Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications for veterinary medical devices in Korea based on data obtained through analyses of those medical devices. General standards for electromechanical, electromagnetic, and biological safety and individual standards for 76 electric and 70 general medical device products have been established by the Korean Ministry of Food and Drug Safety. However, the first standards and specifications for veterinary medical devices were established in March 2000 for two products (disposable needle and syringe). Similar to the large number of standards for medical devices, there have been general standards for safety and individual standards for 72 veterinary medical devices (27 electric medical devices, 12 non-electric medical devices, 10 medical supplies, and 23 other types) established since 2014. These new standards considered, among other aspects, the devices' applications, usage characteristics, and industrial environment. To date, the establishment of standards and specifications for veterinary medical devices remains limited. This study suggests that improvements should be made to the regulation of general and individual standards associated with various veterinary medical instruments, supplies, and in vitro diagnostic medical reagents.
Equipment and Supplies ; Equipment Safety ; In Vitro Techniques ; Indicators and Reagents ; Korea* ; Licensure ; Magnets ; Needles

PURPOSE: Takotsubo cardiomyopathy is a relatively uncommon type of stress-induced cardiomyopathy characterized by transient left ventricular regional wall motion abnormalities. Emotional and physical stresses play a key role in this type of cardiomyopathy in postmenopausal women. The current hypothesis is that the syndrome represents a form of catecholamine surge due to stress or epinephrine-mediated acute myocardial stunning. METHODS: A 44-year-old woman had suffered premature ventricular contraction following a cardiogenic shock during a breast augmentation surgery under enflurane anesthesia and tumescent solution infiltration. She was treated with cardiopulmonary resuscitation at a local clinic. Then she was brought to the Emergency Department of the authors' hospital. RESULTS: The woman's echocardiogram showed an ejection fraction of 20~25% with associated basal hyperkinesis and left ventricular apical ballooning. The patient was admitted to the ICU and required inotropic support for two weeks. The patient's condition dramatically improved, and her ejection fraction returned to 70%. CONCLUSION: It is believed that there were multiple triggering factors of the onset of Takotsubo cardiomyopathy in the woman's social and family history, including infiltration of a large volume of the tumescent solution and VPCs induced by enflurane anesthesia without premedication. The importance of careful history-taking, careful pre-operative consultation on psychological suffering especially for breast surgery, premedication before surgery, patient reassurance, and post-operative psychosocial and emotional assistance was again seen in this case.
Adult ; Anesthesia ; Breast ; Cardiomyopathies ; Cardiopulmonary Resuscitation ; Emergencies ; Enflurane ; Female ; Humans ; Hyperkinesis ; Premedication ; Shock, Cardiogenic ; Stress, Psychological ; Takotsubo Cardiomyopathy ; Ventricular Premature Complexes

BACKGROUND/AIMS: Peptic ulcer disease (PUD) is one of the common gastrointestinal diseases, and its medical management has been developed so much that the incidence of its serious complications, such as bleeding and perforation, are declining significantly. Its prevalence in Korea is not definitely decreased, probably due to increasing proportion of elderly patients and their rising usage of non-steroidal anti-inflammatory drugs (NSAIDs) and aspirins. This study was conducted to identify the risk factors for development and recurrence of peptic ulcer disease in Korea. METHODS: From 2003 to 2008, upper gastrointestinal endoscopy and detailed personal questionnaires were performed for patients who visited Department of Gastroenterology at Seoul National University Bundang Hospital. In total, 475 PUD patients and 335 non-ulcer dyspepsia patients were included. The results of questionnaires and repeated upper gastrointestinal endoscopy at initial diagnosis time and follow-up periods were analyzed. RESULTS: Multivariable analysis showed that male, H. pylori infection, NSAIDs use and smoking were risk factors for the development of PUD. The use of proton pump inhibitors (PPIs) and H2 receptor antagonists has significantly reduced the risk of PUD in patients who had taken NSAIDs and/or aspirins. H. pylori infection was found as the only risk factor for the recurrence of PUD. CONCLUSIONS: For the old patients who are taking drugs, such as NSAIDs and aspirins, concomitant use of PPIs or H2 receptor antagonists should be considered to protect from the development of PUD. H. pylori eradication has been confirmed again to be essential for the treatment of PUD patients infected with H. pylori.
Adult ; Aged ; Anti-Inflammatory Agents, Non-Steroidal/therapeutic use ; Aspirin/therapeutic use ; Endoscopy, Gastrointestinal ; Female ; Helicobacter Infections/complications/drug therapy ; Helicobacter pylori ; Histamine H2 Antagonists/therapeutic use ; Humans ; Male ; Middle Aged ; Peptic Ulcer/drug therapy/*etiology ; Proton Pump Inhibitors/therapeutic use ; Questionnaires ; Recurrence ; Risk Factors ; Sex Factors ; Smoking ; Stomach Ulcer/etiology

Cochinchina momordica seed is the dried ripe seed of Momordica cochinchinensis, a perennial vine. The antiulcer effect of an extract from cochinchina momordica seeds (SK-MS10) was evaluated in a rat model of acetic acid-induced gastric ulcers. Gastric ulcers were produced by subserosal injection of acetic acid. SK-MS10 (200 mg/kg) or vehicle was administered orally once per day for 14 days after the acetic acid injection. The stomach was removed and the ulcer size measured at day 7 and 14 of the treatment. Expression of vascular endothelial growth factor (VEGF) was assessed by real-time RT-PCR and Western blot analysis. In addition, the microvasculature density (MVD) adjacent to the ulcer margin was examined by immunohistochemistry. The treatment with SK-MS10 for 7 and 14 days significantly accelerated ulcer healing and increased the expression of mRNA (at day 7) as well as VEGF protein (at day 14) compared to the vehicle-treated rats. The MVD for factor VIII was also higher in the SK-MS10 treatment group compared to the vehicle-treated rats; however, these differences were not statistically significant. These results suggest that SK-MS10 treatment accelerates the healing of gastric ulcers via upregulation of VEGF and angiogenesis in an acetic acid rat model.

PURPOSE: Kimura's disease is a relatively rare head and neck tumor that frequently occurs in young orientals accompanied by eosinophila. We shared our experience of two cases of Kimura's disease, treated by radical resection and post operative steroid therapy, so we report the correlation of eosinophil counts and disease progression. METHODS: A 25 years old male came to the clinic with a mass localized to the right cheek inferior to the right auricle. We could not resect the mass totally. During the follow up period, we checked the eosinophil counts, and steroid therapy was started 7 months after the surgery. A 34 year old female came to the clinic with a mass localized inferior to the left auricle reaching from the posterior portion of the auricle to the left temporal portion. We tried to remove as much tumor as possible, save the temporal region, in regard to the impairment of blood supply to the auricle. After the operation, steroid therapy was started. RESULTS: In the first case, the tumor was easily approachable, and radical resection of the tumor with post operative steroid therapy was an effective treatment. In tumors located at difficult regions to remove, as in the second case, optimal debulking and post operative steroid therapy was also effective in treating Kimura's. There were no recurrences in both cases. Eosinophil counts were always reduced after surgery and steroid therapy, and during the period with low eosinophil counts, there was no recurrence of Kimura's disease. CONCLUSION: Surgery and post operative steroid therapy were effective in treatment of Kimura's disease, and we could assume eosinophil counts as a good indicator for evaluation of the prognosis of Kimura's disease during the follow up period
Cheek ; Eosinophils ; Female ; Follow-Up Studies ; Head ; Humans ; Male ; Neck ; Porphyrins ; Prognosis ; Recurrence

In augmentation surgery, one of the important considerations is the selection of artificial implants. Recently, medium-porosity and high-density expanded polytetrafluoroethylene(ePTFE), which has high biocompatibility without gradual loss of volume, has been used as an implant, however, there are not many cases and reports on the post-operative complications and patient satisfactions. Between 2006 and 2009, a total of 23 patients with a flat or depressed forehead/temple underwent augmentation with medium-porosity and high-density ePTFE at our hospital. During follow up periods, 15 patients visited the clinic to fill out a survey and receive a physical examination for any complications, whereas 8 patients underwent a survey on the phone. The patients were asked questions to score their satisfaction rates on a scale of 1 to 10 points. There were no post-operative complications, and, the average score of satisfaction rates on the survey was 8.3 points. Since there were no complications and high rates of satisfaction during follow up periods, this medium-porosity and high- density ePTFE could be considered as a durable implant.

BACKGROUND/AIMS: Glutathione S-transferase P1 (GSTP1) scavenges radicals via its peroxidase activity. The purpose of this study was to determine the association of GSTP1 genetic polymorphisms with the expression of H. pylori-associated gastroduodenal disease. METHODS: This study involved 1,911 subjects, comprising patients with four diseases (gastric cancer, dysplasia, benign gastric ulcer, and duodenal ulcer disease) and controls. Biallelic polymorphisms were genotyped by restriction fragment length polymorphism techniques. RESULTS: The frequency of the genetic polymorphism at nucleotide 313 of GSTP1 did not differ among the five study groups. However, when the gastric cancer group was subdivided into advanced gastric cancer (AGC) and early gastric cancer, the frequency of the G/G genotype was significantly higher in the AGC group than in all the control subgroups (OR: 1.2, 95% CI: 1.1-4.9). The frequency of this genotype differed significantly in the H. pylori-positive AGC group (OR: 2.7, 95% CI: 1.1-6.3) but not in the H. pylori-negative group. Furthermore, the difference was greater in the intestinal type, and was not found in diffuse types of disease. CONCLUSIONS: This study found that genetic polymorphisms of GSTP1 were associated with H. pylori-associated gastric cancer only during the advanced stage of gastric cancer, with intestinal-type histology evident in H. pylori-positive subjects.
Duodenal Ulcer ; Genotype ; Glutathione ; Glutathione Transferase ; Helicobacter ; Helicobacter pylori ; Humans ; Peroxidase ; Polymorphism, Genetic ; Polymorphism, Restriction Fragment Length ; Stomach Neoplasms ; Stomach Ulcer

The incidence of acute respiratory distress syndrome (ARDS) has been estimated worldwide to range from 1.7 to 75 cases per 100,000. There are many treatments for ARDS, but only the low tidal volume strategy is based on strong clinical evidence from randomized clinical trials. The efficacy of extracorporeal life support (ECLS) in adults remains controversial. Ongoing clinical trials and research have shown a benefit for its use to salvage severe ARDS patients that are in failure with conventional treatment. We encountered a 41-year-old woman who developed ARDS induced by pneumococcal pneumonia. Despite conventional mechanical ventilation in the emergency room, severe hypoxia remained. We treated the patient immediately with ECLS. The patient has almost fully recovered, and was discharged from a 177-day stay at our hospital.
Adult ; Anoxia ; Emergency Service, Hospital ; Female ; Humans ; Incidence ; Pneumonia, Pneumococcal ; Respiration, Artificial ; Respiratory Distress Syndrome, Adult* ; Tidal Volume

The incidence of acute respiratory distress syndrome (ARDS) has been estimated worldwide to range from 1.7 to 75 cases per 100,000. There are many treatments for ARDS, but only the low tidal volume strategy is based on strong clinical evidence from randomized clinical trials. The efficacy of extracorporeal life support (ECLS) in adults remains controversial. Ongoing clinical trials and research have shown a benefit for its use to salvage severe ARDS patients that are in failure with conventional treatment. We encountered a 41-year-old woman who developed ARDS induced by pneumococcal pneumonia. Despite conventional mechanical ventilation in the emergency room, severe hypoxia remained. We treated the patient immediately with ECLS. The patient has almost fully recovered, and was discharged from a 177-day stay at our hospital.
Adult ; Anoxia ; Emergency Service, Hospital ; Female ; Humans ; Incidence ; Pneumonia, Pneumococcal ; Respiration, Artificial ; Respiratory Distress Syndrome, Adult* ; Tidal Volume

BACKGROUND AND OBJECTIVES: The objective of this study was to assess the short- and long-term clinical outcomes and valvular changes after percutaneous mitral valvuloplasty (PMV) in Sejong Hospital. SUBJECTS AND METHOD: Four hundred sixty-seven patients received PMV (Ed-already defined above) using the Inoue Balloon at Sejong hospital from 1990 to 2002. Short and long-term results, restenosis-free survival rate and prognostic factors for each result were analyzed by Chi-square, Cox regression analysis, Life table method and Cox proportional hazard model. RESULTS: After PMV, mitral valve area increased from 0.94+/-0.21 cm2 to 1.76+/-0.37 cm2 and the success rate (MVA>1.5 cm2 or increased by at least 50% without the development of moderate to severe mitral regurgitation) was 78.9%. Age (< or =50 years, p=0.018), echo score (< or =9, p=0.05) and pre-procedural mitral valve area (MVA, > or =1.1 cm2, p=0.001) were independent favorable prognostic factors for short-term result. As for the development of moderate to severe mitral regurgitation, pre-procedural MVA (< or =1.0 cm2, p=0.031) and echo score (>9, p=0.043) were independent predictive factors. Median restenosis-free survival was 82.98 months and the restenosis-free survival rate was 70.9% at 3 years post-PMV, 48.1% at 6 years and 29.6% at 10 years. The independent prognostic factor for restenosis-free survival rate was left atrial dimension (LAD< or =60 mm, p=0.015). In addition, echo score (< or =8, p=0.412), pre-procedural MVA (> or =1.0 cm2, p=0.24) and ejection fraction (EF> or =55%, p=0.146) had an effect on the good long-term results of PMV from multivariate analysis. CONCLUSION: PMV was a very successful treatment method for mitral stenosis. Pre-procedural MVA was a representative predictive factor for short and long-term outcomes and the development of mitral regurgitation.
Balloon Valvuloplasty ; Echocardiography ; Humans ; Life Tables ; Mitral Valve ; Mitral Valve Insufficiency ; Mitral Valve Stenosis ; Multivariate Analysis ; Proportional Hazards Models ; Survival Rate