In Recognition of Sepsis Awareness Month, Magnolia Medical Intensifies Efforts to Combat the Clinical and Economic Risks of Sepsis Misdiagnosis

News provided by

Sep 07, 2023, 13:15 ET

The company's goal is to further educate the patient and provider community on the
devastating impacts of sepsis misdiagnosis, including its role in antimicrobial
resistance.

SEATTLE, Sept. 7, 2023 /PRNewswire/ -- Magnolia Medical Technologies, Inc., the inventors of the Steripath® Initial Specimen Diversion Device® (ISDD®) and the ISDD market, is intensifying efforts to combat sepsis misdiagnosis this Sepsis Awareness Month. In recognition of the far-reaching implications of an inaccurate sepsis test result, including the risk of accelerating antimicrobial resistance (AMR), the company is committed to raising awareness through peer-reviewed scientific data and programmatic education.

"Sepsis is not just a medical emergency; it's a societal crisis that exacts a terrible toll on patients and the healthcare system, alike. Our company mission is to prevent the avoidable harm and unnecessary deaths caused by sepsis misdiagnoses via our innovative platforms and solutions that help address this significant risk to patient safety and care quality," said Greg Bullington, CEO and Co-Founder of Magnolia Medical.

The Importance of Sepsis Awareness Month
Sepsis Awareness Month is of particular significance to Magnolia Medical. The company's co-founders have observed firsthand the effects of inaccurate sepsis test results, fueling their passion for eliminating this preventable error for the world. According to a recent survey conducted among over 1,000 Americans, 31% of respondents have either had sepsis or have had a loved one directly impacted. Bullington elaborates that, "Sepsis is the leading cause of death, readmissions, and healthcare costs in U.S. hospitals. A staggering 270,000 Americans die from sepsis annually. Yet, the condition and the role of key diagnostic tests remain poorly understood by the public."

The Purpose of Blood Cultures
Blood cultures are the gold standard test for detecting bloodstream infections, including sepsis. This 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.^1,2 These false-positive results compromise the quality of patient care and can lead to unnecessary and prolonged antibiotic exposure, extended hospital stay, significant avoidable hospital costs, and an increase in in-patient mortality rates. In a recent study performed at the University of Arkansas, researchers found a significant, near doubling (8% vs 4.6%) of in-patient mortality rate for patients that had contaminated blood cultures vs. the true negative blood culture control group.³

The Link to Antimicrobial Resistance
The misdiagnosis of sepsis has additional implications, including its connection to antimicrobial resistance (AMR). The World Health Organization has identified AMR as one of the top 10 global public health threats facing humanity. "When sepsis is misdiagnosed, it often leads to the unnecessary administration of antibiotics. Antibiotics, while lifesaving, can contribute to the development of antimicrobial resistant bacteria. This is a critical issue that requires immediate attention," said Tammy Johnson, AVP, Clinical Strategy at Magnolia Medical.

Magnolia Medical's Initiatives
Magnolia Medical is sponsoring a webinar at the 2023 Sepsis Alliance Summit, titled "State of Sepsis Awareness 2023," on September 28th. The webinar will feature key findings from the company's extensive survey, provide valuable insights into the current state of sepsis awareness, and offer actionable steps for healthcare providers. One key finding from the survey is that respondents impacted by sepsis are 49% more aware that "inaccurate results from a blood culture test can lead to unnecessary administration of antibiotics" compared to those who have not been impacted by sepsis.

A Call to Action
Despite its severity, sepsis still does not receive the level of public attention it deserves, creating the need for educational outreach and innovative solutions. "We are fully committed to bridging this gap," stated Bullington. "Our education efforts through Sepsis Alliance are just one of many initiatives we are engaged in to promote patient safety and advocacy. We are committed for the long-term, and will continue to drive awareness, action, and better standards for blood culture results and improved sepsis testing accuracy. We remain steadfast in driving our mission forward until we have reached our goal of zero patients harmed."

About Steripath
The Steripath^® Initial Specimen Diversion Device^® family of products are FDA 510(k)-cleared with a specific indication to reduce blood culture contamination.⁴ They are the only all-in-one device platform clinically proven to meet the ENA, INS, CDC, and CLSI evidence-based best practice guidelines to reduce blood culture contamination.^5,6,7,8,9 To date, 20 clinical studies have been completed supporting the clinical and cost effectiveness of Steripath. All studies reported sustained contamination rates of 0-1% using Steripath, 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.^10,11,12

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 Initial Specimen Diversion Device® (ISDD®) for blood culture collection and contamination prevention. The company has amassed an intellectual property portfolio protecting its novel innovative technologies, including more than 150 issued method, apparatus, and design patents with more than 50 additional patent applications pending. For more information, visit www.magnolia-medical.com.

CLSI. Principles and Procedures for Blood Cultures; Approved Guidelines. CLSI document M47-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2007.
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.
Klucher J, Davis K, Lakkad M, Painter JT, Dare RK. Risk factors and clinical outcomes associated with blood culture contamination. Infect Control Hosp Epidemiol. 2022;43(3):291-297. doi:10.1017/ice.2021.111.
Indicated to reduce the frequency of blood culture contamination when contaminants are present, compared to standard method controls without diversion.
Blood Culture Contamination Prevention Actions: An Overview of Infection Control and Antibiotic Stewardship Programs Working with the Clinical Laboratory. July 2022.
Principles and Procedures for Blood Cultures. 2nd Ed. CLSI Guideline M47. Clinical and Laboratory Standards Institute; 2022.
CDC National Email Update to Clinicians. Clinicians: Use this guide to decrease blood culture contamination rates. July 22, 2022.
Vanhoy MA, Horigan A, Kaiser J, et al. Emergency Nurses Association (ENA). Clinical practice guideline: prevention of blood culture contamination. 2020.
Gorski LA, Hadaway L, Hagle ME, et al. Infusion therapy standards of practice, 8th edition. J Infus Nurs. 2021 Jan-Feb 01;44(1S Suppl 1): S1-S224.doi: 10.1097/NAN.0000000000000396.
Date on file.
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. Accepted for publication by ICHE on Nov 7, 2022.