腹膜透析導管及血液透析導管之無菌性監測

Sterility Surveillance of Peritoneal Dialysis Catheters and Hemodialysis Catheters in Taiwan

腹膜透析導管及血液透析導管皆為無菌性醫療器材，用於腎功能衰退並需藉由腹膜或血液透析方式置換體內廢物之患者，由於前述導管會直接接觸病患體液或血液，若因滅菌不良或保存不當，可能造成使用者感染，為提升民眾使用醫療器材之安全性，降低感染風險，監控其無菌性確有必要。本計畫預計監測國產及輸入且標示“已滅菌”腹膜透析導管委請全台各縣市衛生局抽樣，惟部分地區無法抽得足量腹膜透析導管則改抽樣血液透析導管，抽得之檢體再由食品藥物管理署（以下簡稱食藥署）依據中華藥典第七版進行無菌試驗。本年度總計抽樣28件檢體（17件腹膜透析管及11件血液透析導管），無菌試驗結果全數合格。本次調查亦發現9件檢體（腹膜透析導管6件，血液透析導管為3件）有包裝標示缺失的情形，包含中文品名及英文品名與許可證登記不符、製造廠名稱及廠址與許可證登記不符等。標示不符合之檢體，已逐一函送各轄區衛生局處辦，並由衛生局請廠商限期回收違規產品進行改正，以保障國人之健康及醫療品質。

Peritoneal dialysis catheters and hemodialysis catheters are sterile medical devices used in patients with renal failure. As the catheters are in direct contact with the patients' blood or body fluids, poor sterilization or improper storage can cause infection. Post-market surveillance of the sterility of such devices is required to ensure safety and reduce the risk of infection. In this study, we inspected the sterility of peritoneal dialysis catheters and hemodialysis catheters in the market. From January to June 2015, 28 samples (17 peritoneal dialysis catheters and 11 hemodialysis catheters) were collected by the local health authorities from hospitals, pharmacies, factories, and agents in Taiwan. Sterility tests were conducted using the direct transfer method or the membrane filtration method as described in the seventh edition of the Chinese Pharmacopoeia. The results showed that all the samples complied with the sterility regulations. However, 9 samples (6 peritoneal dialysis catheters and 3 hemodialysis catheters) had labeling mistakes, such as the product names, manufacturers' names and addresses, were different from those stated in the licenses, the manufacturers were made to recall the affected products and make the relevant corrections.