Newly Released CLSI National Blood Culture Guidelines Identify Best Practices and Evidence-Based Technology Solutions Such as Steripath® to Improve Patient Safety and Outcomes

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May 05, 2022, 13:15 ET

Steripath^® Initial Specimen Diversion Device^®, a clinically proven solution, enables hospitals to meet the new goal of 1% blood culture contamination as published in CLSI's M47 Principles and Procedures for Blood Cultures, 2^nd Edition 2022

SEATTLE, May 5, 2022 /PRNewswire/ -- Magnolia Medical Technologies, Inc., commends Clinical Laboratory Standards Institute (CLSI) for establishing a goal of 1% blood culture contamination with best practices in its M47 Principles and Procedures for Blood Cultures, 2^nd Edition 2022.

This new 1% goal for blood culture contamination represents a 66% reduction to the long-standing national standard of care target. Additionally, CLSI is recognizing for the first time, based on clinical studies conducted using Steripath, the critical role that diversion technology can play in diagnostic testing accuracy for sepsis.

Magnolia Medical's flagship product family, Steripath, was designed and developed to enable hospitals to dramatically reduce blood culture contamination. Steripath is supported by extensive clinical evidence including 20 clinical and cost-effectiveness studies all citing sustained contamination rates of 1% or below. This performance profile with Steripath aligns with CLSI's new best practice guidelines. Steripath is the only commercially available device platform with the specific FDA 510(k)-cleared indication to reduce blood culture contamination.¹

CLSI, a non-profit member organization, develops and establishes standards for laboratory quality and performance. CLSI employs a rigorous evidence-based process to set medical laboratory standards and guidelines that help laboratories fulfill their responsibilities with testing quality, effectiveness, and accuracy.

The new CLSI M47 Principles and Procedures for Blood Cultures, 2^nd Edition 2022 includes recommendations for collecting, transporting, and processing specimens for blood culture, the standard of care test used to diagnose blood stream infections including sepsis. The guidelines are intended to help inform standards for laboratorians and other healthcare providers including administrators who develop institutional best practices.

The new M47 guidelines state, "Even when optimal blood specimen collection protocols are used, completely eliminating blood culture contamination may be impossible. However, laboratories should still be able to achieve blood culture contamination rates substantially lower than 3%. When best practices are followed, a target contamination rate of 1% is achievable".²

The new guidelines include a QA Indicator for Specimen Collection, "The benchmark for blood culture contamination rate is less than 3%, with a goal of 1% when best practices are followed".²

The guidelines conclude with, "Recently, self-contained devices that achieve initial specimen diversion without extra collection tubes have become available. Studies have also demonstrated reduced blood culture contamination rates when these devices are used^91-96".²

Of note, all six studies cited in CLSI's new guidelines examined the clinical efficacy of Steripath and/or referenced Steripath-specific studies and reported a sustained 1% or lower contamination rate.^3-8

"CLSI's newly established best practice goal of 1% blood culture contamination represents a major step forward for patient safety and quality outcomes in the suspected sepsis population," said Greg Bullington, CEO of Magnolia Medical. "We are proud to partner with hospitals using Steripath, a clinically proven technology platform, to achieve this new goal for sepsis testing accuracy and to support their diagnostic and antimicrobial stewardship initiatives."

To date, 20 clinical studies have reported sustained contamination rates of 1% or less using Steripath. Additional results reported within these studies utilizing Steripath include up to a 31% reduction in vancomycin days of therapy, and as much as a 12-fold decrease in false-positive central line-associated blood stream infections (CLABSIs) over extended periods of time.^9,10,11

Thirteen of the 20 studies evaluated Steripath's effectiveness in reducing blood culture contamination via both venipuncture and peripheral IV starts. All 13 studies reported sustained contamination rates of 1% or below when Steripath was used in the emergency department, inpatient departments, and hospital wide.^3,4,8,9,11

These studies with Steripath have been conducted at all types of acute care hospitals, including major academic teaching institutions, government military and VA medical centers, and large and small community hospitals, and demonstrate improved sepsis testing accuracy.¹¹

Steripath has been adopted by hundreds of U.S. hospitals and healthcare 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 healthcare resources.

About Magnolia Medical Technologies

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.

Indicated to reduce the frequency of blood culture contamination when contaminants are present, compared to standard method controls without diversion.
CLSI. Principles and Procedures for Blood Cultures. 2^nd Ed. CLSI Guideline M47. Clinical and Laboratory Standards Institute; 2022.
Arenas M, Boseman GM, Coppin JD, Lukey J, Jinadatha C, Navarathna DH. Asynchronous testing of 2 specimen-diversion devices to reduce blood culture contamination: a single-site product supply quality improvement project. J Emerg Nurs. 2021;47(2):256-264.e6. doi:10.1016/j.jen.2020.11.008.
Bell M, Bogar C, Plante J, Rasmussen K, Winters S. Effectiveness of a novel specimen collection system in reducing blood culture contamination rates. J Emerg Nurs. 2018;44(6):570-575. doi:10.1016/j.jen.2018.03.007.
Geisler BP, Jilg N, Patton RG, Pietzsch JB. Model to evaluate the impact of hospital-based interventions targeting false-positive blood cultures on economic and clinical outcomes. J Hosp Infect. 2019;102(4):438-444. doi:10.1016/j.jhin.2019.03.012.
Rupp ME, Cavalieri RJ, Marolf C, Lyden E. Reduction in blood culture contamination through use of Initial Specimen Diversion Device. Clin Infect Dis. 2017;65(2):201-205. doi:10.1093/cid/cix304.
Skoglund E, Dempsey CJ, Chen H, Garey KW. Estimated clinical and economic impact through use of a novel blood collection device to reduce blood culture contamination in the emergency department: a cost-benefit analysis. J Clin Microbiol. 2019;57(1):e01015-18. doi:10.1128/JCM.01015-18.
Zimmerman FS, Assous MV, Zevin S, Wiener-Well Y. Reducing blood culture contamination using an Initial Specimen Diversion Device. Am J Infect Control. 2019;47(7):822-826. doi:10.1016/j.ajic.2018.12.004.
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.
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.
Date on file.