Equashield, a leading provider of closed system transfer devices (CSTDs) for hazardous drugs, announced that its first and second generation closed systems have received FDA ONB product code clearance and have been substantiated to prevent microbial ingress up to a time period of seven days and for up to ten reconnections of drug transfer components. The multiple reconnection capabilities of Equashield are expected to result in significant cost savings for hospitals.

"We are pleased our products have received FDA clearance and have been uniquely substantiated to prevent microbial ingress for a time period of up to seven days," said Marino Kriheli, co-founder of Equashield. "Having passed through the FDA's rigorous 510(k) review process, we will continue to ensure that hundreds of healthcare environments remain as safe as possible by preventing hazardous drug exposure."

Equashield mechanically prevents the transfer of environmental contaminant into the system and the escape of drug or drug vapour and aerosols outside the system. This minimises both environmental and individual exposure to hazardous drugs.

"The FDA created the new ONB code for closed antineoplastic and hazardous drug transfer systems over a year ago to simply improve the information available to users of closed system transfer devices," added Kriheli. "But today, more validated third-party evidence is required to obtain clearance."

A study recently published in The Journal of Oncology Pharmacy Practice entitled "Syringe plunger contamination by hazardous drugs: A comparative study." and performed at Detroit's Karmanos Cancer Center, found that Equashield's products also uniquely prevent plunger contamination, a major route of exposure to hazardous drugs.