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Study Performed by Nebraska Methodist Medical Center, Omaha Nebraska. Performed by Fred Massoomi, Fouzia Berdi & Richard Gonzalez, 2015
Over the last 15 years, CSTDs have evolved in technology and offer various mechanism for containing liquid and protecting healthcare workers. Some systems perform better than others and 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 newest addition in the market, compares with its claims to be leak-free and dry for up to 10 connections or membrane activations. This study looks 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
manufacturer’s claims.
Tests performed with 3 different PH liquid and was qualitative in nature.
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 routinebasis.To perform this test the followingmaterialswere used:
Prior to start of the test, 10 vials each of varying pH solutions were prepared for assessment in lieu of actual drugs for a total of 30 vials.
All necessary supplies were gathered for testing and following process steps were performed:
Data collection sheets were effectively 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.
After performing the dry connection effectiveness test for 300 samples, 0 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
Key take away from the study can be summarized below:
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 vendor’s claims.
Study Performed by Nebraska Methodist Medical Center, Omaha Nebraska. Performed by Fred Massoomi, Fouzia Berdi & Richard Gonzalez, 2015
Over the last 15 years, CSTDs have evolved in technology and offer various mechanism for containing liquid and protecting healthcare workers. Some systems perform better than others and 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 newest addition in the market, compares with its claims to be leak-free and dry for up to 10 connections or membrane activations. This study looks 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
manufacturer’s claims.
Tests performed with 3 different PH liquid and was qualitative in nature.
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 routinebasis.To perform this test the followingmaterialswere used:
Prior to start of the test, 10 vials each of varying pH solutions were prepared for assessment in lieu of actual drugs for a total of 30 vials.
All necessary supplies were gathered for testing and following process steps were performed:
Data collection sheets were effectively 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.
After performing the dry connection effectiveness test for 300 samples, 0 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
Key take away from the study can be summarized below:
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 vendor’s claims.
EQUASHIELD® is a technology leader. We set the industry bar on quality, ease of use, safety, and efficiency.
“It is a privilege to design and manufacture highly innovative compounding solutions that protect healthcare workers from exposure to hazardous drugs”
