• Journal of radiological science and technology
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• v.22 no.2
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• pp.33-39
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• 1999

This paper included a data analysis of the unit of medical devices using mainternance recording card that had medical devices of unit failure mode, hospital of failure mode and MTBF. The results of the analysis were as follows : 1. Medical devices of unit failure mode was the highest in QC/PM such A hospital as 33.9%, B hospital 30.9%, C hospital 30.3%, second degree was the Electrical and Electronic failure such A hospital as 23.5%, B hospital 25.3%, C hospital 28%, third degree was mechanical failure such A hospital as 19.5%, B hospital 22.5%, C hospital 25.4%. 2. Hospital of failure mode was the highest in Mobile X-ray device(A hospital 62.5%, B hospital 69.5%, C hospital 37.4%), and was the lowest in Sono devices(A hospital 16.76%, B hospital 8.4%, C hospital 7%). 3. Mean time between failures(MTBT) was the highest in SONO devices and was the lowest in Mobile X-ray devices which have 200 - 400 failure hours. 4. Anverage failure ratio was the highest in Mobile X-ray devices(A hospital 31.3%, B hospital 34.8%, C hospital 18.7%), and was the lowest in Sono(Ultrasound) devices (A hospital 8.4%, B hospital 4.2%, C hospital 3.5%). 5. Failure ratio results of medical devices according to QC/PM part of unit failure mode were as follows ; A hospital was the highest part of QC/PM (50%) in Mamo X-ray device and was the lowest part of QC/PM(26.4%) in Castro X-ray. B hospital was the highest part of QC/PM(56%) in Mobile X-ray device, and the lowest part of QC/PM(12%) in Gastro X-ray. C hospital was the highest part of QC/PM(60%) in R/F X-ray device, and the lowest a part of QC/PM(21%) in Universal X-ray. It was found that the units responsible for most failure decreased by systematic management. We made the preventive maintenance schedule focusing on adjustement of operating and dust removal.

• Journal of the Korean Society of Radiology
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• v.81 no.4
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• pp.863-885
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• 2020

A variety of medical devices have evolved throughout the years. Commonly used devices have typical radiological appearances which are familiar to radiologists. However, some new devices, as well as devices that are not commonly used, may be missed or misinterpreted by radiologists. It is even more difficult to identify a certain medical device with limited clinical history. Therefore, accurate identification of medical devices is crucial to diagnose malposition and potential complications. In this article, we provide a pictorial review of medical devices of the abdomen and pelvis according to classifications that include gastrointestinal devices, hepatobiliary devices, genitourinary devices, and miscellaneous. We also comprehensively review the clinical and radiologic features of complications related to these medical devices.

• Journal of Biomedical Engineering Research
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• v.42 no.3
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• pp.86-93
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• 2021

Purpose: The purpose of this study is to find out the cognizance of medical device safety information (MDSI) monitoring in the hospital and oriental hospital workers, and the different aspect of MDSI between oriental medical devices and medical devices. Methods: The survey was performed both in the oriental medicine hospital and general hospital. The survey had 16 items; 2 items basic questions, 5 items in the awareness of MDSI, 5 items in the education of MDSI, 4 items in the necessity of defining oriental medical devices and differences between general and oriental medical devices. A total of 120 hospital worker were participated; 60 oriental medicine hospital workers and 60 general hospital workers. They had worked in the oriental medicine or general hospital associated with 'Medical Device Safety Monitoring Center, Dongguk University Ilsan Hospital' in 2019 and 2020. Results: The cognizance of MDSI was high both in oriental medicine hospital and general hospital workers and there were no significant differences between oriental medicine and general hospital workers. When we divided the hospital workers into the senior workers who had worked for over 3 years and junior workers for less than 3 years, the senior workers had higher awareness of MDSI than junior workers. However, the cognizance of education of MDSI was high which was not different between senior and junior workers. Both hospital workers thought that it was necessary to define oriental medicine device legally and the oriental medical device might have low risk and less side effect than medical device. Conclusion: The cognizance of MDSI was high and there was no significant differences between oriental medicine and general hospital workers. Because the senior hospital workers had higher recognition of MDSI, we need to provide the continuous education program for junior hospital workers. Although oriental medical device are thought to be safer than medical device, we need to have a legal definition.

• Journal of Biomedical Engineering Research
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• v.40 no.1
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• pp.20-31
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• 2019

Medical device performance management is an activity that allows a device to be safely used and maintained even after it is put on the market. The purpose of this study is to provide procedures and criteria for selection of medical device items that should manage the safety and performance among medical devices in hospital. Investigate the performance management status of medical devices in hospitals and identify the performance management status by domestic and advanced regulatory agencies. Provides selection procedures and test methods for medical devices subject to performance management in hospitals based on medical device risk management and reliability. In addition, a case study on drug infusion pumps was conducted.

• Journal of Korean Clinical Nursing Research
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• v.16 no.2
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• pp.69-84
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• 2010

Purpose: The purpose of this study was to identify the state of infection control in neonatal intensive care units (NICUs) including disinfection methods, disinfection cycles, and exchange cycles for medical devices and to suggest a basic framework which would help develop standardized infection control guidelines. Methods: From a list of NICU equipment developed from the NICUs in 4 tertiary hospitals, a structured questionnaire on 74 types of medical equipment was developed and sent to 31 hospitals by mail. The results were reviewed by panel of experts (56 persons), and analyzed for internal validity by a focus group (4 persons) using guidelines from the Centers for Disease Control and the Korean Hospital Nurses Association. Results: The results showed various methods, cycles, disinfectant levels for the disinfectants and exchange cycles in the medical equipment infection control of the 31 hospitals. The focus group developed a 66-item basic framework based on validity testing. Conclusion: From the results of this study, a framework of infection control standards for 66 types of medical equipment in the NICU was developed. It is suggested that further study be done to more precisely establish standard infection control guidelines for NICU medical equipment.

• The Journal of the Institute of Internet, Broadcasting and Communication
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• v.13 no.6
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• pp.255-262
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• 2013

Medical Gateway(MG), that integrates medical devices with its unique data format in various hospital information systems, provides effectiveness in the cost of the management unlike existing systems that uses PC as a gateway to hospital information systems because MG enables to interface medical devices with itself. However, in spite of using MG for integrating medical devices, we need additional programs or systems to interwork with EMR system of each hospital in accordance with the configuration of DB. In this paper, we design and implement the format of medical information and server system for interworking MG with EMR system. The proposed system makes easy exchanging medical data between MG and EMR system. Thus, the proposed system can contribute to a national project to export abroad advanced hospital setup converged with IT.

• Journal of Biomedical Engineering Research
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• v.29 no.2
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• pp.164-171
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• 2008

Recently, many of hospitals have hurried to computerize the resulting data from medical devices, in order to introduce Electric Medical Record(EMR). In terms of the linkage between medical devices and hospital information systems, however, many difficulties have arisen due to some reasons such as the variety of prescription input, the format difference of the resulting data sheet, and the interface difference between medical devices from different companies. To solve these problems, many researches on standardization of the resulting data of medical devices have been performed. In this study, the linkage between hospital information systems and resulting datum in Electrocardiogram(ECG) generating biosignal waveform was tested by applying Medical waveform Format Encoding Rules(MFER) Version 1.02, which has more advantages than existing global standard. MFER viewer, in addition, was made to display the resulting data on a screen. The MFER viewer was tested and compared to the existing Scalable Vector Graphics (SVG) Viewer. The results showed that this method is more effective in the interface the data storage and application, because of simplicity and easiness in data applications. And the results show that the MFER is convenience and effective for physician. It is considered that the role of MFER as the interface in biosignal waveform including Electrocardiogram medical devices would expand in the near future.

• 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 rehabilitation welfare engineering & assistive technology
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• v.11 no.4
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• pp.287-297
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• 2017

This exploratory study aimed to explore the perception (knowledge and attitude) and behaviors of medical personnel regarding medical device safety and to identify the differences in results linked with the type of their task. A questionnaire was administered to medical personnel working at a tertiary care hospital with 900 beds in Incheon, Korea, and 220 completed questionnaires were used for analysis. The results revealed that the majority of the medical personnel perceived the potential risk involved in different types of medical devices they use and stated that they need training programs for safe use of medical devices. Concerning the perception regarding medical devices across different positions within the hospital, it was found that the residents had a low awareness about safety issues, although the medical services they handled involve high risks, thereby calling for safety training. Further nationwide studies are needed to improve the quality and validity of data and eventually to provide important information required by policy makers and academicians to manage medical device safety.

• Archives of Obesity and Metabolism
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• v.2 no.1
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• pp.17-24
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• 2023

Obesity is a major public health problem worldwide, with several methods having been proposed as a means of weight loss. If diet, exercise, and medication are insufficient, a healthcare professional may suggest weight loss treatments, including bariatric surgery or medical devices. Antiobesity medical devices are an option for patients who do not want to undergo bariatric surgery. Compared with bariatric surgery, medical devices have the advantage of being reversible and easier to operate. The U.S. Food and Drug Administration (FDA) regulates medical devices, including those used for weight loss and weight management. This article provides an overview of the FDA-regulated weight loss and weight management devices.