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JKM > Volume 43(3); 2022 > Article
Jang, Chung, Moon, Choi, Sung, Hwang, Lee, Kim, Yoon, and Kim: 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 drafted

Results

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.

Table 1
Number of Patients Treated with Traditional Indirect Moxibustion and Electronic Moxibustion in the Past 5 Years
2017 2018 2019 2020 2021
Traditional indirect moxibustion 2,926,065 2,628,922 2,344,900 2,015,571 1,907,406
Electronic moxibustion 1,460,101 1,882,851 2,230,577 2,330,137 2,576,799
Table 2
Delphi method results on a 9 point likert scale, from Korean medicine doctors specialized in Acupuncture and moxibustion and medical device specialist for Electronic Warm-needle acupuncture apparatus.
Avg. Standard Deviation Highest Value Lowest Value
Recommendations for development
Scope and Definition of Terms 8.56 0.73 7.00 9.00
Component 8.33 0.87 7.00 9.00
Temperature of the heating device 8.44 0.73 7.00 9.00
Timer Function 8.44 0.73 7.00 9.00
Normal Operation of the device 8.67 0.71 7.00 9.00
User’s Guide 8.22 0.83 7.00 9.00
Recommendations for acupuncture used for warm-needle acupuncture 8.67 0.71 7.00 9.00

Performance evaluation items and methods
Appearance and indications 8.44 0.73 7.00 9.00
Size and Dimensions 8.44 0.73 7.00 9.00
Variation test of input power 8.56 0.73 7.00 9.00
Operation test 8.56 0.73 7.00 9.00
Accuracy 8.11 1.96 3.00 9.00
Output temperature 8.22 1.39 5.00 9.00
Safety Measures 8.22 1.09 6.00 9.00

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