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KMID : 1142220220170010087
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Regulatory Research on Food, Drug & Cosmetic
2022 Volume.17 No. 1 p.87 ~ p.94
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Development of Safety and Performance Evaluation Guidelines for Wearable Blood Flowmeter
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Na Young-Jun
Jeong Jae-Hoon
Kim Sung-Min
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Abstract
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The ultrasonic blood flowmeter is being used for TCD monitoring to prevent and diagnose stroke. For TCD monitoring, a diagnostic specialist at a medical institution should examine it for 30 to 40 minutes, and the patient should keep his/her head fixed while the examination is in progress. In order to overcome these inconveniences, research and development of the patch-type ultrasonic blood flowmeter has been carried out, and accordingly, it is necessary to prepare a method to prove the safety and performance of the patch-type ultrasonic blood flowmeter. Therefore, the purpose of this study was to present a safety and performance evaluation method suitable for the patch-type ultrasonic blood flowmeter. As the research method of this study, domestic and foreign standards and guidelines were investigated and analyzed. Safety and performance test items suitable for the ultrasonic blood flowmeter were derived from the existing standard, and safety and performance test items suitable for the characteristics of the patch-type ultrasonic blood flowmeter were additionally derived. In consideration of the characteristics that the patch-type ultrasonic blood flowmeter is attached to the skin and needs to be easily monitored without discomfort, tests related to biological safety and recommended tests related to the performance of ultrasonic gel pads, such as demensions and adhesiveness, were prepared. In consideration of the characteristics of home health care medical devices used for patients and the general public at the site, test items related to safety, such as mechanical strength and battery capacity, were prepared. Through this study, it is expected that the results of this study will be utilized as a patch-type ultrasonic blood flowmeter guideline by proposing safety and performance evaluation items and methods considering the characteristics of the patch-type ultrasonic blood flowmeter
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KEYWORD
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Ultrasonic Blood Flowmeter, TCD monitoring, Werable Ultrasonic, Guideline
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