Magnolia Medical Technologies today touted “unprecedented” results from a clinical study of its Steripath in sepsis testing.
Seattle-based Magnolia Medical’s Steripath, a blood culture contamination product, was being evaluated for its impact in reducing false-positive blood culture results in sepsis testing, according to a news release. Results of the study were presented by Stanford Healthcare’s Dr. Lucy Tompkins at IDWeek 2020.
The study reported zero blood culture contamination events and zero false-positive central line-associated bloodstream infections (CLABSIs) out of 4,462 blood cultures drawn with the Steripath Gen2 Initial Specimen Diversion Device (ISDD)— a blood collection system that has been available since garnering FDA approval in August 2018 — versus 29 contaminated sets in 922 blood cultures using traditional methods, which produced a contamination rate of 3.15%.
Additionally, the study concluded that the adoption of the Steripath Gen2 led to a substantial decrease in contaminated blood cultures and false-positive CLABSis, which can affect inappropriate antibiotic usage, improve diagnoses, minimize patient discomfort and reduce hospital-acquired infections associated with longer stays, the company said.
“Blood culture contamination is a serious patient safety issue and is associated with several harmful outcomes,” Dr. Tompkins said in the release. “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.”
Magnolia Medical also noted that the strong results of the study led to Stanford Hospital adopting the Steripath Gen2 ISDD for phlebotomy use across the hospital.
“We are delighted to have Stanford’s Steripath study results formally presented at IDWeek,” Magnolia Medical CEO Greg Bullington said. “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 Healthcare to help advance a new national benchmark for sepsis diagnostic accuracy and antibiotic stewardship to further enhance patient safety and outcomes.”