A Study on Developing Safety and Performance Assessment Guideline for Electronic Warm-Acupuncture Apparatus

Abstract

Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity.Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was draftedResults: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety.Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

The Characteristics of Temperature Variation in Electronic Warm Acupuncture Device

“…뜸의 경우 이러한 화상, 연기의 위험성을 피하고자 현재 전기를 열원으로 이용하는 전기식 온구기가 개발되어 활발히 사용되고 있 으며 여러 임상연구들이 시행되었다 13,14) . 온침기의 경우에도 이러 한 불편함을 극복하는 대안으로써 개량 애주(艾炷)를 사용한 온침 15) , 전자기파 자기장을 열원으로 사용하는 온침기기 16,17) , 전기를 열원 으로 사용하는 온침기 18) 등의 다양한 열원을 사용하는 온침기가 개발 완료되었다.…”