• Korean Journal of Radiology
• /
• v.22 no.11
• /
• pp.1743-1748
• /
• 2021

• Convergence Security Journal
• /
• v.21 no.1
• /
• pp.63-72
• /
• 2021

The hospital biomedical engineering team is responsible for establishing and regulating the Medical Device Management Program (MEMP) to ensure that medical devices are safe and reliable. As technology advances, medical devices such as artificial intelligence and precision medicine are developing into a form that allows connection between objects anytime, anywhere, and as various technologies converge, internal and external security threats continue to increase. In this paper, we present a study of the Medical Device Management Program (Secure-MEMP) method, considering that the security threat of medical devices continues to increase due to advances in technology.

• Journal of rehabilitation welfare engineering & assistive technology
• /
• v.11 no.4
• /
• pp.299-306
• /
• 2017

The Korean medical device industry has increased dramatically due to various investments in the domestic medical device industry and the introduction of new technologies, but the domestic medical device usage rate in great hospital is still low. In this paper, improvement point for domestic medical device was suggested by domestic medical device usage rate and user and manager's perception survey in great hospitals in Korea. To do this, a survey on the types of medical devices and domestic medical device usage rates were conducted at four national university hospitals in Korea. From this results, the priority survey medical devices were selected. Improvements of Korean medical devices were suggested by failure mode analysis and user awareness surveys for the priority survey medical devices.

• Journal of the Korean Medical Association
• /
• v.61 no.12
• /
• pp.765-775
• /
• 2018

With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, 'digital exceptionalism' (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.

• Journal of Korean Clinical Nursing Research
• /
• v.18 no.2
• /
• pp.296-306
• /
• 2012

Purpose: This study was done to compare the physical injury, emotional response and unplanned self-removal of medical devices in patients with physical restraints and patients not restrained. Methods: Eighty patients admitted to the intensive care unit (ICU) of a university hospital in Seoul participated in this study. Forty patients made up each group and the group not restrained was matched with the restraint group for age and history of smoking and alcohol consumption. Data on occurrence of physical injury, intensity of anxiety, stage of agitation and unplanned self-removal of medical devices were collected by observation and medical chart review using a structured instrument. Statistical processing of collected data was done with the SPSS WIN 17.0 program. Results: The physically restrained group experienced more physical injuries and recorded significantly higher levels of anxiety and agitation than the unrestrained group. However, there were no significant differences between the groups in occurrence of unplanned self-removal of medical devices. Conclusion: Results indicate a need for critical care nurses to carefully monitor physical injuries and emotional responses of physically restrained patients and to develop nursing interventions to prevent adverse effects associated with restraint use. There is also a need to develop patient safety guidelines when using physical restraints.

• The Journal of Korean Medicine
• /
• v.43 no.3
• /
• pp.150-163
• /
• 2022

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.

• The Korean Journal of Emergency Medical Services
• /
• v.27 no.2
• /
• pp.7-17
• /
• 2023

Purpose: This study aimed to identify the factors that contribute to head injuries among drivers of personal mobility devices and provide insights into safety perceptions. Methods: This retrospective study analyzed data of 221 trauma patients obtained from electronic medical records and the National Emergency Department Information System (NEDIS) over one year, from August 1, 2021, to July 31, 2022. The patients, all in their 20s and 30s, presented to a single emergency medical center following personal mobility device accidents (motorcycles, electric scooters, and bicycles). Results: Among motorcycle riders, 18.2% were not wearing helmets, while the percentage of e-scooter riders not wearing helmets was 87.5%. Wearing a helmet was associated with a 71.2% lower likelihood of head injuries (OR=0.288, CI=0.163 to 0.509, p=0.000). Of the personal mobility devices, motorcycles had a 0.431 times lower odds ratio for head injury compared to e-scooters (p=0.009), and there was no significant difference between e-scooters and bicycles (p=0.776). Conclusion: It is imperative to strengthen safety regulations by mandating helmet use for riders of personal mobility devices. A system to enhance driving enforcement for electric scooters, which are increasingly popular among young adults, should also be established.

• Journal of Korean Biological Nursing Science
• /
• v.20 no.4
• /
• pp.228-235
• /
• 2018

Purpose: This study aimed to investigate the clinical alarm occurrence and management of nurses toward clinical alarms in the intensive care unit (ICU). Methods: This observational study was conducted with 40 patients and nurses cases in two ICUs of a university hospital. This study divided 24 hours into the unit of an hour and conducted two times of direct observation per unit hour for 48 hours targeting the medical devices applied to 40 patients. Data were analyzed using IBM SPSS Statistics 23. Results: On average, 3.8 units of medical devices were applied for each patient and the ranges of alarm settings were wide. During 48 hours, 184 cases of clinical alarm were occurred by four types of medical devices including physiological monitors, mechanical ventilators, infusion pumps, and continuous renal replacement therapy. Among them, false alarm was 110 cases (59.8%). As for the alarm management by ICU nurses, two-minute alarm mute took up most at 38.0% (70 cases), and no response was second most at 32.6% (60 cases). When valid alarm sounded, nurses showed no response at 43.2%. Conclusion: The findings suggest that a standard protocol for alarm management should be developed for Korean ICU settings. Based on the protocol, continuous training and education should be provided to nurses for appropriate alarm management.

• Journal of rehabilitation welfare engineering & assistive technology
• /
• v.4 no.1
• /
• pp.35-41
• /
• 2010

By the development of medical devices, high-frequency medical devices are becoming widely used. Imaging diagnosis in hospital and clean treatment by high-frequency medical devices and cancer treatment through high-frequency heaters around us, all serve as the examples. However, it still lacks the measures to the problems of the RF(Radio Frequency) mutual interference between the high-frequency devices. In order to prevent the problematic factors for technical and industrial development, a new reasonable and suitable test method is required. In this paper, we study a standard test method for EMC evaluation to solve the RF mutual interference.

• Journal of Convergence for Information Technology
• /
• v.9 no.4
• /
• pp.1-7
• /
• 2019

The medical environment, combined with IT technology, is changing the paradigm for medical services from treatment to prevention. In particular, as ICT convergence digital healthcare technology is applied to hospital medical systems, infrastructure technologies such as big data, Internet of Things, and artificial intelligence are being used in conjunction with the cloud. In particular, as medical services are used with IT devices, the quality of medical services is increasingly improving to make them easier for users to access. Medical institutions seeking to incorporate IoT services into cloud health care environment services are trying to reduce hospital operating costs and improve service quality, but have not yet been fully supported. In this paper, a patient information collection model from hospital IoT system, which has established a cloud environment, is proposed. The proposed model prevents third parties from illegally eavesdropping and interfering with patients' biometric information through IoT devices attached to the patient's body at hospitals in cloud environments that have established hospital IoT systems. The proposed model allows clinicians to analyze patients' disease information so that they can collect and treat diseases associated with their eating habits through IoT devices. The analyzed disease information minimizes hospital work to facilitate the handling of prescriptions and care according to the patient's degree of illness.