• The Korean Society of Law and Medicine
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• v.15 no.2
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• pp.63-89
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• 2014

In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

• Journal of Acupuncture Research
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• v.18 no.2
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• pp.227-236
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• 2001

Objectives : This study was performed to evaluate the clinical results of the thoracolumbar fracture patients treated with oriental medical methods. Methods : We reviewed 40 patients of thoracolumbar fracture, who were hospitalized at WonKwang University KwangJu Oriental Medical Hospital and treated by oriental medical methods. We classified thoracolumbar fracture according to three column theory and then analyzed the cause of injury, sex-age distribution, treatment, and etc.. Results : 1. The distribution showed female predominance(72.5%) in sex and 70age-bracket predominance in age. 2. In the distribution of causes, the largest group was "lifting heavy objects"(40%) and the next was "slip down"(37.5%). 3. In the duration of symptoms, the largest group was the group of "acutest" (40%). 4. The distribution of injured level was L1 body the most(20%). 5. In classification of fracture, "compression fracture" was the most(57.5%) and the next was "burst fracture", "unstable fracture" in order. 7. Therapeutic effects above "fair" were 37 cases(92.5%). 8. The higher grade of clinical symptoms is, the lower therapeutic effect is. 9. In the distribution of treatment results according to classification of fracture, both the compression fracture and the burst fracture were almost same high and the unstable fracture is relatively lower than them. Conclusions : The result to treating thoracolumbar fracture by oriental medical methods is satisfactory.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.32 no.4
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• pp.380-383
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• 2006

Tetanus is rare in Korea due to the introduction of vaccination programs and the advancement in public health. Its common signs are trismus, voice disturbance, neck stiffness, and difficulty in swallowing, etc. A 56 years old man was injured by grasping a high voltage electric cable. After the accident, he fell down on a steel plate and had a head trauma. When he visited Emergency Department, there was multiple electric burn wound on left arm and left facial area. He was hospitalized on a department of neurosurgery, because intra cranial hemorrhage was presumed. 12 days later, he was referred to department of OMFS with developed painful masseter spasms and trismus. That night he violently bit his tongue with his denture. Because masseter muscle and temporal muscle constriction was involuntary, tongue was lacerated and denture was distorted. At first we supposed that the symptom was related with neurologic disturbance following head trauma or electric shock. But it was revealed that trismus was caused by tetanus on an electrophysiological test. By using mechanical ventilation and administration of tetanus immunoglobulin, muscle-relaxant, and sedatives at ICU, symptoms had subsided (4-weeks). Because tetanus is rare disease, we rarely suppose tetanus infection to be a cause of a trismus. Especially it is more difficult to diagnose in patient who has head trauma, burn and neurologic problem as in this case.

• PNF and Movement
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• v.7 no.4
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• pp.31-36
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• 2009

Many daily activities require people to complete a motor task while walking. Substantial gait decrements during simultaneous attention to a variety of cognitive tasks have been shown by a group of severely injured neurological patients of mixed etiology. And previous studies have shown that the attentional load of a walking-associated task increased with its level of difficulty. The purpose of this study was to analyze subjects' gait changes are affected by the effects of arithmetic task difficulty and performance level. Participants performed a walking task alone, three different Arithmetic tasks while seated, and among them, two kinds of the simillar Arithmetic tasks in combination with walking. Reaction time and accuracy were recorded for two of the Arithmetic tasks. The mean values of the gait were measured using a Timed Up and Go test among 11 with post-stroke patients while walking with and without forward counting (WFC) and backward counting(WBC).There was significant Arithmetic Task Difficulty level between the 10-forward counting task condition(FC) and the 10-backward counting task condition(BC)(p=0.008). The mean values of T.U.G time were significantly higher under backward counting dual-task condition than during a simple walking task(p=0.009) and WFC(p=0.009). The change in T.U.G time during WFC was higher when compared with the change during a simple walking, but there was no significant difference (p=0.246). This study suggesting that a high interference could be linked with a high level of difficulty, whereas adaptive task enabled participants to perfectly share their attention between two concurrent tasks. Future research should determine whether dual task training can reduce gait decrements in dual task situations in people after stroke. And the dual-task-based exercise program is feasible and beneficial for improving walking ability in subjects with stroke.

• Archives of Plastic Surgery
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• v.37 no.6
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• pp.788-794
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• 2010

Purpose: The fingertip is the most commonly injured part of the hand and its injury frequently results in avulsion or crushing of a segment of the nail bed and fracture of the distal phalangeal bone. Restoration of a flat and smooth nail bed is essential for regrowth of a normal nail, which is important not only for cosmetic reasons but also for tactile capability of the fingertip. It is also anatomical reduction of the distal phalanx to promote patient's cosmetics and prevent nail bed deformity. Absence or no replacement of the nail plate results in obliterated proximal skin fold. When the avulsed nail plate cannot be returned to its anatomic position or when it is absent, we use a synthetic material for splinting the nail bed and alternative reductional method for distal phalangeal bone fracture, especially, instead of hardwares. Methods: From January of 2006 to June of 2009, a total of ten patients and fourteen fingers with crushing or avulsion injuries of the fingertip underwent using the artificial nails for finger splint. We shaped artificial nails into the appropriate sizes for use as fingernail plates. We placed them under the proximal skin fold and sutured to the fold proximally and to the lateral and medial edges of the nail bed or to the distal fingertip. Our splints were as hard as K-wire and other fixation methods and more similar to anatomic nail plates. Artificial nails were kept in place for at least 3 weeks. Results: No artificial nail related complication was noted in any of the ten cases. No other nail fold or nail bed complications were observed, except for minor distal nail deformity because of trauma. Conclusion: In conclusion, in order to secure the nail bed after injury and reduce the distal phalangeal bone fracture, preparing a nail bed splint from a artificial commercial nail is a cheap and effective method, especially, for crushed or avulsion injuries of the fingertip.

• Journal of Chest Surgery
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• v.28 no.7
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• pp.671-677
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• 1995

Skeletonization of the internal mammary artery [IMA during myocardial revascularization procedures may provide some advantages, compared with the pedicle graft of the artery. In 17 patients undergoing IMA grafting by skeletonization technique, flow through the artery was measured on mean arterial pressure of 50-55 mmHg immediately after cardiopulmonary bypass started [first flow and just before its anastomosis to left anterior descending artery [second flow . In 16 patients except 1 patient whose graft was injured during mobilization, the first flow of IMA graft was 32.3 $\pm$ 7.4 ml/min and the second flow increased to 59.6$\pm$25.9 ml/min without any treatment and the site for anastomosis of the IMA graft was more than 1.0 cm above the bifurcation. On the basis of previous clinical studies, the flow of the skeletonized IMA was greater than that of the pedicle graft [59.6 $\pm$ 25.9 ml/min versus 37.7$\pm$ 14.1 ml/min, p < 0.05 . In comparison between the skeletonized IMA and the IMA graft intraluminally dilated with papaverine solution, there was no significant difference between two flows[59.6 $\pm$25.7 ml/min versus 74.7 $\pm$31.4 ml/min, not significant , but the former showed longer graft and anastomosis of more proximal portion of the graft to left anterior descending artery. In conclusion, the technique of internal mammary artery skeletonization has consistently produced a satifactory conduit for myocardial revascularization procedures. We have adopted IMA skeletonization not only because of the flow, diameter, and vessel length obtained but also because of limited perivascular tissue disruption that occurs during the dissection.

• The Journal of Internal Korean Medicine
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• v.18 no.2
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• pp.177-194
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• 1997

This thesis, deduced from studying eastern and western medical records, deals with geriatric demedtia in modern society. The result were obtained as follows : 1. Dementia is a kind of chronic, progressive, degenerative disease. The chief expression and pathogenic change of the disease is organic: e.g., extensive change such as cerebrum - atrophy, and denaturalization result. in such a situation intellectual capacities and the ability to enjoy daily life deteriorate trenendously. 2. A basic internal cause of the disease is Defficiencies of the heart, liver and kidneys. An exterior cause is an Excessiveness of the 'Dam'(痰), 'Blood Stasis', 'Fung'(風) and 'Fire'. In a Western Medical view, the reason for dementia is due to the onset of Alzheimer's disease and Brain anemia resulting from Multi - infarction or some other reason. If the white - matter of the brain is injured, then dementia easily to results. 3. Disease symptoms result in troubles in intellectual functions : e.g., memory, orientation, intelligence, judgement, common sence and calculating abilities. 4. The proper therapeutic treatment depends on the causes. When the Deficiency is serious, Fortification (heart, liver. and kidney deficiency) is applied and Decrease is follow. When Excessiveness of wrong is serious, the Decrease is tried before the supplement measure is used depending on the deficiency, which generally is used together with 'Fortify Right - Decreace Wrong'. 5. If the disease wasn't caused by some mental reason, it's difficult to be cured of the disease. When the degree of the disease is light and it doesn't continue for a long time, the therapeutic treatment can block the disease's progress and improve the patient's symptoms.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.20 no.4
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• pp.252-258
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• 2017

Purpose: Blunt trauma of pancreas in children is uncommon and its management varies from observational to early operative intervention. We analysed the feasibility and outcome of non-operative management in all grades of paediatric pancreatic injuries. Methods: A total of 15 patients of pancreatic trauma seen in a Paediatric Surgery Unit were retrospectively analyzed. Results: Age of the patients ranged from 3-11 years (mean, 7.7 years). The mode of injury was local trauma in 9 children. Only 3 patients had associated injuries and all were haemodynamically stable. Serum amylase levels were raised in 12 patients at admission which ranged from 400-1,000 IU. Computed tomography scan made a correct diagnosis in 14 patients. Grades of the injury varied from grade I-V (1, 3, 6, 4, 1 patients respectively). Fourteen patients were managed conservatively. One patient underwent laparotomy for suspected superior mesenteric hematoma. The average duration of enteral feeds was 3.7 days and of hospital stay was 9.4 days. Six patients formed pancreatic pseudocysts; two were managed conservatively while the other four underwent cystogastrostomy. The patients were followed up for a period of 1-12 years. All remained asymptomatic and none had exocrine or endocrine deficiencies. Conclusion: Non-operative treatment for isolated blunt trauma of pancreas in children may be safely followed for all the grades of injury; if associated injuries requiring surgical intervention are ruled out with a good quality imaging and the patients are hemodynamically stable. It did not increase the hospital stay and morbidity and avoided operative intervention on acutely injured pancreas.

• Journal of Korean Neurosurgical Society
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• v.29 no.3
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• pp.353-359
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• 2000

Objective : The fracture on the frontal bone in head-injured patients may be commonly encountered in the clinical situations. Biomechanical studies demonstrate that the anterior wall of the frontal sinus is intermediate in its ability to resist fracture on direct impact. If the frontal sinus is large and the anterior table is able to disperse the force of the impact over a greater area, the posterior table and intracranial contents usually can be spared. We analyzed the clinical features of the patients who presented with frontal skull fracture due to frontal blows. Patients and Methods : From January, 1992 to December, 1997, 172 patients with frontal skull fracture were selected among 1911 patients with head injury who were admitted to department of neurosurgery. Clinical records and radiological studies of all patients were reviewed and evaluated retrospectively. Results : The neurobehavioral changes was seen in 34 cases(19.8%) and showed statistical significances in case of facial bone fractures, acute subdural hematoma(SDH), and positive frontal lobe releasing sign(p<0.05). The good glasgow outcome score group(GOS, good recovery & moderate disability) at discharge was revealed in 77.3% of total patient population. The poor GOS group(severe disability & vegetative state & death) at discharge was revealed in 22.7%. The poor GOS group at discharge have statistical significances with acute epidural hematoma(EDH), traumatic intraventricular hemorrhage(t-IVH), traumatic intracranial lesion, poor initial glasgow coma scale(GCS) scores & Revised Trauma Score(RTS)(p<0.05). Conclusion : Because of their anatomical relationships and neurobehavioral patterns due to vulnerability of the frontal lobe, the frontal injury should be considered as complicated facial injuries. Therefore, these patients are more likely to have a cosmetic or neuropsychiatric problems.

• Journal of The Korean Society of Emergency Medicine
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• v.29 no.6
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• pp.585-594
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• 2018

Objective: This study was designed to report on the progress of the fire at Jecheon sports complex and to assess the adequacy of Disaster Medical Assistant Team (DMAT)'s activities in response to the fire disaster. Methods: We conducted a retrospective review based on camera recordings and medical records that were recorded at the disaster site for assessment of activities. We cooperated with firefighters, police officers, local hospital medical staffs and public health personnel in Jecheon in order to classify patients in the disaster field and to understand the patients' progress. Results: At 15:53, the first request for emergency rescue came to the 119 general emergency call center, and a request for DMAT activation came at 16:28. DMAT arrived at the site at 17:04 and remained active until the following day at 00:43. The total number of casualties was 60, including 27 minimal (Green) patients, 29 expectant (Black) patients, three delayed (Yellow) patients, and one immediate (Red) patient. There were 32 patients who received on-site care by DMAT. Two patients were transferred from a local hospital to Wonju Severance Christian Hospital for hyperbaric oxygen therapy. Conclusion: Twenty-nine victims were found in the sports complex building, and there were 31 mildly to moderately injured patients in this fire disaster. The main cause of death was thought to be smoke suffocation. Although DMAT was activated relatively quickly, it was not able to provide effective activity due to the late rescue and difficulty with fire suppression.