Stanford Health Care Presents Unprecedented Study Results with Steripath Gen2 ISDD to Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria

SEATTLE, Feb. 11, 2021 /PRNewswire/ -- Magnolia Medical Technologies, Inc. – inventors of Steripath^®, the only FDA-cleared device platform indicated to reduce blood culture contamination¹ – today announced that unprecedented Steripath clinical study results were presented to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB).

Lucy S. Tompkins, MD, Ph.D., a professor and infectious diseases, microbiology and epidemiology expert at Stanford Health Care, presented Steripath^® Gen2 Initial Specimen Diversion Device^® (ISDD^®) phase-one study results at the PACCARB meeting in Washington, DC demonstrating unmatched reductions to blood culture contamination and false-positive central line-associated bloodstream infection (CLABSI) rates.

PACCARB advises and provides information and recommendations to the Secretary of the U.S. Department of Health and Human Services relating to programs and policies intended to reduce or combat antibiotic-resistant bacteria that pose a public health threat. The goal of the council's recommendations is to improve capabilities to prevent, diagnose, mitigate or treat such resistance. 

The phase-one study results presented from Stanford Health Care, titled "Getting to Zero, Eliminating Blood Culture Contamination with ISDD", reported 0.0% blood culture contamination events and 0.0% false-positive CLABSIs out of 4,462 blood cultures drawn with the Steripath Gen2 Initial Specimen Diversion Device during a four-month study, versus a 3.15% contamination rate (29 contamination events in 922 blood cultures) using standard method.

The study concluded that adoption of the Steripath Gen2 ISDD led to a substantial decrease in contaminated blood cultures and false-positive CLABSIs, which lead to enhanced sepsis diagnosis accuracy, mitigates inappropriate antibiotic treatment, minimizes patient discomfort and reduces hospital-acquired infections related to longer stays – all of which improve patient safety and outcomes.

"Blood culture contamination is a serious patient safety problem and is associated with several harmful outcomes, including excess antibiotic treatment which can lead to C. difficile and other antibiotic-resistant infections," said Dr. Tompkins. "In our phase-one trial of the Steripath Gen2, our phlebotomy team was able to reduce the blood culture contamination rate to zero when the Steripath device was used in 4,462 blood cultures."

"What was even more clinically significant is that a 0.0% contamination rate and 0.0% false-positive CLABSI rate were maintained across over 11,000 blood cultures when Steripath was used throughout the course of the 10-month total trial period," continued Dr. Tompkins.

"As a human-factor engineered device, Steripath can dramatically reduce blood culture contamination and has clearly demonstrated that getting to 0.0% is achievable," added Dr. Tompkins. "As a result of our experience with the Steripath Gen2 platform, we join others in the national movement to establish a goal of 0.0% blood culture contamination starting with a new standard benchmark of less than 1.0% as the new standard of care."

"We are delighted to have Stanford's exceptional and unprecedented study results with Steripath formally presented to PACCARB," said Greg Bullington, CEO of Magnolia Medical. "These results definitively prove that blood culture contamination is a preventable error. Steripath's 0.0% blood culture contamination and 0.0% false positive CLASBIs rates across over 11,000 blood cultures at Stanford Health Care strongly support the formal change to the national standard of care for sepsis testing accuracy that is underway."

The patented Steripath^® Initial Specimen Diversion Device^® product portfolio, including the Steripath Gen2 direct-to-media and syringe configurations in addition to the new Steripath Micro platform, are the only FDA 510(k)-cleared devices indicated to reduce blood culture contamination.¹   

Steripath is a clinically proven solution to address a significant hidden problem in healthcare: the misdiagnosis of sepsis.^2,3 Improving the accuracy of diagnostic test results for sepsis can reduce unnecessary antibiotic treatment, in turn helping to address the growing threat of antibiotic-resistance while decreasing hospital length of stay and associated healthcare-acquired infections and significantly reducing avoidable hospital costs.^4,5

About PACCARB: The rise of antibiotic-resistant bacteria represents a serious threat to public health and the economy. Detecting, preventing, and controlling antibiotic resistance requires a strategic, coordinated, and sustained effort. The federal government works domestically and internationally to detect, prevent, and control illness and death related to antibiotic-resistant infections by implementing measures that reduce the emergence and spread of antibiotic-resistant bacteria and help ensure the continued availability of effective therapeutics for the treatment of bacterial infections. The PACCARB provides advice, information, and recommendations to the Secretary regarding programs and policies intended to support and evaluate the implementation of U.S. government activities related to combating antibiotic-resistant bacteria. Visit https://www.hhs.gov/ash/advisory-committees/paccarb/index.html

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 70 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. M. Bell, et al. Journal of Emergency Nursing (2018)
3. M. Rupp, et al. Clinical Infectious Diseases (2017)
4. E. Skoglund, et al. Journal of Clinical Microbiology (2019)
5. B. Geisler, et al. Journal of Hospital Infection (2019)

SOURCE Magnolia Medical Technologies

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