Novel Study Demonstrates the Hospital-Wide Impact of the Steripath® Initial Specimen Diversion Device® on Blood Culture Contamination Rates and Sepsis Testing Accuracy at WVU Medicine - United Hospital Center

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Apr 06, 2022, 13:15 ET

First of its kind peer-reviewed study, published in the American Journal of Medical Quality, shows that irrespective of clinical environment, draw site, and staff skillset, Steripath reduced blood culture contamination rates by 81% versus conventional method.

SEATTLE, April 6, 2022 /PRNewswire/ -- Magnolia Medical Technologies, Inc., inventors of Steripath^®, the only FDA 510(k)-cleared device platform indicated to reduce blood culture contamination for sepsis testing accuracy,¹ today announced the publication of results from a study performed by United Hospital Center, a member of the West Virginia University Health System, clinically evaluating the impact of Steripath in reducing false-positive blood culture results throughout the hospital.

The scope of this study was novel. While other studies have assessed the efficacy of Steripath in either the emergency department or inpatient environments, never have both been studied simultaneously, and included use by nursing, medical technologists, and phlebotomists via venipuncture and newly placed peripheral intravenous (IV) lines.

The study objective was to significantly reduce the hospital-wide blood culture contamination rate from 3.06% prior to the study period to a target performance level below 1%. This 1% or below performance level is now consistent with the new benchmark with best practices proposed by the Clinical and Laboratory Standards Institute (CLSI) in its draft, updated standards included in M47 ED2-2021, Principles and Procedures for Blood Cultures. Importantly, the reduction in benchmark false-positive rates is intended to provide patients with a higher standard of care by reducing misdiagnoses of blood stream infections, including sepsis. This, in turn, enables reduction of unnecessary and prolonged broad-spectrum antibiotic therapy, and shortening length of hospital stay.

The study measured the efficacy of Steripath in reducing false-positive blood cultures hospital-wide. Emergency department staff, laboratory phlebotomists, and nursing staff on acute-critical care floors used Steripath for blood culture collection via venipuncture and newly placed peripheral IVs over an eight-month period. Of the total 5,642 blood cultures performed hospital-wide during the study period, 4,631 were collected with Steripath resulting in a compliance rate of 82%.

The study, entitled "Initial Specimen Diversion Device Utilization Mitigates Blood Culture Contamination Across Regional Community Hospital and Acute Care Facility," concluded that irrespective of clinical environment, draw site, and staff skillset, Steripath reduced contamination rates hospital-wide by 81%, from 4.06% with conventional method to 0.78%, during the study period. Approximately 148 contamination events were prevented during the study period. WVU Medicine - United Hospital Center estimated a mean cost of $2,100 per contamination event which equates to over $300,000 in cost avoidance attributable to contamination rate reductions achieved with Steripath. The WVU Medicine leadership have prioritized a strategic initiative to reduce blood culture contamination system-wide, which includes an assessment of the impact of Steripath.

"At WVU Medicine, we recognize that false-positive blood cultures are detrimental to quality and patient safety," said Dr. Mark Povroznik, Vice President of Quality and Chairman of Infection Control, at WVU Medicine - United Hospital Center. "Our collective vision is to surpass the accepted norm for blood culture contamination rates. We began our quality improvement project with Steripath after previous concerted interventions and devices had failed to sustain contamination rates below 3%."

"The results from our study were the impetus for system-wide value analysis approval, and we are already seeing mirrored results within our health system. The process we followed can be readily adopted at other hospitals to drive practice change to achieve a contamination rate of less than 1%. We implemented a 'triple aim' quality improvement initiative that focused on culture change, value analysis, and evidence-based best practices. We delivered both clinical and economic value through establishing improved practice standards that support the use of evidence-based technology innovations," said Povroznik.

Povroznik concluded by saying, "we have promoted a process through objective study that endorses Steripath for blood culture collection and contamination prevention for all WVU Health System facilities."

"Tackling a hospital-wide quality improvement initiative is a significant but imperative undertaking. We commend United Hospital Center for their passion and commitment to patient safety, and their integrated method of sharing best practices across the WVU Health System," said Greg Bullington, CEO of Magnolia Medical. "We are privileged to have the opportunity to collaborate with change agents like Dr. Povroznik and look forward to WVU Medicine's continued success in achieving their diagnostic and antimicrobial stewardship goals."

Steripath has been adopted in 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, false-positive central line-associated blood stream infections (CLABSIs), and wasted healthcare resources.

Steripath has demonstrated significant clinical efficacy as well as cost-effectiveness in over 20 studies, reporting sustained results of zero or near-zero blood culture contamination rates, up to a 31% reduction in vancomycin days of therapy, and as much as a 12-fold decrease in false-positive CLABSIs over extended periods of time.^2,3,4

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.

1. Indicated to reduce the frequency of blood culture contamination when contaminants are present, compared to standard method controls without diversion.

2. Date on file.

3. 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.

4. 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. Submitted to Clin Infect Dis in December 2021.

SOURCE Magnolia Medical Technologies