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Long Term Results of Valve Replacement with the St. Jude Medical Heart Valves: Thirteen Year Experience (St. Jude 기계판막을 이용한 판막 치환술의 장기 성적)

  • Kim, Chang-Gon;Gu, Ja-Hong;Jo, Jung-Gu;Kim, Gong-Su
    • Journal of Chest Surgery
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    • v.30 no.9
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    • pp.891-898
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    • 1997
  • Between May 1984 and January 1996, 130 patients were replaced cardiac valve using 150 St. Jude Medical prosthetic valves(42 aortic, 68 mitral, 20 aortic and mitral valve replycements). Follow-up was 97.6% complete. The early mortality rate was 5.4%, and late mortality rate was 4.9%. The valve-related late mortality rate was 3.3%. Of late complications, there were 6 anticoagulant related hemorrhages, 4 thromboembolisms and 1 paravalvular leakage. Linearized rates of late complication and valve-related late mortality were as follows: total late complications, .1.68o per patient-year: anticoagulant related hemorrhages, 0.92% per patient-year: thromboembolism, 0.61% per patient-year: paravalvular leakage, 0.15% per patient-year: reoperation, 0.15% per patient-year: and valve-related late mortalities, 0.61% per patient-year. Actuar al event free rate at 10 years was 87.4 $\pm$ 3.2%. The overall actuarial survival rate was 90.4$\pm$2.7% at 5 years, 87.5$\pm$3.3% at 10 years. Ninety eight percent of the survivors were in the New York Heart Association functional class I or II at the end of follow-up. There was significant improvement of cardiothoracic ratio. In conclusion, this study suggests the excellent durability of the St. Jude Medical Heart valve and remarkable functional benefit for the majority of the patients. However, prosthesisrelated complications are still common. Outcome is strongly related to the patient's preoperative cardiac condition and to the adequacy of anticoagulation control.

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정지궤도 통신해양기상위성의 기상분야 요구사항에 관하여

  • Ahn, Myung-Hwan;Kim, Kum-Lan
    • Atmosphere
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    • v.12 no.4
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    • pp.20-42
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    • 2002
  • Based on the "Mid to Long Term Plan for Space Development", a project to launch COMeS (Communication, Oceanography, and Meteorological Satellite) into the geostationary orbit is undergoing. Accordingly, KMA (Korea Meteorological Administration) has defined the meteorological missions and prepared the user requirements to fulfill the missions. To make a realistic user requirements, we prepared a first draft based on the ideal meteorological products derivable from a geostationary platform and sent the RFI (request for information) to the sensor manufacturers. Based on the responses to the RFI and other considerations, we revised the user requirement to be a realistic plan for the 2008 launch of the satellite. This manuscript introduces the revised user requirements briefly. The major mission defined in the revised user requirement is the augmentation of the detection and prediction ability of the severe weather phenomena, especially around the Korean Peninsula. The required payload is an enhanced Imager, which includes the major observation channels of the current geostationary sounder. To derive the required meteorological products from the Imager, at least 12 channels are required with the optimum of 16 channels. The minimum 12 channels are 6 wavelength bands used for current geostationary satellite, and additional channels in two visible bands, a near infrared band, two water vapor bands and one ozone absorption band. From these enhanced channel observation, we are going to derive and utilize the information of water vapor, stability index, wind field, and analysis of special weather phenomena such as the yellow sand event in addition to the standard derived products from the current geostationary Imager data. For a better temporal coverage, the Imager is required to acquire the full disk data within 15 minutes and to have the rapid scan mode for the limited area coverage. The required thresholds of spatial resolutions are 1 km and 2 km for visible and infrared channels, respectively, while the target resolutions are 0.5 km and 1 km.

Outcome of patients with neuroblastoma aged less than 1 year at diagnosis (진단 시 1세 이하인 신경모세포종 환자의 치료성적)

  • Suh, Jung Min;Lee, Sang Goo;Yoo, Keon Hee;Sung, Ki Woong;Koo, Hong Hoe;Kim, Ju Youn;Cho, Eun Joo;Lee, Suk Koo;Kim, Jhingook;Lim, Do Hoon
    • Clinical and Experimental Pediatrics
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    • v.52 no.1
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    • pp.93-98
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    • 2009
  • Purpose : The purpose of this study was to evaluate the clinical characteristics and outcomes of patients with neuroblastoma aged less than 1 year. Methods : From January 1997 to December 2007, 41 patients aged less than 1 year were diagnosed with neuroblastoma. Patients were divided into 3 risk groups according to the stage of the disease and N-myc amplification. Low-risk patients underwent surgery with (stage 2) or without (stage 1) short-term chemotherapy. Intermediate-risk patients underwent chemotherapy and surgery with or without local radiation therapy. High-risk patients underwent chemotherapy, surgery, radiation therapy, and high-dose chemotherapy/autologous stem cell rescue (HDCT/ASCR). Results : While tumor relapse occurred in only 1 patient, 7 patients died of treatment-related toxicities. Causes of treatment- related death included infection during conventional chemotherapy in 5 patients and acute myocarditis during HDCT/ASCR in 2 patients. The overall 5-year survival (${\pm}$ standard error) and 5-year event-free survival (EFS) rates after diagnosis for all 41 patients were $82.8{\pm}5.9%$ and $80.0{\pm}$6.3%$, respectively, with a median follow-up of 58 (9-137) months. The 5-year EFS rates for low-risk, intermediate-risk, and high-risk patients were 100%, $68.4{\pm}10.8%$, and $66.7{\pm}19.3%$, respectively. Conclusion : Increased efforts to reduce infection-associated toxicity deaths during conventional chemotherapy are needed to further improve the survival of patients with neuroblastoma aged less than 1 year.

The current status and control measures of BSE in the worldwide (국내, 외 광우병의 발생 현황과 대응 방안)

  • Yoo, Han-Sang
    • 한국환경농학회:학술대회논문집
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    • 2009.07a
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    • pp.273-282
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    • 2009
  • The transmissible spongiform encephalopathies (TSEs) disease group are fatal neurodegenerative disorders affecting a wide range of hosts. The group includes kuru and Creutzfeldt-Jakob disease (CJD) in humans, scrapie in sheep and goats and Bovine spongiform encephalopathy (BSE) in cattle. The exact nature of the infectious agent involved in the transmission of these diseases remains controversial. However, a central event in their pathogenesis is the accumulation in infected tissues of an abnormal form of a host-encoded protein, the prion protein (PrP). Whereas the normal cellular protein is fully sensitive to protease ($PrP^{sen}$), the disease-associated prion protein ($PrP^d$) is only partly degraded ($PrP^{res}$), its amino-terminal end being removed. BSE was first reported in the mid-80s in the UK. Ten years later, a new form of human prion disease, variant CJD (vCJD) developed in the wake of the BSE epidemic, and there is now strong scientific evidence that vCJD was initiated by the exposure of humans to BSE-infected tissues, thus indicating a zoonotic disease. However, the ban on the feeding of animal-derived proteins to ruminants, and the apparent lack of vertical transmission of BSE, have led to a decline in the incidence of the disease within cattle herd and therefore, an assumed decreased risk for human contacting vCJD. The origin of the original case(s) of BSE still remains an enigma even though three hypotheses have been raised. Hypotheses are i) sheep- or goat-derived scrapie-infected tissues included in meat and bone meal fed to cattle, ii) a previously undetected sporadic or genetic bovine TSE contaminating cattle feed or iii) originating from a human TSE through animal feed contaminated with human remains. A host cellular membrane protein ($PrP^C$), which is abundant in central nervous system tissue, appear to be conformationally altered in the diseased host into a prion protein ($PrP^{Sc}$). This $PrP^{Sc}$ is detergent insoluble and partially protease-resistant ($PrP^{res}$). The term $PrP^{res}$ is normally used to describe the protein detected after protease treatment, in techniques such as Western immunoblotting, and enzyme-linked immunosorbant assay using fresh/frozen tissue. Immunohistochemistry may performed with formalin-fixed tissues. Also, clinical signs of the BSE are one of the major diagnostic indicators. Recently, atypical forms (known as H- and L-type) of BSE have appeared in several European countries, Japan, Canada and the United States. An unusual case was also reported in a miniature zebu. The atypical BSE fall into two groups based on the relative molecular mass (Mm) of the unglycosylated $PrP^{res}$ band relative to that of classical BSE, one of the higher Mm (H-type) and the other lower (L-type). Both types have been detected worldwide as rare cases in older animals, at a low prevalence consistent with the possibility of sporadic forms of prion diseases in cattle. This raises the unwelcome possibility that vCJD could increase in the human population. Now, active surveillance program against BSE is going on in Korea. In regional veterinary service lab, ELISA is applied to screen the BSE in slaughter and confirmatory tests by Western immunoblotting and immunohistochemisty are carried out if there are positive or suspect in the screening test. Also, the ruminant feed ban is rigorously enforced. Removal of specified risk materials such as brain and spinal cord from cattle is mandatory process at slaughter to prevent the infected material from entering the human food chain.

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Twenty-year Experience of Mitral Valve Replacement with the St. Jude Medical Mechanical Valve Prosthesis (St. Jude 기계 판막을 이용한 승모판막 치환술의 20년 장기성적)

  • Seo Yeon-Ho;Kim Kong-Soo;Jo Jung-Ku
    • Journal of Chest Surgery
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    • v.39 no.7 s.264
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    • pp.527-533
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    • 2006
  • Background: A retrospective study was conducted to analyze the results of St. Jude Medical mitral valve replacement at the Chonbuk National University Hospital since the initial implant in May 1984. Material and Method: Between May of 1984 and December of 1996, 95 patients underwent MVR with the St. Jude Medical mechanical valve prosthesis at Department of Medical Science of Chonbuk National University Hospital and follow-up ended in May of 2004. Result: Age ranged from 19 to 69 years. Follow-up (mean${\pm}$standard deviation) averaged $10.6{\pm}4.2\;year$. Thirty-day operative mortality was 4.2% (4/95). Nine late deaths have occurred and actuarial survival was $90.5{\pm}3.0%,\;87.9{\pm}3.4%\;and\;83.2{\pm}4.6%$ at 5, 10 and 20 years, respectively. Probability of freedom from valve-rotated death was $95.5{\pm}2.1%,\;94.3{\pm}2.4%\;and\;91.0{\pm}3.9%$ at 5, 10 and 20 years, respectively. Seven patients have sustained thromboembolic events (1,05%/patient-year). Fifteen patients had anticoagulation related hemorrhage (3.56%/patient-year). There was no structural valve deterioration. Probability of freedom from all complications was $82.0{\pm}3.9%,\;71.3{\pm}4.8%\;and\;42.4{\pm}10.5%$ at 5, 10 and 20 years, respectively. Conclusion: We confirm the effective and excellent durability of the St. Jude Medical prosthesis in the mitral position with a low event rate at long-term follow-up. It also demonstrates the commonly encountered practical difficulty of adjusting the anti-coagulation protocol in patients with prosthetic mitral valves.

The Study of Comparative Legal Review According to Data Exclusivity of Pharmaceutical Marketing Authorization - In preparation for the development of drugs and vaccine of COVID-19 - (의약품 자료독점권(Data Exclusivity)에 대한 비교법적 고찰 - COVID-19 치료제 및 백신 개발을 대비하여 -)

  • Park, Jeehye
    • The Korean Society of Law and Medicine
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    • v.21 no.1
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    • pp.223-259
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    • 2020
  • With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

Role of Citrate Synthase in Acetate Utilization and Protection from Stress-Induced Apoptosis

  • Lee, Yong-Joo;Kang, Hong-Yong;Maeng, Pil Jae
    • Proceedings of the Microbiological Society of Korea Conference
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    • 2008.05a
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    • pp.39-41
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    • 2008
  • The yeast Saccharomyces cerevisiae has been shown to contain three isoforms of citrate synthase (CS). The mitochondrial CS, Cit1, catalyzes the first reaction of the TCA cycle, i.e., condensation of acetyl-CoA and oxaloacetate to form citrate [1]. The peroxisomal CS, Cit2, participates in the glyoxylate cycle [2]. The third CS is a minor mitochondrial isofunctional enzyme, Cit3, and related to glycerol metabolism. However, the level of its intracellular activity is low and insufficient for metabolic needs of cells [3]. It has been reported that ${\Delta}cit1$ strain is not able to grow with acetate as a sole carbon source on either rich or minimal medium and that it shows a lag in attaining parental growth rates on nonfermentable carbon sources [2, 4, 5]. Cells of ${\Delta}cit2$, on the other hand, have similar growth phenotype as wild-type on various carbon sources. Thus, the biochemical basis of carbon metabolism in the yeast cells with deletion of CIT1 or CIT2 gene has not been clearly addressed yet. In the present study, we focused our efforts on understanding the function of Cit2 in utilizing $C_2$ carbon sources and then found that ${\Delta}cit1$ cells can grow on minimal medium containing $C_2$ carbon sources, such as acetate. We also analyzed that the characteristics of mutant strains defective in each of the genes encoding the enzymes involved in TCA and glyoxylate cycles and membrane carriers for metabolite transport. Our results suggest that citrate produced by peroxisomal CS can be utilized via glyoxylate cycle, and moreover that the glyoxylate cycle by itself functions as a fully competent metabolic pathway for acetate utilization in S. cerevisiae. We also studied the relationship between Cit1 and apoptosis in S. cerevisiae [6]. In multicellular organisms, apoptosis is a highly regulated process of cell death that allows a cell to self-degrade in order for the body to eliminate potentially threatening or undesired cells, and thus is a crucial event for common defense mechanisms and in development [7]. The process of cellular suicide is also present in unicellular organisms such as yeast Saccharomyces cerevisiae [8]. When unicellular organisms are exposed to harsh conditions, apoptosis may serve as a defense mechanism for the preservation of cell populations through the sacrifice of some members of a population to promote the survival of others [9]. Apoptosis in S. cerevisiae shows some typical features of mammalian apoptosis such as flipping of phosphatidylserine, membrane blebbing, chromatin condensation and margination, and DNA cleavage [10]. Yeast cells with ${\Delta}cit1$ deletion showed a temperature-sensitive growth phenotype, and displayed a rapid loss in viability associated with typical apoptotic hallmarks, i.e., ROS accumulation, nuclear fragmentation, DNA breakage, and phosphatidylserine translocation, when exposed to heat stress. Upon long-term cultivation, ${\Delta}cit1$ cells showed increased potentials for both aging-induced apoptosis and adaptive regrowth. Activation of the metacaspase Yca1 was detected during heat- or aging-induced apoptosis in ${\Delta}cit1$ cells, and accordingly, deletion of YCA1 suppressed the apoptotic phenotype caused by ${\Delta}cit1$ mutation. Cells with ${\Delta}cit1$ deletion showed higher tendency toward glutathione (GSH) depletion and subsequent ROS accumulation than the wild-type, which was rescued by exogenous GSH, glutamate, or glutathione disulfide (GSSG). Beside Cit1, other enzymes of TCA cycle and glutamate dehydrogenases (GDHs) were found to be involved in stress-induced apoptosis. Deletion of the genes encoding the TCA cycle enzymes and one of the three GDHs, Gdh3, caused increased sensitivity to heat stress. These results lead us to conclude that GSH deficiency in ${\Delta}cit1$ cells is caused by an insufficient supply of glutamate necessary for biosynthesis of GSH rather than the depletion of reducing power required for reduction of GSSG to GSH.

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Spatial Patterns and Temporal Variability of the Haines Index related to the Wildland Fire Growth Potential over the Korean Peninsula (한반도 산불 확장 잠재도와 관련된 Haines Index의 시.공간적 특징)

  • Choi Cwang-Yong;Kim Jun-Su;Won Myoung-Soo
    • Journal of the Korean Geographical Society
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    • v.41 no.2 s.113
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    • pp.168-187
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    • 2006
  • Windy meteorological conditions and dried fire fuels due to higher atmospheric instability and dryness in the lower troposphere can exacerbate fire controls and result in more losses of forest resources and residential properties due to enhanced large wildland fires. Long-term (1979-2005) climatology of the Haines Index reconstructed in this study reveals that spatial patterns and intra-annual variability of the atmospheric instability and dryness in the lower troposphere affect the frequency of wildland fire incidences over the Korean Peninsula. Exponential regression models verify that daily high Haines Index and its monthly frequency has statistically significant correlations with the frequency of the wildland fire occurrences during the fire season (December-April) in South Korea. According to the climatic maps of the Haines Index created by the Geographic Information System (GIS) using the Digital Elevation Model (DEM), the lowlands below 500m from the mean sea level in the northwestern regions of the Korean Peninsula demonstrates the high frequency of the Haines Index equal to or greater than five in April and May. The annual frequency of the high Haines Index represents an increasing trend across the Korean Peninsula since the mid-1990s, particularly in Gyeongsangbuk-do and along the eastern coastal areas. The composite of synoptic weather maps at 500hPa for extreme events, in which the high Haines Index lasted for several days consecutively, illustrates that the cold low pressure system developed around the Sea of Okhotsk in the extreme event period enhances the pressure gradient and westerly wind speed over the Korean Peninsula. These results demonstrate the need for further consideration of the spatial-temporal characteristics of vertical atmospheric components, such as atmospheric instability and dryness, in the current Korean fire prediction system.

Efficacy and Safety of Red Ginseng on Women's Health Related Quality of Life and Sexual Function (여성의 건강관련 삶의 질과 성기능에 대한 홍삼의 효과 및 안전성 연구)

  • Kim, Dong-II;Choi, Min-Sun;Alm, Hong-Yeop
    • Journal of Ginseng Research
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    • v.33 no.2
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    • pp.115-126
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    • 2009
  • To evaluate the efficacy and safety of red ginseng on women's health-related quality of life (QOL) and sexual function. A randomized, double-blind, placebo-controlled, crossover clinical study was performed. The main efficacy was measured using the Female Sexual Function Index (FSFl) and the 36-Item Short-Form Health Survey (SF-36). Twenty-four healthy, married women aged 30-45 years with FSFl scores below 25 were randomly divided into two groups: the red-ginseng group (N=12) and the placebo group (N=12). During the first six-week period (Study 1), each group was given red ginseng or placebo twice a day. Before the start of the second six-week period (Study 2), a crossover design was chosen with a two-week break (washout period). Interchanging the two groups after the washout period, red ginseng and placebo were given to each group. The outcomes were measured before and after each six-week period. Overall, 23 participants completed the study. In Study 1, the changes relative to the baseline in the FSFl total score were 22.50% and 22.99% for red ginseng and placebo, respectively. In Study 2, the relative changes were 8.14% for red ginseng and 6.29% for placebo. The results showed a greater improving trend in Study 1 with respect to all of the participants' sexual functions, but no significant difference was found between the groups (P=0.9567). After taking red ginseng, all the participants exhibited an improving trend in the desire domain of FSFl, but no significant difference was shown. In the measurement of SF-36, no significant difference was likewise shown. After taking red ginseng, though, all the participants exhibited an improving trend in the physical functioning (PF) domain of SF-36, with no significant difference. Moreover, there was no significant adverse event related to red ginseng. The QOL and sexual function of the study participants in the red-ginseng group were mostly improved, but no statistically significant effect of red ginseng was shown. It is supposed that this result was partly due to the affirmative impression of red ginseng in Korea. Thus, it is anticipated that a long-term clinical trial will show a significant effect of red ginseng on the QOL and sexual function.

Legislative Study on the Mitigation of the Burden of Proof in Hospital Infection Cases - Focusing on the revised Bürgerliches Gesetzbuch - (병원감염 사건에서 증명책임 완화에 관한 입법적 고찰 - 개정 독일민법을 중심으로 -)

  • Yoo, Hyun Jung
    • The Korean Society of Law and Medicine
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    • v.16 no.2
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    • pp.159-193
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    • 2015
  • Owing to causes such as population aging, increased use of various medical devices, long-term hospitalization of various patients with reduced immune function such as cancer, diabetes, and organ transplant patients, and the growing size of hospitals, hospital infections are continuing to increase. As seen in the MERS crisis of 2015, hospital infections have become a social and national problem. In order to prevent damage due to such hospital infections, it is necessary to first strictly implement measures to prevent hospital infections, while, on the other hand, providing proper relief of damage suffered due to hospital infections. However, the mainstream attitude of judicial precedents relating to hospital infection cases has been judged to in fact shift responsibility over damages due to hospital infections on the patient. In light of the philosophy of the damage compensation system, whose guiding principle if the fair and proper apportionment of damages, there is a need to seek means of drastically relaxing the burden of proof on the patient's side relative to conventional legal principles for relaxing the burden of proof, or the theory of de facto estimation. In relation to such need, the German civil code (Burgerliches Gesetzbuch), which defines contracts of medical treatment as typical contracts under the civil code, and has presumption of negligence provisions stipulating that, in cases such as hospital infections which were completely under the control of the medical care providers, if risks in general medical treatment have been realized which cause violations of the life, body, or health of patients, error on the part of the person providing medical care is presumed, was examined. Contracts of medical treatment are entered into very frequently and broadly in the everyday lives of the general public, with various disputes owing thereto arising. Therefore, it is necessary to, by defining contracts of medical treatment as typical contracts under the civil code, regulate the content of said contracts, as well as the proof of burden when disputes arise. If stipulations in the civil code are premature as of yet, an option may be to regulate through a special act, as is the case with France. In the case of hospital infection cases, it is thought that 'legal presumption of negligence' relating to 'negligence in the occurrence of hospital infections,' which will create a state close to equality of arms, will aid the resolution of the realistic issue of the de facto impossibility of remedying damages occurring due to negligence in the process of occurrence of hospital infections. Also, even if negligence is presumed by law, as the patient side is burdened with proving the causal relationships, such drastic confusion as would occur if the medical care provider side is found fully liable if a hospital infection occurs may be avoided. It is thought that, alongside such efforts, social insurance policy must be improved so as to cover the expenses of medical institutions having strictly implemented efforts to prevent hospital infections in the event that they have suffered damages due to a hospital infection accident, and that close future research and examination into this matter will be required.

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