Evaluation of three barrier-type closed system transfer devices using the 2015 NIOSH
vapor containment performance draft protocol
Andrew Szkiladz PharmD, BCPS, BCOP 1; Shawn Hegner PharmD, BCSCP 2
1 Baystate Health, Springfield, MA; 2 Riverside Health System, Newport News, VA

Results

Introduction

Objectives• To evaluate the performance of three barrier-type CSTDs in
minimizing the transfer of 70% IPA vapor into the surrounding
environment during simulated compounding andadministration tasks.
• Efficiency and ease of use during simulated compounding andadministration tasks were assessed as secondary outcomes.

Maximum Readings of 70% IPA Vapor During Tasks 1 and 2
30...i===+=====i=======+=====+=======+=====+=======+=====i====a25+---+---+-----+---+------t---+----

Maximum Reading (ppm)• Healthcare worker exposure to hazardous drug (HD) vapor
may result in serious side effects.
• To verify that a Closed System Transfer Device (CSTD) canmechanically restrict the release of HDs, NIOSH has provided
guidance for the evaluation of barrier-type CSTDs.
• To evaluate a CSTD’s performance in preventing the escape ofdrug vapors, NIOSH developed a 2015 draft testing protocol
incorporating two compounding tasks utilizing 70% isopropylalcohol (IPA) as a hazardous drug surrogate.

Conclusion

20-+---+----+-----+----l------+----+-----+----1-----1

15-+---+----+-----+----l------+----+-----+----1-----110+--+---l-----+---l-----+-----!-------,1--+---I

5-+---+----+-----+----1------+----+-----+----I-----I

Q+---'

TaskDevice

121

Che mo Lock

21PhaSeal

212

EquaShieldP. Control♦ EquaShield_. P. ControlDevice♦ Chemolock■ PhaSeal

7C06

Time to Complete (min)• Three different CSTDs were evaluated by repeating eachsimulated compounding and administration tasks six times• Task 1 involved compounding of a lyophilized drug and IV bag
preparation• Task 2 involved compounding of lyophilized drug and bolus
administration• Tasks were performed inside a Secador Technidome 360
Vacuum Desiccator with IPA escaping vapor collected andanalyzed using a Miran SapphIRe Infrared Analyzer• Modifications were made to the protocol to allow the CSTDs
to be used in accordance with manufacturer’s instruction foruse and to represent clinical practice• Time to complete tasks was recorded for each CSTD

05§> ~- "'
(X)

4-)

--~

Contact and Disclosures-0'• Andrew Szkiladz — andrew.szkiladz@baystatehealth.org• Shawn Hegner – dr.hegner@gmail.com• Andrew Szkiladz and Shawn Hegner have received honorarium from ICU
Medical for previous speaker roles

0~3~l-a;-n'0·~-00

2----1.,_-.,_-0TaskDevice'1References[1] National Institute for Occupational Safety and Health(NIOSH): A Performance Test Protocol for Closed System
Transfer Devices Used During Pharmacy Compounding andAdministration of Hazardous Drugs. NIOSH Docket # 288-A

Duration to Complete Tasks 1 and 2Methods• Measurements from the three CSTDs were determined tohave statistically equivalent IPA vapor release below the IPA
1.0 ppm limit of detection.
• In comparison, the positive control (needle and syringe),demonstrated significantly higher vapor release and increased
time commitment to perform the simulated tasks.
• Max duration to complete each task was shortest withChemolock, followed by Equashield and PhaSeal• Given that barrier type CSTDs are effective in vapor
containment, healthcare workers should consider otherfactors (ease of use, workflow, time savings), when choosing aCSTD.
• Healthcare workers should remain cognizant that CSTDs only
provide an additional layer of safety and does not take theplace of other engineering and safety controls and practices'2Chemolock

'1''

2

1PhaSeal'2'1'2EquaShieldP. Control□ EquaShield□ P. ControlDevice□ Chemolock□ PhaSeal

Secador Technidome
360 Vacuum Desiccator