Hospital Pharmacy - December 2020 - 391

848730
research-article2019

HPXXXX10.1177/0018578719848730Hospital PharmacyHalloush et al

Original Article

Evaluating Six Commercially Available
Closed-System Drug-Transfer Devices
Against NIOSH's 2015 Draft Vapor
Protocol

Hospital Pharmacy
2020, Vol. 55(6) 391--399
© The Author(s) 2019
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https://doi.org/10.1177/0018578719848730
DOI: 10.1177/0018578719848730
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Shiraz Halloush1,2 , Ivan A. Reveles3, and Jim Koeller1,2

Abstract
Purpose: In 2015, the National Institute for Occupational Safety and Health (NIOSH) published a draft vapor containment
protocol to quantitatively evaluate combined liquid, aerosol, and vapor containment performance of commercially available
closed-system drug-transfer devices (CSTDs) that claim to be effective for gas/vapor containment within a controlled test
environment. Until the release of this proposed protocol, no standard method for evaluating airtightness of CSTDs existed.
The aim of this study was to evaluate six commercially available CSTDs utilizing NIOSH draft protocol methodology to
evaluate vapor containment under a robust vapor challenge. Methods: In this study, six commercially available CSTDs were
tested utilizing draft NIOSH vapor containment protocol methodology to simulate drug compounding and administration
using 70% isopropyl alcohol (IPA) as the challenge agent. All device manipulations were carried out in an enclosed test
chamber. A Miran sapphIRe gas analyzer was used to detect IPA vapor levels that escaped the device. Study test included the
two tasks designated by the NIOSH protocol, with additional steps added to the evaluation. Tasks were repeated 10 times
for each device. Results: Only three of the six tested CSTDs (Equashield®, HALO®, and PhaSealTM) had an average IPA vapor
release below the quantifiable performance threshold (1.0 ppm) for all tasks performed. This value was selected by NIOSH
to represent the performance threshold for successful containment. The remaining three CSTDs had vapor release above 1
ppm at various times during the IPA manipulation process. Conclusion: Equashield®, HALO®, and PhaSealTM devices tested
met the 2015 NIOSH protocol quantifiable performance threshold, functioning as a truly closed system. Quantifiable effective
data may be useful in product selection.
Keywords
CSTD, hazardous drugs, NIOSH, vapor release, health care workers, occupational exposure

Introduction
Exposure to hazardous drugs (HDs) including antineoplastic
agents has been associated with adverse health outcomes
including reproductive toxic effects and cancer.1 While many
health care workers can be at risk of HD occupational exposure,2,3 pharmacists, pharmacy technicians, and nurses are
most likely to be exposed,3 especially throughout the preparation or administration process.4
Dermal contact with HD-contaminated surfaces is the primary route of occupational exposure, and have the predominant role in the HD uptake by health care personnel,5,6 as
evidenced by drug excretion in health care worker urine samples.7 Several environmental wipe sampling studies have
demonstrated widespread surface contamination including
the outer surface of syringes, drug vials, and preparation and
administration areas.8-18 To limit this exposure and protect
health care workers, safe HD-handling guidelines have been

incorporated such as a biological safety cabinet (BSC) and
personal protective equipment (eg, gloves, gowns, mask).1,19-21
However, studies show that occupational exposure still occurs
despite the use of these protective guidelines.3,22-26
Furthermore, detection of measurable concentrations of HDs
from urine samples of exposed workers implies that drug
absorption still occurs.2,26
1

The University of Texas at Austin, USA
UT Health San Antonio, USA
3
UT Health San Antonio MD Anderson Cancer Center, USA
2

Corresponding Author:
Jim Koeller, MS, Professor, College of Pharmacy, The University of
Texas at Austin and Adjunct Professor of Medicine and Oncology,
Pharmacotherapy Education & Research Center, UT Health
San Antonio, 7703 Floyd Curl Drive, MC 6220, San Antonio,
TX 78229-3900, USA.
Email: koeller@uthscsa.edu
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