| 中文摘要 |
為瞭解市售醫療器材是否符合前行政院衛生署100年5月23日署授食字第1001603415號公告「高鄰苯二甲酸二（2-乙基己基）酯（DEHP）暴露風險之聚氯乙烯（PVC）材質醫療器材相關標示規定」，食藥署於106年1月至4月間，委由各地方政府衛生局赴轄區內各級醫院、藥局、醫療器材行及製造商等地進行市售產品之抽驗，抽得PVC製醫療器材共29件，包括輸液套、血液透析導管及血袋、腸胃營養導管等，其中國產品11件，輸入品18件，進行鄰苯二甲酸二（2-乙基己基）酯（DEHP）之檢驗，結果29件檢體中，計有10件檢體檢出DEHP，其中1件外包裝未有相關標示，標示有疑慮者已函送原抽樣衛生局進行後續行政處理。相關檢驗結果提供行政管理單位作為參考，期能降低相關醫療器材產品對敏感族群之健康風險疑慮，維護國民健康。
In order to investigate whether marketed phthalates-contained PVC medical devices conform to the administrative interpretation NO. 1001603415, which was announced by Department of Health, Executive Yuan, R.O.C (Taiwan) on May 23, 2011. Twenty-nine samples were randomly collected by local health authorities from hospitals, drug stores, medical device stores and manufacturers in Taiwan area between January and April, 2017. Samples were tested for DEHP residues including intravascular administration set, hemodialysis catheter, blood bag, gastrointestinal nutrition catheter, etc. In the samples, 11 samples were made in Taiwan, others were imported. The results showed that 10 samples were positive, and one of them was even not labeled with warnings on its package. The surveillance results were forwarded to relative authorities for further corrective actions. |
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