• Title/Summary/Keyword: Event Reporting

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Perspective Diversity of Domestic Stakeholders on Medical Device Adverse Event Reporting (의료기기 이상사례 보고에 대한 국내 이해관계자의 관점 차이)

  • Lee, Ye Jin;Yoon, Chiho;Choi, Soo Jeong;Kang, Youngjoon;Kim, Jin Kuk;Kwon, Bum Sun;Lee, You Kyoung;Nam, Ki Chang
    • Journal of Biomedical Engineering Research
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    • v.40 no.5
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    • pp.171-178
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    • 2019
  • This study was conducted to observe the differences in perspective of medical device adverse events and report exchange for domestic stakeholders. The post-market surveillance of medical device not only improves the usability and functionality of the device but also identifies new or growing risks caused by the device. APEC (Asia-Pacific Economic Cooperation) have established and operated post-market surveillance systems for medical devices based on IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force) guidelines. However, there are significant gaps in many aspects. It is essential to apply harmonized guidelines internationally but also to interpret and apply the guidelines consistently to report and exchange medical device adverse event in domestic. This study retrospectively analyzed the results of surveys conducted by providing examples of the adverse events and guidelines for post-market surveillance. The results of the study showed that there was a considerable difference in the judgment on the phase of using medical device for patient. In the case of medical device adverse event, different opinions shown according to knowledge and experience. Education and training are needed to have a harmonized perspective on the reporting and exchanging international guidelines of the adverse event for domestic stakeholders.

Patient safety practices in Korean hospitals (우리나라 병원의 환자안전 향상을 위한 활동 현황)

  • Hwang, Soo-Hee;Kim, Myung-Hwa;Park, Choon-Seon
    • Quality Improvement in Health Care
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    • v.22 no.2
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    • pp.43-73
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    • 2016
  • Purpose: The aims of this study were to assess the presence of core patient safety practices in Korean hospitals and assess the differences in reporting and learning systems of patient safety, infrastructure, and safe practices by hospital characteristics. Methods: The authors developed a questionnaire including 39 items of patient safety staffing, health information system, reporting system, and event-specific prevention practices. The survey was conducted online or e-mail with 407 tertiary, general and specialty hospitals. Results: About 90% of hospitals answered the self-reporting system of patient safety related events is established. More than 90% of hospitals applied incidence monitoring or root cause analysis on healthcare-associated infection, in-facility pressure ulcers and falls, but only 60% did on surgery/procedure related events. More than 50% of the hospitals did not adopted present on admission (POA) indicators. One hundred (80.0%) hospitals had a department of patient safety and/or quality and only 52.8% of hospitals had a patient safety officer (PSO). While 82.4% of hospitals used electronic medical records (EMRs), only 53% of these hospitals adopted clinical decision support function. Infrastructure for patient safety except EMRs was well established in training, high-level and large hospitals. Most hospitals implemented prevention practices of adverse drug events, in-facility pressure ulcers and falls (94.4-100.0%). But prevention practices of surgery/procedure related events had relatively low adoption rate (59.2-92.8%). Majority of prevention practices for patient safety events were also implemented with a relatively modest increase in resources allocated. Conclusion: The hospital-based reporting and learning system, EMRs, and core evidence-based prevention practices were implemented well in high-level and large hospitals. But POA indicator and PSO were not adopted in more than half of surveyed hospitals and implementation of prevention practices for specific event had low. To support and monitor progress in hospital's patient safety effort, national-level safety practices set is needed.

Distributed System Architecture Modeling of a Performance Monitoring and Reporting Tool (분산 시스템의 성능 모니터링과 레포팅 툴의 아키텍처 모델링)

  • Kim, Ki;Choi, Eun-Mi
    • Journal of the Korea Society for Simulation
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    • v.12 no.3
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    • pp.69-81
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    • 2003
  • To manage a cluster of distributed server systems, a number of management aspects should be considered in terms of configuration management, fault management, performance management, and user management. System performance monitoring and reporting take an important role for performance and fault management. In this paper, we present distributed system architecture modeling of a performance monitoring and reporting tool. Modeling architecture of four subsystems are introduced: node agent, data collection, performance management & report, and DB schema. The performance-related information collected from distributed servers are categorized into performance counters, event data for system status changes, service quality, and system configuration data. In order to analyze those performance information, we use a number of ways to evaluate data corelation. By using some results from a real site of a company and from simulation of artificial workload, we show the example of performance collection and analysis. Since our report tool detects system fault or node component failure and analyzes performances through resource usage and service quality, we are able to provide information for server load balancing, in short term view, and the cause of system faults and decision for system scale-out and scale-up, in long term view.

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A Model on the OSI Fault Management Implementation for Effective Alarm Processing (효과적인 경보 처리를 위한 OSI 장애 관리 구현 모델)

  • 이재오;조국현
    • The Journal of Korean Institute of Communications and Information Sciences
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    • v.18 no.4
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    • pp.537-548
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    • 1993
  • The OSI fault management is composed of specific management functions such as the Alarm Reporting Function, Event Report Management Function, and Log Control Function. The fault management is to notify and manage the events and the alarm data which are transfered as the information of the fault management may be managed effectively. And it is necessary to design the model of the fault management properly by using these functions for the study of network management activities. Therefore, in this paper, the integrated management model of the Event Report Management and Log Control Function based on Alarm Reporting Function is investigated. Also, the system component of alarm collector which is added in the manager system for the effective fault management is studied and proposed.

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Reporting of Adverse Events in Randomized Controlled Trials of Bee Venom Acupuncture: A Systematic Review (봉침을 이용한 무작위배정 비교임상시험연구에서의 유해사례 보고에 대한 체계적 문헌고찰)

  • Yi, Woon-Sup;Kim, Sung-Soo
    • Journal of Korean Medicine Rehabilitation
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    • v.24 no.4
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    • pp.97-109
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    • 2014
  • Objectives Bee venom acupuncture (BVA) is emerging as a potential therapeutic option for several conditions. However, evidence regarding accurate estimates of its adverse events are not available. Therefore, by combining occurrence rates of adverse events in relevant randomized controlled trials (RCTs), we have aimed to give an overall estimated rate of each adverse event following BVA intervention. Methods A systematic search for adverse events of BVA in Pubmed, Cochrane Central Register of Controlled Trials, Embase, NDSL, KoreaMed, KISS, RISS, KISTI, and KMbase was performed. For the quality assessment of the trials, we applied the CONSORT harms reporting recommendations. The overall occurrence rate of each adverse event was assessed as the primary outcome. The overall drop-out rate due to adverse events was assessed as the secondary outcome. Results Ten RCTs reported adverse events following BVA. Two RCTs were eligible of further synthesis. Adverse events of pruritus, localized edema, and erythema occurred significantly more frequently in the BVA group compared to the control group. Data of drop-outs were available in seven RCTs. However, no comparisons showed a significant difference. Conclusions Currently evidence of adverse events is far from sufficient for assessing a reliable, precise occurrence rate. Still, limited evidence shows a tendency that adverse events occur more frequently after the appliance of BVA compared to the control. Thus, we await well designed future studies of BVA with more proper and strict harms reporting methods.

Design for a Medical Devices Safety Information Reporting System for the Hospitals (의료기기 안전성 정보 원내 보고 시스템 설계)

  • Jang, Hye Jung;Choi, Young Deuk;Kim, Nam Hyun
    • Journal of the Institute of Electronics and Information Engineers
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    • v.52 no.1
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    • pp.140-147
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    • 2015
  • In this study, medical devices safety information reporting system was designed to manage medical devices for the efficient management of in-hospital adverse events. The current management of medical device adverse event reporting regulations and the legal status of the system and procedures for identifying the system were reviewed. MSF/CD(Microsoft Solution Framework/Component Design) was applied to the system design. Through this study, we can understand medical devices management including the notice provisions of the Ministry of Food and Drug Safety for medical devices safety information reporting. We also expect this study will help to improve patient safety and the effective management of medical equipment, and contribute to activating medical devices safety information reporting.

What to Teach? A Critical Linguistic Perspective on News Reporting

  • Min, Su-Jung
    • English Language & Literature Teaching
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    • v.9 no.spc
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    • pp.113-129
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    • 2003
  • This study aims to probe for ideological construction within the linguistic structure of newspaper reporting. The study focuses on news reports relating the issue of new IOC chairman election in English version of four mainstream newspaper published in Korea: The Donga Daily News, The Jungang Daily News, The Chosun Daily News, and The Korea Times. The analysis of these reports adheres to the analytic paradigm of critical linguistic analysis and shows how the newspaper articulate conflicting ideological positions in their reports of new IOC chairman election. The analysis demonstrates how the event of new IOC chairman election is naturalized in racist accounts. This study is important for understanding the constructive nature of language practices. The study concludes with a discussion to explain the need for critical awareness in choosing right teaching material, considering that news reports are widely accepted as an authentic material for English education.

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An Implementation of Automatic Transmission System of Traffic Event Information (교통이벤트 정보의 자동 전송시스템 구현)

  • Jeong, Yeong-Rae;Jang, Jae-Hoon;Kang, Seog Geun
    • The Journal of the Korea institute of electronic communication sciences
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    • v.13 no.5
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    • pp.987-994
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    • 2018
  • In this paper, an automatic transmission system of traffic information is presented. Here, a traffic event is defined as an obstacle to an emergency vehicle such as an ambulance or a fire truck. When a traffic event is detected from a video recorded by a black box installed in a vehicle, the implemented system automatically transmits a proof image and corresponding information to the control center through an e-mail. For this purpose, we realize an algorithm of identifying the numbers and a character from the license plate, and an algorithm for determining the occurrence of a traffic event. To report the event, a function for automatic transmission of the text and image files through e-mail and file transfer protocol (FTP) is also appended. Therefore, if the traffic event is extended and applied to the presented system, it will be possible to establish a convenient reporting system for the violation of various traffic regulations. In addition, it will contribute to significantly reduce the number of traffic violations against the regulations.

Comparative Analysis of Ethical-the-counter Drugs and Over-the-counter Drugs for the Adverse Events from the Community Pharmacy (지역약국에서 보고된 전문의약품과 일반의약품의 이상사례 보고현황 비교 분석)

  • Lee, Mo-Se;Park, So-Hee;Kim, Na-Young;Oh, In-Sun;Lee, Jung-Min;Lee, Eui-kyung;Shin, Ju-Young
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.3
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    • pp.230-237
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    • 2018
  • Objective: To compare adverse event reporting patterns between ethical-the-counter and over-the-counter drugs from community pharmacies and outpatient settings. Methods: We conducted a descriptive study using the adverse event reporting database, wherein data were collected from the regional pharmacovigilance centers of the Korean Pharmaceutical Association between January 1, 2016 and December 31, 2016. The reported drugs were classified into either ethical-the-counter or over-the-counter drugs, and we compared the distribution of patient age and gender, frequent adverse events and medications, serious adverse events, and causality assessment results, where causality assessments were performed according to the World Health Organization-The Uppsala Monitoring Centre's system. Results: We included 17,570 reports (75,451 drug-adverse event pairs). Ethical-the-counter and over-the-counter drugs accounted for 81.4% and 18.6% of the total adverse event reports, respectively. The use of over-the-counter drugs was higher in females and patients aged <18 years, whereas the use of ethical-the-counter drugs was higher in those aged >65 years. Alimentary tract and metabolism drugs, and respiratory system drugs were the most frequent ethical-the-counter and over-the-counter drugs, respectively. From causality assessment results, "possible" (75.4%) was the most commonly assigned category for ethical-the-counter drugs, while "possible" (44.0%) and "unlikely" (47.7%) were the most common categories for over-the-counter drugs. The distribution of serious adverse events were similar for both ethical-the-counter and over-the-counter drugs. Conclusion: Differences were observed in age, gender, reported medications, and symptoms for both ethical-the-counter and over-the-counter drugs. Further pharmacovigilance activities considering the adverse event characteristics of over-the-counter drugs, which are comparable to ethical-the-counter drugs, should be performed.