Disruptions in Availability of BD BACTEC Blood Culture Bottles: Current Situation

Current situation

CDC is alerting healthcare providers, laboratory professionals, healthcare facility administrators, and state, tribal, local, and territorial health departments of a critical shortage of Becton Dickinson (BD) BACTEC^TM blood culture media bottles.

This shortage has the potential to disrupt patient care by leading to delays in diagnosis, misdiagnosis, or other challenges in the clinical management of patients with certain infectious diseases.

Healthcare providers, laboratory professionals, healthcare facility administrators, and state, tribal, local, and territorial health departments affected by this shortage should immediately begin to assess their situations and develop plans and options to mitigate the potential impact of the shortage on patient care.

Recommendations

Institute best practices to reduce unnecessary blood cultures and, when needed, contamination events or instances in which an inadequate blood volume is cultured. Ensuring the right samples are collected from the right patients, the right way the first time, could help mitigate negative impacts of the shortage.

Recommendations for Healthcare Providers and Phlebotomists

• Implement practices to optimize the use of blood cultures at your facility.
• Take steps to prevent blood culture contamination.
• Ensure that the appropriate volume is collected when collecting blood for culture.

Laboratory Professionals and Healthcare Facility Administrators

• Determine the type of blood culture bottles your laboratory or facility uses and whether this shortage will impact you.
• Implement practices to optimize the use of blood cultures at your facility. Doing so may be helpful even for facilities not affected by the shortage.
• Take steps to prevent blood culture contamination. Contamination can negatively affect patient care and may require the collection of more blood cultures to help determine whether contamination has occurred.
• Ensure that the appropriate volume is collected when collecting blood for culture. Underfilling bottles decreases the sensitivity to detect bacteremia/fungemia and may require additional blood cultures to be drawn to diagnose an infection.
• If your laboratory or facility will be impacted by the bottle shortage, determine whether you have alternative options for blood cultures (e.g., working with a nearby facility or sending samples out to a laboratory not affected by the shortage).
• Monitor current and future supplies of blood culture bottles at your laboratory or facility and report any potential shortages or interruptions to the Food and Drug Administration (FDA).
• If your facility will be impacted by the bottle shortage, convene a group of local laboratory and clinical experts to determine how a limited supply of blood culture bottles will be prioritized for use in your facility.

Recommendations for State, Tribal, Local, and Territorial Health Departments

• Contact hospitals and laboratories in your jurisdiction that serve acute care patients (i.e., patients who are hospitalized or visiting an emergency department) to determine what type of blood culture bottles they use and whether this shortage will impact them.
• Focus the following interventions on impacted facilities and laboratories:
  • Provide education on the supply shortage, optimal use of blood cultures, and mechanisms for reporting supply chain shortages or interruptions and suspected adverse events to the FDA.
  • Facilitate communication between laboratories and facilities willing to assist others in need, either by sharing supplies of available blood culture bottles or working out arrangements for nearby laboratories using continuous monitoring blood culture systems unaffected by the shortage to perform blood cultures on behalf of the affected laboratory or facility.

Report Supply Chain Challenges

• FDA encourages health care 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.

Additional Resources