• Journal of radiological science and technology
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• v.47 no.2
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• pp.97-105
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• 2024

The examination needle used in ultrasound biopsy is a medical device used to determine whether there is an abnormality in the tissue. Typically, stainless steel is the standard material used for such needles; however, this study wanted to identify a material that could better enhance sound compared to traditional stainless steel. In this study, six types of needle materials available with the biopsy gun were inserted into pork and ultrasound images according to the curved probe and linear probe were evaluated using ultrasound equipment. The findings revealed significant improvements in ultrasound acoustic enhancement with alternative materials compared to stainless steel (p<0.05). The results regarding the depth of each ultrasound image using the curved probe showed that tungsten and brass had high sound enhancement(p<0.05), while with the linear probe, sound enhancement was high in brass, pla, aluminum, and copper(p<0.05). Due to these results, the previously used stainless needle showed lower ultrasound acoustic enhancement than the five types of materials being compared. Consequently, the outcomes of this study provide valuable insights for the development of new needle technologies aimed at minimizing patient risks and improving diagnostic accuracy.

• Clinical Endoscopy
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• v.57 no.4
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• pp.434-445
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• 2024

Pancreatic cystic lesions (PCLs) have increased in prevalence due to the increased usage and advancements in cross-sectional abdominal imaging. Current diagnostic techniques cannot distinguish between PCLs requiring surgery, close surveillance, or expectant management. This has increased the morbidity and healthcare costs from inappropriately aggressive and conservative management strategies. Endoscopic ultrasound (EUS) needle-based confocal laser endomicroscopy (nCLE) allows for microscopic examination and delineation of the surface epithelium of PCLs. Landmark studies have identified characteristics distinguishing various types of PCLs, confirmed the high diagnostic yield of EUS-nCLE (especially for PCLs with an equivocal diagnosis), and shown that EUS-nCLE helps to change management and reduce healthcare costs. Refining procedure technique and reducing procedure length have improved the safety of EUS-nCLE. The utilization of artificial intelligence and its combination with other EUS-based advanced diagnostic techniques would further improve the results of EUS-based PCL diagnosis. A structured training program and device improvements to allow more complete mapping of the pancreas cyst epithelium will be crucial for the widespread adoption of this promising technology.

• Journal of rehabilitation welfare engineering & assistive technology
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• v.4 no.1
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• pp.1-8
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• 2010

The combination of medical devices and IT convergence technology has made it possible to check health whenever and wherever people want. The recent development of various Ubiqutous Healthcare medical devices ensures the convenient measurements of health variations in daily lives and at home. However, considering that there is a growing prevalence of the devices and a great interest in the development of Ubiqutous Healthcare device, it is urgent to secure the stability and to establish performance evaluation. Therefore, it is needed to develop standard testing methods for the stability and the performance evaluation on before and after selling products. In this paper, I studied the standard testing method of both compulsory tests and performance evaluation which are for the electric stability evaluation on Ubiqutous Healthcare devices.

• Human Ecology Research
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• v.58 no.4
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• pp.613-633
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• 2020

This study identifies consumers' perceived benefits and costs when using Samsung Health (a healthcare app) based on consumer reviews from Google Play Store's app and social media discourse. We examine the differences in the benefits and the costs of Samsung Health using these two sources of data. We conducted text frequency analysis, clustering analysis, and semantic network analysis using R programming. The major findings are as follows. First, consumers experience benefits and costs on several functions of the app, such as step counting, device interlocking, information acquisition, and competition with global consumers. Second, the results of semantic network analysis showed that there were eight benefit factors and three cost factors. We also found that the three costs correspond to the benefits, indicating that some consumers gained benefits from certain functions while others gained costs from the same functions. Third, the comparison between consumer app review and social media discourse showed that the former is appropriate to assess the performance of app functions, while the latter is appropriate to examine how the app is used in daily life and how consumers feel about it. The current study suggests managerial implications to healthcare app service providers regarding what they should strengthen and improve to enhance consumers' satisfaction. It also suggests some implications from the two media, which can be mutually complementary, for researchers who study consumer opinions.

• Information Systems Review
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• v.19 no.2
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• pp.57-70
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• 2017

Researchers and industry managers highlight the emergence of mobile healthcare market given the rapid development of IT and the expansion of average life expectancy. Medical institutions, such as university hospitals, are aiming to achieve convenience and effectiveness of treatment by providing patient education through a mobile device. This study examines a case related to the development and usage of a mobile application based on Lean Canvas, namely, the Smart Explanation Service released by Samsung Medical Center. This application comprehensively analyzes the usage status of mobile application-based patient education and its application in clinical settings. This study also examines the level of satisfaction of patients and medical workers toward this application. The result of this study is expected to provide meaningful implication to medical institutions and related industries and enable them to create and offer prepare mobile healthcare services.

• The Journal of Korea Institute of Information, Electronics, and Communication Technology
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• v.11 no.1
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• pp.34-39
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• 2018

Along with the development of ICT technology, wearable devices of various sizes and shapes have been developed. In addition, performance and specifications are rebuilt with IOT fusion products so that they can connect with the current smartphone. This is one of the general-purpose technologies of the 4th industrial revolution, which is spot-lighted with technology that changes the quality and environment of our lives. Along with this, as new technology products combining health care technology increases, various functions are provided to users who need it. Wearable technology is ongoing trend of technology development. It also sells products developed as products in the form of smart watches. At present, various related products are made in various ways, and it is recommended to use the Arduino processor in accordance with the application. In this study, we developed wearable physical activity monitoring system using open source hardware based TinyDuino. TinyDuino is an ultra-compact Arduino compatible board made on the basis of Atmega process Board, and it can be programmed in open source integrated development environment(named Sketch). The physical activity monitoring system of the welfare body can be said to be a great advantage, as a smart u-Healthcare system that can perform daily health management.

• Korea Trade Review
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• v.48 no.3
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• pp.131-150
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• 2023

The purpose of this study was to find a countermeasure to the U.S. import refusals for the Korean healthcare and life sciences industry. To this end, an analysis of trends during the pandemic was conducted using the KITA Border Rejection Database, which includes information on items and types of import refusals. The reason for rejection was also analyzed according to the FDA violation codes. The degree of countermeasure for import refusals was identified by measuring the unit rejection rate (URR). The results of the analysis showed that the major U.S. import refusals for the Korean healthcare and life sciences industry had expanded from contact lenses to COVID-19 diagnostic kits and drugs after the pandemic broke out. The major reasons for import refusals were non-compliance with the Predicate Device and Drugs Act and non-approval by the FDA for products and facilities. On the other hand, the unit rejection rate (URR) of major items in the Korean healthcare and life sciences industry was measured higher than the industry average. The results therefore showed a low level of response to U.S. import refusals. The results of the analysis of reasons for import refusals by item according to FDA violation codes were as follows. First of all, the main violation for contact lenses and COVID-19 diagnostic kits corresponded to misbranding. This was often due to the fact that Korean companies did not provide the relevant notices and information required by the FDA. Many cases also failed to demonstrate a substantial equivalency compared to predicate devices already on the market. On the other hand, applications for new unapproved drugs were not accepted as they had yet to pass relevant regulations that would prove their safety and efficacy. In conclusion, import refusals for the Korean healthcare and life sciences industry were found to be closely related to technical barriers to trade (TBT).

• Journal of Biomedical Engineering Research
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• v.40 no.5
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• pp.215-221
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• 2019

The respiratory medical device is a medical device that delivers optimal oxygen or a certain amount of humidification to a patient by delivering artificial respiration to a patient through a machine when the patient has lost the ability to breathe spontaneously. These include respirators for use in chronic obstructive pulmonary disease and anesthesia or emergency situations, and positive airway pressure devices for treating sleep apnea, and as the population of COPD (chronic obstructive pulmonary disease) and elderly people worldwide surge, the market for the respiratory medical devices it is getting bigger. As the demand for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, the boundaries between the items are blurred due to the purpose, intended use, and method of use overlapping similar items in a respiratory medical device. In addition, for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, in this study, we propose clear classification criteria for the respiratory medical devices according to the purpose, intended use, and method of use and provide safety and performance evaluation guidelines for those items to help quality control of the medical devices. And to contribute to the rapid regulating and improvement of public health. This study investigated the safety and performance test methods through the principles of the respiratory medical device, national and international standards, domestic and international licensing status, and related literature surveys. The results of this study are derived from the safety and performance test items in the individual ventilator(ISO 80601-2-72), the International Standard for positive airway pressure device (ISO 80601-2-70), The safety and performance of humidifiers (ISO 80601-2-74) and the safety evaluation items related to home healthcare environment (IEC 60601-1-11), In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers and importers, certified test inspection institutions, academia, etc., the final guidelines were established through revision and supplementation. Therefore, in this study, we propose guidelines for evaluating the safety and performance of the respiratory medical device in accordance with growing technology development.

• Journal of Biomedical Engineering Research
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• v.42 no.6
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• pp.259-267
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• 2021

Recently, the market for personal health care and medical devices based on Bluetooth Low Energy(BLE) has grown rapidly. BLE is being used in various medical data communication devices based on low power consumption and universal compatibility. However, since data errors occurring in the transmission of medical data can lead to medical accidents, it is necessary to analyze the causes of errors and study methods to reduce data error. In this paper, the minimum communication speed to be used in medical devices was set to at least 800 byte/sec based on the wireless electrocardiography regulations of the Ministry of Food and Drug Safety. And the data loss rate was tested when data was transmitted at a speed higher than 800 byte/sec. The factors that cause communication data error were classified, and the relationship between each factor and the data error rate was analyzed through experiments. When there were two or more activated peripherals connected to the central, data error occurred due to channel hopping and bottleneck, and the data error rate increased in proportion to the communication distance and the number of activated peripherals. Through this experiment, when the BLE is used in a medical device that intermittently transmits biosignal data, the risk of a medical accident is predicted to be low if the number of peripherals is 3 or less. But, it was determined that BLE would not be suitable for the development of a biosignal measuring device that must be continuously transmitted in real time, such as an electrocardiogram.

• Journal of Internet Computing and Services
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• v.15 no.3
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• pp.21-30
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• 2014

Hypertension is one of the major causes of death in the world as it is related with cardiovascular or cerebrovascular disease, so it is needed to provide continuos management for blood pressure. This study selected Health Level 7 Fast Health Interoperability Resources (HL7 FHIR) as a bio-signal data exchange service model that can provide constant blood pressure management in the rapidly growing mobile health care environment. The HL7 FHIR framework developed communicates with the IEEE 11073-10407 Personal Health Device (PHD) protocol through the bluetooth Health Device Profile (HDP) between the manager (smart phone) and the agent (hemomanometer) and acquires information about blood pressure. According to the test results, it performed its tasks successfully including hypertension patients' blood pressure monitoring, management on measured records, generation of document, or transmission of measured information. Because in the actual, clinical environment, it is possible to transmit measured information through the TCP/IP protocol, it will be needed to conduct constant research on it and vitalize it in the field of mobile health care afterwards.