Jul 23, 2021
The U.S. Food and Drug Administration (FDA) is aware the US is experiencing significant interruptions in the supply of sodium citrate blood specimen collection tubes, also known as light blue top tubes (hereafter “sodium citrate tubes”), used for coagulation (blood clotting) testing because of an increase in demand and recent vendor supply challenges.
On June 10, 2021, the FDA added these tubes (product codes GIM and JKA, sodium citrate tubes only) to the section 506J device shortage list. The FDA has also provided conservation strategies for these tubes during the COVID-19 public health emergency.
The FDA recommends health care and laboratory facilities develop and implement conservation strategies to minimize the use of these tubes and maintain the quality and safety of care for patients who need coagulation testing.
On July 22, 2021, the FDA issued an Emergency Use Authorization (EUA) for specific sodium citrate tubes for emergency use in health care settings to collect, transport, and store blood specimens for coagulation testing to aid in the identification and treatment of coagulopathy in patients with known or suspected COVID-19, with testing performed by authorized laboratories.
Q: What does it mean to be an “authorized laboratory” that can use tubes under this EUA?
A: Testing using these blood collection tubes is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 USC §263A), and that meet requirements to perform moderate and high complexity tests.
Q: Is there a shortage of sodium citrate (light blue top) tubes?
A: The FDA has determined that, based on available information, due to an increase in demand and recent vendor supply challenges, there is a shortage of sodium citrate (light blue top) tubes at this time, and added these devices (product codes GIM and JKA, sodium citrate tubes only) to the section 506J device shortage list on June 10, 2021. The device shortage list reflects the categories of devices the FDA has determined to be in shortage at this time, and the FDA will continue to update the list as the COVID-19 public health emergency evolves.
The FDA continues to monitor the current situation to help ensure that coagulation testing remains available for patients for whom such testing is medically necessary.
Q: Are sodium citrate (light blue top) tubes from different manufacturers interchangeable for coagulation testing?
A: Not necessarily. Draw and test specifications for certain tests may differ among sodium citrate tubes from different manufacturers thereby potentially altering the test results.
Trained staff should perform validation testing using established reagents and instruments before transitioning between tubes from different manufacturers. Furthermore, certain tube collection systems from other manufacturers may not work with your current collection system. Additional staff training may be necessary to use other blood collection tube systems.
Q: What is FDA doing to mitigate the supply challenges of sodium citrate (light blue top) tubes?
A: On July 22, 2021, to help with availability of sodium citrate tubes during the pandemic, the FDA issued an EUA for BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) used to collect, transport, and store blood samples for testing to aid in the identification and treatment of coagulopathy in patients with known or suspected COVID-19. Testing using these blood collection tubes is limited to authorized laboratories. For more information on these authorized tubes, please review the EUA authorization letter and accompanying Fact Sheet.
In addition, the FDA has provided recommendations for conservation strategies for use by health care organizations, laboratory facilities, and their personnel—categorized for a range of clinical needs and supply levels—to assist these groups in determining conservation procedures during this time period.
The FDA continues to work diligently to mitigate any supply chain shortages and is taking action to assure health care and laboratory personnel have sufficient supplies for coagulation testing.
Q: Can sodium citrate tubes that are not FDA-cleared or authorized in the United States be used during the COVID-19 pandemic?
A: Sodium citrate tubes that are not FDA-cleared or authorized under an emergency use authorization (EUA) under section 564(c) of the FD&C Act are not legally marketed devices and should not be used.
Q: Can we use expired sodium citrate blood tubes for patient specimen collection?
A: Expired sodium citrate blood tubes should not be used for patient specimen collection. Expired sodium citrate tubes should be discarded because out-of-date tubes may have decreased vacuum (preventing a proper fill) or degraded additives. Underfill of the specimen collection tube can result in inaccurate test results.
Q: My health care organization already has a plan for how we will handle the supply availability challenges for sodium citrate tubes. Are we required to follow the FDA's recommendations listed in the letter to health care providers?
A: The letter to health care providers is intended to aid facilities in the management of supply challenges related to sodium citrate tubes. The FDA's recommendations in the letter, as well as FDA’s recommended conservation strategies, are suggestions that can help supplement health care organizations’ and laboratories’ current conservation strategies.
Q: What can I do if I have concerns about my health care organization’s supply of sodium citrate tubes?
A: The FDA encourages health care providers to review and implement conservation strategies. If you have implemented mitigation strategies and your organization has less than a two-day supply of inventory, the FDA encourages you to contact your group purchasing organization (GPO), local product representative, or account manager.
In addition, the FDA is interested in hearing from health care facilities, laboratories, and providers experiencing difficulty obtaining devices, as well as from other stakeholders who may be able to help mitigate potential shortages. You may email the FDA at email@example.com.
Q: How do I report problems to the FDA?
A: The FDA encourages health care providers and end users to report any adverse events or suspected adverse events experienced with sodium citrate blood specimen collection (light blue top) tubes.
- Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
- Health care and laboratory personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
- This press release was provided by U.S. Food and Drug Administration