氣管內管及氣切管檢驗方法建立與品質監測   全文下載

Establishment of Test Methods and Quality Inspection of Tracheal Tube and Tracheostomy Tube in Taiwan

依據我國醫療器材分類分級管理辦法之鑑別定義，氣管內管（Tracheal tube）是經由鼻或口置入氣管之器材；氣切管（Tracheostomy tube）為執行氣管切開術後，放置於氣管切口之器材，兩者品項代碼分別為D.5730及D.5800，均列屬第二等級醫療器材，主要目的皆為維持氣道開放，透過連接呼吸器或其他設備，以利患者進行人工換氣，有效維持呼吸功能。為適當固定於氣管、提升換氣效率及避免異物進入下呼吸道，兩種器材多附有氣囊，惟曾有產品尺寸與標示不符或氣囊品質不良等不良事件，除可能影響人工換氣之效率外，更可能造成患者氣管黏膜受損等二度傷害。本計畫參考ISO 5361及ISO 5366等國際標準，建立氣管內管及氣切管之檢驗方法，項目包含尺寸（內、外徑）、氣囊靜止直徑測量，另進行氣囊洩漏、氣囊突出，氣管內管管身塌陷及氣切管15 mm連接頭及頸盤與管體連結安全性等測試，並應用於4件氣管內管及13件氣切管之檢測，各測項測試結果皆能符合ISO國際標準之要求，除1件氣管內管檢體標示之氣囊靜止直徑與原查驗登記核准不符，已函送地方衛生機關予以行政處理，本調查結果將提供行政管理參考。

Tracheal tubes are intended to be inserted through the larynx into the trachea and tracheostomy tubes are designed for insertion into the trachea through a tracheostomy. These medical devices provide a patent airway in patients and maintain the air delivery from the mechanical ventilator to lungs. Tracheal tubes and tracheostomy tubes may be equipped with a cuff in order to secure the patient’s airway and prevent secretions from entering into lower respiratory tract. Both the designated size of the product is incompatible with the labelling and the cuff have a poor quality may affect the efficacy of mechanical ventilation or cause secondary injury to mucosa of the airway. The study established testing methods for tracheal tubes and tracheostomy tubes based on ISO 5361 and ISO 5366, including measurement of the designated size (inner diameter and outer diameter) and cuff resting diameter, along with cuff leak test, cuff herniation, cuffed tube collapse of tracheal tube and the security of 15 mm connector and neck-plate test of tracheostomy tube. The methods were also applied to 17 samples (4 tracheal tubes and 13 tracheostomy tubes). The results showed all the samples met the tolerance or specifications set by ISO standards except one tracheal tube’s marked value of cuff resting diameter is different from the registration. The violated product case was sent to administrative authorities for penalty. The results will be offered to competent authorities as regulatory references.