• Title/Summary/Keyword: Medical Device Management

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Updates of Nursing Practice Guideline for Enteral Nutrition (경장영양 간호실무지침 개정)

  • Cho, Yong Ae;Gu, Mee Ok;Eun, Young;Yu, Mi;Kim, Jung Yeon;Lee, Hyun Hee;Min, Ja Kyung;Song, Jung Mi
    • Journal of Korean Clinical Nursing Research
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    • v.26 no.1
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    • pp.10-25
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    • 2020
  • Purpose: The purpose of this study was to update the previously developed nursing practice guideline for enteral nutrition (EN). Methods: The guideline update was done in 22 steps using standardized methodology for nursing practice guidelines. Results: The updated EN guideline consisted of 16 domains and 228 recommendations. The domains and number of recommendations in each domain were for IDSA (Infectious Diseases Society of America): 8 on general instruction, 9 on general instruction for special nutrition, 9 on general instruction for EN, 3 on assessment of EN, 10 on access to EN, 18 on EN device insertion, 16 on selection and preparation of nutritional supplements, 46 on administration and stopping EN, 22 on maintenance and management of EN, 9 on monitoring EN, 16 on prevention and management of complications of EN, 18 on medication administration, 20 on EN in various situations, 20 on prevention of errors, 1 on nursing education, and 3 on nursing documentation. For the levels of evidence, there were 9.7% for level I, 13.1% for level II, 62.5% for level III and 1.1% for GRADE (Grading of Recommendations Assessment, Development and Evaluation): 3.3% for low, 0.8% for moderate, 9.3% for very low. A total of 133 recommendations were newly developed and 10 previous recommendations were modified. Conclusion: This updated EN nursing practice guideline can be used to enhance evidence-based practice in fundamentals of nursing practice and it should be disseminated to nurses nationwide in order to improve the efficiency of EN practice.

A Preference and Satisfaction Survey on the Wound Management System (창상 치료 시스템에 대한 선호도 및 만족도 조사)

  • Kang, Yoon Kyeong;Hong, Aram;Lee, Boung Chul;Kim, Dohern;Seo, Cheong Hoon
    • Journal of the Korean Burn Society
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    • v.16 no.2
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    • pp.99-103
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    • 2013
  • Purpose: The biggest problem of wound healing is a possible occurrence of lesion. Especially, in the case of patients who have a skin injury around exposed body parts, if their treatment period drag on for long time, they can suffer from aftereffects and the costs can be passed on to a society. Therefore, in this research, we investigated the need to develop the effective medicine and appliances for the patients by examining which therapy methods are being applying to the skin damage and what is the advantage and limit by evaluating the patient's satisfaction level. Methods: We carried out an online and offline survey targeting medical teams in order to analyze device for wound care. A total of 125 medical teams applied to the research, and investigate the level of customer satisfaction. Results: The moist dressings are the most used method for wound healing. When it comes to the level of customer satisfaction, biological dressing product also has a high satisfaction level. However its high cost tends to limit the use. Conclusion: This research reached a conclusion that it is need to develop a low cost and high efficiency wound care product considering the fact that its high cost and low efficiency induced economic problems. Generally, it is needed to develop a product for skin regeneration based on biological technologies, not a product just for damage cure.

Reproducibility Evaluation of Deep inspiration breath-hold(DIBH) technique by respiration data and heart position analysis during radiation therapy for Left Breast cancer patients (좌측 유방암 환자의 방사선치료 중 환자의 호흡과 심장 위치 분석을 통한 Deep inspiration breath-hold(DIBH) 기법의 재현성 평가)

  • Jo, Jae Young;Bae, Sun Myung;Yoon, In Ha;Lee, Ho Yeon;Kang, Tae Young;Baek, Geum Mun;Bae, Jae Beom
    • The Journal of Korean Society for Radiation Therapy
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    • v.26 no.2
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    • pp.297-303
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    • 2014
  • Purpose : The purpose of this study is reproducibility evaluation of deep inspiration breath-hold(DIBH) technique by respiration data and heart position analysis in radiation therapy for Left Breast cancer patients. Materials and Methods : Free breathing(FB) Computed Tomography(CT) images and DIBH CT images of three left breast cancer patients were used to evaluate the heart volume and dose during treatment planing system( Eclipse version 10.0, Varian, USA ). The signal of RPM (Real-time Position Management) Respiratory Gating System (version 1.7.5, Varian, USA) was used to evaluate respiration stability of DIBH during breast radiation therapy. The images for measurement of heart position were acquired by the Electronic portal imaging device(EPID) cine acquisition mode. The distance of heart at the three measuring points(A, B, C) on each image was measured by Offline Review (ARIA 10, Varian, USA). Results : Significant differences were found between the FB and DIBH plans for mean heart dose (6.82 vs. 1.91 Gy), heart $V_{30}$ (68.57 vs. $8.26cm^3$), $V_{20}$ (76.43 vs. $11.34cm^3$). The standard deviation of DIBH signal of each patient was ${\pm}0.07cm$, ${\pm}0.04cm$, ${\pm}0.13cm$, respectively. The Maximum and Minimum heart distance on EPID images were measured as 0.32 cm and 0.00 cm. Conclusion : Consequently, using the DIBH technique with radiation therapy for left breast cancer patients is very useful to establish the treatment plan and to reduce the heart dose. In addition, it is beneficial to using the Cine acquisition mode of EPID for the reproducibility evaluation of DIBH.

Research on Surface Contamination Analysis of Radiology Examination Equipment in Medical Institutions (의료기관 내 영상의학 검사 장비의 표면 오염도 분석 연구)

  • Shin-Woo Lee;Da-eun Kim;Chae-won Mun;Gap-Jung Kim;Sang-Ha Kim;Hye-mi Park;Se-Jong Yoo
    • Journal of the Korean Society of Radiology
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    • v.18 no.2
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    • pp.171-177
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    • 2024
  • In this study, two general X-ray device, CT, and MRI inspection devices were selected from general hospitals in the Daejeon area and an experiment was conducted to predict the level of infection by measuring the surface contamination of the inspection devices at different times and to use it as basic data for infection prevention. As a result, the surface contamination level by time zone for general X-ray devices and MRI examination devices was in the order of 13H > 8H > 16H, and for CT examination devices, it was 13H > 16H > 8H, which appeared to be influenced by the number of tests. In addition, the surface contamination results for each part of the test device showed that the highest ATP contamination value was found on the stand bucky handle for the general X-ray device, the headrest for the CT examination device, and the operation switch for the MRI examination device, which was closely related to the number of contacts. As a result of comparing before and after disinfection, all devices showed a significant decrease after disinfection. Based on the results of the experiment, it is believed that it can be used as basic data to identify the level of contamination in radiology laboratories and prevent infectious diseases.

A Study on the Decision Factors for AI-based SaMD Adoption Using Delphi Surveys and AHP Analysis (델파이 조사와 AHP 분석을 활용한 인공지능 기반 SaMD 도입 의사결정 요인에 관한 연구)

  • Byung-Oh Woo;Jay In Oh
    • The Journal of Bigdata
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    • v.8 no.1
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    • pp.111-129
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    • 2023
  • With the diffusion of digital innovation, the adoption of innovative medical technologies based on artificial intelligence is increasing in the medical field. This is driving the launch and adoption of AI-based SaMD(Software as a Medical Device), but there is a lack of research on the factors that influence the adoption of SaMD by medical institutions. The purpose of this study is to identify key factors that influence medical institutions' decisions to adopt AI-based SaMDs, and to analyze the weights and priorities of these factors. For this purpose, we conducted Delphi surveys based on the results of literature studies on technology acceptance models in healthcare industry, medical AI and SaMD, and developed a research model by combining HOTE(Human, Organization, Technology and Environment) framework and HABIO(Holistic Approach {Business, Information, Organizational}) framework. Based on the research model with 5 main criteria and 22 sub-criteria, we conducted an AHP(Analytical Hierarchy Process) analysis among the experts from domestic medical institutions and SaMD providers to empirically analyze SaMD adoption factors. The results of this study showed that the priority of the main criteria for determining the adoption of AI-based SaMD was in the order of technical factors, economic factors, human factors, organizational factors, and environmental factors. The priority of sub-criteria was in the order of reliability, cost reduction, medical staff's acceptance, safety, top management's support, security, and licensing & regulatory levels. Specifically, technical factors such as reliability, safety, and security were found to be the most important factors for SaMD adoption. In addition, the comparisons and analyses of the weights and priorities of each group showed that the weights and priorities of SaMD adoption factors varied by type of institution, type of medical institution, and type of job in the medical institution.

Change of Pyogenic and Tuberculous Spondylitis between 2007 and 2016 Year : A Nationwide Study

  • Kim, Yeon Jee;Hong, Je Beom;Kim, Yeo Song;Yi, Jeeeun;Choi, Jung Min;Sohn, Seil
    • Journal of Korean Neurosurgical Society
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    • v.63 no.6
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    • pp.784-793
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    • 2020
  • Objective : We attempted to compare the incidence of pyogenic spondylitis (PS) and tuberculous spondylitis (TS) between 2007 and 2016. Furthermore, we investigated the patients who underwent surgery in 2016 compared to that in 2007. Methods : We used a nationwide database managed by the Korean National Health Insurance Service (NHIS) in 2007 and 2016. Total 9655 patients with a newly diagnosis of PS or TS were enrolled in PS or TS group. Among them, 1721 patients underwent either fusion or decompression surgery. We analyzed demographic distribution of patients according to gender and age and year of diagnosis. Results : Comparing between 2007 and 2016, the incidence of PS has increased in 2016 than in 2007 (4874 vs. 2431, p<0.0001). Conversely, declination of incidence of TS was discovered in 2016 compared to 2007 (594 vs. 1756, p<0.0001). Females showed predominance over males regarding both PS and TS (5228 vs. 4427, p<0.0001). Among them, the number of PS patients who underwent surgery increased significantly in 2016 relative to that in 2007 (979 vs. 592, p<0.0001). Conclusion : This nationwide study suggests that PS may increase and TS may decrease in Korea. In addition, demand for surgery regarding PS may increase.

A Study on the Quantitative Evaluation Method of Quality Control using Ultrasound Phantom in Ultrasound Imaging System based on Artificial Intelligence (인공지능을 활용한 초음파영상진단장치에서 초음파 팬텀 영상을 이용한 정도관리의 정량적 평가방법 연구)

  • Yeon Jin, Im;Ho Seong, Hwang;Dong Hyun, Kim;Ho Chul, Kim
    • Journal of Biomedical Engineering Research
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    • v.43 no.6
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    • pp.390-398
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    • 2022
  • Ultrasound examination using ultrasound equipment is an ultrasound device that images human organs using sound waves and is used in various areas such as diagnosis, follow-up, and treatment of diseases. However, if the quality of ultrasound equipment is not guaranteed, the possibility of misdiagnosis increases, and the diagnosis rate decreases. Accordingly, The Korean Society of Radiology and Korea society of Ultrasound in Medicine presented guidelines for quality management of ultrasound equipment using ATS-539 phantom. The DenseNet201 classification algorithm shows 99.25% accuracy and 5.17% loss in the Dead Zone, 97.52% loss in Axial/Lateral Resolution, 96.98% accuracy and 20.64% loss in Sensitivity, 93.44% accuracy and 22.07% loss in the Gray scale and Dynamic Range. As a result, it is the best and is judged to be an algorithm that can be used for quantitative evaluation. Through this study, it can be seen that if quantitative evaluation using artificial intelligence is conducted in the qualitative evaluation item of ultrasonic equipment, the reliability of ultrasonic equipment can be increased with high accuracy.

Legal Issues in Clinical Trial on Minor (미성년자 대상 임상시험에 관한 법적 문제점)

  • Song, Young-min
    • The Korean Society of Law and Medicine
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    • v.17 no.2
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    • pp.125-144
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    • 2016
  • All forms of Clinical trial should be fully equipped with protection systems for experimental subjects considering their uncertainty and various risks. Existing laws have some regulations in pharmaceutical affairs act and medical device act. Nonetheless, there is a limit to protect the subjects considering law objective to perform administration of medicine. Furthermore, the clinical trial on minor has no direct regulations in pharmaceutical affairs act, but prescribes certain portion in clinical trial assessment guideline on infants or medicine clinical trial management standard, however there is a limit because that is just recommendation not having legal effectiveness. The legislative solution would be possible for legal problems of clinical trial on minor by examining treatment system on minor in organ transplant act and clinical trial on minor in other foreign laws stronger than usual medical practice in terms of degree of human body invasion. I suppose that the control system of clinical trial being done focusing on the pharmaceutical affairs act, medical device act and other guidelines in existing laws system should be resolved by legislating 'trial subject protection law', in addition, this would be well balanced in organ transplant act on protection system of minor organ donors. Furthermore, the judgement on the consent ability and spontaneity in clinical trial on minor should be judged considering maturity and mentality of minor by clinical trial institutional review board based on legislative solution mentioned above.

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Analysis of the Outcomes of Surgically-Treated Spinal Epidural Hematomas (척추 경막외 출혈에 대한 수술적 치료성적 분석)

  • Cho, Young-Hyun;Park, Jin-Hoon;Kim, Ji-Hoon;Roh, Sung-Woo;Kim, Chang-Jin;Jeon, Sang-Ryong
    • Journal of Trauma and Injury
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    • v.23 no.2
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    • pp.163-169
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    • 2010
  • Purpose: Spinal epidural hematoma (EDH) is a rare condition requiring an urgent diagnosis and management. We describe here the clinical features, magnetic resonance image (MRI) findings, and outcomes of surgery in six patients with spinal EDH. Methods: We retrospectively analyzed six patients who underwent surgery for spinal EDH between April 2004 and May 2010. Preoperative MRI findings within 48 hours of symptom occurrence were analyzed for cord compression, extent of EDH, and presence of vascular abnormalities. Pre- and postoperative neurological status was also assessed comparatively. Results: Our six patients consisted of three men and three women, with a mean age of 70 years (range: 54-88 years), who presented with the back pain or motor weakness. The mean follow-up period was 34 months (range: 2-72 months). Two patients had cardiovascular disease and were taking warfarin, but the others had no history of medical comorbidity. Those two patients taking warfarin had a history of trauma, another one experienced symptoms during a strenuous effort, and the others developed spontaneously. Before surgery, motor power was grade III in three patients, grade 0 in two patients, and normal in one patient. Preoperative MRI showed no vascular abnormalities except for the EDH in any patient. At the last follow-up, all those five patients with motor weakness showed neurological improvement compared to their preoperative status. There were no complications related to surgery. All six patients were able to ambulate with or without an assistive device. Conclusion: Spinal EDH can occur in patients without trauma, bleeding diathesis, or combined vascular pathology. The surgical outcomes of spinal EDH seem to be satisfactory, even in quadriplegic patients.

2023 Survey on User Experience of Artificial Intelligence Software in Radiology by the Korean Society of Radiology

  • Eui Jin Hwang;Ji Eun Park;Kyoung Doo Song;Dong Hyun Yang;Kyung Won Kim;June-Goo Lee;Jung Hyun Yoon;Kyunghwa Han;Dong Hyun Kim;Hwiyoung Kim;Chang Min Park;Radiology Imaging Network of Korea for Clinical Research (RINK-CR)
    • Korean Journal of Radiology
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    • v.25 no.7
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    • pp.613-622
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    • 2024
  • Objective: In Korea, radiology has been positioned towards the early adoption of artificial intelligence-based software as medical devices (AI-SaMDs); however, little is known about the current usage, implementation, and future needs of AI-SaMDs. We surveyed the current trends and expectations for AI-SaMDs among members of the Korean Society of Radiology (KSR). Materials and Methods: An anonymous and voluntary online survey was open to all KSR members between April 17 and May 15, 2023. The survey was focused on the experiences of using AI-SaMDs, patterns of usage, levels of satisfaction, and expectations regarding the use of AI-SaMDs, including the roles of the industry, government, and KSR regarding the clinical use of AI-SaMDs. Results: Among the 370 respondents (response rate: 7.7% [370/4792]; 340 board-certified radiologists; 210 from academic institutions), 60.3% (223/370) had experience using AI-SaMDs. The two most common use-case of AI-SaMDs among the respondents were lesion detection (82.1%, 183/223), lesion diagnosis/classification (55.2%, 123/223), with the target imaging modalities being plain radiography (62.3%, 139/223), CT (42.6%, 95/223), mammography (29.1%, 65/223), and MRI (28.7%, 64/223). Most users were satisfied with AI-SaMDs (67.6% [115/170, for improvement of patient management] to 85.1% [189/222, for performance]). Regarding the expansion of clinical applications, most respondents expressed a preference for AI-SaMDs to assist in detection/diagnosis (77.0%, 285/370) and to perform automated measurement/quantification (63.5%, 235/370). Most respondents indicated that future development of AI-SaMDs should focus on improving practice efficiency (81.9%, 303/370) and quality (71.4%, 264/370). Overall, 91.9% of the respondents (340/370) agreed that there is a need for education or guidelines driven by the KSR regarding the use of AI-SaMDs. Conclusion: The penetration rate of AI-SaMDs in clinical practice and the corresponding satisfaction levels were high among members of the KSR. Most AI-SaMDs have been used for lesion detection, diagnosis, and classification. Most respondents requested KSR-driven education or guidelines on the use of AI-SaMDs.