REGULATORY UPDATE: FDA Issues Blood Culture Media Bottle Shortage Letter

The U.S. Food and Drug Administration (FDA) issued a letter to health care providers (LHCP) on July 10 focusing on disruptions in the availability of BD BACTEC blood culture media bottles.

In a June 11 letter to customers, BD (Becton, Dickinson, and Company) addressed the shortage and detailed the specific SKUs affected. AABB has confirmed that the BD BACTEC aerobic platelet testing medium (SKU 442053) and BD BACTEC anaerobic platelet testing medium (SKU 442054) are currently not included in the BD impacted products list.

In the FDA's letter, the agency emphasized that the U.S. is experiencing interruptions in the supply of BD BACTEC blood culture media bottles due to recent supplier issues. The agency expects the supply disruptions to impact patient diagnosis, follow-up patient management and antimicrobial stewardship efforts.

In conjunction with the LCHP, FDA updated the Medical Device Shortages List to include blood culture media bottles (product code MDB). The update provides detailed information about the estimated shortage duration and recommendations for health care providers and laboratories.

Health care providers and laboratories are urged to stay informed through FDA updates and BD communications to effectively manage the supply constraints and ensure patient care continuity.