市售聚氯乙烯(PVC)材質醫療器材中鄰苯二甲酸二（2 -乙基己基）酯(DEHP)之品質監測   全文下載

Survey of Bis(2-ethylhexyl)phthalate (DEHP) in Polyvinyl Chloride (PVC) Medical Devices in Taiwan

為了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」，食品藥物管理署於110年1月至6月間，委由各縣市衛生局赴轄區內各級醫院、藥局、醫療器材行及製造業者等地進行市售產品之抽驗，抽得聚氯乙烯（PVC）製醫療器材共31件，其中國產品13件，輸入品18件。品項包括輸液套、血液透析導管及血袋、腸胃營養導管等，進行鄰苯二甲酸二（2-乙基己基）酯（DEHP）之檢驗，調查結果顯示共計2件檢體不符規定，1件輸液套檢體檢出DEHP，惟其外包裝宣稱不含DEHP；另1件血袋檢體則未標示中文品名，均已函送地方衛生機關予以行政處理，本調查結果將提供行政管理參考。

In order to investigate the conformity of marketed PVC medical devices to the administrative announcement NO. 1001603415 published by the Department of Health, Executive Yuan, R.O.C. (Taiwan) May 23, 2011, the Taiwan Food and Drug Administration entrusted local health authorities to sample products from hospitals, medical appliances stores, manufacturers and pharmacies in Taiwan market from January to June 2021.A total of 31 including 13 domestic and 18 imported products were collected. These samples including intravascular administration sets, hemodialysis catheters, blood bags, gastrointestinal nutrition catheters, etc. were examined for DEHP residues. The results showed that two samples were non-compliant, one intravascular administration set claiming contained no-DEHP on the labelling was detected of DEHP, while another blood bag didn’t label its product name in Chinese. The violated products were sent to local health authorities for administrative disposition. The surveillance results will be provided to competent authorities as regulatory references.