January 19, 2022

The U.S. Food and Drug Administration (FDA) is aware the United States is experiencing significant interruptions in the supply of several blood specimen collection (blood draw) tubes because of an increase in demand during the COVID-19 public health emergency and recent vendor supply challenges. The FDA is expanding the medical device shortage list to include all blood specimen collection tubes. The FDA previously issued a letter to health care and laboratory personnel on June 10, 2021, about a shortage of sodium citrate blood specimen collection (light blue top) tubes. 

Recommendations

The FDA recommends health care providers, laboratory directors, phlebotomists, and other personnel consider the following conservation strategies to minimize blood collection tube use and maintain quality and safety of patient care:

• Only perform blood draws considered medically necessary.
  • Remove duplicate test orders to avoid unnecessary blood draws.
  • Avoid testing too frequently or extend time intervals between tests whenever possible.
• Reduce tests at routine wellness visits and allergy testing only to those that target specific disease states or where it will change patient treatment.
• Consider add-on testing or sharing samples between laboratory departments if previously collected specimens are available.
• If you need a discard tube, use a tube type that has a greater quantity available at your facility.
• Consider point of care testing that does not require using blood specimen collection tubes (lateral flow tests).

FDA Actions

On January 19, 2022, the FDA updated the medical device shortage list to include all blood specimen collection tubes (product codes GIM and JKA). 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.

Previously, on:

• June 10, 2021, the FDA added sodium citrate (light blue top) tubes under the same product codes (GIM and JKA) to the medical device shortage list during the COVID-19 public health emergency.
• July 22, 2021, the FDA issued an Emergency Use Authorization (EUA) to Becton Dickinson for certain sodium citrate blood specimen (light blue top) collection tubes used to collect, transport, and store blood samples for coagulation testing to better identify and treat coagulopathy in patients with known or suspected COVID-19.

The FDA continues to monitor the current situation to help ensure blood testing remains available for patients where testing is medically necessary. The FDA will inform the public if significant new information becomes available.

The FDA reviews each notification received under section 506J and uses this information, along with any additional details about the supply and demand of a device, to determine whether a device is in shortage.

Reporting Problems to the FDA

The FDA encourages health care providers to report all adverse events or suspected adverse events experienced with any blood specimen collection tube.

• 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 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.

In addition, the FDA would like to hear from health care providers who have trouble obtaining devices, as well as from other stakeholders who may help mitigate potential shortages. You may email the FDA at [email protected]. Note that pursuant to section 506J manufacturers must notify the FDA of an interruption or permanent discontinuance in manufacturing of these devices.

Contact Information

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).