The FDA is working with Baxter Healthcare, B. Braun and other manufacturers to find ways to alleviate the shortage of IV saline, which is used by dialysis clinics and other health care providers.
“Based on the information we’re receiving from companies and the actions we’ve taken at FDA, we continue to expect that the shortage of IV fluids will improve in the coming weeks and months,” FDA Commissioner Scott Gottlieb, MD, said in a statement released on Jan. 16. “In addition to working with manufacturers to ensure that their Puerto Rico facilities can operate at full capacity, we’ve worked with manufacturers such as Baxter and B. Braun to import product into the U.S. from their foreign facilities, including most recently from a Baxter facility in Brazil. We are also looking at additional potential import sites for both small and larger volume IV saline bags.”
Gottlieb said the agency has approved the import of IV saline products from manufacturers outside the United States, such as Fresenius Kabi and Laboratorios Grifols, to increase supply and is checking with manufacturers to see if expiration dates for shortage products can be safely extended.
Dialysis staff use saline to help filtrate blood in and out of dialysis machines. Baxter, one of the leading producers of saline, said it had minimal structural damage to manufacturing plants in Puerto Rico after Hurricane Maria hit the mainland in October, but production was hampered by problems with the island’s power grid.
“Manufacturing operations are being driven by diesel generators designed to power the facilities and satellite communications are also being used to restore connectivity and support plant operations,” the company said in a press release issued on Oct. 12.
While power on the island is being restored, Gottlieb said the FDA also worked with Baxter facilities in the United Kingdom and Italy to bring in more supplies. “Small volume IV saline bags, or those in 50 ml- and 100 ml-sizes, are often used to deliver other medicines like antibiotics to patients while larger volume sizes are typically used to hydrate patients,” Gottlieb said, adding that the “tight supply of saline products has been exacerbated by an increased demand for saline we’re seeing as a result of the worse-than-typical flu season.” – by Mark E. Neumann