Advocacy Update

• CDC Warns Labs About Critical Shortage of Blood Culture Media Bottles
• Chief Regulator of Medical Devices Leaves FDA
• PHOTO: Dr. Martinez-Torres Meets with US Senator
• Take Our News Quiz for July

The Centers for Disease Control and Prevention (CDC) issued a health advisory about a critical shortage of Becton Dickinson (BD) BACTEC™ blood culture media bottles on July 23. The advisory followed an announcement by the Food and Drug Administration (FDA) regarding the disruption in availability of BD BACTEC blood culture media bottles on July 10.

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, the CDC said. Those 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.

The CDC recommended instituting 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.

Additional recommendations for laboratory professionals include:

• 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 (eg, 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 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.

Additional Resources:

• CDC Health Advisory
• Medical Device Shortages List | FDA

On July 23, Jeffrey Shuren, longtime chief regulator of medical devices at the Food and Drug Administration (FDA), announced that he is leaving the agency. After almost 15 years as director of the Center for Devices and Radiological Health (CDRH), he announced he will leave the FDA later this year. Starting next week, Michelle Tarver, deputy center director for transformation, will take on the role of CDRH acting director.

During his time, CDRH launched new regulatory initiatives like a digital health center of excellence, as well as establishing the agency’s stance toward artificial intelligence-powered devices. The center also worked on the FDA’s laboratory-developed test final rule that was issued May 6, 2024.

CAP Governor and former CAP Foundation Board President Guillermo G. Martinez-Torres, MD, FCAP and US Senator Susan Collins (R-ME) pose for a photo at an event in Maine in July. They discussed the Food and Drug Administration’s laboratory-developed test rule and the Verifying Accurate Leading-edge IVCT Development Act (VALID Act).

Are you up to speed on CAP advocacy news? Take our new monthly news quiz and see how many you can get right and share your results on social media.

Take the quiz.