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C-QUEST MEDICAL RECEIVES FDA 510(k) CLEARANCE FOR SEQUESTRATION SYRINGE™

Updated: Feb 23

Blood culture collection device features proprietary initial specimen diversion technology.

 

Englewood, CO USA… C-Quest Medical LLC announced today the U.S. Food and Drug Administration (FDA) has granted it 510(k) clearance to market the company's Sequestration Syringe™


 Blood Culture Collection Device.

 

Designed to reduce false-positive blood culture test results and improve clinical outcomes, the clinician-friendly Sequestration Syringe is easy-to-use and requires virtually no training to enhance efficiency and cost savings, while promoting standardization throughout the hospital.

 

The patent-pending device features a proprietary Unidirectional Check Valve that diverts and sequesters the initial 1.5mL of blood during collection. The valve assures that blood can only flow in one direction, to prohibit sequestered blood from contaminating the culture. In addition, a distinctive “T” Valve on the syringe connects to a universal bottle holder that enables conventional blood culture collection in either thin or wide neck bottles.

 

Overview:

Blood culture collection has long been the standard of care to detect serious blood stream infections. However, false positive blood culture test results, which generally stem from contaminated skin samples, can reach as high as 50%.(1) This unsettling statistic is cause for significant clinical and cost concerns for healthcare professionals worldwide. Yet according to the CDC, the use of “initial specimen diversion devices” during blood collection can be effective in reducing the rate of blood culture contamination.(2)

 

 

The consequences of false-positive blood culture test results can include the following:

· Contribute to unnecessary antibiotic use and resistance. Antibiotic mistreatment can also lead to drug resistant “super bugs.”

· Create delays in proper treatment, increasing the length and cost of a hospital stay.

· Cost an additional $4,500 - $10,000+ per patient, creating a financial burden for all parties.(3)

· Result in penalties to hospitals that are not demonstrating facility-wide antibiotic stewardship best practice, including avoiding unnecessary antibiotic use.

 

Bibliography:

1. American Hospital Association: National Movement to a New Blood Culture Contamination Benchmark of 1%: Are You Ready? Webinar, August 25, 2021.

 

2. Centers for Disease Control. Blood Culture Contamination: An Overview for Infection Control and Antibiotic Stewardship Programs Working with the Clinical Laboratory. 2022.

 

3. Garcia RA, et al. Multidisciplinary team review of best practices for collection and handling of blood cultures to determine effective interventions for increasing the yield of true-positive bacteremia, reducing contamination, and eliminating false-positive central line-associated bloodstream infections. Am J Infect Control. 2015 Nov 1;43(11):1222-37.




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