on most indicators, including sales volume, operating profit ratio, and net profit ratio, while it had positive (+) [ED highlight - these are unnecessary if negative and positive are also written out.] effects only on intangible assets. Additionally, domestic patents were found to have negative (-) effects on sales, cash flow ratings, and dropped capital return, and positive (+) effects on net profit growth. Moreover, the business performance variables affected by the company characteristics were sales volume and cash flow ratings. The medical device industry is dominated by small and medium-sized businesses Although research and development activities and patents have been shown to have a negative impact on corporate management in the short term, they are expected to have a positive long-term impact when reflecting the characteristics of the medical device industry that must undergo clinical trials and authorization procedures after R&D.

• Korean Journal of Clinical Pharmacy
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• v.33 no.4
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• pp.221-241
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• 2023

Background: The purpose of this systematic review was to investigate the effects of digital therapeutics for insomnia on sleep disorders and mental health improvement compared to the control group. Methods: Following the guidelines on systematic review(PRISMA, NECA), a literature search was conducted through PubMed, Cochrane Library, EMBASE, RISS, KISS, and KoreaMed using keywords. The Cochrane Risk of Bias Tool and Review Manager version 5.3 were used for risk of bias and effect size assessment. Results: Thirty eight RCT met criteria for inclusion. When compared against three control conditions, the digital therapeutics for insomnia was an effective intervention for improvement sleep disorders and mental health in comparison to waiting list and Patient-directed care with some intervention by medical staff. However, digital therapeutics for insomnia were no more effective than face-to-face CBT-I control group. Conclusion: The efficacy of digital therapeutics for insomnia was evaluated differently depending on the control group. Therefore, in phase 3 clinical trials for efficacy evaluation, it is necessary to review whether the control group has been properly established.

• Journal of radiological science and technology
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• v.22 no.2
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• pp.33-39
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• 1999

This paper included a data analysis of the unit of medical devices using mainternance recording card that had medical devices of unit failure mode, hospital of failure mode and MTBF. The results of the analysis were as follows : 1. Medical devices of unit failure mode was the highest in QC/PM such A hospital as 33.9%, B hospital 30.9%, C hospital 30.3%, second degree was the Electrical and Electronic failure such A hospital as 23.5%, B hospital 25.3%, C hospital 28%, third degree was mechanical failure such A hospital as 19.5%, B hospital 22.5%, C hospital 25.4%. 2. Hospital of failure mode was the highest in Mobile X-ray device(A hospital 62.5%, B hospital 69.5%, C hospital 37.4%), and was the lowest in Sono devices(A hospital 16.76%, B hospital 8.4%, C hospital 7%). 3. Mean time between failures(MTBT) was the highest in SONO devices and was the lowest in Mobile X-ray devices which have 200 - 400 failure hours. 4. Anverage failure ratio was the highest in Mobile X-ray devices(A hospital 31.3%, B hospital 34.8%, C hospital 18.7%), and was the lowest in Sono(Ultrasound) devices (A hospital 8.4%, B hospital 4.2%, C hospital 3.5%). 5. Failure ratio results of medical devices according to QC/PM part of unit failure mode were as follows ; A hospital was the highest part of QC/PM (50%) in Mamo X-ray device and was the lowest part of QC/PM(26.4%) in Castro X-ray. B hospital was the highest part of QC/PM(56%) in Mobile X-ray device, and the lowest part of QC/PM(12%) in Gastro X-ray. C hospital was the highest part of QC/PM(60%) in R/F X-ray device, and the lowest a part of QC/PM(21%) in Universal X-ray. It was found that the units responsible for most failure decreased by systematic management. We made the preventive maintenance schedule focusing on adjustement of operating and dust removal.

• Biomedical Engineering Letters
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• v.8 no.4
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• pp.399-404
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• 2018

The purpose of this study was to evaluate the accuracy of a mobile wireless digital automatic blood pressure monitor for clinical use and mobile health (mHealth). In this study, a manual sphygmomanometer and a digital blood pressure monitor were tested in 100 participants in a repetitive and sequential manner to measure blood pressure. The guidelines for measurement used the Korea Food & Drug Administration protocol, which reflects international standards, such as the American National Standard Institution/Association for the Advancement of Medical Instrumentation SP 10: 1992 and the British Hypertension Society protocol. Measurements were generally consistent across observers according to the measured mean ${\pm}SD$, which ranged in $0.1{\pm}2.6mmHg$ for systolic blood pressure (SBP) and $0.5{\pm}2.2mmHg$ for diastolic blood pressure (DBP). For the device and the observer, the difference in average blood pressure (mean${\pm}$SD) was $2.3{\pm}4.7mmHg$ for SBP and $2.0{\pm}4.2mmHg$ for DBP. The SBP and DBP measured in this study showed accurate measurements that satisfied all criteria, including an average difference that did not exceed 5 mmHg and a standard deviation that did not exceed 8 mmHg. The mobile wireless digital blood pressure monitor has the potential for clinical use and managing one's own health.

• Health Policy and Management
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• v.31 no.2
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• pp.148-157
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• 2021

Background: Based on that the key function of health technology is improving the quality of healthcare services, our study purports to explore the process of medical device development in detail and to discuss its policy implications. Methods: A total of 12 in-depth interviews were conducted with four groups of industry, hospital, academia, and civil society. All of the interviewees except those from civil society were involved in the new medical device development between 2009 and 2018. We performed a text network analysis and content analysis of the interview data. Results: The frequency and the degree centrality rankings suggested a close association between the utilization issue and the technology development. Similarly, the results of the content analysis showed that the appropriate intervention in the utilization of technology has a direct impact on the progress of development. Under the continuous industrial effort to boost profits by developing new technology, service providers and citizens should be knowledgeable of and make good use of the new technology for the provision of better services. Conclusion: As the development itself would not guarantee the improvement of service quality and better health outcomes, health technology policies should take a more comprehensive view to serve the unmet needs and even to facilitate the technology development.