醫院用無菌導尿管之無菌性監測

Sterility Testing of Urinary Catheters in Taiwan: A Survey Report

葉美伶(Mei-Ling Yeh) ； 林育如(Yu-Ju Lin) ； 翁淑菁(Shu-Ching Weng) ； 章偉浩(Wei-Hao Chang) ； 許家銓 ； 楊依珍(Yi-Chen Yang) ； 王德原(Der-Yuan Wang) ； 陳惠芳(Hwei-Fang Cheng) ； 施養志(Daniel Yang-Chih Shih)

《食品藥物研究年報》 5期 (2014/12) Pp. 264-270

摘要

無菌導尿管常用於手術過後、長期臥床之病患或長期行動不便無法自行排尿者，因使用時直接侵入人體，其產品無菌性直接影響使用者安全，故本署已將此類型醫材無菌性列為102年後市場監測重點項目。本計畫針對國內核准製造及輸入之24張標示“已滅菌”導尿管許可證，委由各地方政府衛生局進行分階段抽樣，第一階段由各衛生局就轄區內醫療院所及導尿管販賣場所隨機抽樣，第二階段由衛生局直接赴製造廠及輸入商進行源頭抽樣，第三階段則赴22家醫學中心進行抽樣，共抽得80件檢體，產品種類佔該有效許可證之79.1%。各檢體依據中華藥典第七版無菌試驗法進行試驗。檢驗結果有13件檢體檢出遭細菌或／與黴菌污染，不合格率達16.3%，其中國產、陸輸及輸入產品不合格率分別為25、14.3、13.2%，而在國內22家醫學中心的抽驗不合格率則為13%。此外，本次調查亦發現部分檢體有包裝標示之缺失，包括品名標示與許可證登記不符、未標示許可證字號、生產國家與許可證登記不符等情形。上述各無菌試驗不合格及標示不符合檢體，已逐一函送各轄區衛生局進行後續裁處，同時本署依據風險管控之原則，針對國產業者啟動不定期GMP查核；另有關輸入產品，要求其原製造廠提出矯正預防措施送本署核備，以確保醫療器材之安全及有效性。此外，為提升國內無菌醫療器材之品質，本署亦於102年度推動「醫療器材無菌確效作業之品質提升及查核計畫」，以輔導訪查方式強化業者對於無菌醫材產品之滅菌相關作業能力，希望藉此降低無菌醫療器材之不符合率，減少無菌產品對患者造成之風險性，以保障國人之健康及醫療品質。

關鍵字

無菌導尿管 ； 無菌試驗 ； 環氧乙烷(E.O.)

並列摘要

Sterile catheters are commonly used during surgery and for long-term bedridden patients. However, if catheters are not sterilized completely, they may cause infection. From January to June in 2013. 80 random samples were collected by the local health authorities from hospitals, pharmacies, factories and agents in Taiwan. The sterility test was conducted in accordance to the direct transfer method as described in the Chinese Pharmacopoeia VII. The results showed that 13 samples (16.25%) were disqualified and bacteria and/or fungi were isolated. Among the 13 samples, 21.7%, 14.3% and 14.0% were made in Taiwan, China and other countries, respectively. The disqualified rate of the samples collected from 22 medical centers was 13%. The result of this report has been sent to local health authorities to enforce the penalties to the suppliers who provided substandard samples. Based on risk management principles, random GMP inspection will also be implemented with domestic manufactures. Moreover, the TFDA has also introduced a program to strengthen the capacity of manufacturers to properly sterilize medical devices in the year of 2013. This report not only provides the current status of the relevant products to the medical institutions and health authorities, but also the strategies to reduce the rate of disqualification of sterile medical devices.

並列關鍵字

urinary catheter ； sterility test ； γ-ray