A longtime shortage of a type of sterile intravenous saline is now resolved, the Food and Drug Administration announced Friday.
According to the FDA, sodium chloride 0.9% injection products have been in shortage since 2018. The shortage was exacerbated when Hurricane Helene flooded a Baxter manufacturing plant in Marion, N.C. last fall what was responsible for 60 percent of the IV fluid in the country.
“This marks a significant milestone for public health and reinforces the FDA’s commitment to ensuring Americans have consistent access to life-saving medical products,” FDA Commissioner Marty Makary said in a statement.
Hospitals were left scrambling in the aftermath of Helene, as the shortage of multiple types IV fluid highlighted the fragility and vulnerability of the country’s medical supply chain. Many were forced to curtail elective procedures and ration supplies.
The IV fluid market is made up of primarily four manufacturers: Baxter International, which makes about 60 percent; B. Braun Medical, which makes about 23 percent; along with ICU Medical and Fresenius Kabi.
It’s common to see the same products go on and off the shortage list for years. Prior to Helene, certain IV solutions had been in shortage for almost 10 years.
Experts have long warned about allowing critical supplies to be highly concentrated in one place.
But manufacturing requirements for sterility mean a high barrier to entry into the market, and with low returns on investment for manufacturers, hospitals and suppliers have few options for recourse.
The FDA said it is working closely with manufacturers and will continue to monitor the supply of other IV fluids, which are still in shortage.
“The availability of reliable medical products is essential to patient care and the overall resilience of our healthcare system. Addressing this shortage has been a top priority for the FDA,” Makary said.
