Sam Brusco, Associate Editor04.13.23
Magnolia Medical Technologies has earned U.S. Food and Drug Administration (FDA) 510(k) clearance of 19 new Steripath configurations in the company’s ISDD potfolio. The clearance provides an array of new options, including direct-to-bottle and BD Vacutainer UltraTouch push-button blood collection set configurations.
The Steripath Micro device family combines a small, intuitive design with the speed of traditional blood culture collection methods. The low-diversion volume blood culture collection device family has a specific FDA indication to reduce blood culture contamination.
All of the Steripath Micro needle configurations integrate with BD’s Vacutainer UltraTouch blood collection set. The needles have an ultra thin wall cannula for a larger inner diameter while maintaining a true-to-gauge outer cannula diameter. According to the company, the tech permits greater sample volume to be collected in blood culture bottles by improving rates of blood flow.
"We are delighted to launch the expanded family of Steripath Micro configurations as an integral part of our Initial Specimen Diversion Device portfolio. We developed the Steripath Micro platform in close collaboration with our customers to ensure the ability to provide improved blood culture accuracy for all patient populations, including those that are most vulnerable," Greg Bullington, CEO of Magnolia Medical told the press. "The availability of these configurations will further accelerate our co-selling and co-marketing activities with BD as all Steripath Micro needle configurations come standard with BD's best-in-class UltraTouch needle innovation. This new product offering demonstrates our continued commitment to providing hospitals and healthcare systems with the best possible solutions that optimally balance ease of use and clinical performance to support achievement of CLSI and CDC's new 1% goal for blood culture contamination rates."
Using an active blood culture bottle- or syringe-driven diversion method, Steripath Micro diverts the initial 0.5 to 1.0 mL of blood into the diversion chamber, preventing potential contaminants from distorting the blood sample. Once diversion is finished, the clinician pushes a button to sequester potential contaminants and automatically open a second, sterile blood flow pathway to collect blood for testing.
In October 2022, BD and Magnolia Medical began a co-exclusive commercial agreement aimed at helping U.S. hospitals reduce blood culture contamination by improving sepsis testing accuracy.
The Steripath Micro device family combines a small, intuitive design with the speed of traditional blood culture collection methods. The low-diversion volume blood culture collection device family has a specific FDA indication to reduce blood culture contamination.
All of the Steripath Micro needle configurations integrate with BD’s Vacutainer UltraTouch blood collection set. The needles have an ultra thin wall cannula for a larger inner diameter while maintaining a true-to-gauge outer cannula diameter. According to the company, the tech permits greater sample volume to be collected in blood culture bottles by improving rates of blood flow.
"We are delighted to launch the expanded family of Steripath Micro configurations as an integral part of our Initial Specimen Diversion Device portfolio. We developed the Steripath Micro platform in close collaboration with our customers to ensure the ability to provide improved blood culture accuracy for all patient populations, including those that are most vulnerable," Greg Bullington, CEO of Magnolia Medical told the press. "The availability of these configurations will further accelerate our co-selling and co-marketing activities with BD as all Steripath Micro needle configurations come standard with BD's best-in-class UltraTouch needle innovation. This new product offering demonstrates our continued commitment to providing hospitals and healthcare systems with the best possible solutions that optimally balance ease of use and clinical performance to support achievement of CLSI and CDC's new 1% goal for blood culture contamination rates."
Using an active blood culture bottle- or syringe-driven diversion method, Steripath Micro diverts the initial 0.5 to 1.0 mL of blood into the diversion chamber, preventing potential contaminants from distorting the blood sample. Once diversion is finished, the clinician pushes a button to sequester potential contaminants and automatically open a second, sterile blood flow pathway to collect blood for testing.
In October 2022, BD and Magnolia Medical began a co-exclusive commercial agreement aimed at helping U.S. hospitals reduce blood culture contamination by improving sepsis testing accuracy.