Evaluation of two closed system transfer devices based on the proposed
National Institute for Occupational Safety and Health performance test protocol
Andrew Szkiladz, PharmD, BCPS, BCOP, Baystate Health, Springfield, MA; Shawn Hegner, PharmD, UCHealth- Northern Colorado, Loveland, COPurposeResults

Methods

Two Vial Adapter Technologies Tested Included
AIR-CAPTURE BARRIER

Barrier Technology
Utilizes an external balloon designed
to equalize pressure in the vial andlimit the escape of hazardous drug
particles and air.

AIRFROM
VIAL

Barrier Technology

Air-cleaning Technology
Utilizes a 0.22 micron Filter designedto equalize pressure in the vial andlimit the escape of hazardous drug
particles while allowing air to escape.

Task 2 – Administration: Simulate administration via IV push by reconstituting
a drug using a vial adapter, CSTD syringe adapter and administration
set with a Y-site and CSTD port.
Task 3 – Liquid Compounding: Simulate admixing an IVPB medication using
a vial adapter, CSTD syringe adapter and bag spike. This task is notoutlined in the NIOSH protocol, however, was added to simulate acommonly performed task in the pharmacy.
ChemoLockwith Air-Cleaning

ChemoClavewith Barrier

ChemoClavewith Air-Cleaning

Needle andSyringe

Task 1 – Reconstitution

44443

Task 2 – Administration

4444

N/A

Task 3 – Liquid Compounding

4444

N/A

ChemoClave“ICU Medical acknowledges that NIOSH’s draft Performance Test Protocol referenced in the study is not an accepted test protocol tomeasure the effectiveness of a closed system and is yet to be finalized; therefore, any references to a “pass result” does not indicate thatthe draft Performance Test Protocol includes any finalized standards or criteria to be satisfied or that NIOSH endorses ICU Medical or
any other manufacturer as a vendor of closed system transfer devices.” NIOSH defines a closed system as a “a drug transfer device thatmechanically prohibits the transfer of environmental contaminants into the system and the escape of HD or vapor concentrations outsideof the system.123”

23NIOSH Alert Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings.
Available from https://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf Accessed June 2019.
USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings 2017.
Available from https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare Accessed June 2019.
ASHP Guidelines on Handling Hazardous Drugs.
Available from https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/handling-hazardous-drugs.ashx Accessed June 2019.

NeedleandSyringe

Task 1
Reconstitution
Task 2Administration

47000ng

4817ngTask 3Liquid Compounding

Negative
Control

ChemoLock ChemoLock ChemoClave ChemoClave
withwithwithwith
Air-Cleansing
Barrier
Air-Cleansing
Barrier

Nondetectable

Nondetectable

Nondetectable

Nondetectable

Nondetectable

Nondetectable

Nondetectable

Nondetectable

Nondetectable

Nondetectable

Nondetectable

Nondetectable

Nondetectable

Nondetectable

Nondetectable

Detection of Propylene Glycol outside of a Closed System Transfer Device
50,00030,00020,00010,0000Positive
Control

18G Needle
and Syringe

Negative
Control

ChemoLock
Vial Spike with
Barrier
Technology

ChemoLock
Vial Spike with
Air-Cleaning
technology

ChemoClave
Vial Spike with
Barrier
Technology

ChemoClave
Vial Spike with
Air-Cleaning
Technology

Conclusions

Air-Cleaning Technology

1

Positive
Control<25ng considered static non-detectable

ChemoLockwith Barrier

ChemoLock

Detection of Propylene Glycol outside of a Closed System Transfer Device

40,000

Task 1 – Reconstitution: Simulate reconstitution using a vial adapter, CSTD
syringe adapter and bag spike.

# of Trials

0.22 MICRON FILTERAIRFROM
VIAL

The protocol as outlined by NIOSH Docket
Number 288-A, CDC-2016-0090 was used
for the evaluation of the two CSTD. Propylene
glycol, chosen as a surrogate to represent
hazardous drugs, was diluted in a 10:1 ratio
in water and a ¼ inch stainless steel thermal
desorption tube with Tenax TA sorbent 35/60
was used. The air pump flow rate was set to50ml/min with a task time of 5 minutes. A needle-free membrane-to-membrane
barrier and air-cleaning CSTD, a needle-free ISO standard luer lock barrier
and air-cleaning CSTD, and a traditional needle and syringe were all evaluated.
A positive control was also evaluated by placing one drop of the surrogate onto
the chamber platform. An independent laboratory using thermal desorption-gas
chromatography-mass spectrometry (TD-GC-MS) analyzed the desorption tubes.

Ng

A performance test protocol for closed system transfer devices (CSTD) is currently
being developed by National Institute for Occupational Safety and Health (NIOSH)
researchers along with healthcare industry representatives and individual
researchers. The intent of this protocol is to test the CSTD’s ability to restrict drug
mass from escaping the system. While the current third iteration of the protocol isapplicable to both barrier and air-cleaning types of CSTD, it should be noted that
this protocol is not yet finalized and subject to change. The purpose of this study
was to evaluate two different CSTD technologies based on the most recent NIOSH
performance test protocol, NIOSH Docket Number 288-A, CDC-2016-0090. The
two CSTD tested included a needle-free membrane-to-membrane connection witha barrier type vial adaptor or an air-cleaning vial type adaptor, and a needle-free
ISO standard luer lock connection with a barrier type vial adaptor or an air-cleaningvial adaptor.

Each CSTD evaluated yielded non-detectable results, passing the current
proposed NIOSH test protocol. These results demonstrate the effectiveness ofeach CSTD in reducing and limiting any potential hazardous drug exposure during
all tasks performed, especially when compared to a needle and syringe. However,results of this assessment should not be interpreted to represent the performanceof all FDA cleared CSTDs. While the purpose of the draft NIOSH performance
test protocol is to test the capability of a CSTD to perform as such, it is importantto evaluate other design characteristics of the CSTD as well, such as bonding,locking mechanism, and ease of use. It should be noted that all current CSTD on
the market are FDA cleared and meet the USP 800 standard. Furthermore, it is
crucial to be cognizant of the fact that a CSTD only provides an additional layerof safety and does not take the place of other engineering and safety controls.

REFERENCES
National Institute for Occupational Safety and Health (NIOSH): A Performance Test Protocol for Closed System Transfer
Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs. NIOSH Docket Number 288-A

Barrier
Vial Adaptor

Air-Cleaning
Vial Adaptor

Barrier
Vial Adaptor

Air-Cleaning
Vial Adaptor

DISCLOSURESAndrew Szkiladz: Honoraria - ICU Medical; Shawn Hegner: Honoraria - ICU Medical