The FDA is recommending that healthcare providers only perform blood draws considered medically necessary, after interruptions in the nationwide supply chain and the COVID-19 pandemic have caused broad shortages of blood specimen collection tubes.
The agency had previously listed one specific type of blood collection tube in shortage—those containing the anticoagulant sodium citrate and typically identified by a light blue cap—starting in June 2021. Now, the FDA has expanded that list to include all specimen tubes.
In a letter to phlebotomists and laboratory directors, the FDA urged clinicians to remove duplicate test orders to avoid unnecessary draws, and to extend time intervals between tests whenever possible.
That includes reducing the number of preventive tests at routine wellness visits and prioritizing diagnostics that target specific diseases or directly guide patient treatment. The agency also recommended relying on point-of-care tests, such as lateral flow assays, that do not require storing a specimen drawn from a vein in a specialized container.
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Last July, after sodium citrate tubes became harder to find—due to the widespread need to monitor patients with COVID-19 for blood clots and coagulation complications—the FDA granted an emergency authorization for additional, U.K.-manufactured tubes from BD, maker of the near-ubiquitous Vacutainer brand of blood collection tubes. These sterile, plastic tubes were specifically greenlit for use among coronavirus patients.
The spread of COVID-19 has strained different points up and down the diagnostic supply chain since the beginning of the pandemic.
By mid-2020, it became clear that reagents and specialized chemicals wouldn’t be the only products in high demand as the world clamored for more coronavirus tests: Every piece necessary, from swabs and gloves to transport containers, has been listed in short supply at one point or another.
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In one out-of-the-box effort to help meet that demand, when sterile tubes were needed to simply hold swab samples before testing, the U.S. government and the Oak Ridge National Laboratory began collaborating with a group of independent soda bottle manufacturers working for Coca-Cola to help fill the gap.
Before being heated and shaped into their iconic curves, Coca-Cola bottles begin life as a simple, nondescript, mass-produced plastic tube, which happened to be the perfect size for holding a swab. The companies went on to produce millions of test kit tubes using their injection molding machinery.