Equashield logo black
Evaluation of Vial Transfer Devices for Containment of Hazardous Drug Vapors
Cam Au, Pharm.D, Bart Smith, Pharm.D

Evaluation of Vial Transfer Devices for Containment of Hazardous Drug Vapors

University of Utah
Cam Au, Pharm.D, Bart Smith, Pharm.D
Salt Lake City, Utah
2016

Background

Medical personnel have been examining the issues of exposure to hazardous medications and prevention. Malformations, spontaneous abortions, and stillbirths have been associated with exposures to cytostatic agents. Closed-system drug transfer devices are recommended by the National Institute for Occupational Safety and Health (NIOSH) for the containment of hazardous drugs. The purpose
of this study is to examine available products utilized for drug-transfer to determine which device prevents the escape of vapor meeting the NIOSH definition of closed.

Methods

Nine drug-transfer devices were tested:

  • Spiros™ Male Connector and Clave® (ICU Medical Inc.)
  • Vial Adapter and Clave® (ICU Medical Inc.)
  • B. Braun OnGuard™ System (Teva Medical Ltd.)
  • Chemo Mini-Spike Plus™ Dispensing Pin (B. Braun Medical Inc.)
  • Alaris’ Smart Site® (Cardinal Health)
  • CyTwo-Fer (Baxa)
  • CHEMO-AIDE (Baxter)
  • Chemoprotect Spike® (Codan US Corporation)
  • PhaSeal® Protector 50 & Injector Luer Lock (Carmel Pharma)

Titanium tetrachloride (TiCl4) was used to simulate gas-containing active drug. Titanium tetrachloride generates very visible smoke when it comes into contact with moisture in the air. It was placed into glass vials attached to the above transfer devices to determine which system prevents the escape of vapor.

Results / Conclusions

Only the PhaSeal® System prevented the release of titanium smoke out of the closed-system drug transfer device. Only the PhaSeal® System met the NIOSH definition of a closed-system drug transfer device.

PhaSeal® by Carmel Pharma

Evaluation of Vial Transfer Devices for Containment of Hazardous Drug Vapors

PhaSeal® by Carmel Pharma

Chemo Mini-Spike Plus™ Dispensing Pin

Spiros™ Male Connector and Clave® by ICU Medical Inc.

Spiro Male Connector and Clave

Vial Adapter and Clave® by ICU Medical Inc.

Vial Adapter and Clave® by ICU Medical Inc.

B. Braun OnGuard™ System by Teva Medical Ltd.

Evaluation of Vial Transfer Devices for Containment of Hazardous Drug Vapors

Alaris’ Smart Site® by Cardinal Health

Alaris’ Smart Site® by Cardinal Health

CyTwo-Fer by Baxa

CyTwo-Fer by Baxa

CHEMO-AIDE by Baxter

CHEMO-AIDE by Baxter

Chemoprotect Spike® by Codan US Corporation

Chemoprotect Spike® by Codan US Corporation

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
#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. National Institute for Occupational Safety and Health. NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf American Society of Health System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63: 1172-93.