First FDA-cleared blood culture diversion device with preassembled integrated syringe optimized for ‘hard stick’ patients and syringe collection protocols.
Magnolia Medical announced today the launch of the new Steripath Gen2 Initial Specimen Diversion Device with integrated syringe. The trusted solution for reducing blood culture contamination is now optimized for ‘hard stick’ patients and syringe collection protocols.
The Steripath Gen2 with integrated syringe is designed to address the difficult intravenous access (DIVA) or ‘hard stick’ patient population. This innovative device provides healthcare workers the precise control to carefully collect blood samples from patients with compromised vasculature. The DIVA population represents a large percentage of all patients, 17-59%, that present symptomatic for sepsis and require blood cultures. Steripath Gen2 with integrated syringe additionally benefits hospitals that require syringe collection as part of their blood culture protocol.
“We are pleased to introduce the first FDA-cleared initial specimen diversion device with integrated syringe,” said Greg Bullington, CEO of Magnolia Medical. “This new product introduction represents an important step forward for the Steripath product family as we expand the tools available to help nurses, phlebotomists and healthcare workers address unique needs for specific patient circumstances.”
The patented Steripath® Gen2 ISDD® product portfolio, including both direct-to-media and syringe configurations, are the only FDA 510(k)-cleared devices indicated to reduce blood culture contamination. This exclusive indication was cleared by the FDA based on peer-reviewed published controlled clinical studies demonstrating Steripath’s ability to reduce blood culture contamination by 83% and 88%.
The Steripath Gen2 platform integrates user-controlled negative pressure to divert and sequester the initial 1.5 to 2.0 mL of blood collected for culture, the portion known to most likely contain contaminants. The device has been demonstrated effective for use with blood cultures drawn via both venipuncture and peripheral IV starts.
Steripath is a clinically proven solution to address a significant hidden problem in healthcare: the misdiagnosis of sepsis. Improving the accuracy of diagnostic test results for sepsis reduces unnecessary antibiotic treatment. This helps to address the growing threat of antibiotic-resistance, decreases hospital length of stay and associated healthcare-acquired infections while significantly reducing avoidable hospital costs.