• Title/Summary/Keyword: effectiveness of safety device

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A Safety Process Guideline of Medical Device System Based on STPA (STPA를 적용한 의료기기 시스템의 안전성 프로세스 가이드라인)

  • Choi, Bo-yoon;Lee, Byong-gul
    • Journal of Internet Computing and Services
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    • v.22 no.6
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    • pp.59-69
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    • 2021
  • Malfunctions and failures linked to medical devices may result in significant damage for human being. Thus, in order to ensure that safety of medical device is achieved, it should be established and applied the international standard. It is required to integrate and customize activities at standards, owing to reference relationship between standards, especially, activities based safety analysis is too expensive. This paper proposes a integration process that integrate activities of development lifecycle and safety process. Additionally, we derived a guidance based on STPA for integration process. As a result, we can be performed systematically from early stage of the development and increased effectiveness of integration process by the guidance.

Development of Complex Module Device for Odor Reduction in Sewage

  • KIM, Young-Do;KWON, Woo-Taeg
    • Journal of Wellbeing Management and Applied Psychology
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    • v.4 no.3
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    • pp.1-9
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    • 2021
  • Purpose: This study was conducted to develop a module with higher removal efficiency and effectiveness by adapting two or more deodorization techniques for main cause of odor pollution exposed citizen living near water treatment facilities. Research design, data and methodology: To consider the standard, unity, electrical wire, compatibility of detachable device by installing two types of dry deodorization device within one module for easy replacement. Complex odor, H2S, NH3 were collected from sewage treatment facilities for evaluation of deodorization device. Results: Using the developed application in this study, removal efficiency of complex odor, H2S, NH3 were 93%, 100%, 82%, respectively. Conclusions: The H2S removal efficiency of deodorization device was higher than bio-filter system, which were currently used by sewage treatment. Further, the device should be considered for use in efficient odor removal system.

Research on Reimbursement of Therapeutic Medical Device through Delphi Method and Analytic Hierarchy Process (치료재료 별도산정 기준 개선을 위한 델파이 및 계층분석과정 조사)

  • Noh, Jin-Won;Lee, Yejin;Jang, Suk Yong;Kim, Mi Kyung;Cho, Kyoung Hee;Kim, Jae-Hyun;Yoo, Ki-Bong
    • Korea Journal of Hospital Management
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    • v.23 no.4
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    • pp.15-25
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    • 2018
  • Purposes: The objectives of this study present the direction of the criteria for the separately reimbursement of therapeutic medical device. Methodology: We summarized experts' opinion using Delphi survey and Analytic Hierarchy Process(AHP). 48 experts were gathered from Medical Insurance Review Nurses Association, medical device industry, academy and association, Medical Device Expert Evaluation Committee. Descriptive statistics, consistency index, content validity ratio were analyzed. Findings: Clinical utility, patient safety, infection control, cost-homogeneity, cost-effectiveness showed high feasibility and importance, but market contribution and functional utility showed low feasibility and importance in a relative sense. The results of functional utility differed between clinical and non-clinical experts. Measurability was low across the whole area. Among the criteria for the separately reimbursement of therapeutic medical device. Patient safety/infection control and clinical utility showed the highest relative importance values, analyzed using AHP. Practical Implications: Patient safety and infection control are needed to be considered as one of Value Assessment Criteria. It is important to find out how to improve the measurability of therapeutic medical device.

A Risk Analysis on the Error Code of Vehicle Inspection Utilizing Portfolio Analysis (Portfolio 분석을 활용한 자동차 검사의 부적합항목에 대한 위험도분석)

  • Choi, Kyung-Im;Kim, Tae-Ho;Lee, Soo-Il
    • Journal of the Korean Society of Safety
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    • v.27 no.4
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    • pp.121-127
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    • 2012
  • Vehicle Inspection System is to examine the condition of vehicle regularly at the national level to protect lives and properties of the people from traffic accidents due to vehicle's fault. However, the vehicle inspection method, criteria, period and effectiveness have become a controversial issue, because of examining safety management of vehicle by drivers regardless of regular vehicle inspection. Therefore, the aim of this study is to investigate vehicle inspection timeliness and risk level of inspection items through basic statistical survey and portfolio analysis. The results of the research through practical analysis are: (1) The inspection failure rates between 3 and 6 model year tend to increase. (2) The failure of inspection items for safety highly impacts on traffic accident rate in terms of accident risks. (3) According to the result of portfolio analysis, faulty items located 1st quadrant are riding device, driveline system, controlling device, steering actuator, and fuel system.

A Study on the Application of Systematic Literature Review for Post-Market Clinical Evaluation of Medical Devices: Focused on the Ophthalmic Electrosurgical system (시판 후 의료기기 임상평가를 위한 체계적 문헌고찰 활용 방안 연구: 안과용전기수술기 사례를 중심으로)

  • Kim, Byung Gwan;Choi, Young Sook;Kim, Mi Sun;Yang, Seok-Jo
    • Journal of Biomedical Engineering Research
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    • v.41 no.1
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    • pp.35-41
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    • 2020
  • In this study, we examined whether the systematic literature review method used in the field of evidence-based medicine could be used for post-market clinical evaluation of medical devices by modifying them to fit the regulatory perspective of medical devices in Korea. For this purpose, systematic literature review was modified and applied to conduct a clinical literature survey on the ophthalmic electrosurgical system(Trabectome®, NeoMediX Corp) used for the treatment of glaucoma. A total of six documents were finally selected, and clinical safety and efficacy information on the indications of the ophthalmic electrosurgical system were effectively presented. In addition, general safety information and unexpected safety information could be distinguished through comparison with medical device adverse event reporting cases. The method used in this study is expected to be used in various ways throughout post-market medical device safety management system and for the purpose of regulation improvement, especially in the field of ophthalmic electrosurgical system.

Safety Enhancement of Teleoperation using Haptic Control (햅틱 제어에 의한 원격작업의 안전성 향상)

  • Kim, Yun Bae;Choi, Gi Sang;Choi, Gi Heung
    • Journal of the Korean Society of Safety
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    • v.28 no.4
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    • pp.19-25
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    • 2013
  • For safe remote control, information on remote environment has to be delivered to operator realistically, and there have been numerous research efforts on this respect. Among them, haptic technology can significantly enhance safety and overall effectiveness of remote operation by delivering various kinds of information on virtual or real environment to operator. In this study, remote control based on haptic feedback is applied to control of mobile robot moving according to the command from operator avoiding collision with environmental obstacles and maintaining safe distance from them using ultrasonic sensors. Specifically, a remote feedback control structure for mobile robot is proposed. The controller is based on the inner feedback loop that directly utilizes information on distance to obstacles, and the outer feedback loop that the operator directly commands using the haptic device on which the computed reaction force based on the distance information is acting. Effectiveness of the proposed remote control scheme using double feedback loops is verified through a series of experiments on mobile robot.

Quantitative Risk Assessment based on Fault Tree Analysis for Gangform Accident (갱폼 재해의 FTA를 통한 정량적 위험성 산정에 관한 연구)

  • Ham, Young Jong;Kee, Jung Hun;Park, Jong Yil
    • Journal of the Korean Society of Safety
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    • v.35 no.4
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    • pp.40-47
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    • 2020
  • Although gangform has good workability due to the integration of outer wall forms and working platforms, 22 workers were died from 21 gangform related accidents during 2012 to 2016. Quantitative risk assessment is required for evident based prevention measure selection. In this study, based on 52 accident data from 2004 to the first half of 2019, FTA is conducted for probabilities of direct causes and their contribution to accidents. Three stages are considered; gangform installation, dismantling and lifting, and using. The effectiveness of countermeasures is evaluated through minimum cut set, RAW and RRW. Complete assembly of gangform on the ground level, detailed planning, and fall prevention device are suggested as prevention measures for installation, dismantling and lifting, and using stages, respectively.

Assessment of Volatile Organic Compound Reduction Using an Air Purification Facility in an Adhesive Handling Process (접착제 취급 작업장 내 공기정화 설비를 이용한 휘발성 유기화합물 저감 평가)

  • Jaemin Woo;Dongjun Kim;Jihun Shin;Gihong Min;Chaekwan Lee;Wonho Yang
    • Journal of Environmental Health Sciences
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    • v.49 no.2
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    • pp.78-88
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    • 2023
  • Background: Exposure to volatile organic compounds (VOCs) can have acute and chronic health effects on human beings in general and in working environments. In particular, VOCs are often emitted in large quantities in industrial settings. In such circumstances, there is a need to improve the indoor air quality at workplaces. Objectives: The purposes of this study were to verify the effectiveness of air cleaning devices in workplaces and provide alternative solutions for improving working environments. Methods: Personal exposure and area level of VOCs for workers were evaluated in a car-part adhesive process before and after installing an air cleaning device with a TiO2-coated filter. Passive samplers and direct reading instruments were used to collect and analyze the VOCs, and the removal efficiency and improvement of air quality were evaluated. We also calculated the exposure index (EI) to assess the risk level in the workplace. Results: The removal efficiency for VOCs through the installation of the air cleaning device was approximately 26.9~69.0% as determined by the concentration levels before and after installation. The measured substances did not exceed the exposure limits for the work environment and the EI was less than 1. However, carcinogenic substances such as benzene, formaldehyde, carbon tetrachloride, and trichloroethylene were detected. Conclusions: The application of an air cleaning device can be a solution for controlling the indoor air quality in a workplace, particularly in cases where ventilation systems cannot be installed due to process limitations.

Estimation of Traffic Safety Improvement by Applying a Traffic Control Device (교통통제장치 적용에 따른 교통안전도 향상에 관한 연구)

  • Nam Baek;Lee Chul-Gi;Lee Sang-Soo;Oh Young-Tae;Yu Tae-Ho
    • The Journal of The Korea Institute of Intelligent Transport Systems
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    • v.5 no.1 s.9
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    • pp.55-63
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    • 2006
  • Speeding is one of the major causes of traffic accidnets in urban areas. Driver feedback sign(DFS) is a traffic control device that can be used for many traffic environments including work zones, school zones, and roadways. In this paper, the effectiveness of DFS was evaluated through a field study using speed data collected from before and after study periods. In addition traffic safety improvement was also quantitatively estimated using the variance of speed data collected. Staistical test results showed that the speed difference was statistically significant, and the distribution of speed data was also shifted greatly. Therefore, it was concluded that installing the DFS in roadways might lead to unifomity of speed of traffic flow, thus, potential safety improvement might be expected.

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Structural Analysis of Spaceborne Two-axis Gimbal-type Antenna of Compact Advanced Satellite (차세대 중형위성용 2축 짐벌식 안테나의 구조해석)

  • Park, Yeon-Hyeok;You, Chang-Mok;Kang, Eun-Su;Oh, Hyun-Ung
    • Journal of Aerospace System Engineering
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    • v.12 no.2
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    • pp.37-45
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    • 2018
  • A two-axis gimbal-type antenna for a Compact Advanced Satellite (CAS) is used to efficiently transmit high resolution image data to a ground station. In this study, we designed the structure of a two-axis gimbal-type antenna while applying a launch lock device to secure its structural safety under a launch environment. To validate the effectiveness of the structural design, a structural analysis of the antenna was performed. First, a modal analysis was performed to investigate the dynamic responses of the antenna with and without the mechanical constraints of the launch lock device. In addition, a quasi-static analysis was performed to confirm the structural safety of the antenna structure and bolt I/Fs between the antenna base and the satellite. The suitable range of constraint force on the launch lock device was also determined to ensure the structural safety and mechanical gapping of the ball & socket interfaces, which places multi-constraints on the azimuth and elevation stage of the antenna.