• Title/Summary/Keyword: Biological risk assessment

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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.

Qualitative PCR Detection of Stack Gene GM Rice (LS28 X Cry1Ac) Developed in Korea (국내개발 stack gene GM 벼(LS28 X Cry1Ac)에 대한 정성 PCR 분석)

  • Shin, Kong-Sik;Park, Jong-Hyun;Lee, Jin-Hyoung;Lee, Si-Myung;Woo, Hee-Jong;Lim, Sun-Hyung;Kim, Hae-Yeong;Suh, Seok-Cheol;Kweon, Soon-Jong
    • Journal of Applied Biological Chemistry
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    • v.52 no.1
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    • pp.1-7
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    • 2009
  • For the development of qualitative PCR detection method of genetically modified (CM) rice, rice species-specific gene, OsCc-1 (rice cytochrome c gene), was selected as suitable far use as an endogenous gene in rice. The primer pair OsCytC-5'/3'with 111 bp amplicon was used for PCR amplification of the rice endogenous gene, OsCc-1 and no amplified product was observed from 8 different crops as templates. Qualitative PCR method was carried out with stack traits of L528$\times$CryIAc1 GM rice developed in Korea. For the qualitative PCRs, some primer pairs were designed with a construct-specific and event-specific type based on T-DNA and junction sequences of T-DNA in GM rice. Actck-5'/3' amplifying between actin promoter and OsCK1 gene introduced in LS28 gave rise to an amplicon 306 bp; also, CrLB-5'/3' from CryIAcl and CKRB-5'/3'amplifying the junction region of T-DNA and genome sequence from LS28 as event-specific primers gave rise to an amplicon 142 bp and 91 bp, respectively. These primer pairs for the detection of event-specific targets not produced PCR amplicons on non-CM rice and various crops in contrast to event lines. Therefore, in this study we verified that event-specific primers were effective to specifically detect stack trait lines and demonstrated that this method presented could be provided with the detection-method data for risk assessment analysis of GM rice to be commercialized.

Ttrosine Hydroxylase in Japanese Medaka (Oryzias latipes): cDNA Cloning and Molecular Monitoring of TH Gene Expression As a Biomarker (송사리 Tyrosine Hydroxylase: cDNA 클로닝 및 생물지표로서의 TH 유전자 발현의 분자생물학적 추적)

  • Shin, Sung-Woo;Kim, Jung-Sang;Chon, Tae-Soo;Lee, Sung-Kyu;Koh, Sung-Cheol
    • Environmental Analysis Health and Toxicology
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    • v.15 no.4
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    • pp.131-137
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    • 2000
  • The release of hazardous waste materials into the environment poses serious risks in humans and ecosystems. The risk assessment of environmental pollutants including hazardous chemicals requires a comprehensive measurement of hazard and exposure of the chemicals that can be achieved by toxicity evaluation using a biological system such as biomarkers. In this report we have tried to develop a biomarker used to elucidate a molecular basis of, and to monitor abnormal behaviors caused by diazinon in Japanese medaka (Oryzias latipes) as a model organism. First, an attempt was made to clone tyrosine hydroxylase gene from Japanese medaka that would be a candidate for a biomarker for neuronal modulations and behaviors. For monitoring experiments at behavioral and molecular biological levels, the fish were treated under different sublethal conditions of diazinon and their behavioral responses were observed . In this study we have successfully cloned a partial TH gene from the medaka fish through PCR screening of an ovary cDNA library. DNA sequencing analysis revealed that the amplified fragment was 327 bp encoding 109 amino acids. Comparing the DNA sequence of medaka TH with other species, TH gene revealed the DNA sequence was completely identical to that of rat TH. In the RT-PCR, 330 Up of mRNA was consistently amplified in all the treated samples including control There were no significant differences in the TH expression level regardless of treating concentrations (1∼5,000 ppb) and time (0∼48 hr) The reason appeared to be that RT-PCR was not performed using through a quantitative analysis normalized against an actin gene expression. Organ or tissue - specific detection of TH activity and mRNA as biomarkers will be a useful monitoring tool for neurobehavioral changes in fish influenced by toxic chemicals. Furthermore, quantitative analysis of locomotive patterns and its correlation with the neurochemical and molecular data would be highly useful in measuring toxicity and hazard ofvarious environmental pollutants.

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A Clinical Study of Child Abuse (아동학대로 진단된 환아의 임상적 고찰)

  • Choi, Yoon Jin;Kim, Shin Mi;Sim, Eun Jung;Cho, Do Jun;Kim, Dug Ha;Min, Ki Sik;Yoo, Ki Yang
    • Clinical and Experimental Pediatrics
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    • v.50 no.5
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    • pp.436-442
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    • 2007
  • Purpose : To promote awareness and efforts by pediatricians to identity and prevent child abuse by investigation of characteristics of victim and types of injury caused by abuse. Methods : A retrospective study was performed with 20 patients who had been diagnosed or suspected as child abuse at Hallym University Hospital from January 1999 to December 2005. The medical records, radiologic documents, and social worker's notes were reviewed to investigate age, sex, visiting time, form of abuse, perpetrator, risk factor, and type of injury. Results : The mean age of the subjects was 2.8 years. Fourteen patients were between 0-1 years old, 2 patients between 1-6 years old, 3 patients between 7-12 years old, and 1 case over 13 years old. The ratio of male to female was 1:1. The majority of these patients (70%) visited via emergency department. Eight five percent of these patients reported with physical abuse, 5% psychological abuse, 5% sexual abuse, and 5% neglect respectively. The suspected perpetrator was the biological father in six cases, the biological mother in three cases, the stepmother in two cases, caregiver in one case, relatives in one case and "unknown" in six cases. Bruise and hematoma (80%) were the most common physical findings. Skull fractures were diagnosed in six cases, long bone fractures in two cases, hemoperitoneum in two cases, subdural hemorrhage in 10 cases, epidural hemorrhages in two cases, subarachnoidal hemorrhages in two cases, and retinal hemorrhages in five cases respectively. Seventeen cases required hospitalization and surgical operations performed were in nine cases. Four patients died and three patients had sequalae such as developmental delay and quadriplegia. Conclusion : Child abuse results in high mortality and morbidity in victims. Therefore early recognition and prevention is very important. Pediatricians should always suspect the possibilities of abuse in cases of fracture, intracranial hemorrhage, abdominal injury, or even any injury to the body. We recommend that the clinical investigation of suspicious children should include a full multidisciplinary social assessment, a skeletal survey and CT or MRI.

Biological Toxicity Assessment of Sediment at an Ocean Dumping Site in Korea (폐기물 배출해역 퇴적물의 생물학적 독성평가 연구)

  • Seok, Hyeong Ju;Kim, Young Ryun;Kim, Tae Won;Hwang, Choul-Hee;Son, Min Ho;Choi, Ki-young;Kim, Chang-joon
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.28 no.1
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    • pp.1-9
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    • 2022
  • The effect of sediments in a waste dumping area on marine organisms was evaluated using sediment toxicity tests with a benthic amphipod (Monocorophium acherusicum) and bioluminescent bacterium (Vibrio fischeri) in accordance with the Korean Standard Method for Marine Wastes (KSMMW). Nine sites in the East Sea-Byeong, East Sea-Jeong, and Yellow Sea-Byeong areas were sampled from 2016 to 2019. The test results showed that the relative average survival rate (benthic amphipods) and relative luminescence inhibition rate (luminescent bacteria) were below 30%, which were judged to be "non-toxic." However, in the t-test, a total of 12 benthic amphipod samples (6, 1, 1, and 4 in 2016, 2017, 2018, and 2019, respectively) were significantly different (p<0.05) from the control samples. To identify the source of toxicity on benthic amphipods, a simple linear regression analysis was performed between the levels of eight heavy metals (Cr, As, Ni, Cd, Cu, Pb, Zn, and Hg) in sediments and the relative average survival rate. The results indicated that Cr had the highest contribution to the toxicity of benthic amphipods (p = 0.000, R2 = 0.355). In addition, Cr was detected at the highest concentration at the DB-85 station and exceeded the Marine Environment Standards every year. Although the sediments were determined as "not toxic" according to the ecotoxicity criteria of the KSMMW, the results of the statistical significance tests and toxicity identification evaluation indicated that the toxic effect was not acceptable. Therefore, revising the criteria for determining the toxic effect by deriving a reference value through quantitative risk assessment using species sensitivity distribution curves is necessary in the future.

Development and Assessment Individual Maximum Permissible Dose Method of I-131 Therapy in High Risk Patients with Differentiated Papillary Thyroid Cancer (물리학 선량법을 이용한 갑상선암의 개인별 최대안전용량 I-131 치료법 개발과 유용성 평가)

  • Kim, Jeong-Chul;Yoon, Jung-Han;Bom, Hee-Seung;JaeGal, Young-Jong;Song, Ho-Chun;Min, Jung-Joon;Jeong, Heong;Kim, Seong-Min;Heo, Young-Jun;Li, Ming-Hao;Park, Young-Kyu;Chung, June-Key
    • The Korean Journal of Nuclear Medicine
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    • v.37 no.2
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    • pp.110-119
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    • 2003
  • Purpose: Radioiodine (I-131) therapy is an effective modality to reduce both recurrence and mortality rates in differentiated thyroid cancer. Whether higher doses shows higher therapeutic responses was still debatable. The purpose of this study was to validate curve-fitting (CF) method measuring maximum permissible dose (MPD) by a biological dosimetry using metaphase analysis of peripheral blood lymphocytes. Materials and Methods: Therapeutic effects of MPD was evaluated in 58 patients (49 females and 9 males, mean age $50{\pm}11$ years) of papillary thyroid cancer. Among them 43 patients were treated with ${\Leq}7.4GBq$, while 15 patients with ${\geq}9.25GBq$. The former was defined as low-dose group, and the latter high-dose group. Therapeutic response was defined as complete response when complete disappearance of lesions on follow-up I-131 scan and undetectable serum thyroglobulin levels were found. Statistical comparison between groups were done using chi-square test. P value less than 0.05 was regarded as statistically significant. Results: MPD measured by CF method using tracer and therapeutic doses were $13.3{\pm}1.9\;and\;13.8{\pm}2.1GBq$, respectively (p=0.20). They showed a significant correlation (r=0.8, p<0.0001). Exposed doses to blood measured by CF and biological methods were $1.54{\pm}0.03\;and\;1.78{\pm}0.03Gy$ (p=0.01). They also showed a significant correlation (r=0.86, p=0.01). High-dose group showed a significantly higher rate of complete response (12/15, 80%) as compared to the low-dose group (22/43, 51.2%) (p=0.05). While occurrence of side effects was not different between two groups (40% vs. 30.2%, p=0.46). Conclusion: Measurement of MPD using CF method is reliable, and the high-dose I-131 therapy using MPD gains significantly higher therapeutic effects as compared with low-dose therapy.

Assessment of Pre-Harvest Environmental Factors in Domestic Production of Organic Lettuce (국내 유기상추의 생산환경 조사분석)

  • Namgung, Min;Kim, Beom Seok;Heo, Seong Jin;Choi, Yong Beom;Hur, Jang Hyun;Park, Duck Hwan
    • The Korean Journal of Pesticide Science
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    • v.18 no.2
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    • pp.88-94
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    • 2014
  • Among pre-harvest environmental factors, increasing attention has been paid to the effects of chemical and microbiological factors on fresh produce. The occurrence and prevalence of these factors have been usually studied with regard to the final products at the post-harvesting stage and/or when they are sold in the market. However, the origin and routes of transmission of both factors remain to be clarified. In the present study, we examined the contamination levels of food-borne pathogens and chemical factors such as pesticide residues and heavy metals in 83 and 43 samples, respectively, including various soil, water, and fertilizer samples, as well as post-harvested and processed samples. Among the organic farming samples, only one pesticide, dimethomorph, was detected in the soil sample, however no pesticides were observed from any other samples in organic farming system. Thus, it was thought that might be contaminated from conventional farm land in the vicinity. Whereas many pesticide residues were detected in conventional farming systems such as soil, fertilizer, water, and fresh produce as expected. Furthermore, heavy metals detected from all tested samples did not shown contamination levels higher than the standard limit. We comparatively assessed the levels of contamination by food-borne pathogens on the samples from organic and conventional farming systems, and found aerobic bacteria at approximately 7 log CFU/g, with no significant differences observed between the two systems. Coliforms were present at lower levels than aerobic bacteria. No human pathogens were present among the coliforms detected, indicating that these bacteria are saprophytes without the ability to cause food-borne illnesses. In contrast, among the high-risk food-borne pathogens, only sporadic cells of Bacillus cereus were found on samples of organic farming system. These data extend previous findings that the most prevalent food-borne pathogen is B. cereus and demonstrate that it spreads to whole living plants via soil.

Influence of the Increase of Dissolved $CO_2$ Concentration on the Marine Organisms and Ecosystems (해수중 용존 $CO_2$ 농도 증가가 해양생물 및 해양생태계에 미치는 영향: 국내외 사례 연구)

  • Lee, Jung-Suk;Lee, Kyu-Tae;Kim, Chan-Kook;Park, Gun-Ho;Lee, Jong-Hyeon;Park, Young-Gyu;Gang, Seong-Gil
    • Journal of the Korean Society for Marine Environment & Energy
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    • v.9 no.4
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    • pp.243-252
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    • 2006
  • Influence of the increasing carbon dioxide concentration in seawater on various marine organisms is assessed in this article with regard to the impacts of anthropogenic $CO_2$ introduced into surface or deep oceans. Recent proposals to sequester $CO_2$ in deep oceans arouse the concerns of adverse effects of increased $CO_2$ concentration on deep-sea organisms. Atmospheric introduction of $CO_2$ into the ocean can also acidify the surface water, thereby the population of some sensitive organisms including coral reefs, cocolithophorids and sea urchins will be reduced considerably in near future (e.g. in 2100 unless the increasing trend of $CO_2$ emission is actively regulated). We exposed bioluminescent bacteria and benthic amphipods to varying concentrations of $CO_2$ and also pH for a short period. The ${\sim}l.5$ unit decrease of pH adversely affected test organisms. However, amphipods were not influenced by decreasing pH when HCl was used for the seawater acidification. In this article, we reviewed the biological adverse effects of $CO_2$ on various marine organisms studied so for. Theses results will be useful to predict the potential risks of the increase of $CO_2$ concentrations in seawater due to the increase of atmospheric $CO_2$ emission and/or sequestration of $CO_2$ in deep oceans.

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