Magnolia Medical Technologies, Inc., commends the Center for Disease Control and Prevention (CDC) for releasing its new evidence-based guidelines, Blood Culture Contamination: An Overview for Infection Control and Antibiotic Stewardship Programs Working with the Clinical Laboratory. These guidelines support Magnolia Medical’s Mission to ZERO with the goal of eliminating sepsis misdiagnosis and are intended to aid hospitals and healthcare systems in designing and implementing proven practices and technologies that decrease blood culture contamination rates. Steripath Initial Specimen Diversion Device, is the only FDA 510(k)-cleared device platform specifically indicated to reduce blood culture
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Blood cultures are the gold standard test for detecting bloodstream infections, including sepsis. This blood test is one of the most clinically important and frequently performed diagnostic tests in U.S. hospitals; however, up to half of positive blood culture results are false-positive due to contamination in a typical hospital.3,4 These false-positive results compromise the quality of patient care and can lead to unnecessary and prolonged antibiotic exposure, extended hospital stay, and significant avoidable hospital costs.
Magnolia Medical’s flagship product family, the Steripath Initial Specimen Diversion Device, is the only FDA 510(k)-cleared device platform specifically indicated to reduce blood culture contamination.6 Steripath diverts and sequesters the initial 1.5 to 2.0 mL of blood prior to specimen collection. Steripath® is also the only all-in-one device solution that meets both the recently published CLSI M47 Principles and Procedures for Blood Cultures, 2nd Edition 2022, and CDC’s new evidence-based guidelines for reducing blood culture contamination.
“Magnolia Medical has invested over a decade in product and clinical evidence development as well as training and education to support hospitals and healthcare providers nationwide in our collective mission to eliminate sepsis misdiagnosis,” said Greg Bullington, CEO, and Co-founder of Magnolia Medical. “We are delighted to see the significant progress made toward a 1% or below national standard for blood culture contamination and are humbled to see our technology platform, the Initial Specimen Diversion Device®, specifically recognized within the CDC Guidelines.”
Recently, the Clinical and Laboratory Standards Institute (CLSI), a national organization that develops and sets standards for laboratory quality and performance, established a 1% goal, with best practices, for blood culture contamination.5 This new goal represents a 66% reduction compared to the longstanding national standard target contamination rate. All six studies cited within the CLSI guideline examined the clinical efficacy of Steripath and/or referenced Steripath®-specific datasets and reported a sustained 1% or lower contamination rate.