On July 10, 2024, the U.S. Food and Drug Administration (FDA) updated the Medical Device Shortages List to include blood culture media bottles (product code MDB). It also sent a letter to healthcare providers indicating that it is aware that the United States is experiencing interruptions in the supply of BD BACTEC blood culture media bottles because of recent supplier issues. The FDA said that the supply disruption is expected to affect patient diagnosis, follow-up patient management, and antimicrobial stewardship efforts. BD previously issued a letter in June 2024 to customers identifying the affected product.
Recommendations
For laboratories affected by potential delays in supply of BD BACTEC blood culture media bottles as well as healthcare providers who order blood cultures, the FDA recommended that they develop conservation strategies to prioritize the use of the bottles based on clinical need to maintain quality and safety of patient care, such as:
- Performing blood culture collections when medically necessary, following clinical guidelines, such as those linked 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
- Using safe blood collection and transfer devices to minimize the risk of damage to blood culture media bottles
- Referring to guidelines for best practices for blood collection and potential considerations for prioritization for use of blood culture media bottles:
- Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases: 2024 Update by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM)
- World Health Organization (WHO) Guidelines on Drawing Blood: Best Practices in Phlebotomy
- CDC resources:
The FDA said that it is continuing to monitor the situation to help ensure blood culture media bottles remain available for patients when testing for bloodstream infection is medically necessary and that it will inform the public if significant new information becomes available.
Reporting Problems to the FDA
The FDA encouraged healthcare providers to report any supply chain challenges or suspected adverse events experienced with the blood culture media bottles.
- Submit information on potential shortages or interruptions in availability to deviceshortages@fda.hhs.gov.
- Submit voluntary reports through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting regulations.
- Healthcare personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
“By promptly reporting device availability issues and potential shortages, you can help the FDA understand the scope of the problem and, when possible, mitigate the issue,” the agency said.