The FDA is urging dialysis providers to conserve their supplies of blood flow lines, amid a shortage of the specialized tubing that the agency expects will continue for at least six months.
Early this past January, devicemaker B. Braun sent a letter to healthcare workers alerting them of a disruption affecting one of its suppliers, resulting in reduced production of its 8 mm FMC Streamline bloodline, with part number SL-2000M2095.
The company said in the January 8 letter (PDF) that supply and labor constraints over the holidays were a factor, and that based on inventory at the time, B. Braun “expected to run out of product by January 20 with no additional releases planned in the foreseeable future.” It listed 8 mm bloodlines produced by Fresenius and Nipro as suitable alternatives.
Now, the FDA said it anticipates shortages to continue through the early fall of 2025, and that healthcare providers may be forced to adjust their management of patients receiving acute or chronic dialysis treatments.
The agency said providers should continue to provide therapy, but use their clinical judgment when developing conservation strategies. The FDA said it is working with manufacturers to develop other shortage mitigation plans, while it adds the bloodlines to its official medical device shortage list.
At the same time, the FDA also removed two previous shortages from its list after supplies returned—including blood culture vials, from July 2024, and IV fluid bags, following damage to production facilities during Hurricane Helene last year.