Magnolia Medical Announces Expansion of Its Extensive Clinical Evidence Library with Six Steripath® ISDD® Studies in 2021 Demonstrating Zero or Near-Zero False Positive Sepsis Test Results

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Nov 11, 2021, 13:15 ET

SEATTLE, Nov. 11, 2021 /PRNewswire/ -- Magnolia Medical Technologies, Inc., inventors of Steripath®, the only FDA 510(k)-cleared device platform indicated to reduce blood culture contamination for sepsis testing,¹ today announced that six studies, reporting zero or near-zero blood culture contamination rates and up to a 31% reduction in vancomycin days of therapy (DOT) using Steripath, were submitted, accepted and published in peer-reviewed publications or presented at national medical conferences in 2021.

These conferences and journals include the Emergency Nurses Association (ENA), Association for Professionals in Infection Control (APIC), Society for Healthcare Epidemiology of America (SHEA), American Journal of Medical Quality, Journal of Hospital Infection, American Journal of Infection Control, and Journal of Emergency Nursing.

The six studies reported reductions in blood culture contamination ranging from 80% to 100% with sustained rates of less than 1% in each. This significant improvement in performance level is notable as compared to the national average benchmark of 3%.^2,3,4,5,6,7 Additionally, one study reported the first direct correlation between a demonstrated 90% reduction in blood culture contamination using Steripath and a 31% reduction in vancomycin DOT⁵. This finding is significant as reducing inappropriate antibiotic therapy is the ultimate goal of reducing blood culture contamination.

Blood culture is the gold standard for detecting blood stream infections, including sepsis. It is one of the most frequently performed diagnostic tests in U.S. hospitals with an estimated 58 million tests performed each year. A reduction in blood culture contamination from 3% to 1% equates to approximately 1.2 million fewer patients impacted by a potential misdiagnosis of sepsis.

Additionally, the sites within these studies experienced the added value and convenience of using Steripath for blood culture draws from peripheral intravenous (PIV) starts. Steripath is the only device clinically proven in 12 studies, including 4 peer-reviewed publications, to deliver zero or near-zero contamination rates via this method. Using Steripath with PIV starts aligns with the workflow and sepsis protocol within many emergency departments (EDs), where most blood cultures are typically collected. This technique enables nurses to leverage PIV starts for blood culture draws eliminating up to two additional venipunctures per patient. This reduction in avoidable venipunctures can improve both patient safety and satisfaction.

"We are honored to have been selected by these hospitals and healthcare systems as a partner for their patient safety and quality improvement initiatives to advance to a higher standard for sepsis diagnostic accuracy," said Greg Bullington, CEO and co-founder of Magnolia Medical. "As a company founded on and committed to clinical evidence, we continue to be encouraged by the extensive and consistent clinical data generated by leading healthcare institutions further supporting the impact Steripath can have on improving outcomes."

Blood cultures tests are an essential tool used to diagnose bloodstream infections including sepsis, determine the specific pathogen causing the infection, and target appropriate antimicrobial therapy to treat the patient. The problem with the test lies within the collection process. During venipuncture, skin fragments containing viable microorganisms are often dislodged and collected with the blood specimen. These organisms can contaminate the sample and cause the patient to receive a false-positive result. Decades of research shows that false-positive blood culture results routinely lead to unnecessary and prolonged use of broad-spectrum antibiotics, which can have significant downstream clinical and cost consequences.

Steripath, a sterile vein-to-bottle or vein-to-syringe closed-system device, addresses the issue by diverting and sequestering skin microbes that most commonly cause contamination, helping to ensure specimen integrity and accurate test results.

Steripath has demonstrated clinical and cost-effectiveness in 20 studies, including 7 peer-reviewed publications. Results have demonstrated sustained zero or near-zero blood culture contamination rates, and up to a 12-fold decrease in false-positive CLABSIs.⁸ This data demonstrating the clinical performance of Steripath affirms that patient harm resulting from false-positive sepsis diagnoses can be prevented.

About Magnolia Medical

Magnolia Medical Technologies develops, manufactures, and markets innovative blood and bodily fluid collection devices to facilitate significant improvements in the accuracy, consistency, and predictability of critical laboratory tests. Magnolia Medical invented and patented the Initial Specimen Diversion Technique (ISDT™) and Device (ISDD®) for blood culture collection and contamination prevention. The company has amassed an intellectual property portfolio, including more than 100 issued method, apparatus, and design patents with more than 70 additional patent applications pending. For more information, visit www.magnolia-medical.com.

References:

Indicated to reduce the frequency of blood culture contamination when contaminants are present, compared to standard method controls without diversion.
Merola C. (2021). Initial Specimen Diversion Device Associated with a 94% Lower Blood Culture Contamination Rate. Presented at the Fall 2021 Emergency Nurses Association (ENA) meeting.
Schaefer C. (2021). Antimicrobial Stewardship Standards and Patient Safety: A Case Study in Blood Culture Contamination. Presented at the Spring 2021 The Society for Healthcare Epidemiology of America (SHEA) meeting. https://www.cambridge.org/core/journals/antimicrobial-stewardship-and-healthcare-epidemiology/article/antimicrobial-stewardship-standards-and-patient-safety-a-case-study-in-blood-culture-contamination/5F725CC4A88B49313A942CE0930BDE09
Data on file for submitted manuscript for publication in the American Journal of Medical Quality.
Data on file for pending publication in the Journal of Hospital Infection.
Arenas M, et al. (2021). Asynchronous Testing of 2 Specimen-Diversion Devices to Reduce Blood Culture Contamination: A Single-Site Product Supply Quality Improvement Project. Journal of Emergency Nursing, 47(2): 256-264. https://www.jenonline.org/article/S0099-1767(20)30383-4/fulltext
Brownfield K, et al. (2021). Emergency Department Observes 83% Reduction in Blood Culture Contamination with Initial Specimen Diversion Technology Adoption. American Journal of Infection Control, 49(6): S14. https://www.sciencedirect.com/science/article/abs/pii/S0196655321002479
Tompkins LS, MD, PhD, et al. (2020). Eliminating Blood Culture Contamination with an Initial-specimen Diversion Device. Open Forum Infectious Diseases, 7 (Suppl 1): S187.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7776884/