Sepsis testing device helps provide more accurate results and prevent patient harm

June 10, 2021

Magnolia Medical Technologies, Inc., inventors of Steripath, a FDA 510(k)-cleared device platform indicated to reduce blood culture contamination, announced continued clinical efficacy data supporting multiple, peer-reviewed clinical studies that confirm zero or near-zero false-positive rates from blood cultures drawn from peripheral intravenous (PIV) starts. These data signify that patient harm from avoidable venipunctures and sepsis misdiagnosis can be prevented.

Sepsis is a complex and aggressive syndrome impacting at least 1.7 million people in the U.S. annually of which nearly 270,000 die. When a patient presents with sepsis symptoms, clinical protocol often dictates that among other interventions, two PIVs are inserted for venous access to facilitate rapid treatment and two blood cultures are drawn to rule out or confirm diagnosis. These hospital and laboratory protocols typically disallow blood culture draws from PIVs because microorganisms on the skin and IV hub can contaminate the test blood specimen. Consequently, patients must endure an additional one to two needle sticks.

The Steripath Initial Specimen Diversion Device (ISDD) diverts and sequesters the guideline-recommended blood volume most likely to contain skin-residing microorganisms in an easy-to-use sterile, vein-to-bottle closed system. By engineering human factors out, Steripath has been proven to deliver blood culture contamination rates approaching zero via both venipuncture and PIV starts.

“By reducing the number of venipunctures, Steripath enables us to improve diagnostic stewardship while doing what is best for patients and our nurses,” said Mary Bell, MS, RN, CEN and principal investigator of a large, multicenter study published in the Journal of Emergency Nursing. “Our study demonstrated that even when the majority of 6,293 cultures were drawn from PIV starts, blood culture contamination rates were only 0.6%. Today, over 85% of blood cultures across four Lee Health emergency departments are drawn from PIV starts using Steripath.”

Magnolia Medical Technologies has the release.