符合FDA設計流程之遠距健康照護系統

Abstract

醫療器材一般用於提供病人進行醫療行為或提供醫療資訊，若其產生失效，將對病人或使用者造成危害。本研究以開發一遠距健康照護系統結合臺大醫院提供的醫療服務為例，導入美國食品藥物管理局（Food and Drug Administration, FDA）於醫療器材開發確效通用準則，依循其認證所需進行開發作業程序，包含需求發展、技術解決方案、驗證、確效、上市前呈遞資料、及法規管理等領域，以改善傳統繁瑣的開發流程。 本遠距照護系統的設計理念是結合商用醫療器材（血氧機、血糖機、血壓機與心電圖機）透過其藍牙通信無線傳輸量測資料至Android 行動裝置，亦與藍芽之醫療裝置協定（Health Device Profile, HDP）整合實現Intel ContinuaR醫療聯盟之通訊規範可容性。得以減少實體線路的空間及整合多樣感測設備，使量測環境不受限制，再將所量測的數據及GPS定位資訊通過隨身網路傳送至臺大醫院遠距照護中心的醫療雲端中儲存匯整，以達到即時監測及發送信息或警報等應用，得以幫助長期照護使用者的健康狀況。本系統已完成臺大醫院的臨床試用性評估，基於臨床測試者的使用者經驗回饋，在系統優化、流暢度都更貼近使用需求，友善直覺式的操作將大幅提升大眾的使用意願。 本系統亦可協助判讀量測誤差，經演算法處理後將人為操作所造成的失效量測資料回報給使用者，請求再次量測，如此不但可增進量測效率也可減少個案管理師工作量。基於個人隱私及安全性的考量，我們亦實現符合高級加密標準（Advanced Encryption Standard, AES）之心電圖量測設備。

Medical devices, which used to be designed by users with medical background, such as doctors, technicians, and other medical staff, have become insufficient for today’s needs because of there are more and more non-medical background users. Design methods regulated by United States Food and Drug Administration (FDA) offers a refined solution for the problems in medical device design, as they do in many other medicine fields. In this study, applying these methods to the medical device design process, especially in telehealth system design, is going to be examined. In this thesis, we propose a digital mobile healthcare system, which integrates wearable sensors, smart phone, and National Taiwan University Hospital (NTUH) telehealth center, to facilitate the management of point-of-care. The system utilizes wireless connection between wearable sensors and mobile devices with Bluetooth interface to automatically collect physiological signal, such as blood oxygen saturation, blood glucose, blood pressure, and electrocardiography (ECG). It allows users, especially seniors with chronic diseases, to conveniently record daily measurement results and track long term health condition changes regardless of their locations. For interoperability consideration, we design our system as a ContinuaR- compatible manager. We also perform clinical trial in NTUH to validate our system usability. FDA regulatory decision and security issue are also discussed in the thesis.