Application of the 2015 proposed NIOSH vapor containment performance protocol for closed system transfer devices used during pharmacy compounding and administration of hazardous drugs

Abstract

Purpose

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.

Methods

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.

Results

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.

Conclusion

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.

Keywords

Hazardous drugs medication compounding National Institute for Occupational Safety and Health (US)occupational exposure protective devices

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