血管內導管檢驗方法之建立   全文下載

Establishment of Test Methods for Intravascular Catheter

「血管內導管」泛指經皮穿刺，插入患者血管系統內，以輸注藥品及營養素、採血或進行血液動力學監控之醫療器材。該類醫療器材以「周邊靜脈留置針（Over-needle Peripheral Catheter）」及「中心靜脈導管（Central Venous Catheter,簡稱CVC）」較為常見，兩者皆列屬我國醫療器材分類分級管理辦法「J.5200血管內導管」項下。是類醫材國內外皆有相關不良品事件通報，造成額外臨床處置程序增加，其中又以「洩漏」相關不良事件為多。本研究參照ISO 10555、ISO 11070及ISO 9626等國際標準，建立血管內導管之檢驗方法，項目包括「耐腐蝕性（Corrosion Resistance）」、「峰值拉力（Peak Tensile Force）」、「定壓下液體洩漏（Liquid Leakage Under Pressure）」、「抽吸過程空氣洩漏（Air Leakage into Hub Assembly during Aspiration）」、「針座與針管連結強度（Strength of Union of Needle Hub and Needle Tube）」以及「針管剛性（Stiffness of Tubing）」等測試，並實際應用於市售周邊靜脈留置針與CVC各3款之檢測，檢驗結果顯示6件產品皆能符合ISO國際標準之要求，結果將作為行政管理參考。

Intravascular catheters are intended to be transcutaneously inserted into the vascular system. These medical devices, including over-needle peripheral catheter and central venous catheter (CVC), are designed for infusion of drugs and nutrients, blood sampling or hemodynamic monitoring. Both are classified as“J.5200 Intravascular catheter”in the annex of Regulations Governing the Classification of Medical Devices. Recently, there are numerous adverse events concerning these medical devices, causing additional clinical treatments, most of which were caused by product leakage. This study aimed to establish testing methods for over-needle peripheral catheters and CVCs based on ISO 10555, ISO 11070 and ISO 9626, which included tests of corrosion resistance, peak tensile force, liquid leakage under pressure, air leakage into hub assembly during aspiration, strength of union of needle hub and needle tube, along with stiffness of tubing. These methods were also applied to 6 samples, inclusive of 3 over-needle peripheral catheters and 3 CVCs. The results showed that all the samples met the tolerance or specifications set by ISO standards, and will be offered to the competent authorities as regulatory references.