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

In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.
Agriculture ; Animals ; Certification ; Classification ; Equipment and Supplies ; Indicators and Reagents ; Insemination, Artificial ; Japan ; Korea ; Plants ; Quarantine ; Reagent Kits, Diagnostic

A nationwide survey on radiation safety management in Korean animal hospitals was conducted. By 2013, 53 radiation generators were registered as veterinary medical devices (41 X-ray generators and 12 computed tomography scanners). Additionally there were six approved laboratories for radiation equipment and protection facility, and five approved laboratories for radiation exposure of employees, respectively. By March 2013, 2,030 out of 3,829 animal hospitals operated radiation-generating devices. Among these devices, 389 (19.2%) out of 2,030 were not labeled with the model name and 746 (36.7%) were not labeled with production dates. Thus, most veterinary X-ray generators were outdated (42.6%) and needed replacements. When periodic inspections of 2,018 animal hospitals were performed after revision of the Veterinarians Act in 2011, the hospitals were found to be equipped with appropriate radiation generators and protection facilities. Among 2,545 employees exposed to radiation at the hospitals, 93.9% were veterinarians, 4.3% were animal nurse technicians, and 18% held other positions. Among 169 employees supervised by administrators, none of those had a weekly maximum operating load that exceeded 10 mA.min. This study suggests that the radiation safety management system of animal hospitals was general good.
Administrative Personnel ; Animals ; Hospitals, Animal* ; Humans ; Korea ; Safety Management* ; Veterinarians

A nationwide survey on radiation safety management in Korean animal hospitals was conducted. By 2013, 53 radiation generators were registered as veterinary medical devices (41 X-ray generators and 12 computed tomography scanners). Additionally there were six approved laboratories for radiation equipment and protection facility, and five approved laboratories for radiation exposure of employees, respectively. By March 2013, 2,030 out of 3,829 animal hospitals operated radiation-generating devices. Among these devices, 389 (19.2%) out of 2,030 were not labeled with the model name and 746 (36.7%) were not labeled with production dates. Thus, most veterinary X-ray generators were outdated (42.6%) and needed replacements. When periodic inspections of 2,018 animal hospitals were performed after revision of the Veterinarians Act in 2011, the hospitals were found to be equipped with appropriate radiation generators and protection facilities. Among 2,545 employees exposed to radiation at the hospitals, 93.9% were veterinarians, 4.3% were animal nurse technicians, and 18% held other positions. Among 169 employees supervised by administrators, none of those had a weekly maximum operating load that exceeded 10 mA.min. This study suggests that the radiation safety management system of animal hospitals was general good.
Administrative Personnel ; Animals ; Hospitals, Animal* ; Humans ; Korea ; Safety Management* ; Veterinarians

BACKGROUND: Although several hospital-based stroke studies were published, there has not been any reliable data representing the clinical characteristics of stroke in Korea. We analyzed the clinical characteristics of patients with ischemic stroke registered in the Korean Stroke Registry (KSR), which is the largest prospective hospital-based nation-wide stroke registry in Korea. METHODS: The KSR provided standardized protocols for collecting data, which includes the data of demographics, subtypes of stroke, risk factors, and neurological outcome at discharge. The brain imaging studies, including CT or MRI, were performed in all cases. RESULTS: KSR registered 10,811 patients of acute ischemic stroke between Nov. 2002 and Jun. 2004. The large-artery atherosclerosis was the most common subtype (37.3%), followed by small vessel occlusion (30.8%). Hypertension (65.4%) was the most common risk factor, followed by smoking (34.5%) and diabetes (28.3%). Although most of the hypertensive and diabetic patients had been diagnosed before the stroke, less than 45.4% and 32.5% of them were under regular control. The steno-occlusive lesion of extracranial carotid artery was only 29.3% and the ratio of intra- to extracranial artery disease was more than 2 in KSR. Only 20.5% of patients were admitted within 3 hours after stroke onset and 2.1% were treated with intravenous thrombolysis. In-hospital case-fatality was 5.2%, which is relatively comparable to those of previous studies. CONCLUSIONS: The KSR provided informative data in understanding the clinical characteristics of ischemic stroke in Korea. Further analysis of KSR will facilitate clinical trials and development of guidelines for the management of stroke patients.
Arteries ; Atherosclerosis ; Carotid Arteries ; Cerebrovascular Disorders ; Demography ; Epidemiology ; Humans ; Hypertension ; Korea ; Magnetic Resonance Imaging ; Neuroimaging ; Prospective Studies* ; Registries ; Risk Factors ; Smoke ; Smoking ; Stroke*

Most elderly women experience a decrease in their bone density due to a deficiency of calcium intake, ovariectomy, or menopause. This study evaluated the usability of the microscrew as a skeletal anchorage system in these orthodontic treatment cases, using rats as a research group. The 4 month old sprague-dawley species rats were divided into two groups, the OS (Ovariectomy Screw), and the SS (Sham operation Screw) group. In both the OS and SS groups, microscrews were implanted into the palatal bone between the upper molar teeth and two upper incisors were retracted using NiTi coil spring with 75 g of force. After 3 days, the again after 7 days, 7 rats in each group were sacrificed. Three days before they were sacrificed, Alizarin red S was intraperitoneally injected, and their maxillary bone, tibia and blood from their hearts were taken. The components of the extracted blood were biochemically analyzed and non-decalcified grinding resin sections for maxillary bone and tibia were made. The sections were examined with a polarization microscope, and fluorescent microscope. Smaller concentrations of Ca and P, the inorganic substances closely related to bone density, were found in the extracted blood of the OS group. Both OS and SS groups showed a possibility of bone remodeling with a high concentration of ALP after 7 days. An increase in bone density on the tension and compression sides of the microscrew and the tension side of the tooth for both OS and SS groups was confirmed with a polarization microscope. However, the bone density of the pressure side of the tooth and apical side was decreased. More deposits of Alizarin red S in the bone after 7 days rather than 3 days seen with a fluorescent microscope suggested the existence of new bone formation.
Aged ; Animals ; Bone Density ; Bone Remodeling ; Calcium ; Female ; Heart ; Humans ; Incisor ; Infant ; Maxilla ; Menopause ; Molar ; Osteogenesis ; Osteoporosis ; Ovariectomy ; Rats* ; Rats, Sprague-Dawley ; Tibia ; Tooth

The purpose of this project was to study the effect of growth hormone on early bony consolidation in distraction osteogenesis of a dog mandible. Sixteen dogs were used for this study. An external distraction device was applied to the mandibular body and the mandibular distraction was started five days after the operation at a rate of 1 mm per day up to a 10-mm distraction. Dogs in the growth hormone group received a daily subcutaneous injection of 1 IU of recombinant human growth hormone per kilogram of body weight per week. Normal saline was injected in the control group. Bone mineral density was higher in the growth hormone group than the control group in the whole period. Bone mechanical strength was 300% higher in the growth hormone group than that in the control group. However, results were more suggestive than conclusive. Upon histological examination, the formation of a substantial amount of active woven bone was observed throughout the distracted zone in 6 weeks in the growth hormone group. In the control group, new bone was generated from the edge to the center of the distracted zone. But, the most central area of the distracted zone was filled with fibrous tissue in 6 weeks. In conclusion, growth hormone appears to be effective in early bony consolidation in distraction osteogenesis.
Animals ; Body Weight ; Bone Density ; Dogs ; Growth Hormone* ; Human Growth Hormone ; Injections, Subcutaneous ; Mandible ; Osteogenesis, Distraction* ; Regeneration*

BACKGROUND: It is well known fact to the patients of duodenal ulcer that their condition is frequently accompanied with reflux esophagitis. Therefore this condition is called an "acid-related disorder" because it is commonly associated with increased acidity. But there has been disputes on the effect of Helicobacter pylori eradication in these two conditions and whether H. pylori infection may have a protective role in reflux esophagitis. Only few reports have dealt with the prevalence of reflux esophagitis and gastroesophageal reflux in patients with peptic ulcer. The aim of this study is to estimate the prevalence of gastroesophageal reflux and to analyze the pattern ofthe pathologic reflux in peptic ulcer patients. MATERIALS AND METHODS: The study population consisted of 57 patients with endoscopically confirmed duodenal and/or gastric ulcer who all underwent 24hr ambulatory esophageal pH monitoring. RESULTS: The prevalnace of gastroesophageal reflux in peptic ulcer patients was 54.2% and 54.5% in gastric ulcer, and 62.5% in duodenal ulcer, 50% in combined ulcer, respectively. The prevalence of gastroesophageal reflux in the control group was 22.7%. CONCLUSION: We discovered significantly higher prevalence of gastroesophageal reflux in patients with peptic ulcer disease than in those without it. In conclusion, the presence or absence of gastroesophageal reflux must be considered in the setting of peptic ulcer disease management.
Disease Management ; Dissent and Disputes ; Duodenal Ulcer ; Esophageal pH Monitoring ; Esophagitis, Peptic ; Gastroesophageal Reflux* ; Helicobacter pylori ; Humans ; Peptic Ulcer* ; Prevalence ; Stomach Ulcer ; Ulcer

Intussusception is defined as the telescoping of one segment of the gastrointestinal tract into an adjacent one. The incidence of the adult intussusception is low. It constitutes approximately 5% of all intussusception and accounts for 5% of all cases of intestinal obstruction in adult. The clinical feature in adults is not typical. General symptoms and signs of intestinal obstruction dominate the clinical feature of intussusception in adult. The classic appearance of intussusception on barium studies is the coil spring appearance as contrast is trapped between the intussusceptum and intussuscipiens. Ultrasound and CT scan shows a target-like lesion. Colonofiberscopy shows a round invaginated mass with congested mucosa and by air inflation, round mass is decreased in size and is changed in shape. Differential diagnosis can be made by colonofiberscopy because the most common cause of colonic intussusception in adult is a primary colon cancer. A case of diverticulitis associated with intussusception diagnosed by colonofiberscopy in a 72 years old man was presented with brief review of the literature.
Adult ; Aged ; Barium ; Colon ; Colonic Neoplasms ; Diagnosis, Differential ; Diverticulitis* ; Estrogens, Conjugated (USP) ; Gastrointestinal Tract ; Humans ; Incidence ; Inflation, Economic ; Intestinal Obstruction ; Intussusception ; Mucous Membrane ; Tomography, X-Ray Computed ; Ultrasonography

Acute pancreatitis due to impaction of Ascaris lumbricoides into the pancreatic duct is very rare. Authors hnve experienced one case of pancreatic ascariasis. Patient was a 62-year-old female with epigastric pain. Abdominal USG and endoscopic retrograde cholangiopancreatography showed characteristic finding of pancreatic ascariasis. Ascaris was removed with palypectomy snare and acute pancreatitis was resolved completely.
Ascariasis ; Ascaris lumbricoides* ; Ascaris* ; Cholangiopancreatography, Endoscopic Retrograde ; Female ; Humans ; Middle Aged ; Pancreatic Ducts* ; Pancreatitis* ; SNARE Proteins