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FDA Issues Letter Regarding Shortage of Becton Dickinson Blood Culture Bottles

NEW YORK – The US Food and Drug Administration on Wednesday issued a letter alerting healthcare providers about a shortage of Becton Dickinson blood culture media bottles.

The shortage of BD Bactec bottles, due to a supplier issue, is expected to affect patient diagnosis and management, as well as antimicrobial stewardship efforts, the FDA said.

In the letter, the agency recommended that labs preserve their supply for patients at highest risk by performing blood culture collections only when medically necessary.

In particular, the FDA suggested prioritizing blood culture media bottle use for patients with clinical signs and symptoms of a bloodstream infection, disinfecting skin prior to collection to avoid contamination, collecting the proper volume of blood, and utilizing transport devices that minimize risk of damage to bottles.

The agency will continue to monitor the situation, it said.

In a statement, Nikos Pavlidis, worldwide president of BD Diagnostic Solutions, said that the firm understands the critical role that blood culture testing has in diagnosing and treating infections.

"While we are able to meet the majority of global demand, we are taking all available measures to address this important issue," Pavlidis said, adding that "BD Bactec blood culture vials are being allocated manually so we can best mitigate any impact to patient care."

The firm is also providing the supplier with manufacturing expertise, using air shipments, modifying its manufacturing schedules for rapid production, and collaborating with the FDA to review all potential options to lessen delays in supply, Pavlidis said.

The firm's former supplier of glass vials will also restart production to help fill the intermittent gap in supply, BD said in the statement.

BD advised customers to prioritize the use of blood culture following guidelines from the Infectious Diseases Society of America and the World Health Organization.