市售導尿管之無菌性、球囊安全性及球囊體積維持之監測   全文下載

Inspection of Sterility, Balloon Security and Catheter Inflation Lumen Volume Maintenance of Foley Catheter in Taiwan

為了解市售導尿管之無菌性及球囊品質，食藥署於108年1月至10月間，委由地方政府衛生局至醫療院所、醫療器材行及輸入商所在地進行市售導尿管之抽樣，共計抽樣25件。依據中華藥典第八版無菌試驗法之直接接種法進行無菌性試驗，結果25件檢體中有1件有微生物生長，不符合率為4.0％；在球囊可靠度部分，共計17件檢體參考ISO／DIS 20696 Sterile urethral catheters for single use（BS EN ISO 20696：2018）規範及原查驗登記規格，針對球囊安全性及球囊體積維持等試驗項目進行檢驗，結果球囊安全性試驗均符合標準要求，球囊體積維持試驗則有2件結果不符原查驗登記規格，不符合率為11.8％。標示部分則有6件標示不符規定，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 the foley catheter available on the market, a survey focused on the watertightness performance, balloon security and catheter inflation lumen volume maintenance was conducted in 2019. From January to October, 25 samples were collected from hospitals and authorized dealers by the local health authorities. The sterility test showed that 4.0% sterile catheters were disqualified since bacteria and fungi could be isolated by the direct transfer method as described in the Chinese Pharmacopoeia VIII. The balloon security and catheter inflation lumen volume maintenance tests were carried out in accordance with ISO/DIS 20696 sterile urethral catheters for single use (BS EN ISO 20696:2018) and a total of 17 samples were tested. The results showed all 17 samples met the balloon security requirement, while 2 samples (11.8%) were unable to fulfill the minimum percentage of volume recovered (> 80%) in the catheter inflation lumen volume maintenance test. In regard to the labeling, 6 samples violated the regulation and were sent to administrative authorities for further administrative treatment and penalty. These results will be forwarded to the competent authorities as regulatory references.