Forshay Charlotte M, Streeter Shawn O, Salch Stephanie A, Eckel Stephen F
1 UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, USA.
2 University of North Carolina Medical Center, Chapel Hill, USA.
J Oncol Pharm Pract. 2019 Jul;25(5):1160-1166. doi: 10.1177/1078155218787256. Epub 2018 Jul 24.
The National Institute for Occupational Safety and Health (NIOSH) released a proposed protocol in 2015 to evaluate the vapor containment abilities of closed system transfer device technologies in order to provide meaningful comparisons between products. This study assessed the vapor containment ability of closed system transfer devices when following the methodology as outlined by the 2015 NIOSH proposed protocol.
This study evaluated six closed system transfer device brands following the draft NIOSH vapor containment protocol. The testing evaluated each closed system transfer device brand during both compounding (Task 1) and administration (Task 2). Five pre-specified steps for each task were repeated for a total of four manipulations per device. The Thermo Scientific™ MIRAN SapphIRe XL Infrared Analyzer was used to detect isopropyl alcohol vapor levels after each step.
For Task 1, two closed system transfer device products (PhaSeal™ and Equashield®) adequately contained the isopropyl alcohol vapor and passed the predefined testing criteria. The same two products, plus one additional product (ChemoLock™), contained the vapor for Task 2 manipulations. Based on the results of this study, only two out of the six closed system transfer device brands passed testing criteria for both tasks, functioning as truly closed systems.
To improve employee safety in chemotherapy preparation, closed system transfer devices that demonstrate no leakage should be the preferred choices of healthcare systems. In this study, PhaSeal™ and Equashield® proved to be adequately closed in both Task 1 and Task 2, while ChemoLock™ proved to be closed in Task 2 but not in Task 1. All other products failed both tasks when measuring for isopropyl alcohol vapor release.
美国国家职业安全与健康研究所（NIOSH）于2015年发布了一项拟议方案，以评估封闭系统转移装置技术的蒸汽密闭能力，以便对产品进行有意义的比较。本研究按照2015年NIOSH拟议方案概述的方法，评估了封闭系统转移装置的蒸汽密闭能力。
本研究按照NIOSH蒸汽密闭方案草案，对六个封闭系统转移装置品牌进行了评估。测试在配制（任务1）和给药（任务2）过程中对每个封闭系统转移装置品牌进行了评估。每个任务的五个预先指定步骤重复进行，每个装置总共进行四次操作。使用赛默飞世尔科技™ MIRAN SapphIRe XL红外分析仪在每个步骤后检测异丙醇蒸汽水平。
对于任务1，两种封闭系统转移装置产品（PhaSeal™ 和Equashield®）充分密闭了异丙醇蒸汽并通过了预定义的测试标准。同样的两种产品，加上另一种产品（ChemoLock™），在任务2操作中密闭了蒸汽。根据本研究结果，六个封闭系统转移装置品牌中只有两个通过了两项任务的测试标准，可作为真正的封闭系统运行。
为提高化疗制剂配制过程中的员工安全性，无泄漏的封闭系统转移装置应成为医疗系统的首选。在本研究中，PhaSeal™ 和Equashield® 在任务1和任务2中均被证明密闭良好，而ChemoLock™ 在任务2中被证明密闭良好，但在任务1中并非如此。在测量异丙醇蒸汽释放时，所有其他产品两项任务均未通过。
