• Title/Summary/Keyword: Medical Device Classification System

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Medicare's Reimbursement for Innovative Technologies: Focusing on Artificial Intelligence Medical Devices (미국의 혁신의료기술 지불보상제도: 인공지능 의료기기를 중심으로)

  • Lee, Boram;Yim, Jaejun;Yang, Jangmi
    • Health Policy and Management
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    • v.32 no.2
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    • pp.125-136
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    • 2022
  • The costliness index (CI) is an index that is used in various ways to improve the quality of medical care and the management of appropriate treatment in medical institutions. However, the current calculation method for CI has a limitation in reflecting the actual medical cost of the patient unit because the outpatient and inpatient costs are evaluated separately. It is desirable to calculate the CI by integrating the medical cost into the episode unit. We developed an episode-based CI method using the episode classification system of the Centers for Medicare and Medicaid Services to the National Inpatient Sample data in Korea, which can integrate the admission and ambulatory care cost to episode unit. Additionally, we compared our new method with the previous method. In some episodes, the correlation between previous and episode-based CI was low, and the proportion of outpatient treatment costs in total cost and readmission rates are high. As a result of regression analysis, it is possible that the level of total medical costs of the patient unit in low volume medical institute and rural area has been underestimated. High proportion of outpatient treatment cost in total medical cost means that some medical institutions may have provided medical services in the ambulatory care that are ancillary to inpatient treatment. In addition, a high readmission rate indicates insufficient treatment service for inpatients, which means that previous CI may not accurately reflect actual patient-based treatment costs. Therefore, an integrated patient-unit classification system which can be used as a more effective CI indicator is needed.

The Edge Computing System for the Detection of Water Usage Activities with Sound Classification (음향 기반 물 사용 활동 감지용 엣지 컴퓨팅 시스템)

  • Seung-Ho Hyun;Youngjoon Chee
    • Journal of Biomedical Engineering Research
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    • v.44 no.2
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    • pp.147-156
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    • 2023
  • Efforts to employ smart home sensors to monitor the indoor activities of elderly single residents have been made to assess the feasibility of a safe and healthy lifestyle. However, the bathroom remains an area of blind spot. In this study, we have developed and evaluated a new edge computer device that can automatically detect water usage activities in the bathroom and record the activity log on a cloud server. Three kinds of sound as flushing, showering, and washing using wash basin generated during water usage were recorded and cut into 1-second scenes. These sound clips were then converted into a 2-dimensional image using MEL-spectrogram. Sound data augmentation techniques were adopted to obtain better learning effect from smaller number of data sets. These techniques, some of which are applied in time domain and others in frequency domain, increased the number of training data set by 30 times. A deep learning model, called CRNN, combining Convolutional Neural Network and Recurrent Neural Network was employed. The edge device was implemented using Raspberry Pi 4 and was equipped with a condenser microphone and amplifier to run the pre-trained model in real-time. The detected activities were recorded as text-based activity logs on a Firebase server. Performance was evaluated in two bathrooms for the three water usage activities, resulting in an accuracy of 96.1% and 88.2%, and F1 Score of 96.1% and 87.8%, respectively. Most of the classification errors were observed in the water sound from washing. In conclusion, this system demonstrates the potential for use in recording the activities as a lifelog of elderly single residents to a cloud server over the long-term.

The Comprehensive Management Indexes and Their Application Strategies for Appropriate Medical Care in Primary Care Clinics Under Workers' Compensation Insurance (산재보험지정의원 요양급여적정성 종합관리지표 산출 및 적용방안)

  • Bang, Eun Ju;Choi, Eun Sook;Ko, Young
    • Korean Journal of Occupational Health Nursing
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    • v.17 no.1
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    • pp.86-95
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    • 2008
  • Purpose: The objectives for this study are to produce the comprehensive management indexes and find their application strategies for appropriate medical care in primary care clinics under workers' compensation insurance. Method: Data of this study was workers' compensation insurance medical fees claim's data from July 2006 to June 2007. Data were analyzed using SAS 9.1 version by applying descriptive statistics and Pearson's correlation. The indexes such as costliness index(CI), standard medical fee were calculated based on the fourth revision of korean classification of diseases(KCD-4.). Results: The CI, visiting index(VI), outliers index(OI), and medical review adjustment percentage were positively correlated in the both inpatient and outpatient medical fees in primary care clinics under workers' compensation insurance. The major medical specialities were neurological surgery, general medicine, general surgery, rehabitational medicine, and orthopedic surgery. The CIs were slightly high in rehabitational medicine among major medical specialities. The CIs were mostly high in diagnosis, test, anesthesia, and rehabitational assistive device fees among major medical specialities. The CIs were slightly high in Kwangju, Daegu, Daejeon, and Busan districts among district management centers of Korea Workers' Compensation and Welfare Service. Conclusions: We suggest the continuous development of appropriate disease classification system and medical care quality indicators to successfully take root the comprehensive management for appropriate medical care under workers' compensation.

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Performance assessment and improvement plan of the regulatory management system of veterinary medical devices in Korea (국내 동물용 의료기기 관리실태 평가 및 개선방안 연구)

  • An, Hyo-Jin;Yoon, Hyang-Jin;Kim, Chung-Hyun;Wee, Sung-Hwan;Moon, Jin-San
    • Korean Journal of Veterinary Research
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    • v.55 no.2
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    • pp.97-103
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    • 2015
  • In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.

Smart Helmet for Vital Sign-Based Heatstroke Detection Using Support Vector Machine (SVM 이용한 다중 생체신호기반 온열질환 감지 스마트 안전모 개발)

  • Jaemin, Jang;Kang-Ho, Lee;Subin, Joo;Ohwon, Kwon;Hak, Yi;Dongkyu, Lee
    • Journal of Sensor Science and Technology
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    • v.31 no.6
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    • pp.433-440
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    • 2022
  • Recently, owing to global warming, average summer temperatures are increasing and the number of hot days is increasing is increasing, which leads to an increase in heat stroke. In particular, outdoor workers directly exposed to the heat are at higher risk of heat stroke; therefore, preventing heat-related illnesses and managing safety have become important. Although various wearable devices have been developed to prevent heat stroke for outdoor workers, applying various sensors to the safety helmets that workers must wear is an excellent alternative. In this study, we developed a smart helmet that measures various vital signs of the wearer such as body temperature, heart rate, and sweat rate; external environmental signals such as temperature and humidity; and movement signals of the wearer such as roll and pitch angles. The smart helmet can acquire the various data by connecting with a smartphone application. Environmental data can check the status of heat wave advisory, and the individual vital signs can monitor the health of workers. In addition, we developed an algorithm that classifies the risk of heat-related illness as normal and abnormal by inputting a set of vital signs of the wearer using a support vector machine technique, which is a machine learning technique that allows for rapid binary classification with high reliability. Furthermore, the classified results suggest that the safety manager can supervise the prevention of heat stroke by receiving feedback from the control system.

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.

Amendment of the Inspection Standard for Diagnostic Radiation Equipment Applying IEC 60601-1-3: Medical Electrical Equipment - Part 1-3: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment (KS C IEC60601-1-3: 의료용 전기기기-제1-3부: 기본 안전 및 필수 성능에 관한 일반 요구사항-보조표준: 진단용 X선 장치의 방사선 방어를 적용한 진단용 방사선 발생장치의 검사기준 개선안)

  • Park, Hye-Min;Kim, Jung-Min;Kim, Jung-Su;Kim, Seong-Ok;Choi, Young-Min
    • Journal of radiological science and technology
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    • v.41 no.5
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    • pp.493-504
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    • 2018
  • The diagnostic radiation equipment is managed in accordance with the "Rules for Safety Management of Diagnostic Radiation Equipment" enacted in 1995. The equipments should be inspected before use and every three years after use in accordance with the [Appendix 1] of the same rule. The inspection standard has been maintained without particular revision since enacted. But, over the past two decades new types of equipments have been manufactured and used. So, it is necessary to revise [Appendix 1] by making inspection items and inspection standards. In this study, we revised the classification system of equipments and reviewed international standards of IEC 60601 series, IEC 61223 series and AAPM TG 18 On-line Report No.03. And identified the problem of current inspection standards. Through this, we revised, deleted and added the inspection items and inspection standard of each equipment to meet the domestic circumstances. As a result of the study, we reorganized the classification system of equipment which are current classified as 5 classes into 22 classes as X-ray system etc. (7 classes), CT system etc. (5 classes) and Dental X-ray system etc. (10 classes). And then, we developed 70 inspection items for 6 types of equipments according to the reorganized classification system of equipments. The inspection items and inspection standards derived from this study have been proposed to the KCDC and will be applied to the revision of the Rule's [Appendix 1]. Therefore, we expect to be used as reference materials for domestic medical center, inspection institutions, and equipment manufacturing import companies.

Cross Correlation based Signal Classification for Monitoring System of Abnormal Respiratory Status (상관관계 기반 신호 분류를 이용한 비정상 호흡 상태 모니터링 시스템)

  • Lee, Deokwoo
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.21 no.5
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    • pp.7-13
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    • 2020
  • This paper focuses on detecting abnormal patterns of respiration of humans. In this study, a contact-based device was used to acquire both normal and abnormal respiration signals. To this end, this paper reports the development of a monitoring system to investigate the respiratory status of humans in a normal environment. This work aims to classify the respiratory status, i.e., normal and abnormal status, quantitatively. The respiration signal is acquired using a contact-based medical device (BIOBPAC), and noise reduction is carried out before classifying the respiratory status. To reduce noise, a mixed filter that combines the Savitzky-Golay filter and Median filter is applied to the acquired respiration signals. The inter-class distance is maximized, and the intra-class distance is minimized. The proposed algorithm is straightforward and can be applied to a practical environment. In addition, the experimental results are provided to substantiate the proposed approach.

Regulatory System of Quasi-drugs in Korea (우리나라 의약외품 허가심사제도 고찰 및 개선 방안)

  • Sohn, Hyun-Soon;Shin, Hyun-Taek;Song, In-Sook;Jun, Hyo-Jung
    • Korean Journal of Clinical Pharmacy
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    • v.16 no.2
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    • pp.123-130
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    • 2006
  • The study was aimed to recommend the ways for improving regulatory system of quasi-drugs in governmental authority by comparing with other countries. According to the regulations, the scope of quasi-drugs includes 3 categories of 1) the health aids made of textile, rubber and paper, 2) the health aids which have very minimal effects or no any effects on humans, and 3) disinfectants and pesticides. In US, these quasi-drugs in Korea are classified into 5 categories of medical device, cosmetics, OTC drugs, dietary supplements and pesticides. To improve quasi-drugs administration in Korea, it is concluded that several measures should be implemented : 1) establish clear criteria for classifying into quasi-drugs and more detailed guidelines on designation of quasi-drugs, 2) reform current regulations to meet 3-categories characteristics, supplement detailed guidelines on quasi-drugs administration for effective application process, and update relevant regulations for efficacy, safety and quality, 3) update quasi-drug monographs, 4) re-evaluate current classification of individual quasi-drugs, 5) develop comprehensive list by ingredients, 6) reform post-marketing management system for safety and quality, 7) strengthen the review agency function by increasing the number of experts, 8) develop the database for quasi-drugs for effective information management.

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Surgical prevention of terminal neuroma and phantom limb pain: a literature review

  • Bogdasarian, Ronald N.;Cai, Steven B.;Tran, Bao Ngoc N.;Ignatiuk, Ashley;Lee, Edward S.
    • Archives of Plastic Surgery
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    • v.48 no.3
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    • pp.310-322
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    • 2021
  • The incidence of extremity amputation is estimated at about 200,000 cases annually. Over 25% of patients suffer from terminal neuroma or phantom limb pain (TNPLP), resulting in pain, inability to wear a prosthetic device, and lost work. Once TNPLP develops, there is no definitive cure. Therefore, there has been an emerging focus on TNPLP prevention. We examined the current literature on TNPLP prevention in patients undergoing extremity amputation. A literature review was performed using Ovid Medline, Cochrane Collaboration Library, and Google Scholar to identify all original studies that addressed surgical prophylaxis against TNPLP. The search was conducted using both Medical Subject Headings and free-text using the terms "phantom limb pain," "amputation neuroma," and "surgical prevention of amputation neuroma." Fifteen studies met the inclusion criteria, including six prospective trials, two comprehensive literature reviews, four retrospective chart reviews, and three case series/technique reviews. Five techniques were identified, and each was incorporated into a targetbased classification system. A small but growing body of literature exists regarding the surgical prevention of TNPLP. Targeted muscle reinnervation (TMR), a form of physiologic target reassignment, has the greatest momentum in the academic surgical community, with multiple recent prospective studies demonstrating superior prevention of TNPLP. Neurorrhaphy and transposition with implantation are supported by less robust evidence, but merit future study as alternatives to TMR.