Introduction
Hazards associated with handling of chemotherapy drugs are well documented [1-3]. Ensuring healthcare worker safety should be a priority, and organizations are wise to invest significant time in development of a comprehensive HD safety program. Guidelines provided by NIOSH Alert[1], ASHP recommendations[2] and Proposed USP <800>[3] offer a list of process steps needed to safely compound hazardous drugs. As the new NIOSH proposed CSTD test protocol comes into play, it is crucial to test all aspects of closed systems: exposure containment, fully airtight design and, equally importantly, a dry, leak-free design. This is important as facilities are quickly able to perform benchtop testing to assess the ‘closeness’ of devices.
Objectives
Over the last 15 years, CSTDs have evolved in technology and offer various mechanisms for containing liquid and protecting healthcare workers. Some systems perform better than others, and this is a pure correlation of product design and materials chosen for prevention of leaks and spills. The key objective of this study is to assess how one Closed System Transfer Device, a new addition to the market, compares with its claims to be leak-free and dry for up to 10 connections or membrane activations. This study looks at only one Closed System Transfer Device; the second generation Equashield CSTD was assessed against a predefined and controlled protocol in a hospital facility to validate or invalidate the manufacturer’s claims.
Tests were performed with 3 different pH liquids and were qualitative in nature.
Materials
To assess whether the Closed System is dry, it will be tested against several solutions to mimic various drugs’ pH levels seen in chemotherapy compounding on a routine basis. To perform this test the following materials were used:
- 10 vials with pH 4 liquid solution
- 10 vials with pH 7 liquid solution
- 10 vials with pH 10 liquid solution
- 30 Equashield VA-20/2 vial adaptors
- 30 Equashield SU-EZ60/2 syringe units
- Litmus paper
- Data collection sheets per protocol
Prior to the start of the test, 10 vials each of the three varying pH solutions were prepared for assessment in lieu of actual drugs, for a total of 30 vials.
Figure 1. Sample preparation process.
Figure 2. Test assembly.
Figure 3. pH test summary results.
Methods
All necessary supplies were gathered for testing and the following process steps were performed:
- A pH 4 vial was retrieved.
- The corresponding data collection sheet was retrieved.
- The vial was fitted with a VA-20/2 vial adaptor as per the manufacturer’s instructions for use.
- An SU-EZ60/2 syringe unit was retrieved and connected to the vial with vial adaptor.
- A small volume of fluid was transferred from the vial into the syringe unit.
- The syringe unit was disconnected from the vial with vial adaptor.
- Using litmus paper, both membranes (vial adaptor membrane and syringe unit membrane) were assessed.
- If the litmus paper changed color, it was marked as ‘x’ on the data collection sheet (denoting system failure). If the litmus paper did not change color, it was marked as ‘y’ on the data collection sheet (denoting that the system passed the test).
- After the 1st vial connection and disconnection, the same syringe and vial assembly were connected again, fluid was transferred, the assembly was disconnected, and the membranes were tested for wetness/color change to denote the 2nd connection or membrane activation.
- This action was performed for up to 10 connections per vial and pH solution.
Data collection sheets were populated for all test samples, for a total of 3 buffer solutions, 10 vials per solution and 10 activations per vial, totaling 300 data points.
Results
After performing the dry connection effectiveness test for 300 samples, no failures were documented. None of the samples tested across all 3 pH levels created leaks or wet membranes. Furthermore, it should be noted that the controls were positive, confirming the integrity of the test solution. Figure 3 outlines the summary results of the test.
* Each test included 10 manipulations
√ denotes no residuals detected — X denotes residue was detected
Conclusion
Key takeaways from the study can be summarized below:
- Commonly found pH levels were tested in this protocol to assess the device’s ability to remain dry
- 300 measurements were generated by this study protocol with no residues found on the surface in any sample
- Equashield was put to the test for its claim of being able to maintain a dry connection for up to 10 activations and passed the test
Equashield was leak-free and dry and meets the NIOSH definition of a closed system transfer device with respect to its ability to maintain dry connections, validating the vendor’s claims.
