Disruptions in Availability of BD BACTEC Blood Culture Media Bottles for Bloodstream Infection Testing – Letter to Health Care Providers

Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers to notify providers that we are 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 also updated the medical device shortage list to include blood culture media bottles (product code MDB).

The disruption in availability of this device is expected to have impact on patient diagnosis, follow up patient management, and antimicrobial stewardship efforts.

The FDA recommends laboratories and health care providers consider strategies to conserve the use of blood culture media bottles for patients at highest risk.

The Letter to Health Care Providers includes important information about the blood culture media bottles shortage, including:

• Additional information about BD BACTEC products affected.
• Recommendations for health care providers and laboratorians.
• Actions that the FDA is taking to assess and mitigate the risk.
• Instructions for reporting problems with a device.

Questions?

If you have questions about this Letter to Health Care Providers, contact the Division of Industry and Consumer Education (DICE).