• Title/Summary/Keyword: Medical Engineering

Search Result 8,739, Processing Time 0.036 seconds

A Study on the Improvement of Domestic Medical Device Product Classification through Analysis of Medical Device Classification System in the U.S. and Europe (미국 및 유럽 의료기기 품목분류 체계 분석을 통한 국내 의료기기 품목분류 개선 연구)

  • Kang Hyeon, You;Ji Min, Son;Gyeong Min, Kwon;You Rim, Kim;Hui Sung, Lee;Won Seuk, Jang
    • Journal of Biomedical Engineering Research
    • /
    • v.44 no.1
    • /
    • pp.73-79
    • /
    • 2023
  • The purpose of this study is to derive medical devices with different management systems through comparison of domestic and overseas medical device product classification systems and to propose management conversion measures for the products. The definitions of medical devices were compared and the scope of medical devices defined by each country was confirmed through surveys of the Medical Device Act, Federal Food, Drug & Cosmetics Act (FD&C) in the U.S., and Medical Device Regulations (MDR) in Europe. Using the Ministry of Food and Drug Safety's regulations on medical device products and grades, 21 CFR part 860-892 and product code classification files in U.S., and EMDN in Europe as basic data to compare medical device products and derive medical devices with different management systems. As a result of comparing the definition and product classification systems of medical devices in Korea, the U.S. and Europe, medical device accessories, prosthetic limbs and aids among assistive devices for persons with disabilities, drugs, quasi-drugs and industrial products that are not managed by medical devices in Korea are managed as medical devices in the U.S. and Europe. This study aims to improve public health by securing systematic product safety management and essential performance under medical device regulations. Management within a single medical device system will increase the efficiency of licensing work of domestic medical device manufacturers and related organizations. It is also expected to help advance the system according to the international harmony of the item classification system and enhance smooth import and export competitiveness.

The Analysis of the Muscle Fatigue Recovery Effect on LR9 by Compound Stimulation of the PEMFs and LED (음포혈(陰包, LR9)에서 펄스형 전자기장 및 가시광 LED 복합 자극이 대퇴부 근피로 회복에 미치는 영향 분석)

  • Lee, Na-Ra;Kim, Jung-Yoon;Park, Sun-Woo;Kim, Soo-Byeong;Lee, Hee-Young;Ahn, Soon-Jae;Kim, Young-Ho;Lee, Yong-Heum
    • Korean Journal of Acupuncture
    • /
    • v.28 no.3
    • /
    • pp.13-23
    • /
    • 2011
  • Objectives : The aim of this study was to develop the combined medical stimulus system consisted of the PEMFs (Pulsed electromagnetic fields) and LED which are able to stimulate local point such as acupoints and trigger points. Methods : To evaluate the therapeutic effect on the musculoskeletal disorders and the possibility of alternative method on manual acupuncture, we compared the fatigue recovery of two groups by analyzing the EMG and peak torque (non-stimulation and, stimulation group) after strenuous knee exercise. We chose the LR9 as a stimulation point. Results : The median frequency (MF) and fatigue index (F.I) of the stimulation group were recovered faster than those of the non-stimulation group. Also the peak torques of both groups were not restored until after 20 minutes. However, the peak torque of the stimulation group was regained higher than that of the non-stimulation group. Conclusions : We confirmed that the proposed combined stimulus system had useful effects as treatment instrument of musculoskeletal disorder using non-invasive method of PEMFs and LED.

A Study on the Improvement of the Reports on Details of Supply of Medical Device System Through Selective Application (선별적 적용을 통한 의료기기 공급내역보고 제도 개선 연구)

  • Hyun Ju Jeong;Soo Yeon Lim;Ju Wan Kim;Won Seuk Jang;Byeong-Ju Kwon
    • Journal of Biomedical Engineering Research
    • /
    • v.44 no.5
    • /
    • 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.

The Effects of Partial Vibration on Tibia of Osteoporosis Induced Rat (골다공증이 유발된 쥐 정강이뼈에 적용한 부분 진동자극 효과)

  • Park, Ji-Hyung;Seo, Dong-Hyun;Jung, Young-Jin;Ko, Chang-Yong;Kim, Han-Sung
    • Journal of the Korean Society for Precision Engineering
    • /
    • v.29 no.5
    • /
    • pp.578-583
    • /
    • 2012
  • The pharmacological therapies and whole body vibration as non-pharmacological therapies were known to have adverse side effects. Therefore, partial stimulation was suggested and its effects were evaluated. This study aimed to evaluate the site-specific effects of partial stimulator for treatment of osteoporosis induced by estrogen deficiency. Sixteen virginal Sprague-Dawley rats (12 weeks old) were divided into 2 groups(no stimulation, stimulation groups). All rats were ovariectomised to induce osteoporosis. After 3 weeks of operation, the right tibiae in rats of stimulation group (frequency: 10Hz, cycle: 1500, strain on bone surface: $2000{\mu}{\varepsilon}$) were stimulated perpendicularly at right tibia by using partial stimulator for 6 weeks (3days/week). The right tibiae in rats were scanned, before stimulation (0 week) and at 6 weeks after stimulation by using in-vivo micro computed tomography. For investigation of changes in morphological characteristics, structural parameters were measured and calculated. At 6 weeks the morphological characteristics (relative value) in stimulation group were significantly enhanced than those in no stimulation group (p<0.05). In this study, we find that after 6 weeks of partial stimulation, the morphological characteristics of tibia trabecular bone were enhanced. Thus, we concluded that partial stimulation could be used to treat osteoporosis.