FDA clears device to protect caregivers from hazardous drug exposure

Corvida's Halo--Courtesy of Corvida

Iowa's Corvida Medical won the FDA's 510(k) clearance for its device to prevent healthcare workers from hazardous exposure to chemotherapy drugs.

The company said its Halo Closed System Transfer Device demonstrated that it can prevent escape of drugs and vapors into the environment and protect the drug from external contaminants. It's designed to be an improvement upon existing closed system transfer devices, like drug vial adapters, syringe and line adapters, and bag spikes, which can leak liquid or vapor while the drug is being transferred outs of its container or between different delivery devices.

According to the FDA, closed system transfer devices consist of a vial adapter designed to provide a sealed connection between the syringe, intravenous set, or transfer bag, and the vial storing the chemotherapy drug. The adapter is placed between the vial and the drug delivery device to shield caregivers from exposure.

"We are focused on developing and introducing products designed to meet critical unmet needs, and have worked closely with thought leaders throughout our product development efforts. The feedback on Halo has been phenomenal," said Corvida CEO Kent Smith, in a statement. "Health care professionals appreciate Halo's simplicity and we look forward to introducing it to the market."

Halo will be commercially available in late 2015, Corvida says.

In December the company received $5 million in Small Business Innovation Research Grants from the National Cancer Institute to study and evaluate the Halo. Corvida is still looking for cancer centers to participate in the study, according to its website.

The preparation and delivery of chemotherapy puts more than 5.5 million U.S. healthcare workers at risk of exposure, Corvida estimates. The potential health problems resulting from this exposure include cancer, reproductive and developmental problems, as well as other irreversible events that can occur after even low-level exposures, according to Occupational Safety & Health Administration and the National Institute of Occupational Safety & Health.

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