• Journal of Environmental Health Sciences
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• v.50 no.2
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• pp.125-137
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• 2024

Background: The Korea Risk Information Surveillance System (K-RISS) was developed to enable the early detection of food and drug safety-related issues. Its goal is to deliver real-time risk indicators generated from ongoing food and drug risk monitoring. However, the existing K-RISS system suffers under several limitations. Objectives: This study aims to augment K-RISS with more detailed indicators and establish a severity standard that takes into account structural changes in the daily time series of K-RISS values. Methods: First, a Delphi survey was conducted to derive the required weights. Second, a control chart, commonly used in statistical process controls, was utilized to detect outliers and establish caution, attention, and serious levels for K-RISS values. Furthermore, Bai and Perron's method was employed to determine structural changes in K-RISS time series. Results: The study incorporated 'closeness to life' and 'sustainability' indicators into K-RISS. It obtained the necessary weights through a survey of experts for integrating variables, combining indicators by data source, and aggregating sub K-RISS values. We defined caution, attention, and serious levels for both average and maximum values of daily K-RISS. Furthermore, when structural changes were detected, leading to significant variations in daily K-RISS values according to different periods, the study systematically verified these changes and derived respective severity levels for each period. Conclusions: This study enhances the existing K-RISS system and introduces more advanced indicators. K-RISS is now more comprehensively equipped to serve as a risk warning index. The study has paved the way for an objective determination of whether the food safety risk index surpasses predefined thresholds through the application of severity levels.

• Journal of Environmental Health Sciences
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• v.43 no.4
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• pp.307-313
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• 2017

Objectives: Chemicals derived from various environment media contaminates food across the food supply chain. In Korea, levels of contaminants in food have been sporadically measured by monitoring programs of different government agencies. There is difficulty with data compilation and integrated analysis across media. Therefore, the aim of this study was to propose an overall integrated database and analytical platform design for the 'ECO-FOOD NET (Environmental COntaminant reduction platform for FOOD through an interagency collaboration NETwork)', a tool to support the reduction of environmental contaminants in food. Methods: We developed a new data structure and standardized protocols for the compilation of integrated data. In addition, we conducted subject-oriented logical and physical relational database modeling and created the architecture design of the platform. Results: We established a standardized code system related to exposure media and route, analysis method and food matrix. In addition, we designed the seven software modules of 'About the System', 'Introduction to Interagency Work', 'Media-Chemicals Profiles', 'Method Bank', 'Monitoring Data Base', 'Integrated Media Analysis', and 'Risk-Benefit Analysis'. Conclusions: This study will contribute to decision-making as a tool for executing risk management, such as sustainable reduction policies of contaminants in food.

• Allergy, Asthma & Respiratory Disease
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• v.6 no.6
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• pp.315-321
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• 2018

Purpose: Radiocontrast media are widely used in medical imaging to improve diagnostic accuracy. However, studies on the adverse reactions of radiocontrast media in children are limited. We aimed to describe the characteristics of adverse reactions to radiocontrast media among children who had a computed tomography scan or magnetic resonance imaging in a tertiary university hospital. Methods: We retrospectively collected data on adverse reactions to radiocontrast media by the reporting system of a tertiary university hospital. We selected data from children under the age of 19 from July 2011 to December 2017 and analyzed their characteristics. We focused mainly on the characteristics of the index case which is defined by the first adverse event of each subject. Results: During the period, a total of 88,050 radiocontrast media-enhanced imaging studies were performed and 184 cases of adverse reactions were reported. A total of 71 were identified as index cases. Forty-nine (69.0%) were male and the mean age was $12.7{\pm}3.2$ years. The incidence of radiocontrast media-related adverse reactions was 0.09% and severe reactions were 0.002%. The most common clinical feature was skin manifestations (54.9%), followed by gastrointestinal symptoms (40.8%) and neuropsychiatric symptoms (7.4%). Conclusion: Adverse reactions to radiocontrast media rarely occur in children and the incidence of severe reactions is low. Most reactions are mild and are related to the skin and gastrointestinal system. This report would provide good evidence for establishing a management strategy in children scheduled for imaging studies using radiocontrast media.

• Korean Journal of Veterinary Research
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• v.38 no.3
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• pp.544-552
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• 1998

A random study of 574 dairy farms in Gyeongnam area was designed to determine 1) management factors that may be associated with the occurrence of drug residues; 2) the dairy farmer's attitudes and knowledge about residues; 3) how these variables influence the occurrence of residues in dairy cattle. Management factors perceived as having the greatest influence on drug residues in milk were insufficient knowledge about withdrawal periods, errors due to hired help, insufficient identification and record of animals treated for mastitis, dry cow treatment for mastitis, and metritis treatment. Seventy-one percent of farms with residues problem used mixed own feeds compared with twenty-nine percent of farms with premedicated feeds. Factors significantly associated with the occurrence of residues were herd size, increased number of hired persons, increased frequency of use of mixed-own feeds, category of medicated feed, and producer's attitude toward the public health significance of residues. Our findings suggest that residue occurrence was mainly associated with errors due to hired help, insufficient knowledge about withdrawal periods, poor animal identification and records of treatment animals and use of medicated feeds. Any residue avodiance educational program needs to stress how to deal with these factors. This educational program should be directed to dairy farmers and employees, especially temporary employees. In addition, Dairy farmer's attitudes and knowledge about drug residues need to be improved. More evidence on the public healths significance of residues should be available to them. Because belife in importance of public healths concerns was related to successful residue avidance and because 81.3% of the dairy farmers with residue problem thought public healths concerns were less important than economic ones, it would be helpful to provide educational programs specifically directed to this issue. it may be useful to provide programs not only for the dairy farmers but also change of their concerns about on the public healths.

• YAKHAK HOEJI
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• v.54 no.6
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• pp.455-460
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• 2010

We evaluated the inappropriateness of metformin use in patients with type 2 diabetes and chronic medical conditions to identify the frequency of the prescription metformin in violation of the food and drug administration (FDA) black box warning. We reviewed medical records of 307 outpatients who received metformin at endocrinology department in a hospital setting between January 1, 2005 and August 30, 2009. Of the 307 outpatients, 25 discontinued treatment of metformin due to elevated serum creatinine level (Scr${\geq}$1.5 mg/dl in male, Scr${\geq}$1.4 mg/dl in female), cancers, and/or liver disease. 5 were lost to follow-up. 89 (29.0%) of the patients had cardiovascular disease, 54.1% for hypertension, 9.8% for liver disease, and 60 (20.8%) for chronic kidney disease. 12 patients (3.9%) with chronic kidney disease and/or elevated serum creatinine level, and 1 patient (0.3%) with lactic acidosis were contraindicated to metformin use. Metformin should be avoided in 7 outpatients (2.3%) with active hepatitis and 1 patient (2.6%) with liver cirrhosis. Of the 307 outpatients, 13 (4.2%) patients who received metformin at the first visit and 16 (8.7%) patients who received metformin at the last visit violated to black box warning. 8 (2.6%) of the patients were in precautionary conditions to metformin use. Adjusted mean difference of serum creatinine was -0.16 mg/dl [95% CI: -0.22 to -0.11 (p<0.05)] and adjusted mean difference of alanine aminotransferase was 4.46 IU/l [95% CI: 2.47 to 6.44 (p<0.05)] between the first visit and the last visit. Critical number of elderly patients who are at the high risks of drug-disease and drug-laboratory interaction is exposed to the inappropriate metformin use in violation of black box warning. The periodic evaluation of metformin use and monitoring prescription through drug utility review (DUR) system is needed to improve patients' safety and to reduce adverse drug events.

• Tuberculosis and Respiratory Diseases
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• v.83 no.3
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• pp.218-227
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• 2020

Background: The national Public-Private Mix (PPM) tuberculosis (TB) control project provides for the comprehensive management of TB patients at private hospitals in South Korea. Surveillance and monitoring of TB under the PPM project are essential toward achieving TB elimination goals. Methods: TB is a nationally notifiable disease in South Korea and is monitored using the surveillance system. The Korea Centers for Disease Control and Prevention quarterly generates monitoring indicators for TB management, used to evaluate activities of the PPM hospitals by the central steering committee of the national PPM TB control project. Based on the notification date, TB patients at PPM hospitals were enrolled in each quarter, forming a cohort, and followed up for at least 12 months to identify treatment outcomes. This report analyzed the dataset of cohorts the first quarter of 2016 through the fourth quarter of 2017. Results: The coverage of sputum, smear, and culture tests among the pulmonary TB cases were 92.8% and 91.5%, respectively. The percentage of positive sputum smear and culture test results were 30.7% and 61.5%, respectively. The coverage of drug susceptibility tests among the culture-confirmed cases was 92.8%. The treatment success rate among the smear-positive drug-susceptible cases was 83.2%. The coverage of latent TB infection treatment among the childhood TB contacts was significantly higher than that among the adult contacts (85.6% vs. 56.0%, p=0.001). Conclusion: This is the first official report to analyze monitoring indicators, describing the current status of the national PPM TB control project. To sustain its effect, strengthening the monitoring and evaluation systems is essential.

• Journal of Biomedical Engineering Research
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• v.44 no.6
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• pp.363-376
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• 2023

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.The purpose of this study is to conduct a usability assessment to ensure that ergonomic design has been applied so that the ventilator central monitoring system can improve user satisfaction, efficiency, and safety. The rapid spread of COVID-19, which began in 2019, caused significant damage global medical system. In this situation, the need for a system to monitor multiple patients with ventilators was highlighted as a solution for various problems. Since medical device software is closely related to human life, ensuring their safety and satisfaction is important before their actual deployment in the field. In this study, a total of 21 participants consisting of respiratory staffs conducted usability test according to the use scenarios in the simulated use environment. Nine use scenarios were conducted to derive an average task success rate and opinions on user interface were collected through five-point Likert scale satisfaction evaluation and questionnaire. Participants conducted a total of nine use scenario tasks with an average success rate of 93% and five-point Likert scale satisfaction survey showed a high satisfaction result of 4.7 points on average. Users evaluated that the device would be useful for effectively managing multiple patients with ventilators. However, improvements are required for interfaces associated with task that do not exceed the threshold for task success rate. In addition, even medical devices with sufficient safety and efficiency cannot guarantee absolute safety, so it is suggested to continuously evaluate user feedback even after introducing them to the actual site.

• Korean Journal of Clinical Pharmacy
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• v.26 no.4
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• pp.306-311
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• 2016

Objective: This study was performed to compare the changes in the blood concentrations of tacrolimus when either itraconazole or voriconazole is together with tacrolimus to prevent or treat invasive aspergillus pneumonia (IAP) in patients with lung transplants. Therefore we can compare the degree of drug-drug interactions between tacrolimus and itraconazole against tacrolimus and voriconazole. Methods: Patients who were admitted and had lung transplants in a territory referral hospital from September 2012 to May 2015 were analyzed retrospectively. The effects of itraconazole and voriconazole on the plasma concentrations of tacrolimus were analyzed. Results: Mean tacrolimus concentrations was $10.49{\pm}2.35ng/mL$ vs. $10.95{\pm}2.98ng/mL$ (p=0.722), and mean concentration of tacrolimus over the dose of tacrolimus per day was $8.510{\pm}5.890(ng/mL)/(mg/d)$ vs. $15.45{\pm}28.47(ng/mL)/(mg/d)$ (p=0.947) in itraconazole vs. voriconazole group each. The ratio of the number of the results out of target tacrolimus concentrations to the total number of tacrolimus concentration results was $18.0{\pm}13.3%$ vs. $24.4{\pm}18.5%$ (p=0.185). Conclusion: There were no significant differences between itraconzaole and voriconazole to have influences on mean concentrations of tacrolimus over tacrolimus dose per weight per day. However voriconazole tended to raise tacrolimus plasma concentrations more than itraconazole. Safer and more effective drug management to prevent and treat fungal infections should be done by therapeutic drug monitoring not only of tacrolimus but of itraconazole and voriconazole in lung transplant patients.

• Journal of Biomedical Engineering Research
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• v.41 no.1
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• pp.55-61
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• 2020

Recently, there have been many research on fever management using u-healthcare technology. Especially, fever of infants requires continuous monitoring of body temperature by parents. For infants between 4 weeks and under 5 years old, it is recommended to use an electronic thermometer or chemical thermometer in the axilla, or to use an infrared thermometer. However, in order to overcome the reality of not being able to waste significant time on continuous monitoring, there have been demands of patch type thermometers with the internet of things (IoT) and wireless communication technologies. Existing IoT thermometers are difficult to attach to infants' body because they do not take into account its size, and their interoperability is not guaranteed because they do not comply with standards in communication. Therefore, in this study, a patch-type thermometer with a diameter of 20 mm and a weight of 2.9 g was developed to manage the fever of infants, while it communicates wirelessly with Bluetooth Low Energy (BLE) communication protocol and complies with IEEE 11073 PHD(Personal Health Device) at the same time. We verified its performance under the requirements of thermometers regulated by the Korean Ministry of Food and Drug Safety.

• Korean journal of food and cookery science
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• v.19 no.1
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• pp.24-33
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• 2003

The purpose of the study was to investigate the HACCP systems of contract foodservice establishments by surveying HACCP plans and prerequisite programs from the twelve HACCP-implemented contract foodservice establishments appointed by KFDA. All the subjects (100%) appeared to develop HACCP plans with their own hazard analysis. Except the two giving no response, it turned out that two establishments had 2 CCPs (20%), four had 4∼5 CCPs (40%) and another four had 9 CCPs (40%). Especially, 'cleaning and sanitizing of raw vegetables and fruits (90%)' and 'cooking (temperature) (100%)' were monitored as CCPs by all the subjects. Only one subject (8.3%) answered that continuous monitoring was not conducted. But the verification, record keeping and internal audits were maintained by all the subjects (100%). Most of the surveyed foodservice establishments maintained various prerequisite programs enough to back up HACCP system.