創新醫療器材一致性之研究

電子科技進步，帶動全球醫療器材市場快速成長，電子醫療器材產業快速發展，醫療器材能否安全、快速又準確的判讀成為重要議題。創新醫療器材的推出，則必須與既有的標準醫療器材進行比對，並達到相當程度的一致性。Bland & Altman（1986）對兩種不同醫療器材的判讀值，利用差異（difference）和偏差（bias），提出一致性的上下限（limits of agreement, LOA），以及LOA的信賴區間（confidence interval）。Lu et al.（2016）提出了一致性的檢定方法，要求LOA信賴區間上下界必須同時和臨床顯著差異比較。在給定臨床顯著差異的假設下，本研究將利用蒙地卡羅（Monte Carol）方式進行一致性量化探討，並訂定不同的規格（不同分配型態的人體症狀值和醫療器材量測值），並藉由醫材測量差值信賴區間上下界和臨床顯著差異δ比較之通過率，來比較創新與標準醫療器材間符合一致性的程度。本研究模擬實驗使用軟體R 3.4.1版，結果顯示在常態分配下，創新醫材通過一致性的比例最高。

關鍵字

醫療器材；一致性檢定；一致性通過率

並列摘要

The advancement of electronic technology has driven the rapid growth of the global medical device market and the rapid development has made it an important issue for medical devices to be safe and accurate. The introduction of innovative medical devices must be compared to existing standard medical devices and achieve a considerable degree of consistency. Bland and Altman (1986) interpreted the readings of two different medical devices and used the difference and bias to propose the limits of agreement (LOA) and the confidence interval of the LOA for the interpretation of two different medical devices. Lu et al. (2016) proposed a consistent verification method that requires that the upper and lower bounds of the LOA confidence interval must be satisfy the standard of clinically significant differences at the same time. In this research, given the hypothesis of clinically significant differences, this study used the Monte Carol approach for consistency quantification and set different specifications (different distribution patterns of human symptom values and medical device measurements), and compared the degree of consistency between innovation and standard medical equipment by measuring the difference between the measured value of the medical material and the clinically significant difference δ. Using the R3.4.1, after many simulations and comparisons, it showed that under the normal distribution of both medical devices, the innovated one has the highest agreement rate.

並列關鍵字

medical device ； agreement test ； consistent rate

國際替代計量

創新醫療器材一致性之研究

全文下載

主題瀏覽