• Title/Summary/Keyword: Safety Assessment

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Early Clinical Experience in Aortic Valve Replacement Using On-X$^{circledR}$Prosthetic Heart Valve (On-X$^{circledR}$ 기계판막을 이용한 대동맥판 치환술의 조기 임상 경험)

  • 안병희;전준경;류상완;최용선;김병표;홍성범;박종춘;김상형
    • Journal of Chest Surgery
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    • v.36 no.9
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    • pp.651-658
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    • 2003
  • Since the first implanted in September 1997, the use of On-X prosthetic heart valve has been increasing around in the world. This study was designed to assess the feasibility, safety, and the postoperative hemodynamics with this new valve in clinical setting. Material and Method: The current study was carried out on 52 patients undergoing aortic valve replacement with this prosthesis between April 1999 to August 2002 at Chonnam National University Hospital to evaluate the surgical results. 52% of the patients were male and the average age at implant was 50$\pm$13 years. The study followed the guidelines of the AATS/STS. Preoperatively, 32(61.5%) patients were in NYHA functional class III or IV and 2 patients had previous aortic valve surgery. Concomitant cardiac surgery was performed in 71.1%. The implanted valve sizes were 19 mm in 13 patients, 21 mm in 26, 23 mm in 10 and 25 mm in 3, respectively. Mean follow-up was 16.6$\pm$10.5 months (1∼39 months). Echocardiographic assessment was performed pre- and immediate postoperatively, as well as 3, 6, 12 months after surgery, evaluating pressure loss and regression of left ventricular hypertrophy. Result: Mean cardiopulmonary bypass time was 191$\pm$94.7 minutes with an aortic cross-clamp time of 142$\pm$51.7 minutes. There was no early and late mortality, Freedom from adverse events at 1 year in the study were as follows: thromboembolism, 95.6$\pm$6%; bleeding events, 90.2$\pm$4%; paravalvular leakage 92.3$\pm$4%; and overall valve-related morbidity at 1 year was 76.6$\pm$3%. There were no cases of valve thrombosis, prosthetic valve endocarditis and structural or non-structural failure. Left ventricular function at 12 months after surgery (EF=62.7$\pm$9.8%) revealed a statistically significant improvement compared to preoperative investigation (EF=55.8$\pm$15.9%, p=0.006). Left ventricular mass index was 247.3$\pm$122.3 g/$m^2$ on preoperative echocardiographic study, but regressed to 155.5$\pm$58.2 g/$m^2$ at postoperative 1 year (p=0.002). Over the follow-up period a further decrease of peak transvalvular gradients was observed in all patients: 62.5$\pm$38.0 mmHg on preoperative assessment, 18.2$\pm$6.8 mmHg at immediate postoperative period (p < 0.0001), 7.6$\pm$5.09 mmHg (p<0.0001) at 6 month, 18.0$\pm$10.8 mmHg (p<0.0001) at 1 year. Conclusion: The On-X prosthetic heart valve performs satisfactorily in the first 1 year period. Clinical outcome by examining NYHA functional classification revealed especially good results. Effective regression of left ventricular hypertrophy and statistically significant decrease of transvalvular gradient were observed over the first year, but longer-term follow-up of this patient group is needed to establish the expected rates for late valve-related events as well as the long-term clinical efficacy of this valve.

Assessment of Estimated Daily Intakes of Artificial Sweeteners from Non-alcoholic Beverages in Children and Adolescents (어린이와 청소년의 비알콜성음료 섭취에 따른 인공감미료 섭취량 평가)

  • Kim, Sung-Dan;Moon, Hyun-Kyung;Lee, Jib-Ho;Chang, Min-Su;Shin, Young;Jung, Sun-Ok;Yun, Eun-Sun;Jo, Han-Bin;Kim, Jung-Hun
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.43 no.8
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    • pp.1304-1316
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    • 2014
  • The aims of this study were to estimate daily intakes of artificial sweeteners from beverages and liquid teas as well as evaluate their potential health risks in Korean children and adolescents (1 to 19 years old). Dietary intake assessment was conducted using actual levels of aspartame, acesulfame-K, and sucralose in non-alcoholic beverages (651 beverages and 87 liquid teas), and food consumption amounts were drawn from "The Fourth Korea National Health and Nutrition Examination Survey (2007~2009)". To estimate dietary intake of non-alcoholic beverages, a total of 6,082 children and adolescents (Scenario I) were compared to 1,704 non-alcoholic beverage consumption subjects (Scenario II). The estimated daily intake of artificial sweeteners was calculated based on point estimates and probabilistic estimates. The values of probabilistic artificial sweeteners intakes were presented by a Monte Carlo approach considering probabilistic density functions of variables. The level of safety for artificial sweeteners was evaluated by comparisons with acceptable daily intakes (ADI) of aspartame (0~40 mg/kg bw/day), acesulfame-K (0~15 mg/kg bw/day), and sucralose (0~15 mg/kg bw/day) set by the World Health Organization. For total children and adolescents (Scenario I), mean daily intakes of aspartame, acesulfame-K, and sucralose estimated by probabilistic estimates using Monte Carlo simulation were 0.09, 0.01, and 0.04 mg/kg bw/day, respectively, and 95th percentile daily intakes were 0.30, 0.02, and 0.13 mg/kg bw/day, respectively. For consumers-only (Scenario II), mean daily intakes of aspartame, acesulfame-K, and sucralose estimated by probabilistic estimates using Monte Carlo simulation were 0.52, 0.03, and 0.22 mg/kg bw/day, respectively, and 95th percentile daily intakes were 1.80, 0.12, and 0.75 mg/kg bw/day, respectively. For scenarios I and II, neither aspartame, acesulfame-K, nor sucralose had a mean and 95th percentile intake that exceeded 5.06% of ADI.

Assessment of Demand and Use of Fresh-Cut Produce in School Foodservice and Restaurant Industries (학교급식 및 외식업체에서의 신선편이 농산물 사용실태 및 요구도 평가)

  • Sun, Shih-Hui;Kim, Ju-Hee;Kim, Su-Jin;Park, Hye-Young;Kim, Gi-Chang;Kim, Haeng-Ran;Yoon, Ki-Sun
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.39 no.6
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    • pp.909-919
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    • 2010
  • The purpose of this study was to investigate the demand and use of fresh-cut produce in school foodservice and restaurant industries. The subjects of this survey study were 200 school nutritionists and 70 cooks or managers in the restaurant industry nationwide. The data were collected by means of self-administered or e-mail questionnaires. Data analysis was completed using the SPSS window (ver. 12.0) program including frequency, $\chi^2$-test and t-test. Survey questions assessed the general characteristic of respondents, and the supply, use, and demand of fresh-cut produce in school foodservice and restaurant industries. Over 74% of the subjects have used fresh-cut produce. Most of the school foodservice (84.0%) kept fresh-cut produce for one day, while restaurant industry (28.3%) kept them up to three days. The nutritionists of school foodservice and managers of restaurant industry considered origin and date of production as the most important factor, respectively, when fresh-cut produce were being used. Fresh-cut root vegetable, such as potato and carrot was used mostly. The main reason not to use the fresh cut produce was due to the distrust of the fresh-cut produce safety in school foodservice and cost in restaurant industry. The main problem in fresh-cut produce use was the need of rewashing (29.9%) in school foodservice and irregular size (39.0%) in restaurant industry. These results indicate that the quality standard and size specification must be prepared with production guideline of safe fresh-cut produce.

Review of 2015 Major Medical Decisions (2015년 주요 의료판결 분석)

  • Yoo, Hyun Jung;Lee, Dong Pil;Lee, Jung Sun;Jeong, Hye Seung;Park, Tae Shin
    • The Korean Society of Law and Medicine
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    • v.17 no.1
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    • pp.299-346
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    • 2016
  • There were also various decisions made in medical area in 2015. In the case that an inmate in a sanatorium was injured due to the reason which can be attributable to the sanatorium and the social welfare foundation that operates the sanatorium request treatment of the patient, the court set the standard of fixation of a party in medical contract. In the case that the family of the patient who was declared brain dead required withdrawal of meaningless life sustaining treatment but the hospital rejected and continued the treatment, the court made a decision regarding chargeable fee for such treatment. When it comes to the eye brightening operation which received measure of suspension from the Ministry of Health and Welfare for the first time in February, 2011, because of uncertainty of its safety, the court did not accept the illegality of such operation itself, however, ordered compensation of the whole damage based on the violation of liability for explanation, which is the omission of explanation about the fact that the cost-effectiveness is not sure as it is still in clinical test stage. There were numerous cases that courts actively acknowledged malpractices; in the cases of paresis syndrome after back surgery, quite a few malpractices during the surgery were acknowledged by the court and in the case of nosocomial infection, hospital's negligence to cause such nosocomial infection was acknowledged by the court. There was a decision which acknowledged malpractice by distinguishing the duty of installation of emergency equipment according to the Emergency Medical Service Act and duty of emergency measure in emergency situations, and a decision which acknowledged negligence of a hospital if the hospital did not take appropriate measures, although it was a very rare disease. In connection with the scope of compensation for damage, there were decisions which comply with substantive truth such as; a court applied different labor ability loss rate as the labor ability loss rate decreased after result of reappraisal of physical ability in appeal compared to the one in the first trial, and a court acknowledged lower labor ability loss rate than the result of appraisal of physical ability considering the condition of a patient, etc. In the event of any damage caused by malpractice, in regard to whether there is a limitation on liability in fee charge after such medical malpractice, the court rejected the hospital's claim for setoff saying that if the hospital only continued treatments to cure the patient or prevent aggravation of disease, the hospital cannot charge Medical bills to the patient. In regard to the provision of the Medical Law that prohibit medical advertisement which was not reviewed preliminarily and punish the violation of such, a decision of unconstitutionality was made as it is a precensorship by an administrative agency as the deliberative bodies such as Korean Medical Association, etc. cannot be denied to be considered as administrative bodies. When it comes to the issue whether PRP treatment, which is commonly performed clinically, should be considered as legally determined uninsured treatment, the court made it clear that legally determined uninsured treatment should not be decided by theoretical possibility or actual implementation but should be acknowledged its medical safety and effectiveness and included in medical care or legally determined uninsured treatment. Moreover, court acknowledged the illegality of investigation method or process in the administrative litigation regarding evaluation of suitability of sanatorium, however, denied the compensation liability or restitution of unjust enrichment of the Health Insurance Review & Assessment Service and the National Health Insurance Corporation as the evaluation agents did not cause such violation intentionally or negligently. We hope there will be more decisions which are closer to substantive truth through clear legal principles in respect of variously arisen issues in the future.

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Assessment of Inorganic Nutrients Contents of Seasonal Foods in Seoul (계절별 다소비식품 중 무기영양원소 함량 평가)

  • Lee, Kyeong-Ah;Jang, Mi-Ra;Kim, Ouk-Hee;Park, Young-Ae;Choi, Bu-Chuhl;Han, Sung-Hee;Kim, Li-La;Kim, Jin-Kyeong;Lee, Jib-Ho;Hwang, In-Sook;Oh, Young-Hee;Jung, Kweon
    • Journal of Food Hygiene and Safety
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    • v.32 no.2
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    • pp.123-128
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    • 2017
  • The purpose of this study was to determine the sodium (Na) and potassium (K) content of seasonal foods Four hundred food samples classified into 8 different kinds of seasonal foods were collected from 150 restaurants located in Seoul. The Na and K content in seasonal foods were the analyzed by ICP-OES. The Average content of Na and K in spicy seafood noodle soup were highest as $391.4{\pm}72.7mg$/100 g and $88.6{\pm}21.4mg$/100 g, respectly, while average content of Na was lowest in spicy buckwheat noodles as $255.3{\pm}67.0mg$/ 100 g and the average content of K was lowest in Udon as $36.3{\pm}17.8mg$/ 100 g, respectively. The Na/K ratio of spicy buckwheat noodles was $3.2{\pm}1.0$, while those of cold buckwheat noodles, fish cake, Udon were very high as measured more than 8. Among the seasonal foods, the average content of Na was highest in Winter group as $366.9{\pm}81.8mg$/ 100 g and the average content of K was highest in Autumn group as $84.8{\pm}24.1mg$/ 100 g. The ratio of Na/K was lowest in Summer group as $5.9{\pm}3.3$.

The Content of Heavy Metals in Herbal Pills Used as General Processed Food and Risk Assessment of Heavy Metal Intakes (유통 환(丸)제품의 중금속 함량 및 위해성 평가)

  • Kim, Sung-Dan;Jung, Sun-Ok;Kim, Bog-Soon;Yun, Eun-Sun;Chang, Min-Su;Park, Young-Ae;Lee, Young-Chul;Chae, Young-Zoo;Kim, Min-Young
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.39 no.7
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    • pp.1038-1048
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    • 2010
  • The purpose of this study was to investigate some heavy metals (Pb, Cd, Cr, Cu, Hg) in 52 commercial herbal pills used as general processed food, to identify weekly heavy metal intakes from herbal pills and to evaluate their potential health risks. The samples were digested with a microwave and determinations of heavy metal residues were carried out by inductively coupled plasma mass spectrometry (ICP-MS) and mercury analyzer. The mean values of heavy metal contents for herbal pills used as general processed food were Pb 0.421 (0.032~1.630), Cd 0.157 (0.011~0.515), Cr 1.033 (0.112~9.933), Cu 6.923 (1.333~16.755), Hg 0.010 (0.001~0.088) mg/kg. Lead contents of herba and cadmium of algae, herba were high (ANOVA-test, p<0.05). Levels of cadmium concentrations exceeding WHO reference values (0.3 mg/kg) were observed in 10 samples (4 species). The significant correlation was observed between Pb and Cd (r=0.633, p<0.01). The weekly intakes of Pb, Cd, Cr, Cu, Hg from herbal pills were 1.112 (0.072~5.088), 1.614 (0.029~9.257), 3.000 (0.252~23.690), 0.182 (0.008~1.235), 0.220 (0.000~0.420)%, respectively, as compared with the Provisional Tolerable Weekly Intake (PTWI) established by Joint FAO/WHO Expert Committee for food safety evaluation. Our data suggest regulations limiting heavy metals in herbal pills used as general processed food.

Pesticide Residues Survey and Safety Evaluation for Perilla Leaf & Lettuce on the Garak-dong Agricultural & Marine Products Market (가락동 농수산물도매시장 반입 들깻잎과 상추의 잔류농약 실태 및 안전성 평가)

  • Park, Won-Hee;Hwang, In-Sook;Kim, Eun-Jeong;Cho, Tae-Hee;Hong, Chae-Kyu;Lee, Jae-In;Choi, Su-Jeong;Kim, Jin-A;Lee, Yun-Jeong;Kim, Mi-Sun;Kim, Gi-Hae;Kim, Moo-Sang
    • The Korean Journal of Pesticide Science
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    • v.19 no.3
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    • pp.151-160
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    • 2015
  • This study was conducted to monitor residual pesticides in perilla leaf & lettuce and to assess their risk to human health. The total number of perilla leaf & lettuce were 4,063 and 2,248 respectively and these products were collected at the Garak-dong Agricultural & Marine Products Market sold by auction from 2010 to 2012. Multi-residual analysis of 285 pesticides were performed by GC-ECD, GC-NPD, HPLC-DAD and HPLC-FLD. In perilla leaf, 61 pesticides were detected and detection rate was 20.0%. 28 pesticides were detected in case of lettuce and detection rate was 4.8%. In order to do risk assessment by perilla leaf & lettuce consumption, estimated daily intake of residual pesticides were determined and compared to acceptable daily intake, referring to hazard index (HI values). The range of % HI values of perilla leaf was from 0.000% to 0.049%. The range of % HI values of lettuce was from 0.000% to 0.095%. These results show that the risk caused by pesticide residues in perilla leaf & lettuce intake were very low and these vegetable intake was safe.

Evaluation on Heavy Metal Contents in Agricultural Soils around Industrial Complexes in Korea (공단 인근 농경지 토양 중 중금속 함량 평가)

  • Yun, Sun-Gang;Chae, Mi-Jin;Kim, Yoo-Hak;Kong, Myung-Suk;Jung, Ha-il;Kim, Suk-Cheol;Kim, Myoung-Suk;Park, Seong-Jin;Lee, Chang-Hoon;Yang, Jae-E;Kim, Sung-Chul;Kim, Gi-In;Kim, Gwon-Rae;Jung, Goo-Bok
    • Korean Journal of Environmental Agriculture
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    • v.37 no.2
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    • pp.141-145
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    • 2018
  • BACKGROUND: Agricultural soils are vulnerable from contamination of heavy metal derived from industrial waste. Monitoring on heavy metals on agricultural soils around industrial complexes and evaluation on distributional state on the concentrations of heavy metals in soil have been carried out for problem assessment on soil condition. METHODS AND RESULTS: Soil samples of 1,200, were collected from sixty site of industrial complexes located Gyounggi, Chungbuk, Cheonbuk, and Gyoungnam provinces. Total concentration of Cu, Pb, Zn, Ni, and As were analyzed. Heavy metal concentrations in most soil samples were below warning criteria, except 1 site of Pb, Ni, and As, separately. The comparison of mean values of heavy metal concentrations between soils around industrial complexes and paddy soils, showed similar levels of heavy metals, except Pb. The concentrations of lots of heavy metals were distributed between from warning criteria to one fifth level of warning criteria. However, in the case of Cu and Pb, more than 30% were distributed below one twenties level of warning criteria. These results were very similar with the distribution state of heavy metals in upland soils. The concentrations of heavy metals in surface soil and subsoil were similar among the heavy metals in soils around industrial complexes. CONCLUSION: The concentrations of heavy metals in soils around industrial complexes were distributed close to warning criteria. Long term and continous monitoring and evaluation on heavy metals in agricultural soils are required for food safety and sustainable soil management.

Deterioration Assessment for Conservation Sciences of the Five Storied Stone Pagoda in the Jeongrimsaji Temple Site, Buyeo, Korea (부여 정림사지 오층석탑의 보존과학적 풍화훼손도 평가)

  • Kim, Yeong-Taek;Lee, Chan-Hee;Lee, Myeong-Seong
    • Economic and Environmental Geology
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    • v.38 no.6 s.175
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    • pp.675-687
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    • 2005
  • The rocks of the five storied stone pagoda in the Jeongrimsaji temple site are 149 materials in total with porphyritic biotite granodiorite. They include pegmatite veinlet, basic xenolith and evenly developed plagioclase porphyry. This stone pagoda has comparably small fracture and cracks which are farmed in the times of rock properties, but surface exfoliation and granular decomposition are in process actively since the rocks are generally weakened from the influence of air contaminants and acid rain. Structural instability of constituting rocks in the 4th roof materials are observed to occur from distortion and tilt. Such instability is judged to threat stability of the upper part of the stone pagoda. Also, chemical weathering is operating even more as the contaminants, ferro-manganese hydroxides eluted from water-rock interaction on the rock surface. Most of the rock surface is covered with yellowish brown, dark black and light gray contaminants, and especially occur in the lower part of the roof rocks on each floor. The roof underpinning rocks are severe in surface pigmentation from manganese hydroxides and light gray contaminants. The surface of rocks lives bacteria. algae, lichen, or moss and diverse productions in colors of light gray, dark Bray and dark green. Grayish white crustose lichen grows thick on the surface with darkly discolored by fungi and algae in the first stage on basement rocks, and weeds grows wild on the upper part of each roof rocks. This stone pagoda must closely observe the movements of the upper part rock materials through minute safety diagnosis and long term monitoring for structural stability. Especially since the surface discoloration of rocks and pigmentation of secondary contaminants are severe, establishment of general restoration and scientific conservation treatment are necessary through more detailed study for this stone pagoda.

Glass Dissolution Rates From MCC-1 and Flow-Through Tests

  • Jeong, Seung-Young
    • Proceedings of the Korean Radioactive Waste Society Conference
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    • 2004.06a
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    • pp.257-258
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    • 2004
  • The dose from radionuclides released from high-level radioactive waste (HLW) glasses as they corrode must be taken into account when assessing the performance of a disposal system. In the performance assessment (PA) calculations conducted for the proposed Yucca Mountain, Nevada, disposal system, the release of radionuclides is conservatively assumed to occur at the same rate the glass matrix dissolves. A simple model was developed to calculate the glass dissolution rate of HLW glasses in these PA calculations [1]. For the PA calculations that were conducted for Site Recommendation, it was necessary to identify ranges of parameter values that bounded the dissolution rates of the wide range of HLW glass compositions that will be disposed. The values and ranges of the model parameters for the pH and temperature dependencies were extracted from the results of SPFT, static leach tests, and Soxhlet tests available in the literature. Static leach tests were conducted with a range of glass compositions to measure values for the glass composition parameter. The glass dissolution rate depends on temperature, pH, and the compositions of the glass and solution, The dissolution rate is calculated using Eq. 1: $rate{\;}={\;}k_{o}10^{(ph){\eta})}{\cdot}e^{(-Ea/RT)}{\cdot}(1-Q/K){\;}+{\;}k_{long}$ where $k_{0},\;{\eta}$ and Eaare the parameters for glass composition, pH, $\eta$ and temperature dependence, respectively, and R is the gas constant. The term (1-Q/K) is the affinity term, where Q is the ion activity product of the solution and K is the pseudo-equilibrium constant for the glass. Values of the parameters $k_{0},\;{\eta}\;and\;E_{a}$ are the parameters for glass composition, pH, and temperature dependence, respectively, and R is the gas constant. The term (1-Q/C) is the affinity term, where Q is the ion activity product of the solution and K is the pseudo-equilibrium constant for the glass. Values of the parameters $k_0$, and Ea are determined under test conditions where the value of Q is maintained near zero, so that the value of the affinity term remains near 1. The dissolution rate under conditions in which the value of the affinity term is near 1 is referred to as the forward rate. This is the highest dissolution rate that can occur at a particular pH and temperature. The value of the parameter K is determined from experiments in which the value of the ion activity product approaches the value of K. This results in a decrease in the value of the affinity term and the dissolution rate. The highly dilute solutions required to measure the forward rate and extract values for $k_0$, $\eta$, and Ea can be maintained by conducting dynamic tests in which the test solution is removed from the reaction cell and replaced with fresh solution. In the single-pass flow-through (PFT) test method, this is done by continuously pumping the test solution through the reaction cell. Alternatively, static tests can be conducted with sufficient solution volume that the solution concentrations of dissolved glass components do not increase significantly during the test. Both the SPFT and static tests can ve conducted for a wide range of pH values and temperatures. Both static and SPFt tests have short-comings. the SPFT test requires analysis of several solutions (typically 6-10) at each of several flow rates to determine the glass dissolution rate at each pH and temperature. As will be shown, the rate measured in an SPFt test depends on the solution flow rate. The solutions in static tests will eventually become concentrated enough to affect the dissolution rate. In both the SPFt and static test methods. a compromise is required between the need to minimize the effects of dissolved components on the dissolution rate and the need to attain solution concentrations that are high enough to analyze. In the paper, we compare the results of static leach tests and SPFT tests conducted with simple 5-component glass to confirm the equivalence of SPFT tests and static tests conducted with pH buffer solutions. Tests were conducted over the range pH values that are most relevant for waste glass disssolution in a disposal system. The glass and temperature used in the tests were selected to allow direct comparison with SPFT tests conducted previously. The ability to measure parameter values with more than one test method and an understanding of how the rate measured in each test is affected by various test parameters provides added confidence to the measured values. The dissolution rate of a simple 5-component glass was measured at pH values of 6.2, 8.3, and 9.6 and $70^{\circ}C$ using static tests and single-pass flow-through (SPFT) tests. Similar rates were measured with the two methods. However, the measured rates are about 10X higher than the rates measured previously for a glass having the same composition using an SPFT test method. Differences are attributed to effects of the solution flow rate on the glass dissolution reate and how the specific surface area of crushed glass is estimated. This comparison indicates the need to standardize the SPFT test procedure.

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