• Korean Journal of Digital Imaging in Medicine
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• v.12 no.1
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• pp.5-8
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• 2010

Opened a court in February 10, 2006, a rule of safety management of the diagnosis radiation system was promulgated for safety of the radiation worker, patients and patients' family members. The purpose of this rule is to minimize the risk of being exposed to radiation during the process of handling X-ray. For this reason, we manufactured shielding device of mobile X-ray unit collimator for diminution of skin dose. Shielding device is made to a thickness of Pb 0.375mm. For portable chest radiography, we measured skin dose 50cm from center ray to 200cm at intervals of 20cm by Unfors Xi detector. As a result, a rule of safety management of the diagnosis radiation system has been strengthened. But there are exceptions, such as ER, OR, ICU to this rule. So shielding device could contribute to protect unnecessary radiation exposure and improve nation's health.

• Clinical and Experimental Pediatrics
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• v.58 no.4
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• pp.154-157
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• 2015

Plastibell is one of the three most common devices used for neonatal circumcision in the United States, with a complication rate as low as 1.8%. The Plastibell circumcision device is commonly used under local anesthesia for religious circumcision in male neonates, because of cosmetic reasons and ease of use. Occasionally, instead of falling off, the device may get buried under the skin along the shaft of the penis, thereby obstructing the normal flow of urine. Furthermore, the foreskin of neonates is highly vascularized, and hence, hemorrhage and infection are possible when the skin is cut. Necrosis of penile skin, followed by urethral obstruction and renal failure, is a serious surgical mishap requiring immediate corrective surgery and medical attention. We report a case of fulminant urosepsis, acute renal failure, and pyelonephritis in a 4-day-old male neonate secondary to impaction of a Plastibell circumcision device. Immediate medical management was initiated with fluid resuscitation and mechanical ventilation; thereby correcting life threatening complications. Pediatricians and Emergency Department physicians should be cognizant of the complications from Plastibell circumcision device in order to institute appropriate and timely management in neonates.

• Journal of Korea Society of Industrial Information Systems
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• v.21 no.1
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• pp.71-82
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• 2016

This study has been carried out to provide data for the workforce by analyzing personnel status of medical device manufacturers, level of difficulty in securing human resource, reason for difficulty in securing human resource, resignation rate, and recruitment methods. Results, medical device manufacturers are required overseas sales personnel responsible for international certification and exported, regardless of the production item. And the company is located in the metropolitan area did not facilitate a secure workforce. Medical device manufacturers have difficulties in securing personnel, regardless of the employees and sales. In particular, Class 3 production company was more difficult. The reason that it is difficult to secure the human resources is attributable to the poor working conditions of the private companies and there is a few possible employees equipped with the job competency demanded by corporate entities. With respect to the analysis on the retirement rate, the larger the company scale and the more the employee number, more difficulty is experienced in the human resource management. Therefore, for any medical device manufacturers with large organization scale, it would be critical to introduce appropriate human resource management program.

• International Neurourology Journal
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• v.22 no.4
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• pp.228-236
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• 2018

Neuromodulation was introduced for patients with poor outcomes from the existing traditional treatment approaches. It is well-established as an alternative, novel treatment option for voiding dysfunction. The current system of neuromodulation uses an open-loop system that only delivers continuous stimulation without considering the patient's state changes. Though the conventional open-loop system has shown positive clinical results, it can cause problems such as decreased efficacy over time due to neural habituation, higher risk of tissue damage, and lower battery life. Therefore, there is a need for a closed-loop system to overcome the disadvantages of existing systems. The closed-loop neuromodulation includes a system to monitor and stimulate micturition reflex pathways from the lower urinary tract, as well as the central nervous system. In this paper, we reviewed the current technological status to measure biomarker for closed-loop neuromodulation systems for voiding dysfunction.

• Journal of the Institute of Electronics and Information Engineers
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• v.52 no.1
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• pp.140-147
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• 2015

In this study, medical devices safety information reporting system was designed to manage medical devices for the efficient management of in-hospital adverse events. The current management of medical device adverse event reporting regulations and the legal status of the system and procedures for identifying the system were reviewed. MSF/CD(Microsoft Solution Framework/Component Design) was applied to the system design. Through this study, we can understand medical devices management including the notice provisions of the Ministry of Food and Drug Safety for medical devices safety information reporting. We also expect this study will help to improve patient safety and the effective management of medical equipment, and contribute to activating medical devices safety information reporting.

• Journal of Service Research and Studies
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• v.4 no.2
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• pp.1-10
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• 2014

According to recent trends in technological advances and globalization, medical device industry may improve the constitution to meet worldwide medical equipment management system. Also it is holding a strand of mitigation to reach the level of international regulation. In addition, recent legislation tends are to stay limited ranges of industry regulations at least and take as open attitude for integration of new technologies combined medical devices. A greater environmental risk is not likely to work in medical technology, Combinded medical device is used as close to zero risk in most of the human body, which is classified as Class 1. Even medical device such as little or no risk in handling, it is possible to minimize the unnecessary administrative power and a waste of time to occur. For the medical device may be improving people's choices and access, medical equipment operator is expanding to include dealers, because this will be exalted to particular area of the business of the company. In this paper, we investigate the legal prerequisites for the establishment of a medical device. And propose improved regulations in topics in order to facilitate the repair and distribution markets for fair trade.

• The Journal of the Korean dental association
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• v.57 no.6
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• pp.316-324
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• 2019

The new medical technology assessment system has a basic goal of protecting the public's health rights and promoting the development of the new medical technology with safe and effective medical technology that has been scientifically proven. The purpose of this study is to contribute to the activation of the new medical technology evaluation system by analyzing the application cases of the dental field after the implementation of the new medical technology evaluation system and proposing an efficient approach to approach the new medical technology evaluation system. The number of related literature and medical technology evaluation results are not significant in dental applications, the number of cases and the length of follow-up period of the relevant medical technology adopted as the new medical technology was far higher. As the speed of medical technology development increases, medical technology is expected to develop in the dental field as well. To introduce the medical technology to the clinical site, access to the correct direction of evidence is required to collect and objectify data at the medical site in order to prepare a literary basis for the medical technology.

• Journal of Biomedical Engineering Research
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• v.40 no.6
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• pp.250-259
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• 2019

Ophthalmic Laser System is widely used in Selective Laser Trabeculoplasty of Open Angle Glaucoma and Ocular Hypertension. Versatile ophthalmic laser system is a medical device with technology that checks the condition of the treatment area by irradiating a continuous laser pulse on the treatment area, and monitoring the microbubble reaction caused by the temperature increase of the melanosome through the ultrasonic signal and the optical signal sensor. It performs selective laser treatment without damaging the photoreceptor by controlling the wavelength of the laser when microbubbles are detected. This study aims to suggest a guideline for evaluating safety, performance and clinical effectiveness of Versatile Ophthalmic Laser System in accordance with the growing technology. International Standards, Regulations, and Clinical Trial Protocols were investigated and analyzed for this study. As a result of this study, the safety, performance and clinical effectiveness test guideline for Versatile Ophthalmic Laser System were proposed. This guideline will ensure the safety and efficacy of Medical device, and furthermore it is expected to be able to promote the development of technology development by supporting a clinical trial plan.

• Journal of the Korea Society of Computer and Information
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• v.22 no.6
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• pp.79-86
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• 2017

In this paper, we implement a common module that can integrate multiple biometric information for integrated patient monitoring system. Conventional biomedical instruments have many devices attached to each patient, making it difficult to monitor abnormality signs of many patients in real time. In this paper, we propose a module for an integrated monitoring system that can perform centralized monitoring using a common module that integrates multiple measurement devices. A protocol for sending and receiving packets between the measuring device and the common module is designed, and the packets transmitted through the network are stored and managed through the integrated monitoring system and provide information to various users such as medical staff. The results of this study are expected to contribute to the management of patients and efficient medical services in hospitals.

• Management & Information Systems Review
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• v.35 no.2
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• pp.221-254
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• 2016

With increasing interest of health due to population aging, medical device industry is highlighted as a promising industry. However, Korea medical device industry is not enough market competitiveness compared to global company due to a narrow domestic market and a small company structure. In order to retain the national competitiveness, it is necessary that we have to derive a central technology and its trend. This study has predicted a central technology for medical device industrial using patent network analysis. The central technology is defined as a key technology that is connected to most other technologies and that significantly affects them. For the empirical study, we conducted social network analysis using covariance and correlation coefficient between IPC codes extracted from medical device patents, introduced by Jun(2012). A social network is a social structure of diverse items as well as of human beings. In this study, we set each medical device as a node in an SNA and analyze the Degree values between them. Also, Korea health industrial statistics system are utilized for verification of selected central technology. As a result, we found that the central technology is located on the medical device items, which are listed higher the amount of production. The central technology selected through the proposed methodology will provide a inspiration for establishment of R&D policy.