• The Journal of Korean Medicine
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• v.32 no.2
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• pp.79-91
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• 2011

Objectives: The purpose was to study the market of traditional Korean medical devices and survey, list and number medical devices in traditional Korean medical clinics. Methods: we researched in three ways. 1. We investigated the list of devices regarded as traditional Korean medical devices in 'Report on production, export, and import of medical devices.' 2. We investigated the statistics of medical devices equipped in traditional Korean medical clinics through the website of the Health Insurance Review & Assessment Service. 3. We surveyed medical devices in traditional Korean medical clinics by mail. Results: 1. We could not directly investigate the market for traditional Korean medical devices because they were not categorized as such ('traditional Korean medical devices'). 2. The number of medical devices in traditional Korean medical clinics has increased alongside the increase of traditional Korean medical clinics. 3. Traditional Korean medical clinics hold over 64,962 medical devices and have below 50 percent of traditional Korean medical diagnosis devices. 4. Meridian function testing machines, pulse diagnosis devices, and yangdorak showed ranking of equipment-ratio equal to ranking of insurance fees. Conclusions: Traditional Korean medical device regulations should be enacted following definitive and concrete Korean traditional medical concepts by the Korean traditional medical society.

• The Journal of Korean Medicine
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• v.34 no.1
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• pp.69-79
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• 2013

Objectives: The aim of this survey was to investigate utilization, intended use, problems with and demand for medical devices by surveying members of the traditional Korean medical society. Methods: We distributed questionnaires to 13,957 traditional Korean medical doctors via e-mail, and received replies from 1,225. The questionnaire consisted of 4 multiple-choice questions for survey respondent information, 8 multiple-choice questions about the status of medical devices utilizing, and a short answer question about the demand for medical devices. Results: Use of medical devices in traditional Korean medical clinics is common. Diagnostic medical devices are mainly used to assess the patient's condition and to establish a close rapport with clients. In case of therapeutic medical devices, they are usually used for secondary treatment. Issues with traditional Korean medical devices currently in use were ineligibility for national health insurance, low reliability, uncertain validity, and high price. In development of traditional Korean medical equipment, the need for diagnostic medical devices was greater than for therapeutic, and the need for the recording and analysis of medical image data and visualization of medical information was great. Conclusions: There is growing demand for facilitating the development and commercialization of traditional Korean medical devices. To satisfy this demand, research on evaluation indicators that reflect functional and structural clinical information and how to clinically assess the indicators should proceed.

• Journal of Society of Preventive Korean Medicine
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• v.28 no.1
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• pp.31-42
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• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• Journal of Physiology & Pathology in Korean Medicine
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• v.28 no.4
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• pp.430-439
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• 2014

This study was performed to assess the perception and needs of the traditional Korean Medical Equipment (KME) in clinic. We conducted survey research among 15,550 traditional Korean medical doctors (KMD) responded to e-mail during 2 weeks. 899 participants the survey, consisting of questions regarding 'number of devices of the KME' and 'solution and improvement plan of the KME'. The participants were asked to choose their ranking of problems of the KME and also put a check mark in the column that the reasons for this choice. As results, final scores in priority ranking medical devices were derived in 7 categories. Physical therapy equipment and acupuncture treatment devices were included in high ranks. 42.8 % of the participants responded that the diagnostic medical devices seemed important in clinics and 67.4 % of the participants indicated that the therapeutic medical devices seemed to important in clinics. The identified problems of KME were 'low reproducibility and reliability of a diagnosis result (24.8%)' and 'uncertain validity of a diagnostic medical devices (20.5%)'. The improvement plan of the problems were 'to establish the law for using the medical devices (26.6%)' and 'evaluation of validity of the KME (26.2%)'. A survey of KMD revealed the condition of KME's number of devices and the solution plan for the problem of several KMEs. Understanding the needs of KMD could probably contribute to the research and development of KMEs in the future.

• Korean Journal of Oriental Medicine
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• v.11 no.1
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• pp.119-125
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• 2005

We conduct a survey of actual condition of medical devices in korea traditional medicine on 157 oriental medicine doctors and 183 manufacturers. The 61% percent of doctors indicate the trouble in use of medical devices which is applied to korea traditional medicine. The manufacturers replied that devices have a problem with diagnosis(53%) and treatment(36%). To overcome these problems, it is necessary to develop devices based on the study of basic oriental medicine and the reliable clinical research. This study contributes the improvement of quality and the revision of rules on medical devices.

• Journal of the Korean Medical Association
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• v.61 no.12
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• pp.702-705
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• 2018

Advances in technology lead to advances in medical devices, and these advances have the positive effect of creating opportunities for beneficial developments in healthcare, such as innovating traditional healthcare processes or expanding opportunities for diagnosing and treating diseases. Nonetheless, device developers, suppliers, users, insurers, and patients all face the challenge of balancing patient safety and health effectiveness with a reasonable profit. In Korea, the New Health Technology Assessment system aims to introduce safe and effective health technology, but this is only effective for the entry of devices onto the healthcare market. This system is not enough for creating a healthy ecosystem in which high-quality technologies and devices survive in the market and naturally exit from the market if not successful. The nation must not lag in the rapid development of medical devices, but the concomitant requirement for patient safety is like two rabbits moving in different directions. There is not enough time to resolve each source of uncertainty for both developers and users. The early adoption of health technologies, including medical devices, offers new opportunities for treatment and diagnosis, but also poses unexpected health risks. Thus, we need to design a plan to generate scientific evidence related to medical devices after they introduced into practice. Additionally, regarding the use of individual medical devices, we believe that the creation of a healthy ecosystem for medical devices by implementing medical device surveillance culture is a way to manage the opportunities and risks of the early introduction of innovative medical devices.

• The Korean Society of Law and Medicine
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• v.15 no.1
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• pp.59-80
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• 2014

The Medical Affairs Law regulates that Medical Doctor and Korean Medical Doctor(KMD) can practice in the boundary of each licence. But there is no clear provision to explain what practice in the boundary of MD's permitted region and what is KMD's. Moreover practice over the boundary of licence could be punished as a violation of the Law. KMD's use of medical devices have been objects of legal conflicts in the field. Because there is no clear provision in the Law, judical precedents have played the role as practical and final regulations. In this study, analyses on some judical precedents could show some rationales whether an issued KMD's use of medical devices is in the boundary of license. The courts considered the theories based on the practice, the level of required specialty and education, and the probability of danger to a patient. The judical precedents should be reviewed more precisely in the respects that it is adaptable in "the written law system"and it is desirable to divide boundaries between MD's and KMD's.

• The Journal of the Society of Korean Medicine Diagnostics
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• v.16 no.3
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• pp.23-32
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• 2012

Objectives: The objective of this study is to investigate and valuate currently provided database management systems (DBMS) of traditional Korean medical knowledge. Methods: We searched DBMS on the web and smart device application markets (Apple App Store and Google Play Store). Key words for searching were 'traditional medicine', 'acupuncture', 'moxibustion', 'herbal medicine', and '한의학'. We looked into each DBMS to find out its scopes and limits, and each was valuated according to its functionality, accessibility, and utility. Results: 186 DBMS of traditional Korean medical knowledge were investigated and 91% of them were applications for smart devices. Almost all DBMS provided acupuncture and herb information, and a small amount of DMBS provided prescription and research paper information. Functionality, accessibility, and utility valuation were performed by using scoring system from 0 to 2. Mean values of functionality, accessibility, and utility were 0.86, 1.29, and 1.09. Conclusions: On the whole, high accessibility and low functionality were found, and various data-calculating functions were not implemented. Further researches and developments about traditional Korean medical knowledge DBMS are necessary to provide correct traditional Korean medical information and to support the studies about Korean medicine.

• The Journal of the Institute of Internet, Broadcasting and Communication
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• v.17 no.5
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• pp.137-142
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• 2017

The development of medical devices based on the theory of tranditional Korean medicine is increasing due to population aging and emerging demand for medical services. Various clinical trials are being conducted to ensure the clinical effectiveness of the developed medical devices, and the importance of systematic management of variously collected information in this process is increasing. In this paper, we designed and constructed the database that can systematically manage the medical information of the patient and the pulse measurement information in conducting clinical trials by using pulse analysis system which is a representative diagnostic method of traditional Korean medicine. The constructed database can be efficiently used for the verification of existing algorithms or developing new algorithms through the quality control of various information and measured data on clinical trials. It also has several advantages in the control of clinical data. The results of this study can contribute to the establishment of Korean medical device data standard for the construction of integrated database management system that can share information with different kind of pulse analysis system and other bio-signal measuring devices.

• The Journal of Korean Medical History
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• v.26 no.2
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• pp.135-148
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• 2013

This study analyzed surface-chemical transitions in manufacturing process of traditional acupuncture as proposed method by Dongeuibogam. The manufacturing process of traditional acupuncture from a used iron for a long time was divided by primary medicinal herbs treatment, secondary medicinal herbs treatment and tertiary treatment using by dog meat. The traditional acupuncture research process was measured according to the characteristics and changes of the specimens at each processing step of the manufacturing process. The following devices were used to Surface analysis. Scanning electron microscopy (SEM), Energy Dispersive Spectrometer (EDS), X-ray diffraction analyzer (XRD). As a result, medicinal herbs removed impurities on the surface and raised the antibacterial effect in the manufacturing process of traditional acupuncture. Furthermore, the ingredients of medicinal herbs were coated on the surface of the iron. Dog meat influenced to prevent surface corrosion, reduce friction when the acupuncture was inserted. Although the process empirically obtained, a glimpse of the wisdom of our ancestors was revealed. These ancestral wisdom can be expected to apply today, when used in manufacturing process of a modern stainless steel acupuncture to compensate for the defective part.