BD Bactec Blood Culture Media Bottles in Shortage

FDA today sent a letter to healthcare providers detailing that the United States is experiencing interruptions in the supply of BD Life Sciences Bactec blood culture media bottles due to recent supplier issues. The disruption is expected to impact patient diagnosis, follow-up patient management, and “antimicrobial stewardship efforts,” the notice wrote.

“For several months, we have seen reduced availability of plastic bottles from our supplier that has prevented us from manufacturing BD Bactec media to meet full global demand,” according to a company statement. “To date, we have been able to manage this issue with a variety of measures, but based on the latest demand projections, we anticipate users may begin to experience additional supply constraints and delays in media availability.”

The agency has also updated the Medical Device Shortage List to include blood culture bottles.

To address the supply issues, BD said that it is working with FDA to review all available options to resolve the problem as soon as possible and is already implementing several mitigation measures. The company is working directly with its raw material supplier of the molded bottles to improve production line efficiency and output, is implementing early placement of DB Bactec media on manual allocation to closely manage supply and ensure equitable distribution, is reducing transit times where possible with the use of air shipment to meet regional needs and improve inventory levels, and modifying manufacturing schedules to rapidly respond to bottle shipments from the supplier, according to the company statement.

BD and FDA are recommending users develop strategies to prioritize the use of blood culture media bottles based on clinical need. They said that when developing these strategies, consider “performing blood culture collections when medically necessary, following clinical guidelines prioritizing use for patients with clinical signs and symptoms of a bloodstream infection, performing routine disinfection of skin protocols prior to collection to minimize the risk of contamination of the blood culture, ensuring proper blood volume collection to avoid a need to recollect additional samples, and utilizing safe blood collection and transfer devices to minimize the risk of damage to blood culture media bottles,” according to FDA.

In the statement, the company said that “while inventory is forecasted to tighten in the coming weeks, we expect that ongoing mitigation efforts will lead to increased supply to meet global demand. In the interim, BD will continue to fill customer orders regularly and as supply is available.”

BD expects to provide an additional supply update by September.