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。

An external infusion pump is a medical device used to deliver fl uids 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 ofenvironments. Patient-controlled analgesia (PCA) is an infusion pump on-demand, usually with a preprogrammedceiling to avoid intoxication. Infusion pumps have been a source of multiple patient safety concerns in the past. Asa 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.