Vapor Containment Efficacy of Air-Cleaning CSTDs with 3 NIOSH Surrogates
Vishnuprabha (Dhanapal) Vogel, PharmD, BCPS, BCOP, Szlaczky, Mark, BSc, Pharm D, Rida, Nada, Pharm D, Mazur, Izabela, Pharm D

Vapor Containment Efficacy of Air-Cleaning CSTDs with 3 NIOSH Surrogates

Henry Ford Hospital
Vishnuprabha (Dhanapal) Vogel, PharmD, BCPS, BCOP, Szlaczky, Mark, BSc, Pharm D, Rida, Nada, Pharm D, Mazur, Izabela, Pharm D
Detroit, MI
2021

Purpose:

The primary objective o f this study was to determine the effectiveness of three hazardous drug surrogates suggested by NIOSH with 5 vented CSTDs and thereby help to exclude ineffective surrogates from the NIOSH surrogates list, as ineffective surrogates m ay lead to a false sense o f security from the use o f CSTDs, thereby putting the w ell-being o f healthcare workers at risk

Methods:

The continuously updated NIOSH list of hazardous drugs contains a large variety of molecules and compounds. NIOSH states that “… air-cleaning technologies can have varying efficiencies based upon the chemical and physical make-up of the contaminant.” The current study was intended to assess the varying efficiencies of air-cleaning CSTDS and the appropriateness of 3 out of 9 HD surrogates (tetramethylurea, tetraethylurea, and propylene glycol) suggested by NIOSH for use in testing o f aircleaning CSTDs. This study was designed to evaluate straightforward the vapor containment efficacy o f the air-cleaning technology (air filter test) in 5 commercially available air-cleaning CSTDs during simulated hazardous drug reconstitution using 3 of the 9 NIOSH-proposed surrogates and the Gasmet DX4040 FU R analyzer which is also utilized by NIOSH for the development o f its CSTD performance protocols. The DX4040 analyzer is designed to detect over 300 various gases at low concentrations, including 5 of the 9 NIOSH surrogates. The analyzer’s air sampling funnel was placed externally next to the vent opening o f an air-cleaning CSTD vial adapter during the injection o f 60ml of diluent (water) into a vial containing 3ml of undiluted surrogate.

The analyzer was run on continuous mode to collect the vented air from the CSTDs and any escaped surrogate vapor concentrations were detected, quantified and displayed in real-time. The surrogate concentration selected for this study was intended to correspond to the real-world condition of a 3-gram dose of ifosfamide free of excipients (eg, 3mL surrogate) and the required injection of 60ml of diluent (water) during the reconstitution process. In this study, 10 replications of testing for each of the CSTDs was conducted with each surrogate, yielding a total of 150 measurements. 72-hours after testing, a compatibility assessment was performed to exclude CSTD incompatibility with the surrogates. The compatibility study assessed whether the functionality and integrity of the
tested CSTDs are affected.

Conclusions:

The tested air-cleaning CSTDs failed to contain vapor, and significant concentrations were released into the environment, which were detected and quantified; Tetramethylurea concentrations were the highest, followed by Tetraethylurea. Propylene Glycol was proven to be an inappropriate and
ineffective surrogate since minimal detectable concentrations of Propylene Glycol were released into the environment from CSTDs that utilize carbon filters with additional hydrophobic filters. The study provided evidence and data to confirm that air-cleaning technologies can have varying efficiencies
based upon the chemical and physical make-up of the contaminant. The tested surrogates were found compatible under the tested conditions with the tested CSTDs.

Related Clinical Studies

Peer-Reviewed
2018
#air-tight

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

University of North Carolina
Peer-Reviewed
2021
#air-tight
#syringe unit
#syringe-contamination

An Assessment of Exposed Syringe Inner Walls as a Route of Exposure from Hazardous Drugs

UNC Eshelman School of Pharmacy
Peer-Reviewed
2015
#Head of Pharmacy
#Pharmacist
#plunger-contamination

Syringe plunger contamination by hazardous drugs: A comparative study

Journal Oncology Pharmacy Practice

References

1. (NIOSH) [2015]. A vapor containment performance protocol for closed system transfer devices used during pharmacy compounding and administration of hazardous drugs. Cincinnati, OH: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) NIOSH Docket Number 288, CDC-2015-0075.

2. NIOSH [2016]. A performance test protocol for closed system transfer devices used during pharmacy compounding and administration ofhazardous drugs. Cincinnati, OH: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) NIOSH Docket Number 288-A, CDC-2016-0090

3. Gonzalez R, Nekola J, Massoomi F. Assessment of testing method for closed system transfer devices across vapor release. NIOSH Docket 2016

4. Wilkinson A-S, Allwood MC, Mo11·is CP, Wallace A, Finnis R, Kaminska E, et al. Performance testing protocol for closed-system transfer devices used during pharmacy compounding and administration ofhazardous drugs. PLoS One. 2018;13(1O):e0205263.

5. Forshay CM, Streeter SO, Salch SA, Eckel SF. Application of the 2015 proposed NIOSH vapor containment performance protocol for closed system transfer devices used during pharmacy compounding and administration of hazardous drugs. J Oncol Pharm Pract. 2019;25(5):1160-1166.

6. IFEX (ifosfamide) prescribing information. Deerfield, IL: Baxter Healthcare Corporation. Revised March 2012.

7. NIOSH [2019] Mead KR, Glover SE. Status update to the NIOSH CSTD testing protocols. NIOSH, CDC, 2019.

8. NIOSH [2020] Hazardous drug exposures 1n healthcare. Accessed at: www.cdc.gov/niosh/topics/hazdrug/default.html

9. Gonzalez R, Nekola J, Massoomi F. Assessment of testing method for closed system transfer devices across vapor release. NIOSH Docket 2016.

10. Szkiladz A, Massoomi F, Hegner S. Evaluating a closed syste1n transfer device based on NIOSH performance test protocol, NIOSH Docket Number 288-A, CDC-2016- 0090. Northem Colorado, Loveland, CO: UCHealth; 2018. PMI5.

11. Halloush S, Reveles IA, Koeller J. Evaluating Six Commercially Available Closed­ System Drug-Transfer Devices Against NIOSH’s 2015 Draft Vapor Protocol. Hosp Pharm. 2020 Dec;55(6):391-399. doi: 10.1177/0018578719848730. Epub 2019 Jun 6. PMID: 33245720; PMCID: PMC7672663.