• 제목/요약/키워드: Device safety

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A Comparative Study on the Regulations on Implantable Bioabsorbable Combination Products -Focusing on the U.S., Europe and Korea- (이식형 흡수성 융복합 의료제품 규제 비교 연구 -미국, 유럽, 한국을 중심으로-)

  • Hyeon Jeong Lee;Mi Hye Kim;Ju Eun Seol;Su Dong Kim;Joo Hee Kim
    • Journal of Biomedical Engineering Research
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    • 제44권6호
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    • pp.414-427
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    • 2023
  • Implantable bioabsorbable combination products undergo inherent degradation and systemic absorption within the physiological environment, thereby streamlining the therapeutic regimen and obviating the imperative for invasive extraction procedures. This inherent property not only enhances patient convenience and therapeutic efficacy but also underpins a paradigm of support characterized by heightened safety parameters. Within the regulatory landscapes of Korea, the United States, and Europe, implantable bioabsorbable combination products are meticulously classified into distinct categories, either as pharmaceutical implants or as implantable medical devices, depending on their primary mode of action. This scholarly investigation systematically examines the regulatory frameworks governing implantable bioabsorbable combination products in South Korea, the United States, and Europe. Notable discrepancies across national jurisdictions emerge concerning regulatory specifics, including terminology, product classification, and product name associated with these products. The conspicuous absence of standardized approval regulations presents a formidable barrier to the commercialization of these advanced medical devices. This academic discourse passionately emphasizes the critical need for formulating and implementing a sophisticated regulatory framework capable of streamlining the product approval process, thereby paving the way for a seamless path to commercializing implantable bioabsorbable combination products.

Surgical Resection of Cardiac Hemangiosarcoma Using Articulated Surgical Stapler in a Dog

  • Woo-Jin Kim;Kyung-Min Kim;Won-Jong Lee;Chang-Hwan Moon;Hae-Beom Lee;Seong-Mok Jeong;Dae-Hyun Kim
    • Journal of Veterinary Clinics
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    • 제41권1호
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    • pp.37-42
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    • 2024
  • This case report discusses the successful surgical resection of cardiac hemangiosarcoma in a dog using an articulated surgical stapler. Cardiac tumors, particularly hemangiosarcomas, have a poor prognosis. Recommended treatment involves surgical removal of the primary tumor, along with chemotherapy. However, the use of staples for cardiac tumor resection has not yet been extensively documented in the veterinary literature. A 10-year-old dachshund with pericardial effusion underwent surgery to remove a right atrial mass. An articulated linear cutting stapler was used for tumor resection. The patient experienced chylothorax as a complication but recovered well. However, the patient later developed respiratory symptoms and died, most likely due to aspiration pneumonia. The surgical stapler provided stability, convenience, and a shorter surgical time during tumor resection. Surgical resection combined with chemotherapy improves the survival of dogs with cardiac hemangiosarcoma. The stability and adjustability of the stapling device make it advantageous for cardiac tumor resection. Although complications, such as chylothorax, can arise, appropriate management can lead to positive outcomes. This case report demonstrates the feasibility and safety of using an articulated surgical stapler for cardiac tumor resection in dogs. Insights from this case can guide future research and clinical practice.

A New Radiation-Shielding Device for Restraining Veterinary Patients

  • Songyi Kim;Minju Lee;Miju Oh;Yooyoung Lee;Jiyoung Ban;Jiwoon Park;Sojin Kim;Uhjin Kim;Jaepung Han;Dongwoo Chang
    • Journal of Veterinary Clinics
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    • 제40권6호
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    • pp.429-437
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    • 2023
  • In veterinary medicine, most radiographic images are obtained by restraining patients, inevitably exposing the restrainer to secondary scattered radiation. Radiation exposure can result in stochastic reactions such as cancer and genetic effects, as well as deterministic reactions such as skin burns, cataracts, and bone marrow suppression. Radiation-shielding equipment, including aprons, thyroid shields, eyewear, and gloves, can reduce radiation exposure. However, the risk of radiation exposure to the upper arms, face, and back remains, and lead aprons and thyroid shields are heavy, restricting movement. We designed a new radiation-shielding system and compared its shielding ability with those of conventional radiation-shielding systems. We hypothesized that the new shielding system would have a wider radiation-shielding range and similar shielding ability. The radiation exposure dose differed significantly between the conventional and new shielding systems in the forehead, chin, and bilateral upper arm areas (p < 0.001). When both systems were used together, the radiation-shielding ability was better than when only one system was used at all anatomical locations (p < 0.01). This study suggests that the new radiation-shielding system is essential and convenient for veterinary radiation workers because it is a step closer to radiation safety in veterinary radiography.

A Bibliometric Analysis of Research Trends in Domestic Integrative Medicine Journals : Focused on Integrative Medicine Research (국내 통합의학 저널의 연구 동향에 대한 계량서지학적 분석 : Integrative Medicine Research를 중심으로)

  • Dae-Jin Kim;Tae-Hyung Yoon;Jong-Rok Lee;Byung-Hee Choi
    • Journal of The Korean Society of Integrative Medicine
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    • 제12권2호
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    • pp.197-210
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    • 2024
  • Purpose : This study aimed to analyze research trends in the field of integrative medicine through a bibliometric analysis of articles published in Integrative Medicine Research (IMR) journal from 2017 to 2022. Methods : Articles published in IMR journal between 2017 and 2022 were searched using the Web of Science database on August 22, 2023. The analysis was performed using the Bibliometrix and Biblioshiny tools in R (version 4.3.1) and VOSviewer (version 1.6.19). Results : The key findings were as follows: average citations per article (9.41), total authors (1,142), single-authored articles (12), average articles per author (0.27), average co-authors per article (5.27), and rate of international co-authorships (15.69 %). The most-cited article was on the cryopreservation of cells or tissues and their clinical applications. The top keyword analysis by author keywords showed that "acupuncture" was the most frequently used keyword (33 times). Co-occurrence network analysis showed 85 high-frequency keywords that appeared five or more times, and the top five keywords by total link strength were "acupuncture," "herbal medicine," "prevalence," "alternative medicine," and "complementary." The study found that, contrary to the trend in complementary and alternative medicine research in Korea, the IMR journal actively conducts intervention studies to provide clinical evidence. Conclusion : In the IMR journal, "acupuncture" was the most frequent of author keywords. The analysis of keyword trend topics over time showed that the keyword "systematic review" continued to appear from 2020 to 2022, and the keyword "clinical practice guideline" appeared for the first time in 2021. In particular, the co-occurrence network analysis highlighted keywords related to intervention research, in contrast to domestic research trends. While this study analyzed only one journal, future studies expanding the category of integrative medicine and increasing the number of journals analyzed may provide further insights.

Integrity Guarantee System in IoT Virtual Environment Platform: Through Hyperedfger Indy and MQTT (IoT 가상환경 플랫폼에서의 무결성 보장 시스템:Hyperledger Indy와 MQTT를 통하여)

  • Yoosung Hong;Geun-Hyung Kim
    • Smart Media Journal
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    • 제13권4호
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    • pp.76-85
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    • 2024
  • In this paper, we propose a system that improves the data integrity of IoT(Internet of Things) devices in the virtual environment by combining Hyperledger Indy and MQTT(Message Queuing Telemetry Transport). The system complements the limitations of the centralized system by realizing a DPKI(Decentralized Public Key Infrastructure) structure that utilizes a distributed network in publish-subscribe(pub/sub) pattern communication. Digital signature technology was applied to ensure the data integrity of IoT devices and communication scenarios between the four core components of the client, IoT device, broker, and blockchain, as well as a topic structure using a decentralized identifier to ensure safety in the virtual environment. We present a systematic method for transparent data exchange. To prove the performance of the proposed system, this paper conducted experiments on four scenarios and evaluated communication performance in a virtual environment. The experimental results confirmed that the proposed system provides a reliable IoT data communication structure in a virtual environment.

Impact of a simple non-invasive nasal mask device on intraprocedural hypoxemia in overweight individuals undergoing upper gastrointestinal endoscopy with sedation provided by a non-anesthesiologist provider

  • Jan Drews;Jonas Harder;Hannah Kaiser;Miriam Soenarjo;Dorothee Spahlinger;Peter Wohlmuth;Sebastian Wirtz;Ralf Eberhardt;Florian Bornitz;Torsten Bunde;Thomas von Hahn
    • Clinical Endoscopy
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    • 제57권2호
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    • pp.196-202
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    • 2024
  • Background/Aims: Hypoxemia is a common side effect of propofol sedation during endoscopy. Applying mild positive airway pressure (PAP) using a nasal mask may offer a simple way to reduce such events and optimize the conditions for diagnostic and therapeutic upper gastrointestinal endoscopies. Methods: We compared overweight patients (body mass index >25 kg/m2) with a nasal PAP mask or standard nasal cannula undergoing upper gastrointestinal endoscopies by non-anesthesiologists who provided propofol sedation. Outcome parameters included the frequency and severity of hypoxemic episodes. Results: We analyzed 102 procedures in 51 patients with nasal PAP masks and 51 controls. Episodes of hypoxemia (oxygen saturation [SpO2] <90% at any time during sedation) occurred in 25 (49.0%) controls compared to 8 (15.7%) patients with nasal PAP masks (p<0.001). Severe hypoxemia (SpO2 <80%) occurred in three individuals (5.9%) in both groups. The mean delta between baseline SpO2 and the lowest SpO2 recorded was significantly decreased among patients with nasal PAP mask compared to controls (3.7 and 8.2 percentage points difference, respectively). There were significantly fewer airway interventions performed in the nasal PAP mask group (15.7% vs. 41.2%, p=0.008). Conclusions: Using a nasal PAP mask may be a simple means of increasing patient safety and ease of examination.

Home Bioelectrical Impedance Analysis Management System in Patients With Heart Failure: Rationale and Study Design

  • Min Gyu Kong;Inki Moon;Hye-Sun Seo;Jon Suh;Jah Yeon Choi;Jin Oh Na;Eung Ju Kim
    • International Journal of Heart Failure
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    • 제6권1호
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    • pp.22-27
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    • 2024
  • Body fluid monitoring and management are essential to control dyspnea and prevent re-hospitalization in patients with chronic heart failure (HF). There are several methods to estimate and monitor patient's volume status, such as symptoms, signs, body weight, and implantable devices. However, these methods might be difficult to use for reasons that are slow to reflect body water change, inaccurate in specific patients' condition, or invasive. Bioelectrical impedance analysis (BIA) is a novel method for body water monitoring in patients with HF, and the value in prognosis has been proven in previous studies. We aim to determine the efficacy and safety of home BIA body water monitoring-guided HF treatment in patients with chronic HF. This multi-center, open-label, randomized control trial will enroll patients with HF who are taking loop diuretics. The home BIA group patients will be monitored for body water using a home BIA device and receive messages regarding their edema status and direction of additional diuretics usage or behavioral changes through the linked application system once weekly. The control group patients will receive the usual HF management. The primary endpoint is the change in N-terminal prohormone of brain natriuretic peptide levels from baseline after 12 weeks. This trial will provide crucial evidence for patient management with a novel home BIA body water monitoring system in patients with HF.

An Empirical Study on the Next Generation Installation Device for Application to Multi-Mission Modular Weapon Systems (다중임무 모듈형 무기체계 적용 차세대 설치 장치 실증 연구)

  • Byeong-Jun An
    • The Journal of the Convergence on Culture Technology
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    • 제10권4호
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    • pp.757-761
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    • 2024
  • The need to acquire a multi-mission modular ship to carry out the mosaic warfare of modern warfare is increasing. In such a modular ship, not only domestic R&D equipment/systems but also an manned/unmanned complex system purchased overseas must be mounted together. In order to successfully design/construction a multi-mission modular prototype battle ship and turn it into timely power, it is necessary to apply a new technology so that it can be installed flexibly in a limited space and time. However, the existing welding installation method not only limits flexibility in design/construction due to safety problems, but also has an inherent problem that the cost and time required to correct defects and supplements are excessive. Therefore, this study introduces the current status of next-generation installation devices developed/applied in the advanced navy and the field demonstration results applied to battle ships to provide flexibility in this respect.

Development of Online Tritium Radiation Continuous Monitoring Measurement System and Analysis Optimization Techniques (온라인 삼중수소 방사능 연속모니터링 측정시스템 개발 및 분석 최적화 기법 개발)

  • Hongyeon Lee;Junghun Kim;Raehyun Lee;Yeongtae An;Byeongu Kim;Minjae Choi;Bogil Kim;Yongju Shin
    • Journal of Radiation Industry
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    • 제18권3호
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    • pp.155-166
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    • 2024
  • In this study, a liquid scintillation spectrometer was developed for online continuous monitoring of tritium nuclides in water. The device consists of two photoelectron multiplier tubes (PMT), a simultaneous counting circuit, and a signal processing unit including a multi-channel analyzer (MCA). As a method to verify the performance of the equipment developed in this study, samples were prepared using a standard source, and the spectrum of tritium was measured to evaluate the detector characteristics such as efficiency, background (BKG), and minimum detectable activity (MDA). To evaluate the effect of pretreatment on tritium radioactivity measurement results, the MDA of water (seawater and groundwater) samples before and after pretreatment was calculated and compared. The results of the evaluation confirmed the satisfaction of the reference values of the Nuclear Safety Commission's "Discharge Control Standard in Drainage Water" and the World Health Organization's (WHO) "Tritium Radioactivity Concentration for Drinking Water Standards". The liquid scintillation spectrometer developed in this study, with or without pretreatment, confirmed detection performance equivalent to 1/100th of the discharge control standard for drainage water (40,000 Bq L-1) and the WHO's drinking water standard for tritium radioactivity (10,000 Bq L-1).

Local Ablation for Hepatocellular Carcinoma: 2024 Expert Consensus-Based Practical Recommendations of the Korean Liver Cancer Association

  • Seungchul Han;Pil Soo Sung;Soo Young Park;Jin Woong Kim;Hyun Pyo Hong;Jung-Hee Yoon;Dong Jin Chung;Joon Ho Kwon;Sanghyeok Lim;Jae Hyun Kim;Seung Kak Shin;Tae Hyung Kim;Dong Ho Lee;Jong Young Choi
    • Korean Journal of Radiology
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    • 제25권9호
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    • pp.773-787
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    • 2024
  • Local ablation for hepatocellular carcinoma (HCC), a non-surgical option that directly targets and destroys tumor cells, has advanced significantly since the 1990s. Therapies with different energy sources, such as radiofrequency ablation, microwave ablation, and cryoablation, employ different mechanisms to induce tumor necrosis. The precision, safety, and effectiveness of these therapies have increased with advances in guiding technologies and device improvements. Consequently, local ablation has become the first-line treatment for early-stage HCC. The lack of organized evidence and expert opinions regarding patient selection, pre-procedure preparation, procedural methods, swift post-treatment evaluation, and follow-up has resulted in clinicians following varied practices. Therefore, an expert consensus-based practical recommendation for local ablation was developed by a group of experts in radiology and hepatology from the Research Committee of the Korean Liver Cancer Association in collaboration with the Korean Society of Image-guided Tumor Ablation to provide useful information and guidance for performing local ablation and for the pre- and post-treatment management of patients.