• 대한의용생체공학회:의공학회지
• /
• 제44권5호
• /
• pp.315-323
• /
• 2023

The objective of this study is to identify the selective application targets for reporting on details of supply of class 1 and 2 medical devices as part of the improvement of the reports on details of supply of medical device system, and to analyze its effectiveness. Therapeutic materials covered by health insurance and secondhand medical devices were chosen based on the transparency of health insurance coverage and the management of medical device distribution. As a result, approximately 85% of groups can be excluded from the reporting requirements compared to reporting all items under Class 1 and 2 medical devices. This is expected to enhance the efficiency of supply reporting tasks. Additionally, the information on supply details managed by the regulatory authority can be utilized for statistical analysis and periodic monitoring, serving as fundamental data for the development of medical device-related policies and research in the field of medical devices.

• 반도체디스플레이기술학회지
• /
• 제22권4호
• /
• pp.87-92
• /
• 2023

As the elderly population increases, the number of patients with various joint diseases, including degenerative arthritis, is steadily increasing. CPM medical devices are needed to effectively treat degenerative arthritis that is common in the elderly population. Domestic CPM medical devices have limited functions and are highly dependent on imports for expensive imported medical devices. To solve this problem, we designed a ROM measurement function using a current sensor that is not present in existing composite joint CPM medical devices. The algorithm was designed using the fact that the force caused by joint stiffness greatly increases the current flowing through the DC motor. In addition, the need for digital healthcare in the medical field is gradually expanding as the proportion of chronically ill patients increases due to the spread of the non-face-to-face economy due to COVID-19 and the aging population. Therefore, this paper aims to improve the performance of CPM medical devices by allowing real-time confirmation of rehabilitation exercise information and operation range measurement results in accordance with digital healthcare trends through a Bluetooth application developed as an Android studio.

• 의료법학
• /
• 제15권2호
• /
• pp.63-89
• /
• 2014

In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

• 대한의용생체공학회:의공학회지
• /
• 제44권3호
• /
• pp.190-203
• /
• 2023

The purpose of this study is to provide basic data to ensure the safety and essential performance of a Lower Extremity robotic assisted gait training system and to provide advanced technology and technical basis to the industry handling the system. Based on IEC 60601-1:2012/AMD2:2020 (Medical Electrical Equipment - General requirements for basic safety and essential performance of medical electrical equipment), IEC 62366-1:2015/AMD1:2020 (Medical devices - Part 1: Application of usability engineering to medical devices) and EN ISO 14971:2019 (Medical devices - Application of risk management to medical devices), the requirements for ensuring the safety and essential performance of the Lower Extremity robotic assisted gait training system were derived. Through the Delphi survey method and scenario analysis, which reflects the opinions and knowledge of experts in the fields of development, testing and review of technical documents, and quality assurance of medical devices, validity and reliability were conducted and obtained results with adequate content validity ratio (CVR; 0.7≤) and excellent reliability (Cronbach's α; 0.9≤). As a result, it was confirmed that the reliability and validity of the risk management process to ensure the safety and essential performance of the Lower Extremity robotic assisted gait training system are required a model can be established to provide measures to reduce risks according to the level of risk exposure caused by usage.

• 의료법학
• /
• 제15권1호
• /
• pp.59-80
• /
• 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.

• 전자통신동향분석
• /
• 제32권6호
• /
• pp.27-39
• /
• 2017

A variety of medical devices are utilized to repair or help injured body functions after accidental injury(such as a traffic accident), population aging, or disease. Such medical devices are being actively researched and developed in portable form, skin patchable type, and further, implantable form. In the future, active implantable medical devices for neuro and brain sciences are expected to be developed. Active implantable medical devices that detect brain signals and control neurology for a wider understanding of human cognition and nerve functions, and for an understanding and treatment of various diseases, are being actively pursued for future use. In this paper, the core elements of implantable devices that can be applied to neuro and brain sciences are classified into electrode technologies for bio-signal acquisition and stimulation, analog/digital circuit technologies for signal processing, human body communication technologies, wireless power transmission technologies for continuous device use, and device integration technologies to integrate them. In each chapter, the latest technology development trends for each detailed technology field are reviewed.

• 한국한의학연구원논문집
• /
• 제11권1호
• /
• pp.119-125
• /
• 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.

• 의료법학
• /
• 제11권2호
• /
• pp.337-361
• /
• 2010

In the case of Korea, both of modern medicine and oriental medicine are admitted as medical practices in the system. In other words, healthcare system is dualized. However, medical practice that corresponds to oriental medicine in Korea is substitution of medical practice in cases of foreign countries. For use of medical devices, it is provided only for doctors and medical technician relevant to use. Particularly, although oriental medicine is recognized as orthodox medicine in terms of the features of Korean medical system, superintendency of oriental doctors is not identical with that of doctors for use of medical devices and superintendency toward medical technicians. Recently, Cheongju District Court decided that superintendency of oriental doctor upon physical therapist is not acknowledged. It can be said that the judgement is opposed to the original verdict which judged that oriental doctors' employment and guidance of oriental doctors upon physical therapist is permissible. Hence this study aimed to review on domestic medical law system, which is dualized, roles of medical professionals, intent of the medical license system, provisions related to medical technician law and relevant precedents. Regulations on practices other than licensed practices by medical professionals are made because medical practices may affect on danger toward life and body of human and public health also. Therefore, the nation regulates medical professionals having licenses to perform medical practices within the range of the licenses. It is clearly prescribed that medical technicians may perform medical practices under instructions of doctors or dentists pursuant to the medical technician law. In addition, the court also judges that it is out of the license of oriental doctors if they use CT devices and limits the use of modern medical devices by oriental doctors. That is to say that it limits oriental doctors' employment of medical technicians and pursuant of oriental doctors on medical technicians as well.

• 융합보안논문지
• /
• 제21권1호
• /
• pp.63-72
• /
• 2021

병원의 Biomedical engineering team은 의료기기가 안전하고 신뢰할 수 있도록 의료기기 관리 프로그램(MEMP, Medical Equipment Management Program)을 수립하고 규제할 책임이 있다. 기술의 발전으로 인공지능, 정밀의료 등 의료기기는 언제 어디서나 사물들 간 연결이 가능한 형태로 발전하고 있으며 다양한 기술의 융합에 따라 내외·부 보안위협이 지속적으로 증가하고 있다. 본 논문에서는 기술의 발전으로 지속적으로 증가하는 의료기기의 보안위협을 고려하여 안전한 의료기기 관리 프로그램(Secure-MEMP) 방법을 연구 제시한다.

• 대한의용생체공학회:의공학회지
• /
• 제40권5호
• /
• pp.215-221
• /
• 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.