• Title/Summary/Keyword: Device safety

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A Study on Safety and Performance Evaluation of Smart All-in-one Cardiopulmonary Assist Device (스마트올인원 심폐순환보조장치의 안전성 및 성능평가에 관한 연구)

  • Park, Junhyun;Ho, YeJi;Lee, Yerim;Lee, Duck Hee;Choi, Jaesoon
    • Journal of Biomedical Engineering Research
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    • v.40 no.5
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    • pp.197-205
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    • 2019
  • The existing Extracorporeal membrane oxygenation(ECMO) and Cardiopulmonary bypass system(CPB) have been developed and applied to various devices according to their respective indications. However, due to the complicated configuration and difficult usage method, it causes inconvenience to users and there is a risk of an accident. Therefore, smart all-in-one cardiopulmonary circulation device is being developed recently. The smart all-in-one cardiopulmonary assist device consists of a blood pump for cardiopulmonary bypass, a blood oxidizer for cardiopulmonary bypass, a blood circuit for cardiopulmonary bypass, and an artificial cardiopulmonary device. It is an integrated cardiopulmonary bypass device that can be used for a variety of purposes such as emergency, intraoperative, post-operative intensive care, and long-term cardiopulmonary assist, combined with CPB used in open heart surgery and ECMO used when patient's cardiopulmonary function does not work normally. The smart all-in-one cardiopulmonary assist device does not exist as a standard and international standard applicable to advanced medical devices. Therefore, in this study, we will refer to the International Standard for Blood Components, the International Standard for Blood, the Guideline for Blood Products, and prepare applicable performance and safety guidelines to help quality control of medical devices, and contribute to the improvement of the health of people. The guideline, which is the result of conducted a survey of the method of safety and performance test, is based on the principle of all-in-one cardiopulmonary aiding device, related domestic foreign standards, the status of domestic and foreign patents, related literature, blood pump(ISO 18242), blood oxygenator (ISO 7199), and blood circuit (ISO 15676) for cardiopulmonary bypass.The items on blood safety are as follows: American Society for Testing and Materials ASTM F1841-97R17), and in the 2010 Food and Drug Administration's Safety Assessment Guidelines for Medical Assisted Circulatory Devices. In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers / importers, testing inspectors, academia, etc. the final guideline was established through revision and supplementation process. Therefore, we propose guidelines for evaluating the safety and performance of smart all-in-one cardiopulmonary assist devices in line with growing technology.

A Study on the Standard of Test Method for Estimation of Usage Environment Safety and Performance of U-health Medical Device (유헬스케어의료기기의 사용환경 안전성 및 성능평가를 위한 표준시험방법 연구)

  • Park, S.K.;Cha, J.H.;Hur, C.H.;Park, K.J.;Moon, I.H.
    • Journal of rehabilitation welfare engineering & assistive technology
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    • v.4 no.1
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    • pp.9-14
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    • 2010
  • According to graying of population and income enlargement of people, interest about U-Healthcare of new form fusing with IT technology are enlarged. Need a estimation technology and standard of test method for safety and performance considering usage environment of U-Healthcare medical device. In this research, developed the standard of test method for usage environment safety and performance of U-Healthcare medical device referring IEC standards and KS standards.

Preparation of guidance documents item by item for one-step evaluation and approval for Medical Devices (의료기기 일괄허가 및 기술문서 심사를 위한 품목별 길라잡이 개발)

  • Kim, Yong-Woo;Shin, Chae-Min;Bang, Ji-Young;Yi, Jung-Yeon;Oh, Hyeon-Joo;Bae, Woo-Jin;Choi, Jin-Man;Lim, Kyung-Mi;Oh, Heon-Jin;Kim, Mi-Young;Hur, Chan-Hoi;Kim, Hyung-Bum;Choi, Min-Yong;Kwak, Ji-Young;Kim, Su-Yeon;Hwang, Sang-Yeon;Youn, Hae-Suk;Hong, Hye-Kyeong;Ahn, So-Young;Lee, Chang-Hyung;Jeong, Jin-Baek;Koo, Ja-Jung;Kang, Se-Gu;Jung, Jae-Hoon;Lim, Kyoung-Taek;Lim, Chang-Keun;Kim, Min-Su;Lee, Seong-Hyi;Lee, Jae-Keun;Park, Ki-Jung
    • Journal of Biomedical Engineering Research
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    • v.31 no.4
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    • pp.280-284
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    • 2010
  • Approvals of medical device increase every year as industry of medical device grows. Therefore KFDA keeps trying to improve approval systems. However, the firms of medical device are in trouble due to regulation amendment, a firm of small size, exchange of the person in charge. The staffs of KFDA increase their work load because applicants of approval of medical device aren't used to writing of document. Therefore the firm of medical device in business have a long term. KFDA develops eight guidance document item by item for one-step evaluation and approval for Medical Devices because applicants of approval of medical device write documents easily. KFDA reviewer can carry on quick reviewing in use of this eight guidances. This guidance are improved on satisfaction of applicants of approval of medical device.

Experimental Study on the Safety of Portable Butane Gas Range (휴대용 부탄 가스 레인지의 안전성에 관한 실험적 연구)

  • Keum, Kuk Bin;Kim, Do-Hyun;Kum, Sungmin;Lee, Chang-Eon;Kim, Young-gu
    • Journal of the Korean Society of Combustion
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    • v.22 no.2
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    • pp.50-56
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    • 2017
  • This study was conducted an experiment for the thermal flow mechanism of the surrounding butane gas can and pressure change in butane can with oversized cookware. And numerical analysis was performed to analyze the process of heat transfer around butane can. Effect of radiant heat from small size cookware is very small. Thus small size cookware does not have a significant impact on the butane gas range safety. But radiant heat of oversized cookware is larger than small size cookware. Therefore it gives an adverse effect on the butane can. And when internal pressure of butane can is greater than about 406.8~447.2 kPa, a safety device of portable butane gas range were working. The causes of safety device working is because of trivet height. Trivet height is lowered, the radiant heat is increased. This radiant heat is to raise pressure of inside butane can. Experimental and numerical analysis results, the lower thermal conductivity of the cookware is greater the effects of radiant heat.

Pattern-based Design and Safety Analysis for Networked Supervisory Medical Systems (네트워크 통합형 의료기기를 위한 안전한 상호작용 패턴과 구조적 안전성 검사)

  • Kang, Woochul
    • KIISE Transactions on Computing Practices
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    • v.20 no.10
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    • pp.561-566
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    • 2014
  • There are growing demands for improving the patient safety and the effectiveness of medical services through device connectivity and interoperability. However, integration through networking might greatly increase the complexity of the system if it is not properly designed, jeopardizing patient safety. In this paper, we codify safe medical device interaction patterns, and exploit them for the low complexity design and safety analysis of networked supervisory medical systems. We implement the proposed approach as a plug-in of Architecture Analysis and Description Language (AADL). Our implementation enables the modeling and safety analysis of medical devices and their interactions before actual development.

Study of Radiation Safety Management of Veterinary Hospital in Korea (동물병원 방사선 안전관리체계에 대한 연구)

  • Chae, Soo-young;Choi, Ho-jung;Lee, Young-won
    • Journal of Veterinary Clinics
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    • v.37 no.1
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    • pp.15-22
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    • 2020
  • This study investigated the effectiveness of radiation safety rules in animal hospital and the awareness and behavior of veterinary radiation workers. With the questionnaires, the data was collected from randomly selected veterinarians in animal hospitals and animal medical imaging centers. Collected data were about radiation device, shielding device, regulations, safety management, education, knowledge, behavior and awareness. Frequency, correlation and multiple regression analysis were performed. The medical devices related with radiation in animal hospital were X-ray (59%), CT (15%), fluoroscopy (12%), mobile X-ray (12%) and others (2%). The number of people using radiation shielding device is high. The answers were low on knowing radiation related regulation and receiving radiation protection education. The group with higher knowledge and awareness shows positive correlation with safety behavior. The increase of use of the radiation related medical devices in veterinary hospital causes the increase of radiation exposure risk. This study suggests that radiation safety management system and policies need to be developed to protect radiation workers and give them correct information and consciousness.

Dislocation Injections by a Localized Stress Field in a Strained Silicon

  • Yoon, Ju-Il
    • International Journal of Safety
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    • v.7 no.2
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    • pp.27-30
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    • 2008
  • In the 21st century, safety issues in the strained silicon industry, such as dislocation injection, should be carefully considered. This is because a microelectronic device usually contains sharp features (e.g., edges and corners) that may intensify stresses, inject dislocations into silicon, and ultimately cause the failure of the device. In this paper, critical residual stresses in various strained structures are calculated. It is confirmed that this model correctly predicts trends and the order of magnitude of critical residual stresses.

Frequency Resource Obtaining Method Based on D2D Device Discovery in Public Safety Communication Networks (재난 무선통신을 위한 D2D 단말탐색 기반 주파수 자원 확보 기술)

  • Wu, Shanai;Shin, Oh-Soon;Shin, Yoan
    • The Journal of Korean Institute of Communications and Information Sciences
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    • v.41 no.11
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    • pp.1440-1442
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    • 2016
  • As long term evolution (LTE) is the most widely deployed broadband communication technology so far, efforts are being made to develop LTE-based mission critical public safety (PS) communication systems. In this paper, we propose a device-to-device (D2D) discovery-based radio resource acquisition scheme to support the LTE D2D communication to PS systems and the realization of resource forwarding for user equipments in emergency area.

Structural Safety Analysis of Lifting Device for Spent Fuel Dual-purpose Metal Cask (사용후핵연료 금속겸용용기 인양장비의 구조 안전성 해석)

  • Moon, Tae-Chul;Baeg, Chang-Yeal;Yun, Si-Tae;Choi, Byung-Il;Jung, In-Su
    • Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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    • v.12 no.4
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    • pp.299-314
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    • 2014
  • A lifting device is used to deal with transport cask for the transportation of spent fuels from nuclear power plants. This study performed theoretical analysis and numerical simulation to evaluate the structural integrity of the lifting device based on Nuclear Safety and Security Commission(NSSC) Notice No.2013-27 and US 10CFR Part 71 ${\S}71.45$. The results of theoretical analysis showed that the maximum stresses of all components were below the allowable values. This result confirmed that the lifting device was structurally safe during operation. The results of finite element analysis also showed that it was evaluated to satisfy the design criteria bothyielding and ultimate condition. All components have been shown to ensure the structural safety due to sufficient safety margins. In other words, the safety factor was 3 or more for the yielding condition and was 5 or more for the ultimate condition.

Research on Step-Type Chemical Liquid Deodorizer using Liquid Catalyst

  • WOO, Hyun-Jin;KWON, Lee-Seung;JUNG, Min-Jae;YEO, Og-Gyu;KIM, Young-Do;KWON, Woo-Taeg
    • The Korean Journal of Food & Health Convergence
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    • v.6 no.5
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    • pp.19-25
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    • 2020
  • The purpose of this study was to research and develop a step-type chemical liquid deodorizer including a liquid catalyst that can prevent civil complaints due to odor due to its excellent deodorizing performance. The main composition of chemical liquid deodorizer including liquid catalyst is cleaning deodorization, catalyst deodorization, chemical deodorization, water film plate, deodorization water circulation device, deodorization water injection device, catalyst management system, gas-liquid separation device, chemical supply device, deodorizer control panel, etc. It consists of a device. The air flow of the step-type liquid catalyst chemical liquid deodorizer is a technology that firstly removes basic odor substances, and the liquid catalyst installed in the subsequent process stably removes sulfur compounds, which are acidic odor substances, to discharge clean air. The efficiency of treating the complex odor of the prototype was 98.5% for the first and 99.6% for the second, achieving the target of 95%. The hydrogen sulfide treatment efficiency of the prototype was 100% for the first and 99.9% for the second, which achieved 95%, which was the target of the project. As a result, ammonia was removed by the reaction of ammonia and hydrogen sulfide.