Monday, July 15, 2024

BD Bactec Blood Culture Media Bottles Added to FDA’s Medical Device Shortage List Due to Supply Issues

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Blood culture media bottles from BD Life Sciences Bactec have been added to the Food and Drug Administration’s (FDA) Medical Device Shortage List due to anticipated disruptions in availability. This decision follows projections indicating that recent supplier issues could lead to significant shortages. The FDA addressed healthcare providers in a letter today, highlighting the impact this shortage could have on patient diagnosis, follow-up management, and antimicrobial stewardship efforts.

BD Life Sciences has been facing reduced availability of plastic bottles from their supplier for several months, which has hindered their ability to manufacture BD Bactec media to meet global demand. Despite implementing various measures to manage the shortage, the company now anticipates additional supply constraints and delays in media availability due to increasing demand.

In response to the supply issues, BD is working closely with the FDA to explore all available options to resolve the problem as quickly as possible. Collaborate with the raw material supplier to improve production line efficiency and output, implement early placement of BD Bactec media on manual allocation to ensure equitable distribution and closely manage supply, reduce transit times using air shipment to meet regional needs and enhance inventory levels, and modify manufacturing schedules to respond rapidly to bottle shipments from the supplier.

Managing BD Bactec Blood Culture Media Bottle Shortage

To manage the shortage, BD and the FDA recommend that healthcare providers develop strategies to prioritize the use of blood culture media bottles based on clinical need. Suggested strategies include:

  • Perform blood culture collections only when medically necessary and follow clinical guidelines to prioritize use for patients showing clinical signs and symptoms of a bloodstream infection.
  • Conduct routine skin disinfection protocols before collection to minimize the risk of blood culture contamination, ensure proper blood volume collection to avoid the need for additional sample recollection, and utilize safe blood collection and transfer devices to minimize the risk of damage to blood culture media bottles.

The shortage of BD Bactec blood culture media bottles is expected to impact healthcare providers’ ability to diagnose and manage patient conditions effectively. However, BD remains committed to filling customer orders as supply allows and has forecasted that ongoing mitigation efforts will lead to an increased supply to meet global demand. The company expects to provide an additional supply update by September.

Blood Culture

Critical Implications for Patient Care and Urgent Need for Solutions

Blood culture media bottles are essential in diagnosing bloodstream infections, which can be life-threatening if not promptly and accurately identified. These bottles allow for the cultivation and detection of bacteria and fungi in the bloodstream, providing critical information for effective treatment. The shortage could therefore have significant implications for patient care, highlighting the urgency of addressing the supply issues.

The addition of BD Bactec blood culture media bottles to the FDA’s Medical Device Shortage List underscores the severity of the current supply challenges. While BD and the FDA are taking steps to mitigate the impact, healthcare providers must adapt their practices to prioritize the use of available resources.

The collaboration between BD and the FDA, alongside the proactive measures being implemented, aims to alleviate the shortage and ensure that patient care standards are maintained despite these challenges. As the situation evolves, further updates will be crucial in guiding healthcare providers and ensuring that the supply chain stabilizes.

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Resource: Food and Drug Administration, July 10, 2024

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