The US Centers for Disease Control and Prevention (CDC) yesterday issued a Health Alert Network advisory on the shortage of plastic Becton Dickinson (BD) BACTEC blood culture vials, which is expected to challenge the treatment of some infectious diseases through delayed diagnoses and misdiagnoses and compromise antimicrobial stewardship efforts.
"Blood cultures are critical for assisting healthcare providers with diagnosing patients with bloodstream infections and associated conditions including endocarditis, catheter-related bloodstream infections and sepsis," the advisory said. "Blood cultures can identify the microorganisms causing these infections, and follow-on antimicrobial susceptibility testing can be performed to help guide optimal therapy."
Most US blood cultures have continuous-monitoring blood culture systems like BD's, which is used in roughly half of labs and is compatible with only BD BACTEC vials. The supply disruption was added to the Food and Drug Administration's (FDA's) medical device shortages list on July 10.
BD exec says supply should improve in September
During a CDC/Infectious Diseases Society of America (IDSA)-hosted clinician call yesterday, Chris Beddard, MBA, vice president at BD Life Sciences, said the company's supplier has had manufacturing problems affecting the US and global supply but that more vials should be available in September.
BD is working with the Food and Drug Administration (FDA) to review all options and is working with the supplier to improve production line output, manage and equitably distribute supplies, and speed shipping, she said. It had notified customers of the shortage in June.
In the meantime, BD has temporarily substituted glass bottles for the plastic anerobic culture vials to improve availability. "We are looking to have that within the US market in early September," she said.
The CDC advises healthcare providers and lab professionals to take action now to prevent blood-culture contamination and ensure that enough blood is collected for optimal test sensitivity, to sidestep unnecessary testing, and to avoid additional blood draws that would require the use of more tubes.
"Several studies have demonstrated that unnecessary blood cultures can be reduced without an increase in adverse events," the CDC said. "CDC offers a quality tool to prevent blood culture contamination and improve diagnostic accuracy."
An FDA letter to healthcare providers earlier this month recommended prioritizing the tubes for patients with clinical signs of a bloodstream infection, following skin-disinfection protocols before blood collection, using safe blood-collection and transfer devices to avoid damaging the vials, and reporting problems to the agency.
Labs or facilities that will be affected by the shortage should look for alternative blood-culture options by working with a nearby facility or shipping samples to an unaffected lab and convening lab and clinical experts to decide how to prioritize a limited supply, the advisory said.
And health departments are urged to contact hospitals and labs to determine whether the shortage will affect them, educate them on the optimal use of blood cultures, and help arrange vial sharing or the use of unaffected labs.
Limiting blood cultures, second cultures
On the clinician call, Valeria Fabre, MD, and Aaron Milstone, MD, both of Johns Hopkins University School of Medicine's Division of Infectious Diseases, pointed out that about 90% of blood cultures from adult hospital patients are negative and presented an evidence-based algorithm for bacterial blood cultures.
"By using that as a reference, we estimated that about 30% of blood cultures in our medical adult ICU and 50% of blood cultures in our medicine floors were not appropriate," Fabre said.
