Shortage of blood culture vials could impact patient care, CDC and FDA warn | CNN (2024)

Shortage of blood culture vials could impact patient care, CDC and FDA warn | CNN (1)

Blood culture vials from BD Life Sciences, used to test for bloodstream infections and conditions such as sepsis, are in shortage in the US.

CNN

There is a “critical shortage” of certain vials used to collect samples for blood cultures, the US Centers for Disease Control and Prevention warned health care providers on Tuesday.

These tests help diagnose bloodstream infections and related conditions such as sepsis and endocarditis. Identifying the type of bacteria or other microorganism causing the infection can help ensure patients are treated quickly with the appropriate antibiotics.

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“This shortage has the potential to disrupt patient care by leading to delays in diagnosis, misdiagnosis, or other challenges in the clinical management of patients with certain infectious diseases,” the CDC said in a health advisory.

BD Life Sciences, the company that manufactures the products in shortage, first alerted health care providers about “intermittent delays” to supply in early June. The US Food and Drug Administration added the affected products to their list of medical device shortages two weeks ago.

According to the CDC, about half of all US laboratories use a blood culture system that is only compatible for use with the BD BACTEC vials.

On a call with clinicians hosted by the Infectious Diseases Society of America on Tuesday, Chris Beddard, vice president of microbiology with BD Life Sciences, said that “the issues are more complex” than originally communicated by the supplier, but the company is making certain adaptations – including a temporary shift from plastic to glass for some vials and strategies to manage allocation and transportation – that should help improve the situation by September.

Health care providers are recommended to develop plans to manage the situation “immediately,” the CDC said, using a set of recommendations to optimize their supplies and mitigate potential effects on patient care.

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Blood cultures may be needed in a variety of health care settings, but experts say that hospitals will be affected most acutely; the tests are often needed to respond quickly to serious conditions.

Some studies have found that bloodstream infections have become more common in the US in recent years, and sepsis is known to be a leading cause of death in hospitals. It is a serious condition that can progress rapidly. Overall, the CDC estimates that at ​least 1.7 million adults in the US develop the condition each year, and at least 350,000 die as a result.

“In the short term, hospitals and health systems have ramped up their efforts to be good stewards of blood culture resources, including efforts to reduce waste and unnecessary usage. If those efforts are insufficient, hospitals will have to prioritize patients to receive blood cultures so we’ve been seeking advice from infectious disease experts in the field and at the CDC,” said Nancy Foster, vice president of quality and patient safety policy for the American Hospital Association. “Hopefully hospitals will never have to prioritize patients because our stewardship strategies and BD’s strategies to improve availability of supply will meet the need. But we must be prepared for the potential that we may need to prioritize, so clinical leaders are coming up with plans.”

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    Vanderbilt University Medical Center has less than a week’s supply of blood culture vials available, Dr. Romney Humphries, medical director of the health system’s microbiology laboratory, said on the call with clinicians on Tuesday.

    Completely running out of blood culture vials was a “very real possibility,” she said. But they’ve cut the volume of blood cultures by more than half with a few key mitigation strategies, including scaling the initial testing back to one culture instead of the standard two and waiting 48 hours to retest in most cases.

    “I don’t think it makes any of us happy that we’re doing this, by any means, and I think it’s fairly important to say that that is absolutely not the standard of care, but we’ve been forced into a situation where we can’t provide the standard of care for this shortage,” Humphries said. “It does become a risk decision – is no blood cultures for any patient worse or better than having one set for all patients, and it’s an extremely difficult thing.”

    Shortage of blood culture vials could impact patient care, CDC and FDA warn | CNN (2024)

    FAQs

    Why is there a shortage of blood culture bottles? ›

    The shortage is the result of supply chain disruptions, and more vials should be available in September, a BD vice president told clinicians during a Tuesday call.

    Is the volume of blood cultured still a significant factor in the diagnosis of bloodstream infections? ›

    According to the classic literature, the volume of blood per culture is the single most important variable in recovering microorganisms from patients with sepsis. The higher the blood volume cultured, the higher the rate of detection of bloodstream infections (BSI) (1, 5-7, 9, 12, 15, 18, 20, 21).

    What are the risks of blood cultures? ›

    This can cause sepsis. Sepsis is a medical emergency and you will be admitted to a hospital for treatment. Other types of germs, such as a fungus or a virus, may also be found in a blood culture. Sometimes, an abnormal result can be due to contamination.

    What causes positive blood cultures? ›

    A blood culture is a test that checks for foreign invaders like bacteria, yeast, and other microorganisms in your blood. Having these pathogens in your bloodstream can be a sign of a blood infection, a condition known as bacteremia. A positive blood culture means that you have bacteria in your blood.

    Why is blood shortage important? ›

    Every 2 seconds, someone needs a blood transfusion in the United States. A single blood donation can save the lives of up to three people. Your donation is used during transfusions and procedures that help patients who have lost too much blood.

    Why do we use blood culture bottles? ›

    A blood culture is a laboratory test in which blood, taken from the patient, is inoculated into bottles containing culture media to determine whether infection-causing microorganisms (bacteria or fungi) are present in the patient's bloodstream.

    What is the most common cause of blood culture contamination? ›

    Frequent causes include poor collection technique and insufficient skin disinfection. Typical organisms include coagulase-negative staphylococci, Corynebacterium spp., Bacillus spp. other than Bacillus anthracis, Micrococcus spp., and Cutibacterium acnes among others.

    What are the factors affecting blood culture? ›

    Volume of BC. Distribution of blood between aerobic and anaerobic BC bottles. Disinfection of skin and prevention of BC contamination. The BC collection process itself (to avoid contamination)

    What is the minimum blood volume for culture? ›

    Optimal blood volume for culture is 8-10 mL (1-3 mL for Peds bottle). A suboptimal volume of blood can adversely affect recovery and/or time of detection of organisms. Interpret results accordingly.

    What does "no growth in blood culture" mean? ›

    The test report may list the blood culture test as either negative or positive. A negative test result means that no germs grew in the culture. A positive test result means that one or more germs developed in the dish. A positive result indicates the presence of germs in your blood.

    What is CoNS in blood culture? ›

    Coagulase-negative staphylococci (CoNS) are part of normal human skin flora [1]. While the virulence of these organisms is relatively low, they can cause clinically significant infections of the bloodstream and other tissue sites.

    Why do hospitals do blood cultures? ›

    A blood culture test helps your doctor figure out if you have a kind of infection that is in your bloodstream and can affect your entire body. Doctors call this a systemic infection. The test checks a sample of your blood for bacteria or yeast that might be causing the infection.

    What is the most common bacteria in blood cultures? ›

    Staphylococcus, streptococcus, and enterococcus species are the most important and most common species of gram-positive bacteria that can enter the bloodstream. These bacteria are normally found on the skin or in the gastrointestinal tract.

    What are three factors that can cause a false positive blood culture? ›

    Among the causes of false positive growth in blood culture systems due to the microorganisms include; (i) slow and fastidious microorganisms, (ii) microorganisms that cannot be cultured, (iii) anaerobic microorganisms, (iv) bacteria more sensitive to environmental conditions such as S.

    Can blood cultures be wrong? ›

    Blood cultures are the 'gold standard' test for diagnosing sepsis yet approximately 40% of positive blood culture results are false positive due to contamination.

    Is there a shortage of blood test bottles? ›

    UPDATE SEPTEMBER 16, 2021: SITUATION EASING

    These developments, alongside the efforts of NHS staff to manage use, mean that the supply situation is no longer as constrained as at the end of August. However, the issue is not yet completely resolved and GPs have been used to continue requesting blood tests with caution.

    Why are blood cultures drawn in 2 different bottles? ›

    A typical blood culture collection involves drawing blood into two bottles, which together form one "culture" or "set". One bottle is designed to enhance the growth of aerobic organisms, and the other is designed to grow anaerobic organisms.

    How many blood culture bottles are there? ›

    A blood culture set is defined as two bottles, an aerobic bottle and an anaerobic bottle. Two blood culture sets (a total of 4 bottles) should be drawn. For adults, collect 8-10 ml of blood per bottle. How much blood must I collect for a Pediatrics/Neonatal blood culture?

    Is there a global blood shortage? ›

    Every country in sub-Saharan Africa and South Asia has a significant blood shortage, and as a result, more than half of the global population doesn't have access to basic, life-preserving medical care, said Raykar, who is also a faculty leader in the Program in Global Surgery and Social Change at HMS.

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