Szkiladz Andrew, Hegner Shawn
Department of Pharmacy, Baystate Health, Springfield, MA USA.
Department of Pharmacy, Riverside Health System, Newport News, VA USA.
Drugs Ther Perspect. 2022;38(4):177-184. doi: 10.1007/s40267-022-00905-x. Epub 2022 Mar 16.
Closed System Transfer Devices (CSTD) have been developed to reduce healthcare worker exposure to hazardous drugs during medication handling. To evaluate CSTD performance in preventing the escape of drug vapors, the National Institute for Occupational Safety and Health (NIOSH) developed a 2015 draft testing protocol incorporating two compounding tasks utilizing 70% isopropyl alcohol (IPA) as a medication surrogate.
The objective of this study was to evaluate the performance of three CSTDs (Chemolock [ICU Medical Inc., San Clemente, CA], PhaSeal [BD, Franklin Lakes, NJ], and Equashield [Equashield, Port Washington, NY]) in preventing the escape of drug vapor in accordance with the 2015 NIOSH draft protocol during simulated compounding and administration tasks.
The protocol was modified for the CSTDs to be used in accordance with manufacturer instructions for use and to represent clinical practice through repeated CSTD connections. Tasks were executed with each of the three CSTDs using 70% IPA as the medication surrogate to simulate compounding of a lyophilized drug, intravenous (IV) bag preparation (task 1), and bolus administration through an IV set (task 2). A positive control was performed by completing both tasks in duplicate, utilizing a needle and syringe instead of the CSTD to simulate preparation and injection through luer connectors. Differences in time to complete each simulated task was also evaluated.
The three CSTDs had statistically equivalent performance and maintained IPA vapor levels below the limit of detection (LOD) of 1.0 ppm. Positive controls had mean vapor release of 17.40 ppm and 23.45 ppm for tasks 1 and 2, respectively. Positive controls also required statistically longer mean time to complete both tasks, followed in decreasing order by PhaSeal, Equashield, and Chemolock.
This study suggests that when evaluated in accordance with the 2015 NIOSH draft protocol, the three CSTDs are equivalent in their ability to prevent IPA vapor release while differences in time required for task completion may exist.
The online version contains supplementary material available at 10.1007/s40267-022-00905-x.
密闭式药物传输装置（CSTD）已被开发出来，以减少医护人员在处理药物过程中接触危险药物的风险。为评估CSTD在防止药物蒸汽逸出方面的性能，美国国家职业安全与健康研究所（NIOSH）制定了2015年草案测试方案，其中包含两项使用70%异丙醇（IPA）作为药物替代物的配药任务。
本研究的目的是根据2015年NIOSH草案方案，评估三种CSTD（Chemolock [ICU Medical Inc., San Clemente, CA]、PhaSeal [BD, Franklin Lakes, NJ]和Equashield [Equashield, Port Washington, NY]）在模拟配药和给药任务期间防止药物蒸汽逸出的性能。
对方案进行了修改，以便按照制造商的使用说明使用CSTD，并通过重复连接CSTD来模拟临床实践。使用三种CSTD中的每一种，以70% IPA作为药物替代物，执行任务以模拟冻干药物的配药、静脉（IV）袋制备（任务1）以及通过静脉输液器进行大剂量给药（任务2）。通过使用针头和注射器代替CSTD，重复完成两项任务来模拟通过鲁尔接头进行的制备和注射，从而进行阳性对照。还评估了完成每个模拟任务所需时间的差异。
三种CSTD在统计学上具有等效性能，并将IPA蒸汽水平保持在1.0 ppm的检测限以下。阳性对照在任务1和任务2中的平均蒸汽释放量分别为17.40 ppm和23.45 ppm。阳性对照完成两项任务所需的平均时间在统计学上也更长，按从长到短的顺序依次为PhaSeal、Equashield和Chemolock。
本研究表明，根据2015年NIOSH草案方案进行评估时，三种CSTD在防止IPA蒸汽释放的能力方面是等效的，但完成任务所需的时间可能存在差异。
在线版本包含可在10.1007/s40267-022-00905-x获取的补充材料。
