• Title/Summary/Keyword: Quality control guidelines

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Drug Use Evaluation of Antihypertensive Agents by JNC VI Guidelines (고혈압 치료 지침 Vl에 의한 항고혈압제의 사용평가)

  • Kim, Kyung Hwa;Lee, Suk Hyang
    • Korean Journal of Clinical Pharmacy
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    • v.12 no.1
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    • pp.29-38
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    • 2002
  • Hypertension is an important public health problem because it increases the risk of stroke, angina, myocardial infarction, heart failure, and end-stage renal disease. If it is not actively treated, morbidity and mortality increase with hypertension-induced complications and quality of life decreases. This study was to evaluate the use of antihypertensive drugs and blood pressure changes and to compare algorithms chosen (or the 1st and 2nd line therapy of hypertension based on the JNC VI recommendations. The medical charts of 222 patients with essential hypertension at St. Vincent's Hospital in Suwon from January 1997 to January 2000 were reviewed retrospectively. Data collection and analysis included baseline BP underlying diseases and complications, administered antihypertensives, BP changes, changes of antihypertensive regimen, and adverse effects with treatments. As results, the higher BP the patients had, the more frequent they had target organ damages and clinical cardiovascular diseases. Mean duration to reduce blood pressure less than 140/90 mmHg was 8 weeks in $85.3\%$ of the patients. The rate of control in BP was $82.4\%$ at 6 months. The major antihypertensive drugs prescribed were calcium channel blockers $(61.8\%)$ , ACE inhibitors $(19.1\%),\;\beta-blockers\;(13.7\%)$ and diuretics $(5.3\%)$ as the 1st-line monotherapy. The methods of treatment used as the 1st-line therapy were monotherapy$(59\%)$ and combination therapy $(41\%)$. Blood pressure change was significantly greater for combination therapy than monotherapy$(-26.2\pm21.4\;vs.\;-18.56\pm16.7$ mmHg for systolic blood pressure; P<0.003, $-16.9\pm13.2\;vs.\;-9.2\pm12.8$ mmHg for diastolic blood pressure; p<0.001). When blood pressure was not completely controlled with the first antihypertensive selected, the 2nd line therapy had 4 options: addition of 2nd agent from different class; $66.2\%$, substitution with another drug, $21.9\%$ increase dose $11.9\%$ continue first regimen $27.9\%$ Calcium channel blockers were the most frequently prescribed agents. This was not comparable to the JNC VI guideline which recommended diuretics and $\beta-blockers$ for the 1st-line therapy. Most of patients achieved the goal BP and maintained it until 6 months, but the remaining patients should be controlled more tightly to improve their BP with combination of life style modification, patient education, and pharmacotherapy.

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Epidemiologic Studies of Reproductive Health in Male Workers (남성 근로자의 생식보건 역학연구)

  • Choi, Byeong Ju;Lee, Sanggil;Kim, Seonggyu;Sung, Jungmin;Ye, Shinhee
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.31 no.3
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    • pp.202-212
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    • 2021
  • Objectives: The reproductive health of female workers has been extensively investigated in South Korea and other countries worldwide. However, few studies have discussed the reproductive health of male workers. In this study, we reviewed the recent literature that reports on the effects of occupational exposure on the reproductive health of male workers and the health of their children. Methods: In May 2020 we used the PubMed search engine to search the literature over the last 10 years and chose case-control, cohort, and cross-sectional studies and reviews. We selected epidemiological studies that investigated the association between pre-pregnant occupational exposure and the reproductive health of male workers and the health of their children. We excluded case reports, non-epidemiological studies (animal experiments, cellular-level experiments, and similar articles), and studies that described postnatal occupational exposure. Results: We eventually selected 23 studies. The studies that included exclusively male workers reported that those employed in the agricultural sector or those exposed to pesticides showed lower blood levels of reproductive hormones and a high risk of lympho-hematopoietic system cancer in their children. Male workers exposed to complex organic solvents and organic compounds showed a high risk of poor semen quality, increased time to pregnancy, decreased blood levels of reproductive hormones, and a high risk of lympho-hematopoietic system cancer in their children. Male workers employed in occupations that involved significant social contact, or in the leather and livestock industries, and in occupations with high levels of exposure to lead and organic solvents showed a high risk of malignancies, including lympho-hematopoietic system cancer, neuroblastoma, and central nervous system tumors in their children. Studies that investigated both male and female workers reported that children of male smelters showed a high risk of premature birth, and children of male workers exposed to metals showed a high risk of hypospadias and cryptorchidism. Children of male welders and workers employed in the glass, ceramic, and tile industries showed a high risk of premature birth. Conclusion: The findings of this study will serve as basic data for further research on male workers' reproductive health and provide a scientific basis for the development of strategies to protect the reproductive health of males employed in high-risk occupations. Moreover, the results of this study may provide guidelines to improve the understanding of and knowledge on male workers' reproductive health.

Working Conditions that Impact the Workload of Cytotechnologists: A Study Calculating the Actual Man Power Required (세포병리사의 업무량에 따른 적정인력 산정을 위한 업무실태 조사 연구)

  • Jee, Soo Il;Ahn, Yong Ho;Ha, Hwa-Jeong;Kang, Jeong Eun;Won, Jun Ho
    • Korean Journal of Clinical Laboratory Science
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    • v.53 no.2
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    • pp.174-187
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    • 2021
  • Cytotechnologists evaluate and analyze disorders of cells that constitute the human body, and are involved in the primary assessment of diverse diseases, including cancer. However, the employment conditions and workload of cytotechnologists are poorly understood. This study was undertaken to provide basic data for establishing the criteria for quality control certification factors based on the scope of effective task performance of cytotechnologists, and to provide results of their workload analysis according to the type of medical institution. The study was conducted by enrolling certified cytotechnologists working at various nationwide medical institutions. Our analysis revealed that 178 personnel (72.7%) were involved in primary screening of samples. On an average, the daily number of primary screening of samples performed per cytotechnologist (76 respondents) was determined to be 75.4 chapters (16.8 chapters/hours) at the university hospital level, 72.4 chapters (18.6 chapters/hours) at the general hospital level, and 231 chapters (32.6 chapters/hours) at professional trust institutions. Our results indicate the necessity to establish a consultant with the Korean Cell Pathology Association, to enable finding solutions to solve existing issues by establishing accurate standard guidelines for assessing cell screening.

Determination and Validation of Synthetic Antioxidants in Processed Foods Distributed in Korea

  • Park, Hyeon-Ju;Seo, Eunbin;Park, Jin-Wook;Yun, Choong-In;Kim, Young-Jun
    • Journal of Food Hygiene and Safety
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    • v.37 no.5
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    • pp.297-305
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    • 2022
  • Antioxidants are food additives that extend the shelf life of food products by preventing lipid rancidity caused by active oxygen. They can either be naturally-derived or manufactured synthetically via chemical synthesis. In this study, method validation of five synthetic antioxidants, namely butylated hydroxyanisole, butylated hydroxytoluene, tertiary butylhydroquinone, propyl gallate, and disodium ethylenediaminetetraacetic acid, was performed using a high performance liquid chromatography-ultraviolet visible detector, and the method applicability was evaluated by analyzing foods containing antioxidants. The coefficient of determination (R2) average was 0.9997, while the limit of detection and limit of quantification were 0.02-0.53 and 0.07-1.61 mg/kg, respectively. The intra and inter-day accuracies and precisions were 83.2±0.7%-98.7±2.1% and 0.1%-5.7% RSD, respectively. Inter-laboratory validation for accuracy and precision was conducted using the Food Analysis Performance Assessment Scheme quality control material. The results satisfied the guidelines presented by the AOAC International. In addition, the expanded uncertainty was less than 16%, as recommended by CODEX. Consequently, to enhance public health safety, the results of this study can be used as basis data for evaluating the intake of synthetic antioxidants and assessing their risks in Korea.

A Study on the Utilization and Development of the Korean National Authority Data Sharing System (국가전거공동활용시스템의 활용 및 발전 방안에 관한 연구)

  • Ji-won, Baek;Sungsook, Lee
    • Journal of the Korean BIBLIA Society for library and Information Science
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    • v.34 no.1
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    • pp.121-143
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    • 2023
  • This study was conducted with the aim of identifying the current status of the national authority data construction project centered on the National Library of Korea for the effective construction and utilization of national knowledge information resources. It also aimed to reveal the possibility and improvement of the national information system with the international standard identification system, and suggesting future development plans. To this end, this study conducted interviews and questionnaires with members of the Korean National Authority Data Sharing System(KNASS). The survey consisted of items related to the current status and difficulties related to the authority, the use of the KNASS, the recognition and utilization of identifiers, the awareness and utilization of the linkage with ISNI, the Importance-Performance Analysis for activating the KNASS, and the overall satisfaction and improvement direction. As a result of the analysis, it was proposed to develop rules and guidelines related to the authority works, to increase the quantity and quality of authority data, to raise understanding of the importance and establish a efficient work system, to diversify the authority service and develop a utilization model, to link the KNASS with international identifiers, and to share the necessity of the KNASS.

Market in Medical Devices of Blockchain-Based IoT and Recent Cyberattacks

  • Shih-Shuan WANG;Hung-Pu (Hong-fu) CHOU;Aleksander IZEMSKI ;Alexandru DINU;Eugen-Silviu VRAJITORU;Zsolt TOTH;Mircea BOSCOIANU
    • Korean Journal of Artificial Intelligence
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    • v.11 no.2
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    • pp.39-44
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    • 2023
  • The creativity of thesis is that the significance of cyber security challenges in blockchain. The variety of enterprises, including those in the medical market, are the targets of cyberattacks. Hospitals and clinics are only two examples of medical facilities that are easy targets for cybercriminals, along with IoT-based medical devices like pacemakers. Cyberattacks in the medical field not only put patients' lives in danger but also have the potential to expose private and sensitive information. Reviewing and looking at the present and historical flaws and vulnerabilities in the blockchain-based IoT and medical institutions' equipment is crucial as they are sensitive, relevant, and of a medical character. This study aims to investigate recent and current weaknesses in medical equipment, of blockchain-based IoT, and institutions. Medical security systems are becoming increasingly crucial in blockchain-based IoT medical devices and digital adoption more broadly. It is gaining importance as a standalone medical device. Currently the use of software in medical market is growing exponentially and many countries have already set guidelines for quality control. The achievements of the thesis are medical equipment of blockchain-based IoT no longer exist in a vacuum, thanks to technical improvements and the emergence of electronic health records (EHRs). Increased EHR use among providers, as well as the demand for integration and connection technologies to improve clinical workflow, patient care solutions, and overall hospital operations, will fuel significant growth in the blockchain-based IoT market for linked medical devices. The need for blockchain technology and IoT-based medical device to enhance their health IT infrastructure and design and development techniques will only get louder in the future. Blockchain technology will be essential in the future of cybersecurity, because blockchain technology can be significantly improved with the cybersecurity adoption of IoT devices, i.e., via remote monitoring, reducing waiting time for emergency rooms, track assets, etc. This paper sheds the light on the benefits of the blockchain-based IoT market.

Development of Ceramide NP Analysis Method in Cosmetic Formulations Using Liquid Chromatography (액체크로마토그래피를 이용한 화장품 제형 내 세라마이드엔피 분석법 확립)

  • Ye Ji Lee;Young Eun Kim;Jae Yong Seo;Hyun Dae Cho
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.49 no.4
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    • pp.291-298
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    • 2023
  • In this study, a quantitative analysis method was developed using high-performance liquid chromatography (HPLC) to analyze the content of ceramide NP in lotion, cream, and cleanser formulations in cosmetics. The analysis was performed using a C18 column, and the mobile phase was set at a ratio of 70 : 30 for acetonitrile and methanol, the flow rate was set to 0.8 mL/min, and the column temperature was set to 20 ℃. The method was verified by analyzing specificity, linearity, limit of detection, limit of quantitation, accuracy, and precision in accordance with the ICH guidelines. As a result of validating the method, the linearity of the calibration curve was excellent (R2 = 0.99984). The accuracy of the lotion, cream, and cleanser formulations was confirmed with a recovery rate ranging from 95.11% to 100.48%. The precision analysis showed a low relative standard deviation (RSD) of less than 0.26%. The limit of detection was 0.902 ㎍/mL, and the limit of quantitation was 2.733 ㎍/mL. Through this quantitative analysis method of ceramide NP applied in cosmetics, it is expected to assist in the quality control of products by enabling measurement even when it is difficult to separate the main peak due to the influence of interfering substances.

Analysis of Output Constancy Checks Using Process Control Techniques in Linear Accelerators (선형가속기의 출력 특성에 대한 공정능력과 공정가능성을 이용한 통계적 분석)

  • Oh, Se An;Yea, Ji Woon;Kim, Sang Won;Lee, Rena;Kim, Sung Kyu
    • Progress in Medical Physics
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    • v.25 no.3
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    • pp.185-192
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    • 2014
  • The purpose of this study is to evaluate the results for the quality assurance through a statistical analysis on the output characteristics of linear accelerators belonging to Yeungnam University Medical Center by using the Shewhart-type chart, Exponentially weighted moving average chart (EWMA) chart, and process capability indices $C_p$ and $C_{pk}$. To achieve this, we used the output values measured using respective treatment devices (21EX, 21EX-S, and Novalis Tx) by medical physicists every month from September, 2012 to April, 2014. The output characteristics of treatment devices followed the IAEA TRS-398 guidelines, and the measurements included photon beams of 6 MV, 10 MV, and 15 MV and electron beams of 4 MeV, 6 MeV, 9 MeV, 12 MeV, 16MeV, and 20 MeV. The statistical analysis was done for the output characteristics measured, and was corrected every month. The width of control limit of weighting factors and measurement values were calculated as ${\lambda}=0.10$ and L=2.703, respectively; and the process capability indices $C_p$ and $C_{pk}$ were greater than or equal to 1 for all energies of the linear accelerators (21EX, 21EX-S, and Novalis Tx). Measured values of output doses with drastic and minor changes were found through the Shewhart-type chart and EWMA chart, respectively. The process capability indices $C_p$ and $C_{pk}$ of the treatment devices in our institution were, respectively, 2.384 and 2.136 for 21EX, 1.917 and 1.682 for 21EX-S, and 2.895 and 2.473 for Novalis Tx, proving that Novalis Tx has the most stable and accurate output characteristics.

An Operations Study on a Home Health Nursing Demonstration Program for the Patients Discharged with Chronic Residual Health Care Problems (추후관리가 필요한 만성질환 퇴원환자 가정간호 시범사업 운영 연구)

  • 홍여신;이은옥;이소우;김매자;홍경자;서문자;이영자;박정호;송미순
    • Journal of Korean Academy of Nursing
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    • v.20 no.2
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    • pp.227-248
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    • 1990
  • The study was conceived in relation to a concern over the growing gap between the needs of chronic patients and the availability of care from the current health care system in Korea. Patients with agonizing chronic pain, discomfort, despair and disability are left with helplessly unprepared families with little help from the acute care oriented health care system after discharge from hospital. There is a great need for the development of an alternative means of quality care that is economically feasible and culturally adaptible to our society. Thus, the study was designed to demonstrate the effectiveness of home heath care as an alternative to bridge the existing gap between the patients' needs and the current practice of health care. The study specifically purports to test the effects of home care on health expenditure, readmission, job retention, compliance to health care regime, general conditions, complications, and self-care knowledge and practices. The study was guided by the operations research method advocated by the Primary Health Care Operations Research Institute(PRICOR) which constitutes 3 stages of research : namely, problem analysis solution development, and solution validation. The first step in the operations research was field preparation to develop the necessary consensus and cooperation. This was done through the formation of a consulting body at the hospital and a steering committee among the researchers. For the stage of problem analysis, the Annual Report of Seoul National University Hospital and the patients records for last 5 years were reviewed and selective patient interviews were conducted to find out the magnitude of chronic health problems and areas of unmect health care needs to finally decide on the kinds of health problems to study. On the basis of problem analysis, the solution development stage was devoted to home care program development asa solution alternative. Assessment tools, teaching guidelines and care protocols were developed and tested for their validity. The final stage was the stage of experimentation and evaluation. Patients with liver diseases, hemiplegic and diabetic conditions were selected as study samples. Discharge evaluation, follow up home care, measurement and evaluation were carried out according to the protocols of care and measurement plan for each patient for the period of 6 months after discharge. The study was carried out for the period from Jan. 1987 to Dec. 1989. The following are the results of the study presented according to the hypotheses set forth for the study ; 1. Total expenditures for the period of study were not reduced for the experimental group, however, since the cost per hospital visit is about 4 times as great as the cost per home visit, the effect of cost saving by home care will become a reality as home care replaces part of the hospital visits. 2. The effect on the rate of readmission and job retention was found to be statistically nonsignificant though the number of readmission was less among the experimental group receiving home care. 3. The effect on compliance to the health care regime was found to be statistically significant at the 5% level for hepatopathic and diabetic patients. 4. Education on diet, rest and excise, and medication through home care had an effect on improved liver function test scores, prevention of complications and self - care knowledge in hepatopathic patients at a statistically significant level. 5. In hemiplegic patient, home care had an effect on increased grasping power at a significant level. However. there was no significant difference between the experimental and control groups in the level of compliane, prevention of complications or in self-care practices. 6. In diabetic patients, there was no difference between the experimental and control groups in scores of laboratory tests, appearance of complications, and self-care knowledge or self -care practices. The above findings indicate that a home care program instituted for such short term as 6 months period could not totally demonstrate its effectiveness at a statistically significant level by quantitative analysis however, what was shown in part in this analysis, and in the continuous consultation sought by those who had been in the experimental group, is that home health care has a great potential in retarding or preventing pathological progress, facilitating rehabilitative and productive life, and improving quality of life by adding comfort, confidence and strength to patients and their families. For the further studies of this kind with chronic patients it is recommended that a sample of newly diagnosed patients be followed up for a longer period of time with more frequent observations to demonstrate a more dear- cut picture of the effectiveness of home care.

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Microbiological Hazard Analysis of Sundae (Korean Sausage) Made of Meat By-Products (식육 부산물을 활용한 순대의 미생물학적 위해 분석)

  • Cheong, Jin-Sook;Kim, Yun Jeong;Om, Ae-Son
    • Journal of Food Hygiene and Safety
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    • v.37 no.3
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    • pp.181-188
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    • 2022
  • Despite the recent increase in the consumption level of the processed meat-byproducts, the health and safety issue has consistently been raised in the processes of production, distribution and consumption. The purpose of this study is to analyze and evaluate the microbiological hazard elements in the Korean sausage, "Sundae," to present not only the safety standard of meat by-product vendors based on HACCP (Hazard Analysis Critical Control Point), but also the quality control criteria and sanitary arrangements of small manufacturers. For the study, the microbiological hazards in 24 raw materials, 7 manufacturing processes, 40 facilities and tools, 17 workplace environment, and 12 workers were analyzed. The analysis revealed the hazardous elements in the initial stages with 6.28 and 4.07 log CFU/g of total aerobic count and coliforms, respectively, detected from the porcine blood and 3.23 log CFU/g of coliforms from the porcine small intestines. The result also showed that the total aerobic counts and coliforms in the process of mixing and filling process exceeds the standards in the hygiene guidelines by Natick with the total aerobic counts of 5.23, 5.45 log CFU/g, and the coliforms of 3.25, and 3.31 log CFU/g, respectively. Although the detected total aerobic count and the coliforms in the filling and washing rooms exceeded the standards, it was found that the total aerobic count was significantly reduced by 98% after cleaning and disinfecting and no coliforms was detected in any process thereafter. In order to achieve high level of safety in the manufacturing processes of Sundae, the separation of washing and disinfection room from the other sections and the sanitation control of the workers must be preceded, along with strict monitoring in the storage and distribution processes. The study raises necessity for additional studies for the safety evaluation of the processed meat-byproducts and further researches on the validity of the critical limits.