Closed system drug transfer device

A closed system drug transfer device is a drug transfer device that mechanically prohibits the transfer of environmental contaminants into a system and the escape of hazardous drug or vapor concentrations outside the system.

History

In response to the initial reports of occupationally linked cancer within the scientific community^[1][2] the surgeon, scientist and part time inventor Dr. Bengt Gustavsson from Sahlgrenska University Hospital (Gothenburg, Sweden) designed the first^{[citation needed]} completely sealed drug delivery system where hazardous drugs could be transferred from pharmacy to patient without leakage and/or atmospheric contamination.

Definition

The definition of a closed system drug transfer device was first published in an alert warning released by the American National Institute for Occupational Safety and Health (NIOSH). This warning was issued in relation to studies that showed a correlation between working with or near hazardous drugs in a health care environment and the increased risk of developing skin rashes, infertility, miscarriage and infant birth defects, as well as the possibility of developing leukemia and other forms of cancer. This NIOSH alert recommended that a closed system drug transfer device be used whenever hazardous drugs were to be handled.

NIOSH

NIOSH, in response to the need for a working model as to what a ‘closed system’ and what a ‘closed system drug transfer device’ was, provided the following definitions;

• A closed system is a device that does not exchange unfiltered air or contaminants with the adjacent environment.^[3] This closed system definition originally referred to a biological safety cabinet^[4] and not to the drug containment devices. A drug containment device is one that is both airtight and leakproof.^[5]

• A closed system drug transfer device is a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.^[3]

The NIOSH definition is the only definition that includes drug vapors.^[6]

ISOPP

ISOPP, the International Society of Oncology Pharmacy Practitioners splits the definition of a closed system into two different categories.

• The first defines ‘closed’ in terms of microbiological contamination. This definition deals purely with introducing micro-organisms into a sterile product, and there is no consideration of the sterile product coming out of the vial contaminating the environment.^[5]

• The second category defines ‘closed’ in relation to chemical contamination and refers to drug transfer devices that mechanically prohibit the transfer of environment contaminants into the system and the escape of hazardous drug or vapour concentrations outside the system. ISOPP, however, agree that the NIOSH definition is the most comprehensive and complete.^[5]

References

1. ^ Skov T, Maarup B, Olsen J, Rorth M, Winthereik H and Lynge E. Leukaemia and reproductive outcome among nurses handling antineoplastic drugs. Br J Ind.Med 1992;49:855-61
2. ^ Sessink PJM, Kroese ED, van Kranen HJ and Bos RP. Cancer risk assessment for health care workers occupationally exposed to cyclophosphamide. IIInter Arch Occup Environ Health 1993;67:317-23
3. ^ ^{a b} National Institute for Occupational Safety and Health (September 2004). "Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings". Centers for Disease Control and Prevention. http://www.cdc.gov/niosh/docs/2004-165/2004-165d.html. Retrieved October 26, 2009. 
4. ^ http://www.cdc.gov/od/ohs/biosfty/bsc/bsc.htm
5. ^ ^{a b c} ISOPP Journal of Oncology Pharmacy Practice Volume 13, 2007, pg 28-29.
6. ^ DHHS (NIOSH) Publication Number 2004–165, September 2004.