Chemo Leaks

Team
HumanEra
Timeline
Completed May 2012

Summary

Several instances of leaking chemotherapy were reported at a facility delivering outpatient chemotherapy in Ontario. These leaks occurred at the Clave needle-free connector near the bottom of the primary intravenous tubing set for the Hospira Plum A+ pump. To mitigate these leaks, the facility implemented the Spiros closed male luer. Despite implementing this technology, leaks continued at the facility.

Using a variety of data collection and analysis techniques such as informal interviews, in-house experiments and a cause and effect analysis, the HumanEra team investigated the underlying technical issues that may have contributed to this series of leaks.

Potential factors identified that may have contributed to the leaks included:

  • The manufacturer of the Clave connector changed the design of the bottom-most Clave connector to a lower profile.
  • Chemotherapy agents may cause microcracks, especially at the high fluid flow rates sometimes used when delivering chemotherapeutic agents.
  • The tubing that leaked may have come from a faulty lot or lots.
  • The silicon seal within the Clave connector, which serves to block flow of unwanted fluid, may have become stuck in the “open” position, in effect allowing fluid to flow freely through the device.
  • Two versions of the Spiros closed male luer were available and in use, with one design having a non-visible internal seal that had to be broken during attachment.
  • The two versions of the Spiros closed male luer looked similar.
  • When the non-visible internal seal was broken prior to attachment, it was difficult to achieve a tight connection between the Spiros closed male luer and interfacing components. Loose connections resulted in leaks during bench testing.
  • Differences in manufacturing tolerance were measured on samples of Hospira Plum A+ and Hospira Symbiq primary intravenous tubing sets, with the differences affecting how how the primary intravenous tubing set extended into the Spiros closed male luer.
  • The two versions of the Spiros closed male luer could be removed from each type of connection tested resulting in the potential for an open system, and thus leaks.

In addition to these factors, other circumstances likely played a role in perpetuating the issue at the primary facility including a delay in communication between front-line staff and management, and inconsistent use of personal protective equipment by front-line staff.

Funding Agency

Health Quality Ontario

Research Reports:

Griffin, M., Easty, A., (2012). Chemotherapy Exposure and Closed System Drug Transfer Devices.

Organization

University Health Network

Project Team

Tony Easty

Melissa Griffin (lead)

Arthur Sivadon (student)

Rachel White

Rossini Yue (student)

For more information about this project, contact:

Melissa Griffin