市售導尿管之無菌性及球囊品質監測   全文下載

Sterility and Balloon Quality Surveillance of Commerical Urinary Catheters

為了解市售導尿管之無菌性及球囊品質，衛生福利部食品藥物管理署於112年1月至6月間，委由各地方政府衛生局至轄區內醫療院所及醫療器材商（藥局、醫療器材行、醫療器材製造業者及許可證申請商）所在地進行市售導尿管之抽樣，共計抽樣17件，參考中華藥典第九版無菌試驗法之直接接種法相關規定進行無菌性試驗，結果3件有微生物生長（不符合率17.6%）；在球囊品質部分，17件檢體中，有2件檢體無球囊，參考ISO 20696:2018 Sterile urethral catheters for single use，針對球囊安全性及球囊體積維持等項目進行檢驗，結果均符合標準要求；標示部分則有1件不符規定，該件檢體外包裝標示英文品名與許可證所載不一致。所有不符規定者皆已移請權責衛生局裁處，監測結果將供行政管理單位參考。

To ensure the quality of urinary catheter available on the market, a survey focused on the sterility, balloon safety and catheter inflation lumen integrity and volume maintenance was conducted. From January to June 2023, seventeen samples were collected from hospitals and medical device firms by the local health authorities. Three catheters (17.6%) failed the sterility test as bacteria was isolated by direct transfer method as described in the Taiwan Pharmacopeia IX. The balloon security and catheter inflation lumen integrity and volume maintenance tests were carried out in accordance with ISO 20696:2018 Sterile urethral catheters for single use, and a total of 15 samples were tested. The results showed all 15 samples met the criteria for balloon security, catheter inflation lumen integrity and volume maintenance requirement. In regard to labeling, one sample violated the regulation and was sent to the local health authority for further administrative processing. These results will be forwarded to the competent authority as reference.