109年度無菌手套之無菌性監測   全文下載

Surveillance on the Sterile Quality of Sterile Gloves in Taiwan, 2019

無菌手套用於醫療院所執行外科手術、傷口處理等過程，隔絕醫護人員手部微生物以避免污染病患傷口。若無菌手套滅菌不完全受微生物污染，將導致病患傷口感染、發炎等症狀，因此有必要監控無菌手套之無菌性。為監測醫療手套的無菌性，109年度執行重點以標示“無菌”或“滅菌”之手套為標的，於抽樣前先查詢西藥、醫療器材及化粧品許可證系統，取得目前在臺灣上市之各類無菌手套清單，委請各縣市衛生局抽樣，依據中華藥典第八版進行無菌性試驗。本計畫共抽得66件檢體，其中65件無菌試驗結果合格，1件檢出細菌（Kocuria rhizophila（嗜根柯克氏菌））（不合格率為1.5%）。本次調查亦發現8件檢體（7張許可證）有外包裝標示之缺失，包括中、英文品名標示與許可證登記不符、製造廠或申請商名稱地址與許可證不符等。上述檢驗不合格及標示不符合之情形，已函請所屬縣市衛生局執行相關措施及處分。本計畫之成果可提供各醫療院所及相關衛生主管機關了解此類產品之現況，增強管理量能，並提醒廠商加強產品運銷至醫療使用處之品質管制，維持手套包裝之完整性，提供良好無菌使用品質，以保障病患之健康，提高醫療品質。

Sterile gloves are used in medical institutions to perform surgical operations, wound treatment and other procedures to quarantine microorganisms from the hands of medical staff to prevent patient wound contamination. If the gloves are not completely sterilized and contaminated by microbes, it may cause wound infection, inflammation and other symptoms. Therefore, it is necessary to monitor the sterility of the gloves. This project targeted at the medical gloves with outer package labeled with ''sterile ''or ''sterilized''. From the drug, medical device and cosmetics license inquiry system, we obtained a list of commercial sterile gloves currently in Taiwan and provided it to the local health bureaus as the sampling candidates. The sampling was conducted in three stages by the local government health bureaus. In the first and second stage, the local health authorities randomly took samples in hospitals, pharmacies or medical device shops in the area under their jurisdiction. In the third stage, the local health authorities directly obtained samples from gloves manufacturers and importers. Sterility tests were conducted by using the direct method described in the eighth edition of the Chinese Pharmacopoeia. We had tested 66 samples, of which 1 sample was contaminated with gram positive bacteria (Kocuria rhizophila) (noncompliance rate of 1.5%). The other 65 samples complied with the sterility requirements. In addition, we found 8 samples (including 7 licenses) presented label errors, such as Chinese/English product names, manufacturers' names and addresses not in compliance with the information of registered license. These findings has been forwarded to the local health authorities as references while the corrective actions of the product suppliers and manufacturers were requested.