하지관절 재활 운동 보조기구 개발을 위한 현황, 기술 동향 및 유해사례 통합 고찰
An Integrated Review of Current Status, Technological Trends, and Adverse Events for Development of Lower Limb Rehabilitation Exercise Assistive Devices
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본연구는하지재활운동보조기구의국내품목허가현황과관련특허기술을분석하고, 향후개발될보조기구의안정성확보를위한유해사례를고찰하는데목적이있다. 연구는총세단계로수행되었다. 첫째, 식품의약품안전처품목허가자료를기반으로정형용운동장치의등록현황을조사하고, 이를식품의약품안전평가원의평가가이드라인에따라관절운동, 근력강화운동, 체중부하운동, 보행훈련보조기구로분류한후각기기의특성과장단점을정리하였다. 둘째, KIPRIS와WIPS ON 데이터베이스를활용하여‘무릎’, ‘관절’, ‘재활’, ‘기구’ 등의주제어로검색한특허·실용신안문중최종238건을선정하고기술내용을분석하였다. 셋째, 미국식품의약국(U.S. Food and Drug Administration, FDA) MAUDE(Manufacturer and User Facility Device Experience) 데이터베이스를활용하여관절재활관련유해사례총170건을조사하고, 주요위해요인, 상황및환자에게발생한문제를분류하였다. 연구결과, 현재상용화된하지재활운동보조기구는설계기전과사용목적에따라다양한형태와기술적특성을가지며, 그에따른장점과제한점을동시에지닌것으로나타났다. 이에따라, 신체기동성이제한된환자들이가정에서도안전하고지속적으로사용할수있는경량화되고사용자친화적인하지재활운동보조기구의개발이시급하다. 본연구는이러한기기개발에있어기술적·안전성측면에서기초자료로활용될수있을것으로기대된다.
Abstract
This study aimed to examine the domestic product approval status and related patent technologies of lower limb rehabilitation exercise assistive devices and to analyze adverse events to inform the safe development of future devices. The research was conducted in three phases. First, the registration status of orthopedic exercise devices was reviewed based on data from the Ministry of Food and Drug Safety. Devices were categorized into joint movement, muscle strengthening, weight-bearing, and gait training assistive devices in accordance with the evaluation guidelines of the National Institute of Food and Drug Safety Evaluation. The characteristics, benefits, and limitations of each device were summarized. Second, a total of 238 patent and utility model documents were selected using the keywords ‘knee’, ‘joint’, ‘rehabilitation’ and ‘device’ from the KIPRIS and WIPS ON databases. These were analyzed to identify current technological trends. Third, 170 adverse events related to joint rehabilitation devices were extracted from the Manufacturer and User Facility Device Experience (MAUDE) database of the U.S. Food and Drug Administration (FDA), and categorized by risk factors, incident circumstances, and patient-reported problems. The findings indicate that currently commercialized lower limb rehabilitation exercise devices vary in design mechanisms and intended use, each presenting distinct advantages and limitations. These results underscore the urgent need for the development of lightweight, user-friendly assistive devices that can be safely and independently used at home by patients with limited mobility. This study provides foundational data to support the technological and safety considerations in the development of such rehabilitation devices.