Large-scale, peer-reviewed study quantifies multiple devastating patient harms associated with blood culture contamination and most significantly, a 74% increase in risk of in-hospital patient mortality

Recently published University of Arkansas study examined the patient-specific risk factors and clinical outcomes associated with contaminated blood cultures for patients with suspected bloodstream infections

SEATTLE, Jan. 24, 2023 /PRNewswire/ -- Magnolia Medical Technologies, Inc. ("Magnolia Medical"), inventors of the Steripath^® Initial Specimen Diversion Device^® (ISDD^®), the only FDA 510(k)-cleared device platform specifically indicated to reduce blood culture contamination for sepsis testing accuracy¹, today shared the publication of recent clinical results from the University of Arkansas for Medical Sciences (UAMS) Medical Center in Little Rock, Arkansas. This four-year retrospective analysis examined the clinical and financial impacts of blood culture contamination on patient safety, outcomes, and in-hospital patient mortality.

Blood cultures are the gold standard diagnostic test for detecting blood stream infections, including sepsis. Blood culture is one of the most frequently performed diagnostic tests in U.S. hospitals with an estimated 58 million tests each year. However, positive blood culture results are frequently wrong, with approximately 40% of positive results returning a false-positive result due to contamination.

These false-positive results can lead to the misdiagnosis of sepsis and subject the patient to unnecessary, prolonged, and harmful broad-spectrum antibiotic treatment and unnecessary extended length of in-patient hospital stay. This in turn increases the risk for acute kidney injury, Clostridioides difficile infection (CDI), Multidrug-Resistant Organism (MDRO) infections, other hospital-acquired infections (HAI), and significant avoidable hospital costs.

The study, entitled "Risk factors and clinical outcomes associated with blood culture contamination", published in the peer-reviewed medical journal Infection Control & Hospital Epidemiology, specifically compared clinical outcomes for patients with contaminated blood cultures (cases) against the clinical outcome of patients with negative blood cultures (controls) for inpatients with blood cultures collected in the Emergency Department (ED) from 2014 to 2018.

Based on their four-year retrospective analysis, researchers reported that after controlling for age, race, Body Mass Index (BMI), comorbidities, and sepsis, blood culture contamination increased vancomycin days of therapy by 40 percent, the risk of acute kidney injury by 40 percent as well, and lengthened patient hospital stay by 24 percent. The most alarming finding, however, was the significant, near doubling of in-hospital patient mortality rate – from a 4.6 percent in-hospital patient mortality rate for patients in the true negative blood culture control group to an 8.0 percent in-hospital patient mortality rate for patients that had contaminated blood cultures.

The study concluded that blood culture contamination can have "devastating clinical consequences for patients" including "increased length of stay, vancomycin days of therapy, hospital costs, acute kidney injury, and in-hospital patient mortality". Given these findings, the researchers emphasized the importance of mitigating unnecessary blood culture contamination with novel interventions and a culture of quality change to reduce the negative burden of this essential diagnostic test.

"Blood culture contamination is an underrecognized adverse event in hospitalized patients that increases negative clinical outcomes by directly placing our patients at unnecessary risk," said Dr. Ryan K. Dare, co-author and Associate Professor of Medicine, Infectious Diseases Specialist, and Medical Director of the Antimicrobial Stewardship Program at University of Arkansas for Medical Sciences Health.

"It is imperative for hospital systems to make decreasing blood culture contamination a priority to improve safety for patients under our care. Sterile technique for blood culture collection remains difficult to achieve in high-risk individuals and in high-risk settings such as emergency departments. Access to an initial specimen diversion device that is user friendly, cost effective, and successful at decreasing rates of contamination represents a game changer for patient safety and opportunity to dramatically improve patient outcomes," said Dr. Dare.  

"This study includes one of the largest data sets to date examining and directly quantifying the preventable consequences of blood culture contamination on patient safety and clinical outcomes," said Greg Bullington, CEO and Co-Founder of Magnolia Medical.

"This definitive data adds to the substantial body of evidence that already exists demonstrating that contaminated blood culture results drive avoidable, severely negative outcomes for patients and the healthcare system, including increased costs, inappropriate antibiotic usage that contributes to the rise of multidrug-resistant organisms, increased length of stay, and other preventable adverse events. Given these implications, we remain committed to partnering with all hospitals and health systems in their mission to achieve zero blood culture contaminations and zero patients harmed. We have already supported hundreds of U.S. hospitals and healthcare systems in achieving sustained near-zero blood culture contamination rates with the Steripath^® Initial Specimen Diversion Device^® and are encouraged by our continued rapid growth as we expand the footprint of hospitals we are enabling to address this significant problem," concluded Bullington.

The Steripath^® Initial Specimen Diversion Device^® platform offers the only all-in-one devices that are designed to meet the ENA, INS, CDC, and CLSI evidence-based best practice guidelines to reduce blood culture contamination and clinically proven to meet the CLSI and CDC's new 1% goal for contamination.^2,3,4,5,6 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.^7,8,9

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 130 issued method, apparatus, and design patents with more than 50 additional patent applications pending. For more information, visit www.magnolia-medical.com.

¹ Indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.
² CLSI. Principles and Procedures for Blood Cultures. 2nd Ed. CLSI Guideline M47. Clinical and Laboratory Standards Institute; 2022.
³ CDC. Blood Culture Contamination Prevention Actions: An Overview of Infection Control and Antibiotic Stewardship Programs Working with the Clinical Laboratory. July 2022.
⁴ CDC National Email Update to Clinicians. Clinicians: Use this guide to decrease blood culture contamination rates. July 22, 2022.
⁵ Vanhoy MA, Horigan A, Kaiser J, et al. Emergency Nurses Association (ENA). Clinical practice guideline: prevention of blood culture contamination. 2020.
⁶ 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.
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, Tien V, Madison AN. Getting to zero: impact of a device to reduce blood culture contamination and false-positive central line-associated blood stream infections. Infect Control Hosp Epidemiol. 2022;1-5. doi:10.1017/ice.2022.284.

SOURCE Magnolia Medical Technologies