Magnolia Medical’s Steripath® Initial Specimen Diversion Device® Clinically proven device to meet new CDC guidelines to reduce blood culture contamination

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The CDC guidelines include a formal recommendation to use “initial sample diversion devices – these devices divert the initial 1-2 ml of potentially contaminated blood and then draw blood for blood culture.”1.2

SEATTLE, August 23, 2022 /PRNewswire/ — Magnolia Medical Technologies, Inc., congratulates the Center for Disease Control and Prevention (CDC) on the release of its new evidence-based guidelines, Blood Culture Contamination: Overview of Infection Control and Antibiotic Stewardship Programs in Collaboration with the Clinical Laboratory. These guidelines support Magnolia Medical’s ZERO® mission to eliminate sepsis misdiagnosis and are intended to help hospitals and health systems design and implement proven practices and technologies that reduce rates. contamination of blood cultures..

Blood cultures are the gold standard test for detecting blood infections, including sepsis. This blood test is one of the most clinically important and most frequently performed diagnostic tests in US hospitals. however, up to half of positive blood culture results are false positives 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 exposure to antibiotics, prolonged hospital stay and significant avoidable hospital costs.

Magnolia Medical’s family of flagship products, 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 first 1.5 to 2.0 ml of blood prior to sample collection. Steripath® is also the only all-in-one device solution that meets both recently published standards CLSI M47 Principles and Procedures for Blood Cultures, 2n/a 2022 edition, and new CDC evidence-based guidelines to reduce blood culture contamination.

“Magnolia Medical has invested more than a decade in product development and clinical evidence as well as training and education to support hospitals and healthcare providers nationwide in our collective mission to eliminate misdiagnosis of sepsis,” said Greg Bullington, CEO and co-founder of Magnolia Medical. “We are excited to see the significant progress being made toward a national standard of 1% or less for blood culture contamination and are honored to see our technology platform, the Initial Specimen Diversion Device®, specifically recognized in 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% best practice target for blood culture contamination.5 This new target represents a 66% reduction from the long-standing national standard target contamination rate. The six studies cited in the CLSI guidelines examined the clinical effectiveness of Steripath® and/or referenced Steripath®-specific data sets and reported a sustained contamination rate of 1% or less.

The new CDC guidelines reinforce the CLSI’s goal, stating that “when best practices are followed, a target contamination rate of 1% is achievable. Such thresholds can provide a gold standard within or between facilities.” The CDC guidelines also provided eight evidence-based practices to reduce blood culture contamination rates, including the use of Initial Sample Diversion Devices® that divert the initial 1-2 mL of potentially contaminated blood before the blood sample.

Steripath® is supported by extensive clinical evidence, including 20 clinical and cost-effectiveness studies citing sustained contamination rates of 1% or less, up to a 31% reduction in vancomycin treatment days and a decrease of up to 12 times central false positives. catheter-associated bacteremia (CLABSI) over long periods of time.7,8,9

“By raising awareness of clinically proven technology solutions and best practices, the CDC plays a critical role in mobilizing the healthcare community to institute quality improvement efforts that reduce blood culture contamination in order to significantly improve the accuracy of sepsis testing,” concluded Bullington.

About Magnolia Medical Technologies

Magnolia Medical Technologies develops, manufactures and markets innovative blood and body fluid collection devices to facilitate significant improvements in the accuracy, consistency and predictability of critical laboratory testing. 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 built an intellectual property portfolio, including over 100 issued method, device and design patents and over 70 additional patent applications pending. For more information, visit www.magnolia-medical.com.

  1. CDC. Actions to prevent blood culture contamination: overview of infection control and antibiotic management programs in collaboration with the clinical laboratory. July 2022.
  2. CDC. National email update to clinicians. Clinicians: Use this guide to reduce blood culture contamination rates. July 22, 2022.
  3. CLSI. Principles and procedures for blood cultures; Approved guidelines. CLSI document M47-A. Wayne, Pennsylvania: Clinical and Laboratory Standards Institute; 2007.
  4. Zwang O, Albert RK. Analysis of strategies to improve the profitability 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 M47 guideline. Clinical and Laboratory Standards Institute; 2022.
  6. Indicated to reduce the frequency of contamination of blood cultures when contaminants are present, compared to non-diversion standard method controls.
  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 Centers. J Hosp Infect. 2021;117. do I:https://doi.org/10.1016/j.jhin.2021.10.017.
  9. Tompkins L.S., et al. Getting to Zero: Impact of a Device to Reduce Blood Culture Contamination and False-Positive Bacteremia Associated with Central Lines. Submission to the ICHE in 2022.

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