SEATTLE, Sept. 1, 2020 /PRNewswire/ -- Magnolia Medical Technologies, Inc. today announced the launch of Mission to ZERO, a nationwide initiative to create greater awareness of the patient safety and antibiotic-associated risks caused by false-positive diagnostic test results for sepsis. The goal of the initiative is to drive change by improving national blood culture guidelines and contamination benchmarks, while partnering with hospitals in their mission to eliminate blood culture contamination and false-positive central line-associated bloodstream infections (CLABSIs) reporting.
High blood culture contamination rates are responsible for excessive broad-spectrum antibiotic usage, compromising antimicrobial stewardship efforts and exposing patients to antibiotic-associated adverse drug events including multidrug-resistant organism infections, C. difficile infection and acute kidney injury.3
Currently, blood culture is the standard of care test used to diagnosis sepsis in the United States. Unfortunately, the national benchmark for acceptable rates of contamination sits at 3 percent. At this performance level, 35 percent to over 50 percent of all positive blood cultures are actually false positive in an average hospital.4 This equates to hundreds of patients seriously impacted annually in an average hospital and over 1.4 million patients annually in the US at risk of inappropriate treatment from a diagnosis that may not be accurate, which compromises patient safety and can cause unnecessary health complications. In addition to health risks, an estimated $6 billion is wasted within the US healthcare system each year associated with false-positive blood culture results.5
Based on recently established scientific evidence, significantly better national performance is achievable for blood culture accuracy. Based on this evidence, a multi-discipline consensus manuscript published in the leading peer-reviewed journal Clinical Microbiology Reviews in January 2020 supports lowering this benchmark to less than 1 percent – representing a 66 percent reduction to the current standard of care.3
"Magnolia is committed to diagnostic accuracy and the prevention of patient harm. Scientific and clinical evidence proves that we can significantly improve diagnostic accuracy for sepsis testing. This data underlies our commitment to raising the bar for performance nationally with the belief that we as an industry should be targeting zero preventable diagnostic errors," said Greg Bullington, CEO and co-founder of Magnolia Medical Technologies.
To make this a reality, Magnolia is launching this national patient safety initiative by partnering with emergency departments, critical care units, clinical laboratories, and infection prevention teams within acute care hospitals across the country who see the impact of patient misdiagnoses every day. Each team member makes an individual pledge to participate, which allows all departments to work in tandem to ensure the best possible patient outcomes and experience are achieved.
"We are proud to introduce the Mission to ZERO initiative, empowering all healthcare workers to have a direct impact on helping prevent the risk of patients experiencing a misdiagnosis of sepsis while further enabling driving antibiotic stewardship," said Bullington. "We will achieve this mission through a combination of supporting change in national guidelines and benchmarks, Steripath® technology solutions and a strong partnership with our healthcare community – which begins with each individual patient, healthcare worker and hospital uniting as one team. As a team, we can help stop the significant clinical and economic challenges associated with false-positive blood culture results."
"Once in a lifetime, Infection Preventionists have an opportunity to really make a difference in the lives of their patients. Steripath and Mission to ZERO have provided such an opportunity," said Shannon Colleen Jordan, RN, BSN, CIC, Infection Prevention Manager, University Medical Center of El Paso. "Our biggest silent threat in Infection Prevention is multidrug-resistant organisms. By using Steripath®, we not only decrease blood culture contamination rates, but also decrease antibiotics used as a result of false positive blood cultures. This is a win-win situation!"
The patented Steripath Gen2 ISDD® product portfolio, including both direct-to-media and syringe configurations, is the only FDA 510(k)-cleared device platform indicated to reduce blood culture contamination.6 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%7 and 88%8.
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 for use with blood cultures drawn via both venipuncture and peripheral IV starts.7,8
"The experience accumulated with the Steripath device both in objective, systematic investigations published in the peer-reviewed literature as well as in routine practice in more than a hundred healthcare settings throughout the United States is significantly compelling," said Gary V. Doern, Ph.D., (ABMM), Emeritus Professor of Pathology, University of Iowa Carver School of Medicine and lead author of the consensus manuscript published in Clinical Microbiology Reviews. "Clearly the Steripath device represents a safe, convenient and cost-effective means for reducing blood culture contamination rates to levels of <1.0%."
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.
- ECRI Special Report, Top 10 Patient Safety Concerns (2020)
- Patton, R., et al. Infection Control & Hospital Epidemiology (2016)
- Doern, G., et al. Clinical Microbiology Reviews (2020)
- Zwang, O., et al. Journal of Hospital Medicine (2006)
- Data on file
- Indicated to reduce blood culture contamination when contaminants are present, compared to standard method controls without diversion.
- M. Bell, et al. Journal of Emergency Nursing (2018)
- M. Rupp, et al. Clinical Infectious Diseases (2017)
SOURCE Magnolia Medical Technologies