• Korean Journal of Head & Neck Oncology
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• v.19 no.2
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• pp.164-169
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• 2003

Background and Objectives: The reconstruction is very important in Head and neck cancer surgery to repair the defect created by resection of tumors, to enable successful wound healing, to restore function and to provide acceptable cosmesis. The radial forearm free flap has been the most useful reconstructive flap because it provides a moderate amount of thin, pliable, relatively hairless skin and comparatively simple to do with minimal morbidity. The aims of this study is to estimate the outcome of the reconstruction with radial forearm free flap with the several factors in 140 head and neck cancer cases in our hospital for last 10 years. Materials and Methods: Retrospective review of the records of 140 patients underwent resection of the head and neck tumors and reconstruction with a radial forearm free flap from 1993 to 2003. The age, sex of the patients, Primary site, the complication of donor and recipient site, flap survival rate, median time to start diet, patient subjective symtoms about swallowing and articulating and the fact of revision reconstructive surgery were analyzed. Results: In primary pathologic site, 56 cases were oral cavity cancers, 44 cases, oropharyngeal cancers and 22 cases, hypopharyngeal cancers. Flap survival rate was 93.6% (13 leases). On donor site, wound dehiscence, hematoma, sensory change and infection were noted and on recipient site, most common complication were fistula and wound dehiscence. The complication rate of recipient's site was 19.1 % and donor site, 3.5%. In 118 cases (84.3%), the patients could take all kinds of food. Swallowing difficulty were noted in 22 cases 05.7%). In 5 cases, there was articulation difficulty but most of patients except patients having total laryngectomy (18 cases) couldn't have any difficulty in articulation and speaking. Conclusion: We conclude that the radial forearm free flap is the most appropriate reconstructive material for treating the defect in head and neck reconstruction.

• The Journal of Advanced Prosthodontics
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• v.5 no.1
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• pp.29-35
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• 2013

PURPOSE. To longitudinally assess the quality of life in maxillectomy patients rehabilitated with obturator prosthesis. MATERIALS AND METHODS. Thirty-six subjects were enrolled in the span of 16 months, out of which six were dropouts. Subjects (age group 20-60 years) with maxillary defects, irrespective of the cause, planned for definite obturator prosthesis, were recruited. The Hindi version of European Organization for Research and Treatment of Cancer, Head and Neck version 1 of Quality of Life Questionnaire was used before surgical intervention and one month after definitive obturator. Questionnaire includes 35 questions related to the patient's physical health, well being, psychological status, social relation and environmental conditions. The data were processed with statistical package for social science (SPSS). Probability level of P<.05 was considered statistically significant. RESULTS. The quality of life after rehabilitation with obturator prosthesis was 81.48% (${\pm}13.64$) on average. On item-level, maximum mean scores were obtained for items problem with teeth ($1.87{\pm}0.94$), pain in mouth ($1.80{\pm}0.92$), trouble in eating ($1.70{\pm}0.88$), trouble in talking to other people ($1.60{\pm}1.22$), problems in swallowing solid food ($1.57{\pm}1.22$) and bothering appearance ($1.53{\pm}1.04$); while minimum scores were obtained for the items coughing ($1.17{\pm}0.38$), hoarseness of voice ($1.17{\pm}0.53$), painful throat ($1.13{\pm}0.43$), trouble in having social contacts with friends ($1.10{\pm}0.40$) and trouble having physical contacts with family or friends ($1.10{\pm}0.31$). CONCLUSION. Obturator prosthesis is a highly positive and non-invasive approach to improve the quality of life of patients with maxillectomy defects.

• Journal of Hospice and Palliative Care
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• v.7 no.1
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• pp.64-72
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• 2004

Purpose: This research aims to assess the effect of a single session of group education of hospice program at Seoul National University Hospital for the advanced and terminal cancer patients and their family members. Methods: Response to questionnaires from 89 participants were evaluated using SAS and CHISQ analysis. The questionnaires included the following items: 1) the characteristics of participants; 2) the characteristics of patients; 3) the difficulties of patient care; 4) the satisfaction with the program Results: The participants consist of 33 patients (37.5%) and 56 family members (56.2%). Diagnosis included mainly stomach, lung, breast, and colon cancer. Participants of family members consisted of spouse, parent, children, daughter-in-law, and siblings (in decreasing order). The participants were interested in the medical information, nutrition, pain and symptom management, and psychosocial adaptation. They had difficulties in emotional problem, nutrition and symptom management. Even though it was a single session of group education, the level of satisfaction was high (95%). Conclusion: This research shows that even the single session of the group education for the advanced and terminal cancer patients and their family members is very helpful by giving them the necessary information. In order to develop comprehensive care-giving services, more specific informations, more opportunities to participate in such sessions and longer question-answer time is required.

• Journal of Physiology & Pathology in Korean Medicine
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• v.33 no.5
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• pp.255-260
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• 2019

Oriental Diagnosis System(ODS) is an artificial intelligence program that utilize entered diagnosis knowledge, determine patient's disease and decide right medicine. The purpose of this study is to find a correlation between pattern Identification in Korean medicine and each sasang types(So-Yang, So-Eum and Tae-Eum) by analyzing ODS diagnosis result. Eventually our study secure availability of using ODS program at clinical training or developing diagnosis program. Subject of this study is 32 students participating in Sasang medical practice(12 subjects were So-Yang, 7 subjects were So-Eum, and 13 subjects were Tae-Eum). We analyze subject's clinical practice result reports by using ODS program and obtained result about pattern Identification. We used SPSS statistics 23 in analyzing the differences of the scores of Eight Principle Pattern Identification, Qi-Blood Pattern Identification, Bing-xie Pattern Identification, and Visceral Pattern Identification in each Sasang types (So-Yang, So-Eum, Tae-Eum). In the case of Heat-moisture, Tae-Eum showed higher score than So-Eum, but So-Yang showed no difference from the other two Sasang types(p<0.05). And in the case of Food-accumulation, Tae-Eum and So-Yang showed significantly higher score than So-Eum(p<0.05). It is hard to generalize the result because subject of this study was not enough. However, we explained correlation between pattern Identification in korean medicine and each sasang types based on quantifiable and objective evidence system. Therefore use of ODS program in student clinical practice training help to understand the relationship and correlation between different pattern Identification and will help standardization of clinical practice education.

• Journal of Biomedical Engineering Research
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• v.40 no.5
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• pp.197-205
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• 2019

The existing Extracorporeal membrane oxygenation(ECMO) and Cardiopulmonary bypass system(CPB) have been developed and applied to various devices according to their respective indications. However, due to the complicated configuration and difficult usage method, it causes inconvenience to users and there is a risk of an accident. Therefore, smart all-in-one cardiopulmonary circulation device is being developed recently. The smart all-in-one cardiopulmonary assist device consists of a blood pump for cardiopulmonary bypass, a blood oxidizer for cardiopulmonary bypass, a blood circuit for cardiopulmonary bypass, and an artificial cardiopulmonary device. It is an integrated cardiopulmonary bypass device that can be used for a variety of purposes such as emergency, intraoperative, post-operative intensive care, and long-term cardiopulmonary assist, combined with CPB used in open heart surgery and ECMO used when patient's cardiopulmonary function does not work normally. The smart all-in-one cardiopulmonary assist device does not exist as a standard and international standard applicable to advanced medical devices. Therefore, in this study, we will refer to the International Standard for Blood Components, the International Standard for Blood, the Guideline for Blood Products, and prepare applicable performance and safety guidelines to help quality control of medical devices, and contribute to the improvement of the health of people. The guideline, which is the result of conducted a survey of the method of safety and performance test, is based on the principle of all-in-one cardiopulmonary aiding device, related domestic foreign standards, the status of domestic and foreign patents, related literature, blood pump(ISO 18242), blood oxygenator (ISO 7199), and blood circuit (ISO 15676) for cardiopulmonary bypass.The items on blood safety are as follows: American Society for Testing and Materials ASTM F1841-97R17), and in the 2010 Food and Drug Administration's Safety Assessment Guidelines for Medical Assisted Circulatory Devices. In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers / importers, testing inspectors, academia, etc. the final guideline was established through revision and supplementation process. Therefore, we propose guidelines for evaluating the safety and performance of smart all-in-one cardiopulmonary assist devices in line with growing technology.

• Parasites, Hosts and Diseases
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• v.59 no.6
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• pp.615-623
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• 2021

Human sparganosis is a food-borne parasitic disease caused by the plerocercoids of Spirometra species. Clinical diagnosis of sparganosis is crucial for effective treatment, thus it is important to identify sensitive and specific antigens of plerocercoids. The aim of the current study was to identify and characterize the immunogenic proteins of Spirometra erinaceieuropaei plerocercoids that were recognized by patient sera. Crude soluble extract of the plerocercoids were separated using 2-dimensional gel electrophoresis coupled with immunoblot and mass spectrometry analysis. Based on immunoblotting patterns and mass spectrometry results, 8 antigenic proteins were identified from the plerocercoid. Among the proteins, cysteine protease protein might be developed as an antigen for diagnosis of sparganosis.

• The Journal of the Acoustical Society of Korea
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• v.42 no.5
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• pp.469-490
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• 2023

Survey was carried out on the acoustic outputs from 12 shock wave fields produced by the 10 extracorporeal shock wave lithotriptors whose technical documents are available, among the 33 devices approved by the Ministry of Food & Drug Safety (MFDS).The results show that the acoustic outputs (P+, P-, efd, and E), critical to the therapeutic efficacy and the patient safety, are largely different between the devices. The maximum values of P+, P-, efd, and E vary up to 2.08, 3.72, 3.89, and 15.98 times, respectively. The acoustic output parameters are not thoroughly provided in the technical documents, and some of data (eg. efd) are suspected to be abnormal outside usual ranges. The large device to device differences in the shock wave outputs are likely to undermine equivalence between the ESWL devices approved for the same indication. To verify the reliability of the data in the technical documents of the approved devices and to confirm if the acoustic outputs from the devices in clinical use are the same as those in their technical documents, an authorized test laboratory should be available. A postapproval monitoring led by the regulatory agency is suggested to maintain the acoustic outputs from the ESWL devices that suffer from degrading in performance due to aging.

• The Journal of Korean Medicine
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• v.44 no.1
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• pp.128-128
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• 2023

Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity. Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was drafted Results: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety. Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

• Journal of Biomedical Engineering Research
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• v.44 no.6
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• pp.363-376
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• 2023

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.The purpose of this study is to conduct a usability assessment to ensure that ergonomic design has been applied so that the ventilator central monitoring system can improve user satisfaction, efficiency, and safety. The rapid spread of COVID-19, which began in 2019, caused significant damage global medical system. In this situation, the need for a system to monitor multiple patients with ventilators was highlighted as a solution for various problems. Since medical device software is closely related to human life, ensuring their safety and satisfaction is important before their actual deployment in the field. In this study, a total of 21 participants consisting of respiratory staffs conducted usability test according to the use scenarios in the simulated use environment. Nine use scenarios were conducted to derive an average task success rate and opinions on user interface were collected through five-point Likert scale satisfaction evaluation and questionnaire. Participants conducted a total of nine use scenario tasks with an average success rate of 93% and five-point Likert scale satisfaction survey showed a high satisfaction result of 4.7 points on average. Users evaluated that the device would be useful for effectively managing multiple patients with ventilators. However, improvements are required for interfaces associated with task that do not exceed the threshold for task success rate. In addition, even medical devices with sufficient safety and efficiency cannot guarantee absolute safety, so it is suggested to continuously evaluate user feedback even after introducing them to the actual site.

• Korean Journal of Microbiology
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• v.49 no.3
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• pp.228-236
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• 2013

Campylobacter jejuni is one of important food-borne pathogens causing human gastroenteritis. We isolated 42 strains of C. jejuni from diarrhea patients and 4 food-poisoning outbreaks in 2010, Gyeonggi-do. In this study, 42 strains were tested for genetic characteristics, the serotype distribution and antimicrobial resistant rate. The presence of hipO (100%), cdtB (100%), and mutated gyrA (95.2%) genes was detected in C. jejuni by polymerase chain reaction (PCR). Detection of mutated gyrA gene correlated with ciprofloxacin resistance. Forty isolates had mutated gyrA gene and were actually resistant to ciprofloxacin. Furthermore, comparing the gyrA DNA sequence data, ciprofloxacin-resistant isolates had a mutation of the DNA sequence from ACA (threonine) to ATA (isoleucine). But 41 strains (97.6%) of patient isolates were susceptible to erythromycin and azithromycin. A total of 35.7% among 42 C. jejuni isolates were identified into 4 different serotypes. The serotype distribution of C. jejuni strains were shown to be HS2(B), HS3(C), HS4(D), HS19(O). To investigate the genotypes of C. jejuni isolated in Gyeonggi province, repetitive sequence polymerase chain reaction (rep-PCR) analysis and SmaI-digested pulsed-filed gel electrophoresis (PFGE) profile analysis were performed. From the PFGE analysis of 42 C. jejuni strains, 12 clusters of PFGE profile were obtained. On the other hand, 11 clusters of rep-PCR profile were obtained from 42 strains of C. jejuni.