Equashield Closed System Receives FDA Clearance Under ONB Product Code
PORT WASHINGTON, New York, May 27, 2014 /PRNewswire/ -- Equashield ( http://www.equashield.com ), a leading provider of Closed System Transfer Devices (CSTDs) for hazardous drugs, today 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 vapor and aerosols outside the system. This minimizes both environmental and individual exposure to hazardous drugs.
In a recent article in Pharmacy Practice News, CSTD expert James Jorgenson wrote about the cost saving potential of using closed systems. He noted that while the upfront cost of a CSTD might seem high, “for every $1 spent on CSTDs, a hospital has the potential to save $5,” through drug vial optimization.
“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.
About Equashield
Equashield is a leading provider of Closed System Transfer Devices (CSTDs), clinically proven to protect healthcare professionals from hazardous drug exposure. The company’s flagship device, EQUASHIELD® II, is the fastest CSTD to deploy and easiest to use. It provides superior safety, and covers more routes of exposure than alternative systems, by preventing the contamination of syringe plungers. It also prevents exposure to drug vapor. For more information, visit the company’s website at http://www.equashield.com . Follow Equashield on Twitter: @equashield.
Media Contact: Finn Partners for Equashield Ellie Hanson ellie@finnpartners.com EllieSheva @
SOURCE Equashield
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