FDA Letter to Health Care Providers

9/5/24, 10:53 AM

Disruptions in Availability of BD BACTEC Blood Culture Media Bottles - Letter to Health Care Providers | FDA

Disruptions in Availability of BD BACTEC Blood Culture
Media Bottles - Letter to Health Care Providers
Update: August 15, 2024
The FDA updated this communication to add additional external resources about the BD
BACTEC blood culture media bottle shortage.
The FDA will continue to provide updates if new or additional information becomes
available. 

July 10, 2024
The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing
interruptions in the supply of BD BACTEC blood culture media bottles because of recent
supplier issues. The disruption in supply of this device is expected to impact patient diagnosis,
follow up patient management, and antimicrobial stewardship efforts. The FDA recommends
laboratories and health care providers consider conservation strategies to prioritize the use of
blood culture media bottles, preserving the supply for patients at highest risk.

Recommendations
The FDA recommends laboratories that may experience potential delays in supply of BD
BACTEC blood culture media bottles, and health care providers who order blood cultures,
develop strategies to prioritize the use of blood culture media bottles, based on clinical need, to
maintain quality and safety of patient care. 
In developing strategies to preserve the supply for patients at highest risk, please consider the
following:  
Performing blood culture collections when medically necessary, following clinical
guidelines, such as those provided below. 
Prioritizing use for patients with clinical signs and symptoms of a bloodstream infection. 
Performing routine disinfection of skin protocols prior to collection to minimize the risk of
contamination of the blood culture.
Ensuring proper blood volume collection to avoid a need to recollect additional samples.
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9/5/24, 10:53 AM

Disruptions in Availability of BD BACTEC Blood Culture Media Bottles - Letter to Health Care Providers | FDA

Utilizing safe blood collection and transfer devices to minimize the risk of damage to blood
culture media bottles.
Referring to the following guidelines for best practices for blood collection and potential
considerations for prioritization for use of blood culture media bottles:
Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious
Diseases: 2024 Update by the Infectious Diseases Society of America (IDSA) and
the American Society for Microbiology (ASM)
(https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciae104/7619499) 
(http://www.fda.gov/about-fda/website-policies/website-disclaimer) 
World Health Organization (WHO) guidelines on drawing blood: best practices in
phlebotomy (https://www.who.int/publications/i/item/9789241599221) 
(http://www.fda.gov/about-fda/website-policies/website-disclaimer)
CDC resources: 
Preventing Adult Blood Culture Contamination: A Quality Tool for Clinical
Laboratory Professionals (https://www.cdc.gov/labquality/blood-culturecontamination-prevention.html)
Blood Culture Contamination: An Overview for Infection Control and Antibiotic
Stewardship Programs Working with the Clinical Laboratory
(https://www.cdc.gov/antibiotic-use/core-elements/pdfs/fs-bloodculture-508.pdf)
The FDA will continue to keep health care providers and the public informed if new or additional
information becomes available.

Background
On July 10, 2024, the FDA updated the Medical Device Shortages List (/medicaldevices/medical-device-supply-chain-and-shortages/medical-device-shortages-list) to include
blood culture media bottles (product code MDB). Section 506J of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) requires the FDA to maintain a publicly available, up-to-date list of the
devices the FDA has determined to be in shortage. BD has previously issued a letter
(https://www.medline.com/media/assets/pdf/vendor-list/June2024-BD-BACTEC-BloodCultureMediaSupply.pdf)  (http://www.fda.gov/about-fda/website-policies/website-disclaimer) to
customers identifying the product impacted. 

FDA Actions
The FDA is:
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9/5/24, 10:53 AM

Disruptions in Availability of BD BACTEC Blood Culture Media Bottles - Letter to Health Care Providers | FDA

Continuing to monitor the current situation to help ensure blood culture media bottles
remain available for patients when testing for bloodstream infection is medically
necessary. 
Informing the public if significant new information becomes available.
The FDA reviews each notification received under section 506J of the FD&C Act and uses this
information, along with any additional details about the supply of and demand for a device, to
determine whether the device is in shortage.
The FDA will continue to keep health care providers and the public informed if new or additional
information becomes available.

Reporting Problems to the FDA
The FDA encourages health care providers to report any supply chain challenges or suspected
adverse events experienced with the blood culture media bottles.   
You can submit information on potential shortages or interruptions in availability to
[email protected] (mailto:[email protected]).
You can submit voluntary reports through MedWatch, the FDA Safety Information and
Adverse Event Reporting program (/safety/medwatch-fda-safety-information-and-adverseevent-reporting-program/reporting-serious-problems-fda).
Device manufacturers and user facilities must comply with the applicable Medical Device
Reporting (MDR) regulations (/medical-devices/postmarket-requirementsdevices/mandatory-reporting-requirements-manufacturers-importers-and-device-userfacilities).
Health care personnel employed by facilities that are subject to the FDA's user facility
reporting requirements (/medical-devices/postmarket-requirements-devices/mandatoryreporting-requirements-manufacturers-importers-and-device-user-facilities) should follow
the reporting procedures established by their facilities.
By promptly reporting device availability issues and potential shortages, you can help the FDA
understand the scope of the problem and when possible, mitigate the issue.

Additional External Resources
Laboratorians and other healthcare providers should also be aware of external resources
available from manufacturers and professional societies. These are independent of the FDA’s
actions and recommendations and are provided here for convenience.
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9/5/24, 10:53 AM

Disruptions in Availability of BD BACTEC Blood Culture Media Bottles - Letter to Health Care Providers | FDA

Manufacturer’s web page: BD BACTEC Blood Culture Vial Supply (https://bdbactecupdate.com/)  (http://www.fda.gov/about-fda/website-policies/website-disclaimer)
American Society for Microbiology (ASM) guideline, endorsed by the Society for
Healthcare Epidemiology of America (SHEA): Blood Culture Bottle Inventory Management
and Clinical Conservation During Supply Shortages (https://asm.org/getmedia/8daa65e4c141-4a0b-9d60-0ae2337505fc/Blood-Culture-shortage-FAQ_FINAL.pdf?ext=.pdf) 
(http://www.fda.gov/about-fda/website-policies/website-disclaimer) published August 5,
2024 (PDF - 1039 KB)
Informational web page from the Infectious Disease Society of America (IDSA): Blood
Culture Bottle Shortage (https://www.idsociety.org/clinical-practice/blood-culture-bottleshortage/)  (http://www.fda.gov/about-fda/website-policies/website-disclaimer)

Contact Information
If you have questions about this letter, contact the Division of Industry and Consumer Education
(DICE) (/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-usdivision-industry-and-consumer-education-dice).

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