Korean Journal of Acupuncture

  • 제40권4호
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  • Pages.156-168
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  • 2023
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  • 2287-3368(pISSN)
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  • 2287-3376(eISSN)
경락경혈학회 (Society for Meridian and Acupoint)
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국내 인·허가 온열의료기기 기술 현황 조사 및 분석

The Current State of Intended Equipment for Heating in Medical Use Based on Domestic Licensed Medical Devices

  • 임수란 (가천대학교 한의과대학 해부경혈학교실) ;
  • 박정환 (가천대학교 바이오나노대학 바이오나노학과) ;
  • 박지연 (대전대학교 한의과대학 경락경혈학교실) ;
  • 김송이 (가천대학교 한의과대학 해부경혈학교실)
  • Su-Ran Lim (Department of Anatomy and Acupoint, College of Korean Medicine, Gachon University) ;
  • Jung-Hwan Park (Department of Bionano Technology, College of Bio-Nano Technology, Gachon University) ;
  • Ji-Yeun Park (Department of Meridian & Acupoint, College of Korean Medicine, Daejeon University) ;
  • Song-Yi Kim (Department of Anatomy and Acupoint, College of Korean Medicine, Gachon University)
  • 투고 : 2023.08.24
  • 심사 : 2023.10.11
  • 발행 : 2023.12.27
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초록

Objectives : This study aimed to determine the status of thermal stimulation devices approved in Korea for medical applications over the past 10 years, and based on this, to obtain insight for future thermal treatment in Korean medical institutions. Methods : We searched the item classification list entitled "Regulations on Medical Device Items and Rating by Item" from the Ministry of Food and Drug Safety Notice No. 2021-24, 2021 (Enforced March 19, 2021; www.mfds.go.kr) for individually licensed heaters using the terms "heat" and "heating". Results : We identified 17 items of thermal stimulation product group, of which 1,308 devices were licensed by February 4, 2022, and 53.2% of them (n=696) were devices with valid permits for distribution in Korea. Among the licensed devices, heating pad systems under/overlay (electric, home use) were approved the most, but combinational stimulator (for medical use, home use; Grade 2) accounted for the highest percentage among the current valid permission. Moxibustion apparatuses were licensed separately for electrical use and non-electrical use, and occupied a low percentage of the total devices. We analyzed 307 devices that were accompanied by technical documents and found that the heat sources were wires in 145 (47.2%), infrared rays in 44 (14.3%) and ultrasonic waves in 42 (13.7%) devices. Most (83.1%) devices were used for pain relief, while other applications included beauty, cancer treatment, maintenance of infant body temperature, and healing fractures. Conclusions : Thermal stimulation devices accounted for about 0.9% of all medical devices, and among them, combinational stimulators and heating pad systems under/overlay had the most valid permits. Thermal stimulation devices using heating wires and infrared rays were the most prevalent, and most were used to relieve pain. In order to develop a range of thermal stimulation devices that can be utilized in Korean medical institutions, it is imperative that they have potential applications beyond pain management, addressing various medical purposes. To achieve this, foundational research is necessary to effectively apply diverse heat sources based on medical objectives.

키워드

과제정보

This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number : HF21C0167).

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