Stanford Health Care Study Reports Zero Blood Culture Contaminations and False-Positive CLABSIs Using Steripath Gen2 ISDD

SEATTLE, Oct. 27, 2020 /PRNewswire/ -- Magnolia Medical Technologies, Inc., inventors of Steripath^®, the trusted solution for reducing blood culture contamination – today announced unprecedented clinical results from a study performed by Stanford Health Care evaluating the impact of Steripath in reducing false-positive blood culture results for sepsis testing.

Lucy S. Tompkins, MD, PhD, a professor and physician at Stanford Health Care (Lucy Becker Professor of Medicine – Infectious Diseases, and of Microbiology and Immunology, Stanford University School of Medicine, Hospital Epidemiologist and Medical Director, Infection Prevention & Control at Stanford Health Care) presented an oral abstract of the Steripath^® Gen2 Initial Specimen Diversion Device^® (ISDD^®) study results at IDWeek 2020, the annual conference of Infectious Disease Society of America (IDSA).

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

The study concluded that adoption of Steripath Gen2 ISDD led to a substantial decrease in contaminated blood cultures and false-positive CLABSIs, which can impact inappropriate antibiotic usage, improve correct diagnoses, minimize patient discomfort, and reduce hospital-acquired infections related to longer stays – all of which improve patient safety and outcomes.

"Blood culture contamination is a serious patient safety issue and is associated with several harmful outcomes," said Dr. Tompkins. "Even though Stanford Hospital has a superb phlebotomy team, our team could not always reduce the contamination rate to below 3%, the current industry 'standard'.  When using the Steripath Gen2 ISDD on in-patients and ED patients, many of whom are 'hard sticks', our team was able to reduce the contamination rate to zero over the course of a 4-month clinical trial." 

"Our results confirm those of Dr. Mark Rupp whose seminal Steripath ISDD study clearly demonstrated that the ISDD is the most effective way to reduce, and even eliminate, blood culture contamination," added Dr. Tompkins.

Dr. Tompkins went on to say, "Along with many other hospital epidemiologists, I did not initially believe we could reduce CLABSIs to zero.  With many changes in practice and policies, it is quite clear that the goal of zero CLABSIs can be achieved. As a result of our experience with the Steripath Gen2, we join others in promoting the goal to establish a new standard of zero for blood culture contamination."

The outcomes of this study resulted in Stanford hospital adopting the Steripath Gen2 ISDD for phlebotomy use hospital-wide.

"We are delighted to have Stanford's Steripath study results formally presented at IDWeek," said Greg Bullington, CEO of Magnolia Medical. "These extraordinary results constitute the largest controlled clinical dataset ever documented with zero blood culture contamination events. We are honored to be working with Dr. Tompkins and Stanford Health Care to help advance a new national benchmark for sepsis diagnostic accuracy and antibiotic stewardship to further enhance patient safety and outcomes."

The patented Steripath^® Gen2 ISDD^® product portfolio, including both direct-to-media and syringe configurations, are the only FDA 510(k)-cleared devices indicated to reduce blood culture contamination.¹ This exclusive indication was cleared by the FDA based on peer-reviewed published controlled clinical studies demonstrating Steripath's ability to reduce blood culture contamination by 83%² and 88%³.

The Steripath Gen2 platform integrates user-controlled negative pressure to divert and sequester the initial 1.5 to 2.0 mL of blood collected for culture, the portion known to most likely contain contaminants.⁴ The device has been clinically proven effective for use with blood cultures drawn via both venipuncture and peripheral IV starts.^5,6 

Steripath is the trusted 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. This helps to address the growing threat of antibiotic-resistance, decreases hospital length of stay and associated healthcare-acquired infections while significantly reducing avoidable hospital costs.^5,6

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. Bell, M., et al. Journal of Emergency Nursing (2018)
3. Rupp, M., et al. Clinical Infectious Diseases (2017)
4. Patton, R., et al. Journal of Clinical Microbiology (2010)
5. Skoglund, E., et al. Journal of Clinical Microbiology (2019)
6. Geisler, B., et al. Journal of Hospital Infection (2019)

SOURCE Magnolia Medical Technologies

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