符合FDA建議之輸液幫浦系統設計

Design of an Infusion Pump System with FDA Submissions

陳廷軒(Ting-Hsuan Chen) ； 王建朗(Chien-Lang Wang)

《科儀新知》 185期 (2011/12) Pp. 78-88

https://doi.org/10.29662/IT.201112.0008

摘要

輸液幫浦（infusion pump）是利用機械或電子控制輸液的一種精密醫療器械產品。輸液幫浦主要用於必須嚴格控制輸液藥量（輸液量）的場合，這類藥物主要有降血壓藥、降血糖藥（如胰島素）、抗心率不整藥物、麻醉劑和晚期癌症病人使用的阿片類強鎮痛劑。輸液幫浦依據工作方法的不同可分為氣體帶動和機械帶動，病患自控式止痛器（PCA）就是其中一種不同用途之輸液幫浦，本文說明研究團隊設計開發符合FDA建議規範之病患自控式止痛器。在系統部分也會針對電路與機構說明其設計原理，搭配安全性控制設計進行藥量與時間監控，並進行微小化設計，設計過程中依照FDA建議規範做產品設計以符合510（K）申請。

並列摘要

An extemal infusion pump is a medical device used to deliver fluids into a patient's body in a controlled manner. There are many different types of infusion pumps, which are used for a variety of purposes and in a variety of environments. Patient-controlled analgesia (PCA) is an infusion pump on-demand, usually with a preprogrammed ceiling to avoid intoxication. Infusion pumps have been a source of multiple patient safety concerns in the past. As a result, the Food and Drug Administration (FDA) has launched a comprehensive initiative to improve their safety. The initiative also proposed more strict regulation of infusion pumps.