Queruau Lamerie Thomas, Carrez Laurent, Décaudin Bertrand, Bouchoud Lucie, Goossens Jean-François, Barthélémy Christine, Bonnabry Pascal, Odou Pascal
Biopharmacy, Galenic and Hospital Pharmacy Department, UFR Pharmacie, Université Lille Nord de France, Lille, France.
J Oncol Pharm Pract. 2012 Jun;18(2):191-200. doi: 10.1177/1078155211416531. Epub 2011 Aug 23.
Evaluation of containment safety devices designed and introduced to protect preparers and administrators of hazardous drugs, through a multiple-test assessment.
Six devices were compared: (1) Kis1 gravity-fed infusion set (Doran International, France), (2) Tevadaptor Spike Port Adapter (Teva Pharma AG, France), (3) Phaseal Infusion Adapter C100 (Carmel Pharma AB, France), (4) Codan Connect Z (Codan, France), (5) Pchimx with or without a cap (Doran International, France), and (6) Clave extension set 011-H1225 with or without Spiros (Hospira, France). Assessment of exposure to hazardous drugs was performed using quinine as fluorescent marker. Mechanical tests included tightness, tension tests, and estimation of the force required to connect the infusion device to the bag. Ergonomic tests were performed by six pharmaceutical technicians. Microbiological contamination was tested with media-fill, on connected bag.
No cytotoxic contamination was detected when using Phaseal, Tevadaptor or the Clave extension set with Spiros, Pchimx with a cap or Connect Z devices. For mechanical tests, all devices complied with the norm. Microbiological growth was observed neither in bags nor in tubings. The ergonomic study revealed differences between the devices for potential cytotoxic contamination risk only, but not for handling.
The use of containment safety devices offers improved handling conditions of hazardous compounds. As this study takes various selection criteria into account, its results offer assistance in choosing the most suitable device.
通过多项测试评估，对为保护危险药物配制者和管理者而设计并引入的防护安全装置进行评估。
比较了六种装置：（1）Kis1重力输液器（法国多兰国际公司），（2）特瓦适配器尖端口适配器（法国特瓦制药公司），（3）Phaseal输液适配器C100（法国卡梅尔制药公司），（4）科丹Connect Z（法国科丹公司），（5）带或不带帽的Pchimx（法国多兰国际公司），以及（6）带或不带Spiros的Clave延长管011 - H1225（法国 Hospira公司）。使用奎宁作为荧光标记物对危险药物暴露情况进行评估。机械测试包括密封性、拉伸测试以及估计将输液装置连接到袋子所需的力。由六名制药技术人员进行人体工程学测试。通过在连接的袋子上进行培养基灌装来测试微生物污染情况。
使用Phaseal、特瓦适配器或带Spiros的Clave延长管、带帽的Pchimx或Connect Z装置时，未检测到细胞毒性污染。对于机械测试，所有装置均符合标准。在袋子和管道中均未观察到微生物生长。人体工程学研究表明，仅在潜在细胞毒性污染风险方面，不同装置之间存在差异，但在操作方面没有差异。
使用防护安全装置可改善危险化合物的操作条件。由于本研究考虑了各种选择标准，其结果有助于选择最合适的装置。
