New Congressional Directive for Improved VA Patient Care Enabled by Magnolia Medical's Sepsis Testing Accuracy Technology

SEATTLE, August 3, 2021 /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,¹ today commended the U.S. House of Representatives following the passage of H.R. 4355, the Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2022 (MILCON-VA Act). The legislation's committee report directs the Department of Veterans Affairs (VA) to prioritize the development of a quality measure for blood culture contamination of under 1% to prevent unnecessary, avoidable health risks and harm to veterans undergoing blood testing for the diagnosis of sepsis.

According to the MILCON-VA Act, "VA is to prioritize the development and implementation of a specific quality measure for blood contamination based on a recommendation of less than 1% blood culture contamination rate within 6 months of enactment. VA is directed to report to the Committees on Appropriations of both Houses of Congress within 180 days of the enactment of this Act detailing the implementation of this standard of care across the VA medical system."

"We are pleased that Congress has formally recognized the critical patient safety benefits of reducing blood culture contamination and resulting risk of misdiagnosis of sepsis," said Greg Bullington, CEO and co-founder of Magnolia Medical. "Steripath is already adopted in 15 VHA medical centers via our Federal Supply Schedule (FSS) contract. We look forward to expanding our role within the VA Health system (VHA) by enabling healthcare providers to meet the directive and to provide an equitable standard of care for sepsis testing accuracy to all veterans."

A clinically proven technology solution, Steripath has benefited tens of thousands of veterans to date, delivering significant sustained reductions in blood culture contamination. For example, Steripath delivered a 0.0% contamination rate over a 5-month measurement period at the Central Texas VA Medical Center as published in the Journal of Emergency Nursing.² Additionally, the Houston VA Medical Center, one of the largest in the country, achieved an 83 percent sustained reduction in blood culture contamination with Steripath as presented at the Emergency Nurses Association annual conference.³ Significant sustained reductions were also reported at the VA North Texas Health System in Dallas, the second largest in VA medical center in the country.⁴

Most recently, in March of 2021, the laboratory supervisor at Beckley West Virginia VA Medical Center received the national "HeRO Award", the highest level of High Reliability Organization (HRO) recognition within the VHA, which was awarded for their quality improvement initiative to increase the safety of veteran patients by significantly reducing blood culture contamination with Steripath.⁵

Steripath has demonstrated clinical and cost-effectiveness in 19 studies including six peer-reviewed publications with sustained results of zero or near-zero blood culture contamination rates over extended periods of time. This data demonstrating the clinical performance of Steripath validates that patient harm resulting from false positive sepsis diagnoses can be prevented.

About Magnolia Medical

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 (ISDTtm) and Device (ISDD®) for blood culture collection and contamination prevention. The company has amassed an intellectual property portfolio including more than 80 issued method, apparatus and design patents with more than 70 additional patent applications pending. For more information, visit www.magnolia-medical.com.

References:
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. https://pubmed.ncbi.nlm.nih.gov/33431137/
3. https://magnolia-medical.com/wp-content/uploads/2018/10/VA-Houston-Steripath-Clinical-Trial-Results-ENA-2018.pdf
4. Data on file
5. https://www.usmedicine.com/current-issue/lab-supervisor-helps-reduce-blood-culture-contamination-at-vamc/  

SOURCE Magnolia Medical Technologies