Stanford Health Care Achieves Zero Blood Culture Contaminations and Near Elimination of False-Positive CLABSIs in Large-Scale Study Using the Steripath® Initial Specimen Diversion Device®

Peer-reviewed study published in leading medical journal constitutes the largest controlled clinical dataset ever documented with zero blood culture contamination events. Importantly, the study also demonstrates that it is possible to eliminate blood culture contamination and "get to zero" using Steripath.

SEATTLE, Jan. 10, 2023 /PRNewswire/ -- Magnolia Medical Technologies, Inc. ("Magnolia Medical"), inventors of the Steripath^® Initial Specimen Diversion Device^® (ISDD^®) family of products, today announced the publication of unprecedented clinical results from a study performed by Stanford Health Care at Stanford University Medical Center evaluating the impact of Steripath in reducing false-positive diagnostic test results for bloodstream infections (BSIs), including sepsis, and false-positive central line-associated bloodstream infections (CLABSIs).

The study, published in the peer-reviewed medical journal Infection Control & Hospital Epidemiology, was entitled "Getting to ZERO: Impact of a device to reduce blood culture contamination and false-positive central line-associated bloodstream infections," and had two primary objectives. First, to significantly reduce the hospital's blood culture contamination rate to a sustained target performance level of 1% or below, which aligns with the new national goal with best practices established by the Clinical and Laboratory Standards Institute (CLSI) and reinforced by the Centers for Disease Control and Prevention (CDC).^1,2,3 Second, the study examined the impact of reducing blood culture contamination on false-positive CLABSI rates and the hospital's Standardized Infection Ratio (SIR). SIR is a statistic used to track healthcare-associated infections (HAIs) over time and ties to the reimbursement received by a hospital or healthcare system from the Centers for Medicare and Medicaid Services (CMS).

Based on the study design, phlebotomists collected both inpatient (including patients in intensive care), and Emergency Department (ED) patient blood cultures using best practices and either traditional venipuncture or Steripath ISDD. Of the total 15,961 blood cultures collected by phlebotomists during the study period, 11,202 were collected with the Steripath ISDD resulting in a compliance rate over 70%.

At the end of the 10-month study, researchers reported zero blood culture contamination events (0.0% contamination rate) and near-zero false-positive CLABSIs for the 11,202 blood cultures drawn with the Steripath ISDD versus 111 contaminated matched sets in 4,759 blood cultures using traditional methods (2.3% contamination rate). Additionally, exclusion of probable contaminant-associated CLABSIs resulted in a marked reduction in the hospital's SIR, ranging from a 33% to 57% decrease each quarter in 2019.

The study concluded that reducing blood culture contamination through the adoption of Steripath can have positive effects on the quality of patient safety and care by facilitating accurate diagnoses for patients with suspected bloodstream infections including sepsis, significantly reducing false-positive CLABSI reporting, and sustainably improving antibiotic stewardship practices with minimal training and oversight.

The lead author of the study, Lucy S. Tomkins, MD, PhD, is the Lucy Becker Professor of Medicine, Division of Infectious Diseases and Geographic Medicine, and Professor of Microbiology and Immunology at Stanford University School of Medicine. Additionally, Dr. Tompkins is Hospital Epidemiologist, Medical Director, Infection Prevention and Control Department at Stanford University Hospital.

"False-positive blood culture results and false-positive CLABSIs seriously impact patient safety and care quality, and are associated with multiple harmful, and preventable, outcomes," said Dr. Tompkins.  

"Despite the adherence of our phlebotomy team to best practice techniques, our team could not always achieve sustained reductions in blood culture contamination rates due to the uncontrollable factors of contamination caused by external sources including skin plugs and fragments containing viable microorganisms. When consistently using Steripath on inpatients and ED patients, many of whom are 'hard sticks', our team was able to reduce and sustain zero contaminations over nearly a year and 11,200 blood cultures."

Dr. Tompkins went on to say, "What is remarkable about the study is the significant reduction we achieved for the hospital's SIR simply by reducing false-positive CLABSIs to near-zero. False-positive CLABSIs compromise clinical care and have major implications for benchmark quality rankings and impact reimbursement. During the year of the study, our medical center achieved a top 10 ranking in patient safety from Vizient, a consortium of 101 academic medical centers that ranks each member on several factors, including HAI rates. This achievement was due, in part, to our low CLABSI incidence."

"We are delighted to be able to share Stanford's success with Steripath in dramatically reducing blood culture contamination and further enhancing patient safety and outcomes for the suspected sepsis population," said Greg Bullington, CEO and Co-Founder of Magnolia Medical. "This first-of-its-kind study not only demonstrates that sustaining zero blood culture contamination performance is possible, but also directly links blood culture contamination to false-positive CLABSIs and SIR reporting. Given the patient safety and hospital reimbursement implications of blood culture contamination, we remain committed to partnering with all hospitals and health systems in their mission to achieve the CLSI and CDC's new goal of a sustained 1% or less contamination rate."

The Steripath^® Initial Specimen Diversion Device^® is the only FDA 510(k)-cleared device platform specifically indicated to reduce blood culture contamination and offers the only all-in-one devices that are designed and clinically proven to meet the ENA, INS, CDC, and CLSI evidence-based best practice guidelines to reduce blood culture contamination.^1,2,3,4,5,6 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

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.

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. CLSI. Principles and Procedures for Blood Cultures. 2nd Ed. CLSI Guideline M47. Clinical and Laboratory Standards Institute; 2022.
2. CDC. Blood Culture Contamination Prevention Actions: An Overview of Infection Control and Antibiotic Stewardship Programs Working with the Clinical Laboratory. July 2022.
3. CDC National Email Update to Clinicians. Clinicians: Use this guide to decrease blood culture contamination rates. July 22, 2022.
4. 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.
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