ABOUT Halo®: Literature

Thirteen-Center Site Study Funded by NCI SBIR Grant Shows Halo® Delivers Significant Reduction of Contamination in the Preparation and Administration of Hazardous Drugs – Opens as PDF in your browser.

Corvida Medical’s Halo® Closed System Transfer Device (CSTD) has been shown to reduce surface contamination in both the mixing and administration of antineoplastic hazardous drugs (AHDs) in a thirteen center US site study. The results of the study, which was made possible through an NCI-Funded SBIR grant, were revealed in a poster presentation on March 30, 2017 at the annual Hematology Oncology Pharmacists Association annual conference.

Corvida Halo® CSTD is FDA 510(k) Cleared – Opens as PDF in your browser.

Emerging medical device firm Corvida Medical® has received a 510(k) clearance from the US Food and Drug Administration (FDA) to market its first product, the Halo Closed System Transfer Device (CSTD), to protect healthcare professionals from exposure to hazardous drugs. The device received an ONB product code classification from the FDA, demonstrating no escape of hazardous drug or vapor concentration, no transfer of environmental contaminants, and prevention of microbial ingress.

Using the Corvida Halo® CSTD for the prevention of microbial ingress – Opens as PDF in your browser.

This white paper evaluates the Halo Closed System Transfer Device for the prevention of microbial ingress. Conclusion: Even after severe challenge conditions of fourteen connections, the Halo® dry-to-dry seal connections can effectively prevent microbial ingress when used with aseptic swabbing techniques. All seals in the Halo device feature a raised design to facilitate swabbing.

Drug resistance of materials used in Corvida Halo® Closed System Transfer Device – Opens as PDF in your browser.

This white paper evaluates the drug resistance of materials used with the Halo Closed System Transfer Device.  Conclusion: This series of tests demonstrate that even after Halo® devices are exposed to drugs over extended periods at elevated temperatures (up to 72 hours at 37°C) and subjected to 14 manipulations, they are capable of containing fluid and vapors. The materials within the Halo® components have been shown to be compatible with even the most aggressive drug solvents, including dimethylacetamide, that has been contraindicated for other CSTDs currently on the market.

Pressure test of Corvida Halo® Closed System Transfer Device Opens as PDF in your browser.

This white paper evaluates the ability of Halo Closed System Transfer Device components to contain air pressure as an indicator of the ability to contain fluid and vapors.  Conclusion: The Halo seal system has been designed to assure a high level of safety to the clinician from hazardous drug exposure. This test demonstrated that even after subjected to an extreme number of connections (fourteen), the Halo® components continue to provide containment of pressure. Although it is very unlikely that any of the components would be subjected to 30 psi, this test provides the clinician with the confidence that there is a significant margin of safety when using the Halo® to protect from hazardous drug exposure.

A comparative test for fluid containment between Corvida Halo® and BD PhaSeal® Closed System Transfer Devices – Opens as PDF in your browser.

This white paper evaluates the effectiveness of the Halo Closed System Transfer Device to contain fluids.  Conclusion: Corvida Halo® provides superior fluid containment as compared to BD PhaSeal® when subjected to multiple uses of the devices. The Halo® seal system has been designed to assure a high level, even when challenged to extreme conditions, such as 14 fluid transfers. This is especially important in protecting clinicians when multiple vial accesses and drug transfers are involved.

A comparative test for vapor containment between Corvida Halo® and BD PhaSeal® Closed System Transfer Devices – Opens as PDF in your browser.

This white paper evaluates the effectiveness of the Halo Closed System Transfer Device to contain vapors.  Conclusion: Corvida Halo® provides superior vapor containment as compared to BD PhaSeal® when subjected to multiple uses of the devices. The Halo® seal system has been designed to assure a high level of vapor containment, even when challenged to extreme conditions, such as 14 fluid transfers. This is especially important in protecting clinicians when multiple vial accesses and drug transfers are involved.