Closed system drug transfer device
A closed system drug transfer device or "CSTD" 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 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 definition:
- 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] NIOSH Considers the containment of vapor extremely important that in September 2015, NIOSH issued a Testing Protocol to assess the effectiveness of closed systems[7] NIOSH developed and tested 5 CSTDs to assess its 'closeness.' 2 of the 5 CSTDs passed this testing while the other 3 failed. This protocol is aimed as being a test standard for Closed Systems to assess 'closeness' of each system.
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]
NIOSH Vapor Containment Protocol Proposal Comment Period Developments
In September 2015, the CDC issued a proposal for a testing protocol designed to test various CSTDs on the market today to help healthcare decision makers decipher between various systems available on the market today.[8] This protocol had an initial close date of November 2015 but was extended until March 2016. This period highlighted may opinions of what should be considered a closed system transfer device (Mechanical closure vs. filter based system) and led to several organizations commenting. Only 1 comment presented actual data based on testing performed after the comment period initiation. Below are the findings:
- Testing performed under "Report on NIOSH's Vapor Containment Performance Protocol for CSTDs" showed that Equashield and PhaSeal systems had contamination below the 1ppm recommendation [9]
- Testing performed under "5-FU leakage study" showed that Equashield CSTD passed the leakage testing [10]
- Testing performed under "Testing of Tevadaptor Efficiency in Preventing Cyclophosphamide" showed that the Tevadaptor system FAILED the contain drug vapor within the system.[11]
Solutions
The following vendors provide a CSTD to address the issue:
- ChemoLock by ICU Medical, Inc
- Equashield by Equashield, LLC
- PhaSeal by BD Medical, Inc
- TevAdaptor by Teva Medical Ltd
- YarakShield by CareFusion, Inc
References
- ↑ 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
- ↑ 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
- 1 2 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. Retrieved October 26, 2009.
- ↑ http://www.cdc.gov/od/ohs/biosfty/bsc/bsc.htm
- 1 2 3 ISOPP Journal of Oncology Pharmacy Practice Volume 13, 2007, pg 28-29.
- ↑ DHHS (NIOSH) Publication Number 2004–165, September 2004.
- ↑ "Regulations.gov". www.regulations.gov. Retrieved 2015-11-03.
- ↑ https://www.regulations.gov/#!documentDetail;D=CDC-2015-0075-0007
- ↑ CDC Comment CDC-2015-0075-0027 Attachment 2: https://www.regulations.gov/#!documentDetail;D=CDC-2015-0075-0027
- ↑ CDC Comment CDC-2015-0075-0027 Attachment 3: https://www.regulations.gov/#!documentDetail;D=CDC-2015-0075-0027
- ↑ CDC Comment CDC-2015-0075-0027 Attachment 1: https://www.regulations.gov/#!documentDetail;D=CDC-2015-0075-002