Identifying the limitations of the 2015 NIOSH vapor containment performance protocol for assessing closed system transfer devices.

Abstract

IntroductionThe purpose of this series of three studies was to identify the limitations of the 2015 NIOSH Vapor Containment Performance Protocol for Assessing Closed System Transfer Devices (CSTDs) as well as the variables that may impact results when testing CSTDs.MethodsTwo different lots of Equashield^® CSTDs were tested in accordance with Task 2 of the protocol, using 70% isopropyl alcohol (IPA) as a challenge agent and either a Gasmet™ DX5000 Terra multigas FTIR analyzer or MIRAN^® SapphIRe XL Infrared analyzer to measure IPA vapor concentrations. All studies were conducted in NIOSH-designed, custom-built testing chambers. Variables assessed to determine impact on results included: user technique, brand of IV bag, brand of IV administration line, where (inside or outside the chamber) IV bags, IV lines, and y-site adapter CSTDs were assembled, CSTD manufacturing dates, and analyzer type.ResultsThe variables that impacted testing results included user technique and experience, use or non-use of bulky gloves during y-site adapter-to-IV-line assembly, and analyzer. Variations in the brands of IV bags and IV administration lines and manufacturing dates of CSTDs did not impact the results.ConclusionBased on the known limitations of the 2015 NIOSH protocol, an improved testing protocol - with a better hazardous drug (HD) surrogate than IPA - is needed for assessing the true effectiveness of CSTDs in containing HDs. In the meantime, this protocol can be used to help CSTD manufacturers and/or end users isolate and mitigate potential weaknesses in their CSTD products and/or the compounding techniques used.