Summary: The FDA has alerted healthcare providers to a shortage of BD blood culture media bottles due to supplier issues.

Takeaways:

  1. The shortage of BD blood culture media bottles is expected to impact patient diagnosis and antimicrobial stewardship efforts.
  2. The FDA advises healthcare providers to prioritize the use of blood culture media bottles for patients with the highest clinical need.
  3. Recommended strategies include performing blood cultures only when medically necessary, following strict disinfection protocols, and ensuring proper blood volume collection to avoid the need for recollection.

The U.S. is experiencing interruptions in the supply of BD BACTEC blood culture media bottles as a result of recent supplier issues, according to the U.S. Food and Drug Administration (FDA).

On July 10, 2024, the FDA updated the Medical Device Shortages List to include blood culture media bottles (product code MDB).

The disruption in supply of this device is expected to impact patient diagnosis, follow-up patient management, and antimicrobial stewardship efforts. The FDA recommends laboratories and health care providers consider conservation strategies to prioritize the use of blood culture media bottles, preserving the supply for patients at highest risk.

FDA Recommendations

The FDA recommends laboratories that may experience potential delays in supply of BD BACTEC blood culture media bottles, and health care providers who order blood cultures, develop strategies to prioritize the use of blood culture media bottles, based on clinical need, to maintain the quality and safety of patient care. 

In developing strategies to preserve the supply for patients at highest risk, the FDA says experts should consider the following:  

  • Performing blood culture collections when medically necessary, following clinical guidelines, such as those provided below. 
  • 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.
  • Utilizing safe blood collection and transfer devices to minimize the risk of damage to blood culture media bottles.
  • Refer to guidelines for best practices for blood collection and potential considerations for prioritization for use of blood culture media bottles

The FDA says it will continue to keep health care providers and the public informed if new or additional information becomes available.

FDA Actions

The FDA says it is continuing to monitor the current situation to help ensure blood culture media bottles remain available for patients when testing for bloodstream infection is medically necessary. 

The FDA reviews each notification received under section 506J of the FD&C Act and uses this information, along with any additional details about the supply of and demand for a device, to determine whether the device is in shortage.

The FDA says it will continue to keep health care providers and the public informed if new or additional information becomes available.