Evaluation of three barrier-type closed system transfer devices using the 2015 NIOSH vapor containment performance draft protocol

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Background: 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.

Purpose: 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.

Methods: 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.

Results: 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.

Conclusions: 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.