實驗設計用於筆型注射器之劑量準確性與精確性評估

筆型注射器自從上市以來，最普遍被用在糖尿病患之胰島素注射上，由於筆型注射器提供糖尿病患居家自行注射之便利性與安全性較傳統注射針筒來得高，所以病患及家屬對筆型注射器的接受度也越來越高。因此，近年來有越來越多的醫療器材廠商針對不同注射需求與藥物種類推出比傳統注射器具有更多樣化功能的筆型注射器，甚至標榜具自動注射功能之自動注射器也如雨後春筍般出現。然而，在產品發展越趨向多功能的同時，筆型注射器設計的首要重點依舊是離不開劑量準確性與精確性。本研究以可調劑量可重覆使用之筆型注射器進行劑量準確性與精確性研究，嘗試以實驗設計的方式進行筆型注射器劑量準確性與精確性之實驗，配合量測系統分析法進行線性、偏倚及精確性之研究。其目的在於驗證筆型注射器劑量準確性與精確性能力，並提供一套合理的評估與分析方式及工具給產品開發團隊，協助工程師們在產品開發時進行劑量準確性與精確性分析，以期能快速、準確的發掘問題並理出方向，減少時間及成本的消耗。

關鍵字

筆型注射器；量測系統分析；實驗設計

並列摘要

Since pen injectors have been marketed, it has been commonly used for insulin delivery. It provides people with diabetic convenient and safe injection at home comparing with traditional injection performed with syringes. Considering this, diabetics and their family are getting used to take and give insulin shots using pen injectors. As a result, more and more medical devices makers have recently focused on the development of new pen injectors offering a large variety of functions for the delivery of different medicines. Moreover, manufacturers advertise newer products such as auto-injectors. However, dose accuracy and dose precision remain the primary functions of the device. This study consists of testing the dose accuracy and precision of a multi-dose and reusable pen injector through the discipline of Design of Experiments (DOE) and in accordance with the Measurement System Analysis (MSA) to identify the variations in linearity, bias, and precision. The purpose of this study is to verify the performance of the pen injector for dose accuracy and dose precision; to provide the R&D team with a rational method for evaluation and analysis; and finally to help the engineers to conduct the analysis for dose accuracy and dose precision on the pen injector during the R&D phase, in order to rapidly and accurately uncover potential failure modes, and decrease the time to product release and cost.

並列關鍵字

Design of Experiments ； Measurement System Analysis ； Pen injector

參考文獻

【14】 Radhakrishnan, A. K., Lum, Y. W., Wong, K. C., Goh, J. and Embong, M. (2002). Compatibility of the Omnican® Pen Needles with Insulin Pens, Humapen® and Novopen®; Journal of the ASEAN Federation of Endocrine Societies (2002), 20 (1/2), Jan/July: 36-39.

【5】 AIAG Editing Group (2002), Measurement System Analysis-Reference manual, 3th ed., Automotive Industries Action Group.

【6】 Ganalingham, M. G., Newland, P. and Smith, C. P. (1998). Accuracy and reproducibility of low dose insulin administration using pen-injectors and syringes; Arch. Dis. Child. 1998; 79; 59-62.

【7】 International Organization for Standardization, BS EN ISO 11608-1:2001 Pen-injectors for medical use- Part 1: Pen-injectors－Requirements and test methods.

【8】 International Organization for Standardization, ISO 3207 Statistical interpretation of data－Determination of a statistical tolerance interval; First edition－1975-05-15.

國際替代計量

實驗設計用於筆型注射器之劑量準確性與精確性評估

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