On Friday, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra hosted a roundtable with government officials, hospital and clinical leaders, distributors, and representatives from Becton, Dickinson and Company (BD) to discuss mitigation strategies and solutions to alleviate the shortage of blood culture media bottles. Secretary Becerra began the call by highlighting the importance of acting now in order to avoid more acute shortages as we move into fall respiratory virus season.

During the call, representatives from BD described actions taken to increase and stabilize production output over the past several months, supplement demand with BD BACTEC™ in glass vials and support customers with extended shelf life where possible. BD stated that customers should see improved allocation soon with production levels back to meeting 100% of historic demand levels by end of September for the U.S. market and 125% of historical weekly demand by the end of 2024 to enable distributors and customers in the U.S. to rebuild inventory and safety stock.

The Secretary touched on the ongoing need for voluntary collaboration in order to resolve this shortage quickly, from manufacturer to distributor to providers. On Friday, August 16, Secretary Becerra released a statement about the disruptions in availability of blood culture media bottles and affirmed the Biden-Harris Administration's commitment to mitigate and resolve disruptions as quickly as possible.

The conversation comes after the Food and Drug Administration (FDA) updated the Medical Device Shortages List to include blood culture media bottles in July. Staff from FDA have been in contact with BD to work to resolve this disruption quickly and efficiently. The Centers for Medicare & Medicaid Services (CMS) has also been in contact with the American Hospital Association (AHA) regarding the impact of the disruption on hospitals' ability to perform optimally on certain quality measures such as the Severe Sepsis and Septic Shock measure, and healthcare-associated infection measures, potentially affecting CMS Hospital Star Ratings and CMS' value-based programs.

"Let's bring everyone to the table," Becerra said as he closed the call, reiterating that resolving the shortage now is top priority but finding solutions and increasing collaboration is the best path forward to avoiding similar shortages in the future.

List of Administration participants:

• HHS Secretary Xavier Becerra
• Stephen Colvill, Senior Policy Advisor for Medical Supply Chains, White House Domestic Policy Council
• Bertha Alisia Guerrero, Director, Office of Intergovernmental and External Affairs
• Laina Bush, Deputy Assistant Secretary for Science and Data Policy, Assistant Secretary for Planning and Evaluation
• Hilary Marston, MD, MPH, Chief Medical Officer, U.S. Food & Drug Administration (FDA)
• Dora Hughes, MD, MPH, Acting Chief Medical Officer and Acting Director, Center for Clinical Standards and Quality, Centers for Medicare & Medicaid Services (CMS)

List of Stakeholder Participants:

• American Clinical Laboratory Association
• American Hospital Association
• American Society for Microbiology
• Becton Dickinson
• Berry Global
• Cardinal Health
• Children's Hospital Association
• Federation of American Hospitals
• Health Industry Distributors Association
• Infectious Diseases Society of America
• Medline
• Owens & Minor

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