Closed System Drug Transfer Device
Encyclopedia
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.
, Sweden
) designed the first completely sealed drug delivery system where hazardous drugs could be transferred from pharmacy to patient without leakage and/or atmospheric contamination.
(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.
The NIOSH definition is the only definition that includes drug vapors.
History
In response to the initial reports of occupationally linked cancer within the scientific community the surgeon, scientist and part time inventor Dr. Bengt Gustavsson from Sahlgrenska University Hospital (GothenburgGothenburg
Gothenburg is the second-largest city in Sweden and the fifth-largest in the Nordic countries. Situated on the west coast of Sweden, the city proper has a population of 519,399, with 549,839 in the urban area and total of 937,015 inhabitants in the metropolitan area...
, Sweden
Sweden
Sweden , officially the Kingdom of Sweden , is a Nordic country on the Scandinavian Peninsula in Northern Europe. Sweden borders with Norway and Finland and is connected to Denmark by a bridge-tunnel across the Öresund....
) designed the first 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 HealthNational Institute for Occupational Safety and Health
The National Institute for Occupational Safety and Health is the United States’ federal agency responsible for conducting research and making recommendations for the prevention of work-related injury and illness. NIOSH is part of the Centers for Disease Control and Prevention within the U.S...
(NIOSH). This warning was issued in relation to studies that showed a correlation between working with or near hazardous drugs
Hazardous drugs
In pharmacology, hazardous drugs are drugs that are known to cause genotoxicity, which is the ability to cause a change or mutation in genetic material; carcinogenicity, the ability to cause cancer in animal models, humans or both; teratogenicity, which is the ability to cause defects on fetal...
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. This closed system definition originally referred to a biological safety cabinet and not to the drug containment devices. A drug containment device is one that is both airtight and leakproof.
- 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.
The NIOSH definition is the only definition that includes drug vapors.
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.
- 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.