SEATTLE, May 24, 2022 /PRNewswire/ -- Magnolia Medical Technologies, Inc., ("Magnolia") inventors of the Steripath® Initial Specimen Diversion Device® (ISDD®), today announced that it has received a formal close-out notification from the United States Food and Drug Administration ("FDA") for the warning letter originally sent to the company on September 17, 2021.
This close-out notification was received following an on-site FDA field inspection where FDA conducted a detailed review of each corrective action implemented by Magnolia Medical in response to the warning letter. The mitigation strategies and effectiveness evidence presented to FDA during the inspection demonstrated that Magnolia Medical has successfully addressed each item in the warning letter and that the company's quality system meets regulatory specifications. The inspection was successfully closed with no observations and no 483 resulting.
Additionally, Magnolia has concluded the lot-specific recalls the company voluntarily initiated. All site reconciliations are complete and formal requests for closure have been submitted to FDA for final determinations.
There are no active or on-going product recalls associated with the Steripath® (ISDD®) family of products, and no ongoing FDA actions as the warning letter is officially closed by the FDA.
"We appreciate the collaborative engagement with FDA and recent opportunity to review continued enhancements we have made to our quality system, including migration to a fully electronic QMS," said Greg Bullington, CEO of Magnolia Medical. "As the only FDA 510(k)-cleared device platform specifically indicated to reduce blood culture contamination, we continue to be committed to providing the highest quality products to hospitals and health systems in support of our collective mission to prevent blood culture contamination and false-positive diagnostic test results for sepsis."
Steripath is the only FDA 510(k)-cleared device platform specifically indicated to reduce blood culture contamination.1 To date, 20 clinical studies have been completed supporting the clinical and cost effectiveness of Steripath. All studies reported sustained contamination rates of 1% or less using Steripath,2 which supports the new Clinical and Laboratory Standards Institute (CLSI) M47 2022 goal for blood culture contamination of 1% with best practices.3
Additional results reported within these studies using Steripath include up to a 31% reduction in vancomycin days of therapy and as much as a 12-fold decrease in false-positive central line-associated blood stream infections (CLABSIs) over extended periods of time.4,5
Steripath has been adopted by 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, extended length of hospital stay, false-positive CLABSIs, and wasted healthcare resources.
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 Initial Specimen Diversion 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.
- Indicated to reduce the frequency of blood culture contamination when contaminants are present, compared to standard method controls without diversion.
- Date on file.
- CLSI. Principles and Procedures for Blood Cultures. 2nd Ed. CLSI Guideline M47. Clinical and Laboratory Standards Institute; 2022.
- 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.
- 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. Submitting to ICHE in 2022.
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SOURCE Magnolia Medical Technologies