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{{expert needed|Pharmacology|date=October 2009}}
{{expert needed|Pharmacology|date=October 2009}}
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.
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. As of October 2017, there is insufficient evidence to assess whether CSTD technologies protect handlers of hazardous drugs compared to safe handling.

==Medical use==
Hazardous drugs are often used for patients suffering from cancer.<ref name="Cochrane 2018 Gurusamy" /> For example, [[chemotherapy]] agents are routinely used in the treatment of cancer. However, chemotherapy can be dangerous to a person even if they don't have cancer, as chemotherapy often indiscriminately affects both healthy and cancerous cells.<ref name="ACS Chemo">{{cite web|title=How Chemotherapy Drugs Work|url=https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/chemotherapy/how-chemotherapy-drugs-work.html|website=www.cancer.org|publisher=American Cancer Society|accessdate=15 May 2018|language=en}}</ref> For the healthcare worker tasked with preparing hazardous medications like chemotherapy, manipulation of these agents presents a substantial risk; for example, it may negatively affect their fertility, increase their risk of developing certain cancers themselves, or have unwelcome effects on fetuses.<ref name="Cochrane 2018 Gurusamy" /> As an addition to standard safe handling practices, CSTDs are devices that are designed to additionally limit exposure of hazardous drugs to the personnel that manipulate them.<ref name="Cochrane 2018 Gurusamy" />

==Efficacy==
A [[Cochrane review]], summarizing the current data up until 26 October 2017, found "no evidence for or against adding CSTD to safe handling of hazardous medicines" based on a review of 23 studies.<ref name="Cochrane 2018 Gurusamy">{{cite journal|last1=Gurusamy|first1=Kurinchi Selvan|last2=Best|first2=Lawrence MJ|last3=Tanguay|first3=Cynthia|last4=Lennan|first4=Elaine|last5=Korva|first5=Mika|last6=Bussières|first6=Jean-François|title=Closed-system drug-transfer devices plus safe handling of hazardous drugs versus safe handling alone for reducing exposure to infusional hazardous drugs in healthcare staff|journal=Cochrane Database of Systematic Reviews|date=27 March 2018|doi=10.1002/14651858.CD012860.pub2|accessdate=15 May 2018}}</ref>


==History==
==History==

Revision as of 01:46, 15 May 2018

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. As of October 2017, there is insufficient evidence to assess whether CSTD technologies protect handlers of hazardous drugs compared to safe handling.

Medical use

Hazardous drugs are often used for patients suffering from cancer.[1] For example, chemotherapy agents are routinely used in the treatment of cancer. However, chemotherapy can be dangerous to a person even if they don't have cancer, as chemotherapy often indiscriminately affects both healthy and cancerous cells.[2] For the healthcare worker tasked with preparing hazardous medications like chemotherapy, manipulation of these agents presents a substantial risk; for example, it may negatively affect their fertility, increase their risk of developing certain cancers themselves, or have unwelcome effects on fetuses.[1] As an addition to standard safe handling practices, CSTDs are devices that are designed to additionally limit exposure of hazardous drugs to the personnel that manipulate them.[1]

Efficacy

A Cochrane review, summarizing the current data up until 26 October 2017, found "no evidence for or against adding CSTD to safe handling of hazardous medicines" based on a review of 23 studies.[1]

History

In response to the initial reports of occupationally linked cancer within the scientific community[3][4] 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 definition:

  • A closed system is a device that does not exchange unfiltered air or contaminants with the adjacent environment.[5] This closed system definition originally referred to a biological safety cabinet[6] and not to the drug containment devices. A drug containment device is one that is both airtight and leakproof.[7]
  • 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.[5]

The NIOSH definition is the only definition that includes drug vapors.[8] NIOSH considers the containment of vapor extremely important, such that in September 2015, NIOSH issued a Testing Protocol to assess the effectiveness of closed systems.[9] NIOSH developed and tested 5 CSTDs to assess its "closeness." 2 of the 5 CSTDs tested passed. This protocol is aimed as being a test standard for CSTDs to assess the "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.[7]
  • 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.[7]

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.[10] This protocol had an initial close date of November 2015 but was extended until March 2016. Findings from "Fred Massoomi's Response to Docket No. CDC-2015-0075, NIOSH-288" include:

  • 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.[11]
  • Testing performed under "5-FU leakage study" showed that Equashield CSTD passed the leakage testing.[12]
  • Testing performed under "Testing of Tevadaptor Efficiency in Preventing Cyclophosphamide" showed that the Tevadaptor system FAILED the contain drug vapor within the system.[13]

Solutions

Commercially available CSTD products include the following:[14]

  • PhaSeal
  • Spiros
  • Tesium/SmartSite
  • Tevadaptor
  • ChemoClave
  • ChemoLock
  • Vialshield
  • Equashield II

References

  1. ^ a b c d Gurusamy, Kurinchi Selvan; Best, Lawrence MJ; Tanguay, Cynthia; Lennan, Elaine; Korva, Mika; Bussières, Jean-François (27 March 2018). "Closed-system drug-transfer devices plus safe handling of hazardous drugs versus safe handling alone for reducing exposure to infusional hazardous drugs in healthcare staff". Cochrane Database of Systematic Reviews. doi:10.1002/14651858.CD012860.pub2. {{cite journal}}: |access-date= requires |url= (help)
  2. ^ "How Chemotherapy Drugs Work". www.cancer.org. American Cancer Society. Retrieved 15 May 2018.
  3. ^ 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
  4. ^ 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
  5. ^ 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. Retrieved October 26, 2009.
  6. ^ https://www.cdc.gov/od/ohs/biosfty/bsc/bsc.htm
  7. ^ a b c ISOPP Journal of Oncology Pharmacy Practice Volume 13, 2007, pg 28-29.
  8. ^ DHHS (NIOSH) Publication Number 2004–165, September 2004.
  9. ^ "Regulations.gov". www.regulations.gov. Retrieved 2015-11-03.
  10. ^ https://www.regulations.gov/#!documentDetail;D=CDC-2015-0075-0007
  11. ^ CDC Comment CDC-2015-0075-0027 Attachment 2: https://www.regulations.gov/#!documentDetail;D=CDC-2015-0075-0027
  12. ^ CDC Comment CDC-2015-0075-0027 Attachment 3: https://www.regulations.gov/#!documentDetail;D=CDC-2015-0075-0027
  13. ^ CDC Comment CDC-2015-0075-0027 Attachment 1: https://www.regulations.gov/#!documentDetail;D=CDC-2015-0075-002
  14. ^ Page, Michael. "Closed-System Transfer Devices: Design Characteristics and Evolving Performance Standards". www.pharmacytimes.com. Pharmacy & Healthcare Communications, LLC. Retrieved 15 May 2018.
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