Medical technology company BD and Magnolia Medical Technologies announced a co-exclusive commercial agreement aimed at helping U.S. hospitals reduce blood culture contamination to help improve testing accuracy and clinical outcomes. Under the agreement, BD and Magnolia Medical will both co-sell and co-market Magnolia Medical’s Steripath and Steripath Micro Initial Specimen Diversion Device platforms, complementing the BD specimen collection portfolio, including BD Vacutainer push button and BD Vacutainer UltraTouch blood collection sets.
Steripath is an FDA 510(k)-cleared device platform specifically indicated to reduce blood culture contamination for sepsis testing accuracy.i The Steripath Initial Specimen Diversion Devices divert and sequester the initial 1.5 to 2 mL of potentially contaminated blood from the sample and then collect blood for blood cultures.
The Steripath platform offers all-in-one devices clinically proven to meet the Clinical and Laboratory Standards Institute’s (CLSI) new 1% blood culture contamination goal and new U.S. Centers for Disease Control and Prevention (CDC) guidelines to reduce blood culture contamination. The CDC guidelines specifically recommend use of Initial Specimen Diversion Devices [which] divert the initial 1 to 2 mL of potentially contaminated blood and then collect blood for blood culture.ii ,iii, iv
“Sepsis is the number one cause of death, readmissions and costs in hospitals today,” says Brooke Story, BD Integrated Diagnostic Solutions president. “It’s estimated that up to 56% of positive blood cultures can be contaminated during collection. Reducing blood culture contamination can help improve testing accuracy and ultimately improve clinical outcomes and may lessen the threat of antibiotic resistance by giving health care practitioners more specific, reliable results.”
To date, 20 studies have been completed supporting the clinical and cost effectiveness of Steripath. All clinical studies reported sustained contamination rates of 1% or less using Steripath and a study achieved a 31% reduction in vancomycin days of therapy. v, vi
“This collaboration represents a strong step forward in advancing our Mission to ZERO initiative to increase awareness within the health care community of the role that accurate testing plays in enabling antimicrobial stewardship and quality outcomes,” says Greg Bullington, CEO of Magnolia Medical. “By offering a combined innovative technology solution with the Steripath Initial Specimen Diversion Device platform and BD Vacutainer push-button and BD Vacutainer UltraTouch blood collection sets, we are aligning our shared commitment to improve patient outcomes, help hospitals achieve their quality goals, and reduce unnecessary hospital costs.”
Steripath has been adopted by hundreds of U.S. hospitals and health care systems to address the problem of blood culture contamination, which can lead to sepsis misdiagnosis resulting in unnecessary, prolonged, and harmful antibiotic treatment, extended length of hospital stay, false-positive CLABSIs, and wasted health care resources, according to the company.
i Indicated to reduce the frequency of blood culture contamination when contaminants are present, compared to standard method controls without diversion. K192247 (Steripath Gen2 Blood Collection System FDA clearance letter).
ii CLSI. Principles and Procedures for Blood Cultures. 2nd Ed. CLSI Guideline M47. Clinical and Laboratory Standards Institute; 2022.
iii CDC Blood Culture Contamination Prevention Actions: An Overview of Infection Control and Antibiotic Stewardship Programs Working with the Clinical Laboratory. July 2022
iv CDC National Email Update to Clinicians. Clinicians: Use this guide to decrease blood culture contamination rates. July 22, 2022
v Data on file.
vi Nielsen LE, Nguyen K, Wahl CK, et al. Initial Specimen Diversion Device® reduces blood culture contamination and vancomycin use in academic medical center. J Hosp Infect. 2021;117. doi:https://doi.org/10.1016/j.jhin.2021.10.017.