• Journal of rehabilitation welfare engineering & assistive technology
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• v.9 no.3
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• pp.223-230
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• 2015

There is an increasing trend of medical devices and products moving out of hospitals and clinics into community and residual homes for use by the general public due to both the technological developments and demographic changes resulted from the increased life expectancy and decreased birth rate. In Korea, however, the definition of "home medical device" is rather ambiguous and we thus compared the definition of the term used in the global market with that in Korea. FDA definition of "home medical device" includes the devices intended for use in both professional healthcare facilities and home. The KFDA, does not provide the definition for the "home medical device"and the definition has only been inferred from the results of consumer surveys. With a paradigm shift in advent of u-healthcare era, the definition of "home medical device" in Korea should include the medical devices that could be used both at hospitals and at home.

• 제어로봇시스템학회:학술대회논문집
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• 2003.10a
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• pp.2235-2239
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• 2003

The aim of this research is to study and develop enabling technologies for home healthcare device with ubiquitous network. The motivation of this paper is to enable healthcare in home, to development the device for smart home health care. To achieve the aim, we must develop the prototype platform based on home gateways, distributed context user interface based on UPnP and support for information sharing with high speed power line communication and mobile infra-structures. And IPv6 is the base technology of this platform. In this paper, we concern that physical health, mental health and medical emergencies is all of home healthcare. With the smart device, we evaluate the connectivity, automatic information extraction and private data exchange and event driven message. The result of this paper is demonstration of smart device for ubiquitous communication in a healthcare application such as patient monitoring device and several information services. In conclusion, home healthcare will support more healthy and easy living for a human.

• Medical Lasers
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• v.9 no.2
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• pp.150-158
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• 2020

Background and Objectives Low-level laser therapy (LLLT) is used widely to promote hair growth in androgenetic alopecia (AGA). This study examined the clinical efficacy and safety of a home-use LLLT device with a newly designed array of light sources and software optimized for individual types of AGA. Materials and Methods The study was a randomized, double-blind, sham device-controlled trial. Forty-eight subjects (39 men and nine women) were assigned randomly in a 2:1 ratio to use either the test device (LG Pra'L HGN1, LG electronics, Korea) or sham device. The subjects used the LLLT device three times a week for 16 weeks. Phototrichogram was used to measure the hair density and hair thickness at 0, 8, and 16-weeks. Adverse events were closely monitored. Results After 16 weeks of using the device, the test group showed a significant increase in hair density and hair thickness compared to the control. In the test group, the hair density increased 6.96 counts/cm² at eight weeks and 13.67 counts/cm² at 16 weeks from the baseline. The hair thickness increased 7.21 ㎛ at eight weeks and 11.80 ㎛ at 16 weeks compared to the baseline. Conclusion The home-use LLLT device with a novel array of light sources and an individualized program according to the types of hair loss appears to be an effective and safe treatment modality for both male and female AGA patients.

• Journal of Home Health Care Nursing
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• v.12 no.2
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• pp.63-86
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• 2005

Purpose: This study is a descriptive research which is designed to investigate hospitalized patients' intent to use home care nursing according to the types of medical security. Method: This researcher surveyed 236 patients who were hospitalized at B medical center located in Busan,. Data were collected from Sep. 1 to Nov. 30, 2005 using a questionnaire survey, medical records, face-to-face interviews and observations. Collected data were analyzed in terms of frequency, percentage, mean and standard deviation through $x^2$-test and t-test under SPSS WIN 10.0 Program. Result: Out of the total subjects, 59.3% were medical aid clients and the remaining 40.7%, health insurance ones. The hospitalized period and frequency of the former group were 38.0 days and 4.0 times, respectively, while those of the latter, 37.7 and 3.4. When home care nursing clients were examined using a given classification device, it was found that out of the total 236 subjects, 205(86.9%) were needed to receive home care nursing, 121, medical aid and the other 84, health insurance. 24.0% of medical aid clients heard about home care nursing ever before, lower than 39.3% of health insurance clients. 43.8% of the former clients said cost for home care nursing was high while, 47.6% of the latter group responded expense for the nursing intervention was low. 30.6% of medical aid clients had intent to use home care nursing, lower than 47.6% of health insurance clients. 71.7% of those patients whose monthly income was 99 million won or below had no intent to use home care nursing, higher than 62.5% of those who were 100 million or over in monthly income(p<.05). 76.4% of those clients who had no nursing provider intented to use home care nursing, higher than those who had nursing provider(p<.05). Concerning contents of home care nursing, 85.1% of medical aid clients needed education, training and counseling while, 77.4% of health insurance aids wanted medication and injection. Conclusion: In conclusion, the use of home care nursing by medical aid clients should be promoted through improving conditions for home care nursing in terms of expense, family and residence and making public relations about activities and contents of the home care nursing.

• Journal of the Institute of Electronics and Information Engineers
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• v.50 no.3
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• pp.187-202
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• 2013

The electronic medical device industry and the relevant market have been greatly expanded owing to various factors, such as the advent of the aged society and the spread of the desire for well-being in developed countries, and rapid development of China, India and other emerging markets. The electrical stimulator is one of electronic medical devices most commonly used in homes. The electrical stimulator is widely used for pain relief, rehabilitation, muscle conditioning and others. Since it is mainly used in homes, it is very important to assure the safety and performance for protection of users. However, there is no guideline on evaluation of safety and performance of such electrical stimulator for home use. In this study, various local and foreign references were reviewed to develop the internationally harmonized procedures for safety and performance evaluation of the electrical stimulator and test items, specifications and methods are proposed. In addition, such proposed test items were validated to decide the internationally harmonized tests for safety and performance evaluation. This study will contribute to improvement of quality and safety of electrical stimulators for home use and help the Korean medical device industry have the international competitiveness.

• Journal of Chest Surgery
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• v.47 no.4
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• pp.409-412
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• 2014

Percutaneous extracorporeal life support (P-ECLS) is a useful modality for the management of refractory cardiac or pulmonary failure. However, venoarterial P-ECLS may result in a complication of left ventricular distension. In this case report, we discuss a patient with drug-induced dilated cardiomyopathy managed with venoarterial P-ECLS and a left atrial vent catheter. The venoarterial P-ECLS was modified to a paracorporeal left ventricular assist device (LVAD) by removing the femoral venous cannula. After 28 days of hospitalization, the patient was successfully weaned from the paracorporeal LVAD and discharged home from the hospital.

• 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.

• Research in Community and Public Health Nursing
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• v.19 no.2
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• pp.157-166
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• 2008

This study was conducted with whole home care nurses nationwide to provide secondary analyzed data to understand on their usage of medical equipments and their need of them for a month. This study found that treatments given by home care nurses were nelaton catheterization, bladder washing/urethral washing, newborn care, exchange and care for nasogastric tube and suction in that order of frequency. Second, instruments and equipments used for home care were reported to be stethoscope, patient monitor, blood pressure measuring equipment, air flotation mattresses, beds for patients, mattresses, suctioning device sets, enteral feeding equipment and dressing set in that oder of frequency. Moreover, need assessment of medical instruments and equipments showed renal dialysis was most needed and patient monitor, blood pressure measuring equipment, enteral feeding equipment, solution and other supplies for renal dialysis and beds for patient were necessary in that order. In conclusion, the results of this study investigating special treatments and medical instruments and equipments used for home care patients and analyzing patients' need, were expected to be useful for expansion of application of long-term care insurance for the elderly and health insurance as well as for quality control of home care and development of medial instruments and equipments used at home.

• Journal of the Korea Safety Management & Science
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• v.12 no.3
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• pp.37-52
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• 2010

This study is aimed at proposing the national policy for medical device control system in Korea as deeply analysed the present status of the system. On 1979, Korean government had started to inspect 24 kinds of the medical devices such as X-ray diagnostic equipments, medical sterilizer and etc. mostly imported from advanced countries which USA, Germany and Japan for the first time according to the Pharmaceutical Affairs Law. However medical devices were becoming consideration as an important partner of diagnosis, curing and alleviation of diseases by medical doctors and also much important keeping the health at home. Furthermore medical devices industry can be designated as a national growth engine industry. So it is necessary not only to harmonize to international standards but also the harmonization of the system including pre-market application and post-market surveillance, is strongly needed by the Korea Food and Drugs Administration(KFDA).

• Journal of Korea Multimedia Society
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• v.17 no.5
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• pp.640-653
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• 2014

Recently medical consumers pursue high leveled quality of life through active promotion, prevention, management activity of health as the importance of health during home life is emerged to meet the aging society and chronic diseases. In addition, people are directed to the m-Health for managing yourself their health by using smartphone and various personal health devices, if necessary transmits health data to the physician himself. In the previous studies, m-Health Application were developed and applied in the real clinical environment by adopting the medical information standards was rarely conducted. Therefore, in this study, the m-Health application platform was developed. Developed application was communicate with IEEE 11073 standard protocol using the Bluetooth Health Device Profile in personal health device via smart phone to process blood pressure information, and it converted to HL7 V2.6 ORU_R01 message for send to remote medical server. In addition, we tested the interoperability and safety of the developed application for 23 inpatient and 17 outpatient at D University Hospital. As a result, the blood pressure information has been transmitted without error.