• 제목/요약/키워드: Hospital medical devices

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erratum : 전기식 온침기에 대한 안전성 및 성능평가 가이드라인 개발 연구 (erratum : A Study on Developing Safety and Performance Assessment Guideline for Electronic Warm-Acupuncture Apparatus)

  • 장한솔;정우령;문정현;최성경;성원석;황민섭;이승덕;김경호;윤종화;김은정
    • 대한한의학회지
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    • 제44권1호
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    • pp.128-128
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    • 2023
  • Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity. Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was drafted Results: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety. Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

Evaluations and Comparisons of Body Surface Doses during Breast Cancer Treatment by Tomotherapy and LINAC Radiotherapy Devices

  • Lee, Hyun-Jik;Bae, Sun-Hyun;Cho, Kwang Hwan;Jeong, Jae-Hong;Kwon, Su-Il;Lee, Kil-Dong
    • 한국의학물리학회지:의학물리
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    • 제28권4호
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    • pp.218-225
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    • 2017
  • Effects on skin caused by the dose from linear accelerator (LINAC) opposing portal irradiation and TomoDirect 3-D modeling treatment according to the radiation devices and treatment methods were measured, and a comparative analysis was performed. Two groups of 10 patients each were created and measurements were carried out using an optically stimulated luminescence dosimeter. These patients were already receiving radiation treatment in the hospital. Using the SPSS statistical program, the minimum and maximum average standard deviations of the measured skin dose data were obtained. Two types of treatment method were selected as independent variables; the measured points and total average were the dependent variables. An independent sample T-test was used, and it was checked whether there was a significance probability between the two groups. The average of the measured results for the LINAC opposing portal radiation was 117.7 cGy and PDD 65.39% for the inner breast, 144.7 cGy and PDD 80.39% for the outer breast, 143.2 cGy and PDD 79.56% for the upper breast, 151.4 cGy and PDD 84.11% for the lower breast, 149.6 cGy and PDD 83.11% for the axilla, and 141.32 cGy and PDD 78.51% for the total average. In contrast, for TomoDirect 3-D conformal radiotherapy, the corresponding measurement values were 137.6 cGy and PDD 76.44%, 152.3 cGy and PDD 84.61%, 148.6 cGy and PDD 82.56%, 159.7 cGy and PDD 88.72%, and 148.6 cGy PDD 82.56%, respectively, and the total average was 149.36 cGy and PDD 82.98%. To determine if the difference between the total averages was statistically significant, the independent sample T-test of the SPSS statistical program was used, which indicated that the P-value was P=0.024, which was 0.05 lower than the significance level. Thus, it can be understood that the null hypothesis can be dismissed, and that there was a difference in the averages. In conclusion, even though the treatment dose was similar, there could be a difference in the dose entering the body surface from the radiation treatment plan; however, depending on the properties of the treatment devices, there is a difference in the dose affecting the body surface. Thus, the absorbed dose entering the body surface can be high. During breast cancer radiotherapy, radiation dermatitis occurs in almost all patients. Most patients have a difficult time while undergoing treatment, and therefore, when choosing a radiotherapy treatment method, minimizing radiation dermatitis is an important consideration.

Clinical effectiveness of different types of bone-anchored maxillary protraction devices for skeletal Class III malocclusion: Systematic review and network meta-analysis

  • Wang, Jiangwei;Yang, Yingying;Wang, Yingxue;Zhang, Lu;Ji, Wei;Hong, Zheng;Zhang, Linkun
    • 대한치과교정학회지
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    • 제52권5호
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    • pp.313-323
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    • 2022
  • Objective: This study aimed to estimate the clinical effects of different types of bone-anchored maxillary protraction devices by using a network meta-analysis. Methods: We searched seven databases for randomized and controlled clinical trials that compared bone-anchored maxillary protraction with tooth-anchored maxillary protraction interventions or untreated groups up to May 2021. After literature selection, data extraction, and quality assessment, we calculated the mean differences, 95% confidence intervals, and surface under the cumulative ranking scores of eleven indicators. Statistical analysis was performed using R statistical software with the GeMTC package based on the Bayesian framework. Results: Six interventions and 667 patients were involved in 18 studies. In comparison with the tooth-anchored groups, the bone-anchored groups showed significantly more increases in Sella-Nasion-Subspinale (°), Subspinale-Nasion-Supramentale(°) and significantly fewer increases in mandibular plane angle and the labial proclination angle of upper incisors. In comparison with the control group, Sella-Nasion-Supramentale(°) decreased without any statistical significance in all treated groups. IMPA (angle of lower incisors and mandibular plane) decreased in groups with facemasks and increased in other groups. Conclusions: Bone-anchored maxillary protraction can promote greater maxillary forward movement and correct the Class III intermaxillary relationship better, in addition to showing less clockwise rotation of mandible and labial proclination of upper incisors. However, strengthening anchorage could not inhibit mandibular growth better and the lingual inclination of lower incisors caused by the treatment is related to the use of a facemask.

의료기기 네트워크 트래픽 보안 관련 머신러닝 알고리즘 성능 비교 (Performance Comparison of Machine Learning Algorithms for Network Traffic Security in Medical Equipment)

  • 고승형;박준호;왕다운;강은석;한현욱
    • 한국IT서비스학회지
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    • 제22권5호
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    • pp.99-108
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    • 2023
  • As the computerization of hospitals becomes more advanced, security issues regarding data generated from various medical devices within hospitals are gradually increasing. For example, because hospital data contains a variety of personal information, attempts to attack it have been continuously made. In order to safely protect data from external attacks, each hospital has formed an internal team to continuously monitor whether the computer network is safely protected. However, there are limits to how humans can monitor attacks that occur on networks within hospitals in real time. Recently, artificial intelligence models have shown excellent performance in detecting outliers. In this paper, an experiment was conducted to verify how well an artificial intelligence model classifies normal and abnormal data in network traffic data generated from medical devices. There are several models used for outlier detection, but among them, Random Forest and Tabnet were used. Tabnet is a deep learning algorithm related to receive and classify structured data. Two algorithms were trained using open traffic network data, and the classification accuracy of the model was measured using test data. As a result, the random forest algorithm showed a classification accuracy of 93%, and Tapnet showed a classification accuracy of 99%. Therefore, it is expected that most outliers that may occur in a hospital network can be detected using an excellent algorithm such as Tabnet.

족관절 골절 치료에 사용한 금속 내고정물 제거 수술 시 시행한 균 배양 검사의 결과 (Results of Culture Test at the Time of Removal of Metal Implants Used for Ankle Fracture Management)

  • 정형진;배서영;유재하
    • 대한족부족관절학회지
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    • 제18권2호
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    • pp.68-71
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    • 2014
  • Purpose: The purpose of this study is to report the results of culture test at the time of removal of metal devices used for management of ankle fractures and for analysis of contributing factors. Materials and Methods: We reviewed medical records of 132 patients with lower tibia and ankle fracture who had their metal devices removed during the period from January 2010 to February 2014. Patients with clinical signs of infection were excluded. Culture test was performed by taking the granulation tissue around the metal device at the time of removal. We divided the subjects into two groups, culture positive and negative. We then performed a retrospective review of each medical record of multiple factors that might contribute to the culture results, including laboratory results, medical history, material and size of metal device, indwelling period, and whether or not it was open injury. Results: Among 132 cases, six were culture positive. Enterococcus was detected in two cases and the others were Staphylococcus. No significant difference in medical history of patients and laboratory results, including C-reactive protein level, was observed between the culture positive and negative group. Culture positive rate was 5.4% in titanium and 3.9% in stainless steel. In terms of metal size, culture positive rate was 5.1% in small plates, 6.7% in large plates, and culture negative in intramedullary nails. The average indwelling period of metal device was 61.5 weeks in the culture positive group, and 68.6 weeks in the negative group. Nine cases were open fractures and all were in the culture negative group. Conclusion: Whether or not the culture result was positive, there were no meaningful contributing factors. Presence of bacterium on the metal device could not be screened by any laboratory results or other factors.

Safety Principles in the Application of Lasers in Energy-based Aesthetic Procedures from the Nurse's Perspective

  • Kim, Youn Jeong
    • Medical Lasers
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    • 제9권1호
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    • pp.34-38
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    • 2020
  • Recently, various lasers and energy-based devices (EBDs) have been widely used in aesthetic procedures. Although using lasers and energy-based aesthetic procedures presents a potential risk to doctors, nurses, and patients, aesthetic procedures tend to be performed without the necessary precautions. For injury prevention, it is essential to follow safety rules and be aware of potential accidents. Furthermore, it is important to understand the basic principles of the devices, including the different optical and electrical properties. Acquiring the exact knowledge to control a device is important for two reasons; to maintain a safer operating environment and prolong the lifespan of expensive devices. This review briefly summarizes the knowledge needed for better and safer aesthetic procedures and the proper control of aesthetic devices.

의료영상진단 기기 영상 품질 관리를 위한 비대면 모니터링 시스템 구축 (Construction of Untact Monitoring System for image quality management of medical imaging devices)

  • 김지언;임동욱;유영주;노시형;이충섭;문충만;김태훈;정창원
    • 한국컴퓨터정보학회:학술대회논문집
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    • 한국컴퓨터정보학회 2021년도 제63차 동계학술대회논문집 29권1호
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    • pp.45-46
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    • 2021
  • 의료영상이란 의료영상장비로부터 DICOM이라는 의료영상표준에 따라 저장되며, 의료영상관리 시스템인 PACS를 통해 관리된다. 이러한, 의료영상장비 ICT기술이 융합되어 급격하게 발전되고 있으며 다양한 의료영상장치가 개발되어지고 있다. 하지만, 기술력은 높아지고 있으나 개발된 의료영상장비로부터 촬영된 영상품질관리에 대한 문제점이 제기되고 있다. 이와 관련하여 다기관의 의료영상장비 개발과 해당 기기로부터 수집된 의료영상에 대한 품질을 관리할 필요성이 증가하고 있다. 따라서 코로나 19와 같은 상황에서 의료기기 개발 지원과 관리를 비대면 관리서비스 시스템 개발과 의료영상장치 개발 정도를 관리할 수 있을 뿐만 아니라 의료영상에 대한 품질까지 모니터링하여 및 개선 할 수 있는 시스템을 제안하고자 한다.

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표준전자식 혈압계와 수은혈압계, 전자혈압계의 비교 선행연구 (Comparison of Sphygmomanometer, Fully Automatic Electronic Blood Pressure Meters with Standard Digital Blood Pressure Monitor : Pilot Study)

  • 양지상;임현균;조동헌
    • 대한의용생체공학회:의공학회지
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    • 제33권3호
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    • pp.155-162
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    • 2012
  • Devices to measure the blood pressure of patients are being used without any calibration in a hospital. It is an important to show consistent values when any medical devices measure the same patients regardless they are sphygmomanometer or fully automatic electronic blood pressure meter. We compared sphygmomanometer and fully automatic electronic blood pressure meters with standard digital blood pressure monitor (SDBPM) to evaluate the consistency of the small healthy subjects. We measured the blood pressure from six healthy subjects (three of 20~40 years and three of 40~60 years old). Two sphygmomanometer and two fully automatic electronic blood pressure meters were used and compared with the SDBPM. Blood pressures measured from right and left arms each and were compared. All six healthy subjects showed normal blood pressure values. In general, left blood pressure values showed higher values than right side. Comparing SDBPM, with the other monitors, the systolic pressure showed ${\pm}$ 34.8% difference and ${\pm}$ 33.3% for the diastolic pressure. Correlation between SDBPM and Sphygmomanometer was 0.59~0.71, and 0.50~0.70 for fully automated digital BP monitors. It fell in grade-D when we apply the BHS(British hypertension society). AAMI(American association for the advancement of medical instrumentation) also showed unsatisfactory results for the mean value (${\leq}$ 5 mmHg) and standard deviation (${\leq}$ 8 mmHg). We tested sphygmomanometer and fully automatic electronic blood pressure meters and compared with a standard digital blood pressure monitor. All devices showed inconsistent blood pressures. A reliable calibration system is highly needed for all devices in all hospitals.

흉부 X선 인공지능 검출 보조 의료기기의 임상 적용: 현황 및 현실적 고려 사항 (Clinical Application of Artificial IntelligenceBased Detection Assistance Devices for Chest X-Ray Interpretation: Current Status and Practical Considerations)

  • 황의진
    • 대한영상의학회지
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    • 제85권4호
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    • pp.693-704
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    • 2024
  • 흉부 X선은 인공지능 기술이 활발히 적용되고 있는 대표적인 영상 검사이다. 흉부 X선 영상에서 다양한 이상 소견을 자동으로 검출하여 의사의 판독을 보조하는 인공지능 기반 소프트웨어 의료기기들이 국내에서 시판되고 있고, 임상 적용이 활발히 이루어지고 있다. 이러한 흉부 X선 인공지능 검출 보조 의료기기의 임상 도입에 있어, 도입 전 성능 및 유효성 평가, 적용 대상, 분석 결과 제공의 대상 및 방식, 도입 후 모니터링, 법적 책임 문제 등 다양한 현실적인 사항에 대한 고려가 필요하고, 각 의료기관의 상황에 따른 적절한 의사결정이 필요하다. 인공지능 검출 보조 의료기기의 안전하고 효율적인 도입 및 운영을 위해서는 전문 지식을 갖춘 영상의학과 전문의의 적극적인 역할이 필수적이다.

Safety Management for MR-Guided Interventions

  • Cherkashin, Mikhail;Berezina, Natalia;Serov, Alexey;Fedorov, Artem;Andreev, Georgy;Kuplevatsky, Vladymir
    • Investigative Magnetic Resonance Imaging
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    • 제20권3호
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    • pp.152-157
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    • 2016
  • Purpose: Operating room management is the serious and complex task for hospital managers and the common approach is to develop relevant standard operational procedures. From patient and staff safety perspective, operating room management should be well-studied and hospital should identify and address any potential risks. Simultaneous usage of different imaging and less-invasive treatment technologies demands strong management control. Materials and Methods: We have formed the multidisciplinary expert panel (surgeons, anesthesiologists, radiologists, healthcare managers etc.) for hybrid theater management standard operational procedure development. On the first stage the general concept of hybrid room design and patient routing was developed. The second stage included the technical details discussion. For patient safety improvement we modified the Surgical Safety Check-list in accordance with potential MRI-related safety challenges and concerns. Results: WHO Surgical Safety Checklist is a simple and easy-to use tool which includes three blocks of question (grouped by the surgery process). We have developed two additional blocks of questions for the intraoperative magnetic resonance investigation. It is very important to have a special detailed routing with a strong control of ferromagnetic devices and anesthesiology care. Conclusion: High-energy MRI (1.5-3.0T) is characterized by potential influence on patient and staff safety in case of hybrid surgery. It is obvious to have a strong managerial control of ferromagnetic devices and anesthesiology care. Surgical Safety Checklist is the validated tool for improving patient safety. Modification and customization of this check-list potentially provides the opportunity for surgery processes improving.