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Device Can Quickly Identify Bacteria that Cause Deadly Sepsis Infections

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

The Food and Drug Administration (FDA) has approved a new device that can quickly identify the bacteria responsible for deadly sepsis infections, treatment for which must be swift and aggressive. The device should cut down on misdiagnoses of sepsis in New York patients and reduce the time it takes for patients to get treated for the fatal infection.

What Is Sepsis?

Sepsis, also known as bacteremia or septicemia, is a bacterial infection that is difficult for medical professionals to diagnose. The symptoms of sepsis seem minor at first but rapidly intensify, causing organ failure and, if left untreated, death.

Patients with sepsis often present with vague symptoms, including fever, a racing heartbeat and low blood pressure. Often, they are sent hom e to mend on their own only to be back in the emergency room hours or days later with much more severe symptoms. Occasionally, limb amputation is necessary due to tissue death from the infection.

The mortality rate for patients with untreated sepsis is 20 to 50 percent. The rate increases by over 7 percent for every hour treatment is delayed, a dangerous trend for an infection that is often misdiagnosed. Fortunately, the recently approved testing device dramatically cuts the time it takes doctors to diagnose sepsis; what used to take three days now takes as little as three hours.

New Test Identifies Bacteria that Cause Sepsis

The Verigene Gram-positive Blood Culture Nucleic Acid Test, known as the Verigene test, can identify the bacteria that commonly cause sepsis within a matter of hours, not days. It is the first of its kind and has the real possibility of saving patients’ lives while cutting the costs of diagnosing sepsis. Traditional tests for sepsis take three days and cost about $22,000 apiece. While the Verigene device is purchased for $50,000 to $100,000, it only costs about $75 to run an individual test, saving both lives and money in the long run.

The Verigene test can quickly identify Streptococcus, Enterococcus, Listeria and Staphylococcus, all of which are known to cause sepsis. It can even identify if the bacteria is resistant to the drugs used to treat the infection, including Methicillin-resistant Staph aureus, commonly known as MRSA, and Vancomycin-resistant Enterococci, or VRE.

The approval of this new diagnostic tool is great news for both patients and physicians, and should lead to a reduction in misdiagnosis of sepsis and thus a reduction in deaths caused by the serious infection. However, it will take time and money for hospitals to invest in the new device and medical errors in diagnosis and treatment of sepsis will likely continue.

If a doctor’s failure to diagnose or effectively treat sepsis has resulted in serious injury or death for you or a loved one, please contact an experienced medical malpractice lawyer.

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