(Reuters) – The U.S. Food and Drug Administration issued an alert on Wednesday to laboratories and healthcare providers of a shortage of Becton Dickinson’ blood test tubes used in diagnosing bacterial and fungal infections.
The regulator urged providers to prioritize patients at the highest risk such as those displaying signs of bloodstream infections, which can often be deadly.
WHY IT’S IMPORTANT
The disruption in supply of this device is expected to impact patient diagnosis, follow-up treatment, and antimicrobial management efforts, according to the FDA.
Becton’s BACTEC blood culture media help detect bacterial and fungal infections in the bloodstream. Early detection of an infection help prevent worsening of a condition called sepsis, which occurs when the immune system has a dangerous reaction to an infection.
CONTEXT
Last month, Becton issued a letter warning of potential delays in its BACTEC blood culture media supply over the coming months due to reduced availability of plastic bottles from a supplier.
The company said it will provide an update on supply by September.
KEY QUOTES
“While this supplier issue is not expected to have a material financial impact on BD, we are fully focused on returning the supply of blood culture vials to normal levels,” Nikos Pavlidis, president of BD Diagnostic Solutions, said in a statement.
Becton said it is taking measures to address the issue, including the use of air shipments and modifying manufacturing schedules for rapid production.
BY THE NUMBERS
At least 1.7 million adults in the U.S. develop sepsis each year, and nearly 270,000 die as a result of it, according to the Centers for Disease Control and Prevention.
(Reporting by Mariam Sunny in Bengaluru; Editing by Alan Barona)
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