Magnolia Medical's Steripath® Initial Specimen Diversion Device® Only Device Clinically Proven to Meet CDC's New Guidelines to Reduce Blood Culture Contamination

CDC Guidelines include formal recommendation to use "Initial Specimen Diversion Devices—these devices divert the initial 1 to 2 mL of potentially contaminated blood and then collect blood for blood culture."^1,2

SEATTLE, Aug. 23, 2022 /PRNewswire/ -- 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.

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, 2^nd 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.

The new CDC Guidelines reinforce the CLSI goal, stating that "when best practices are followed, a target contamination rate of 1% is achievable. Such thresholds can provide a method to benchmark within or between facilities." The CDC Guidelines also provided eight evidence-based practices for reducing blood culture contamination rates, including the use of Initial Specimen Diversion Devices® that divert the initial 1 to 2 mL of potentially contaminated blood prior to blood collection.

Steripath® is supported by extensive clinical evidence including 20 clinical and cost-effectiveness studies citing sustained contamination rates of 1% or below, up to a 31% reduction in vancomycin days of therapy, and as much as a 12-fold decrease in false-positive central line-associated bloodstream infections (CLABSIs) over extended periods of time.^7,8,9

"By increasing awareness of clinically proven technology solutions and best practice techniques, the CDC is playing a vital role in mobilizing the healthcare community to institute quality improvement efforts that reduce blood culture contamination in support of significantly improving sepsis testing accuracy," concluded Bullington.

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 Initial Specimen Diversion 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.

1. CDC. Blood Culture Contamination Prevention Actions: An Overview of Infection Control and Antibiotic Stewardship Programs Working with the Clinical Laboratory. July 2022.
2. CDC. National Email Update to Clinicians. Clinicians: Use this guide to decrease blood culture contamination rates. July 22, 2022.
3. CLSI. Principles and Procedures for Blood Cultures; Approved Guidelines. CLSI document M47-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2007.
4. Zwang O, Albert RK. Analysis of strategies to improve cost effectiveness of blood cultures. J Hosp Med. 2006;1(5):272-6. doi:10.1002/jhm.115.
5. CLSI. Principles and Procedures for Blood Cultures. 2nd Ed. CLSI Guideline M47. Clinical and Laboratory Standards Institute; 2022.
6. Indicated to reduce the frequency of blood culture contamination when contaminants are present, compared to standard method controls without diversion.
7. Date on file.
8. 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.
9. Tompkins LS, et al. Getting to zero: impact of a device to reduce blood culture contamination and false-positive central line-associated blood stream infections. Submitting to ICHE in 2022.

SOURCE Magnolia Medical Technologies