• Title/Summary/Keyword: Healthcare Device

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Comparative Evaluation for the Effect of SUV's Due to a Residual Radio-activity Location Inside Vascular Insert Devices During PET/CT Scans (PET/CT 검사 시 혈관삽입기구 내 잔여 방사능 위치에 따른 표준섭취계수의 영향 비교 평가)

  • Sim, Woo Yong;Kim, Jung Yul;Cho, Suk Won;Oh, Shin Hyun;Lim, Han Sang;Park, Hoon-Hee
    • The Korean Journal of Nuclear Medicine Technology
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    • v.18 no.1
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    • pp.94-97
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    • 2014
  • Purpose: Standardized uptake value (SUV) is a simple semi-quantitative method that can measure the ratio of the tissue radioactivity between the tumor and normal. SUV is commonly used in PET/CT, however, SUV is affected by various factor. The purpose of this study was to evaluate the impact of the residual activity on SUV depending on the location of catheter insertion device post injection. Materials and Methods: NEMA IEC Body Phantom was imaged using a Discovery 600 PET scanner. In 22 mm diameter sphere, the different activity of $^{18}F-FDG$ (7.4, 14.8, 22.2, 29.6, 37, 55.5 MBq) was filled and background was filled with $^{18}F-FDG$ (5.7 kBq/mL). We scaned the phantom on the assumption that the radioactivity in sphere was residual activity in insertion device. Simulation of PET was divided into three groups based on the location of sphere in Scan FOV (SFOV); inclusion, 1/2 inclusion and exclusion group. Results: Among three groups, the group of excluded sphere showed the highest SUV regardless of the amount of $^{18}F-FDG$ activity. In case of 7.4 MBq, average SUV of inclusion group, 1/2 inclusion and exclusion group was 0.780, 0.840 and 0.896 respectively. However, average SUV of 55.5 MBq showed 0.372, 0.460 and 0.508 with same order. Depend on residual radioactivity in the sphere and position of sphere, the SUV was different minimum of 10.4%, maximum of 62.8%. Conclusion: This study showed that SUV is underestimated as the residual radio-activity is increased. In addition, SUV was a changed according to the position of residual radio-activity. And among the position, exclusion group showed the difference of SUV was lowest. If we measure the residual radio-activity of inserting devices and radio-activity from extra-vasation in the patients, it seems to be more useful in clinical field.

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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.

Evaluation of the Image Quality According to the Pre-set Method in PET/CT Image (PET/CT 영상 획득 시 사전설정법 차이에 따른 영상 질 평가)

  • Park, Sun-Myung;Lee, Hyuk;Hong, Gun-Chul;Chung, Eun-Kyung;Choi, Choon-Ki;Seok, Jae-Dong
    • The Korean Journal of Nuclear Medicine Technology
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    • v.15 no.2
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    • pp.41-46
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    • 2011
  • Purpose: The result of exam using an imaging device is very closely related with the image quality. Moreover, this image quality can be changed according to the condition of image acquisition and evaluation method. In this study, we evaluated the image quality according to the difference of pre-set method in PET/CT image. Materials & Methods: PET/CT Discovery STe16 (GE Healthcare, Milwaukee, USA), Chest PET phantom (Experiment 1) and 94 NEMA phantom (Experiment 2) were used. Phantom were filled with $^{18}F$-FDG maintaining hot sphere and background ratio to 4:1. In the case of experiment 1, we set the radio activity concentration on 3.5, 6.0, 8.6 kBq/mL. In the case of experiment 2, we set the radio activity concentration on 3.3, 5.5, 7.7, 9.9, 12.1, 16.5 kBq/mL. All experiments were performed with the time-set method for 2 minutes 30 seconds per frame and the count-set method with one hundred million counts in 3D mode after CT transmission scan. For the evaluation of the image quality, we compared each results by using the NECR and SNR. Results: In the experiment 1, both the NECR and SNR were increased as radioactivity concentration getting increased. The NECR was shown as 53.7, 66.9, 91.4. and SNR was shown as 7.9, 10.0, 11.7. Both the NECR and SNR were increased in time-set method. But the count-set method's pattern was not similar with the time-set method. The NECR was shown as 53.8, 69.1, 97.8, and SNR was shown as 14.1, 14.7 14.4. The SNR was not increased in count-set method. In experiment 2, results of both the NECR and SNR were shown as 45.1, 70.6, 95.3, 115.6, 134.6, 162.2 and 7.1, 8.8, 10.6, 11.5, 12.7, 14.0. These results were shown similar patten with the experiment 1. Moreover, when the count-set method was applied, the NECR was shown as 42.1, 67.3, 92.1, 112.2, 130.7, 158.7, and SNR was shown as 15.2, 15.9, 15.6, 15.4, 15.5, 14.9. The NECR was increased but SNR was not shown same pattern. Conclusion: Increment of administered radioactivity improves the quality of image unconcerned with the pre-set method. However, NECR was not influenced by increment of total acquisition counts through simple increasing scan duration without increment of administered activity. In case of count-set method, the SNR was shown similar value despite of increment of radioactivity. So, the administered activity is more important than the scan duration. And we have to consider that evaluation of image quality using only SNR may not be appropriate.

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Development of Video Image-Guided Setup (VIGS) System for Tomotherapy: Preliminary Study (단층치료용 비디오 영상기반 셋업 장치의 개발: 예비연구)

  • Kim, Jin Sung;Ju, Sang Gyu;Hong, Chae Seon;Jeong, Jaewon;Son, Kihong;Shin, Jung Suk;Shin, Eunheak;Ahn, Sung Hwan;Han, Youngyih;Choi, Doo Ho
    • Progress in Medical Physics
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    • v.24 no.2
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    • pp.85-91
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    • 2013
  • At present, megavoltage computed tomography (MVCT) is the only method used to correct the position of tomotherapy patients. MVCT produces extra radiation, in addition to the radiation used for treatment, and repositioning also takes up much of the total treatment time. To address these issues, we suggest the use of a video image-guided setup (VIGS) system for correcting the position of tomotherapy patients. We developed an in-house program to correct the exact position of patients using two orthogonal images obtained from two video cameras installed at $90^{\circ}$ and fastened inside the tomotherapy gantry. The system is programmed to make automatic registration possible with the use of edge detection of the user-defined region of interest (ROI). A head-and-neck patient is then simulated using a humanoid phantom. After taking the computed tomography (CT) image, tomotherapy planning is performed. To mimic a clinical treatment course, we used an immobilization device to position the phantom on the tomotherapy couch and, using MVCT, corrected its position to match the one captured when the treatment was planned. Video images of the corrected position were used as reference images for the VIGS system. First, the position was repeatedly corrected 10 times using MVCT, and based on the saved reference video image, the patient position was then corrected 10 times using the VIGS method. Thereafter, the results of the two correction methods were compared. The results demonstrated that patient positioning using a video-imaging method ($41.7{\pm}11.2$ seconds) significantly reduces the overall time of the MVCT method ($420{\pm}6$ seconds) (p<0.05). However, there was no meaningful difference in accuracy between the two methods (x=0.11 mm, y=0.27 mm, z=0.58 mm, p>0.05). Because VIGS provides a more accurate result and reduces the required time, compared with the MVCT method, it is expected to manage the overall tomotherapy treatment process more efficiently.

Comparison for Glomerular Filtration Rate in Gamma Camera Systems Using Dynamic Renal Phantom System (동적신장팬텀시스템 개발에 따른 장비별 사구체여과율의 비교)

  • Kang, Chun Goo;Park, Hoon-Hee;Oh, Shin Hyun;Lee, Han Wool;Kim, Jung Yul;Oh, Joo Yung;Lee, Ju Young;Kim, Jae Sam;Lee, Chang Ho
    • The Korean Journal of Nuclear Medicine Technology
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    • v.17 no.2
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    • pp.3-9
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    • 2013
  • Purpose: Currently commercially available phantom can reproduce and evaluate only a static situation, the study is incomplete research on phantom and system which is can confirmed functional situation in the kidney by time through dynamic phantom and blood flow velocity, various difference according to the amount of radioactive. Therefore, through this study, it has produced the dynamic kidney phantom to reproduce images through the dynamic flow of the kidney, it desire to evaluate the usefulness of nuclear medicine imaging. Materials and Methods: The production of the kidney phantom was fabricated based on the normal adult kidney, in order to reproduce the dynamic situation based on the fabricated kidney phantom, in this study it was applied the volume pump that can adjust the speed of blood flow, so it can be integrated continuously radioactive isotopes in the kidney by using $^{99m}Tc-pertechnate$. Used the radioactive isotope was supplied through the two pump. It was confirmed the changes according to the infusion rate, radioactive isotopes and the different injection speeds on the left and right, analysis of the acquired images was done by drawn ten times ROI in order to check the reproducibility of each on the front and rear of the kidney and bladder. Results: Under the same conditions infusion rate 40 mL/min fixed to adjust the pressure of the pump when the radiopharmaceuticals between 2-3 minutes in the most integrated in the kidney phantom was excreted inthe bladder. Glomerular filtration rate (GFR), respectively, by each device SYMBIA 1,091 mL/min, FORTE 1,232 mL/min, ARGUS 1,264 mL/min, INFINIA 1,302 mL/min in that there isno statistically significant difference was found, Tmax values and T1/2 values stars from all equipment with no statistically significant difference was found. CV values of the coefficient of variation less than 5% was found to be repeatable, and to 2.67% of the lowest SYMBIA appeared, INFINIA was the highest in the 4.86%. Conclusion: Through this study, the results showed that the dynamic kidney phantom system is able to similarly reproduce renogram in the actual clinical. Especially, the depicted over time for the flow to be excreted through the kidney into the bladder was adequately reproduce, it is expected to be utilized as basic data to check the quality of the dynamic images. In addition, it is considered to help in the field of functional imaging and quality control.

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Evaluation of Temperature and Humidity of a Thermo-Hygrostat of PET/CT Equipment using a Temperature and Humidity Sensor(BME 280) (온·습도센서(BME 280 센서)를 이용한 PET/CT 장비의 항온 항습기 온·습도 평가)

  • Ryu, Chan-Ju;Kim, Jeong-A;Kim, Jun-Su;Yun, Geun-Yeong;Heo, Seung-Hui;Hong, Seong-Jong
    • Journal of the Korean Society of Radiology
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    • v.14 no.1
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    • pp.15-22
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    • 2020
  • PET(Positron Emission Tomography) devices are used as PET/CT or PET/MRI devices fused with the devices of CT or MRI for obtaining anatomical information. Therefore, the devices are constructed in circular ring-type structure whose length of gantry(the main part of filming) becomes wider and the interior depth becomes longer in comparison to other common medical equipments. scintillator, one of the components in PET devices, is inside the gantry, and as it is consisted of crystal which is sensitive to the change of temperature and humidity, large temperature change can cause the scintillator to be damaged. Though scintillator located inside the gantry maintains temperature and humidity with a thermo-hygrostat, changes in temperature and humidity are expected due to structural reasons. The output value was measured by dividing the inside of the gantry of the PET/CT device into six zones, each of which an Adafruit BME 280 temperature and humidity sensor was placed at. A thermo-hygrostat keeps the temperature and humidity constant in the PET/CT room. As the measured value of temperature and humidity of the sensor was obtained, the measured value of temperature and humidity appeared in the thermohygrostat was taken at the same time. Comparing the average measured values of temperature and humidity measured at each six zones with the average values of the thermo-hygrostat results in a difference of 2.71℃ in temperature and 21.5% in humidity. The measured temperature and humidity of PET Gantry is out of domestic quality control range. According to the results of the study, if there is continuous change in temperature and humidity in the future, the aging of the scintillator mounted in the PET Gantry is expected to be aging, so it is necessary to find a way to properly maintain the temperature and humidity inside the Gantry structure.

Suggested Protocol for Efficient Medical Image Information Exchange in Korea: Breast MRI (효율적 의료영상정보교류를 위한 프로토콜 제안: 유방자기공명영상)

  • Park, Ji Hee;Choi, Seon-Hyeong;Kim, Sungjun;Yong, Hwan Seok;Woo, Hyunsik;Jin, Kwang Nam;Jeong, Woo Kyoung;Shin, Na-Young;Choi, Moon Hyung;Jung, Seung Eun
    • Journal of the Korean Society of Radiology
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    • v.79 no.5
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    • pp.254-258
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    • 2018
  • Purpose: Establishment of an appropriate protocol for breast magnetic resonance imaging (MRI) in the study of image quality standards to enhance the effectiveness of medical image information exchange, which is part of the construction and activation of clinical information exchange for healthcare informatization. Materials and Methods: The recommended protocols of breast and MRI scans were reviewed and the questionnaire was prepared by a responsible researcher. Then, a panel of 9 breast dedicated radiologists was set up in Korea. The expert panel conducted a total of three Delphi agreements to draw up a consensus on the breast MRI protocol. Results: The agreed breast MRI recommendation protocol is a 1.5 Tesla or higher device that acquires images with prone position using a breast dedicated coil and includes T2-weighted and pre-contrast T1-weighted images. Contrast enhancement images are acquired at least two times, and include 60-120 seconds between images and after 4 minutes. The contrast enhancement T1-weighted image should be less than 3 mm in thickness, less than 120 seconds in temporal resolution, and less than $1.5mm^2$ in-plane pixel resolution. Conclusion: The Delphi agreement of the domestic breast imaging specialist group has established the recommendation protocol of the effective breast MRI.

Neurotechnologies and civil law issues (뇌신경과학 연구 및 기술에 대한 민사법적 대응)

  • SooJeong Kim
    • The Korean Society of Law and Medicine
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    • v.24 no.2
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    • pp.147-196
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    • 2023
  • Advances in brain science have made it possible to stimulate the brain to treat brain disorder or to connect directly between the neuron activity and an external devices. Non-invasive neurotechnologies already exist, but invasive neurotechnologies can provide more precise stimulation or measure brainwaves more precisely. Nowadays deep brain stimulation (DBS) is recognized as an accepted treatment for Parkinson's disease and essential tremor. In addition DBS has shown a certain positive effect in patients with Alzheimer's disease and depression. Brain-computer interfaces (BCI) are in the clinical stage but help patients in vegetative state can communicate or support rehabilitation for nerve-damaged people. The issue is that the people who need these invasive neurotechnologies are those whose capacity to consent is impaired or who are unable to communicate due to disease or nerve damage, while DBS and BCI operations are highly invasive and require informed consent of patients. Especially in areas where neurotechnology is still in clinical trials, the risks are greater and the benefits are uncertain, so more explanation should be provided to let patients make an informed decision. If the patient is under guardianship, the guardian is able to substitute for the patient's consent, if necessary with the authorization of court. If the patient is not under guardianship and the patient's capacity to consent is impaired or he is unable to express the consent, korean healthcare institution tend to rely on the patient's near relative guardian(de facto guardian) to give consent. But the concept of a de facto guardian is not provided by our civil law system. In the long run, it would be more appropriate to provide that a patient's spouse or next of kin may be authorized to give consent for the patient, if he or she is neither under guardianship nor appointed enduring power of attorney. If the patient was not properly informed of the risks involved in the neurosurgery, he or she may be entitled to compensation of intangible damages. If there is a causal relation between the malpractice and the side effects, the patient may also be able to recover damages for those side effects. In addition, both BCI and DBS involve the implantation of electrodes or microchips in the brain, which are controlled by an external devices. Since implantable medical devices are subject to product liability laws, the patient may be able to sue the manufacturer for damages if the defect caused the adverse effects. Recently, Korea's medical device regulation mandated liability insurance system for implantable medical devices to strengthen consumer protection.