Baxter International, the largest manufacturer of certain intravenous (IV) solutions in the United States, shut down its North Carolina plant after being impacted by Hurricane Helene, disrupting critical supply to hospitals.
Baxter’s North Cove plant “was significantly impacted by the rain and storm surge from Hurricane Helene, which was unprecedented in Western North Carolina and resulted in water permeating the facility,” the firm said in an Oct. 3 news release. The facility has been shut down. “We do not yet have a timeline for when operations will be back up and running.”
The North Cove plant manufactures 1.5 million bags of IV fluids per day and accounts for 60 percent of America’s supply, according to the American Hospital Association (AHA).
The North Cove site is Baxter’s biggest manufacturing facility and primarily produces intravenous and peritoneal dialysis solutions. The firm is the largest manufacturer of these fluids in the country. The company manufactures eight IV solutions, according to its catalog, used by millions of patients, healthcare providers, and caregivers.
Due to the ongoing operational disruption, Baxter has “implemented allocations to help ensure we are appropriately managing our inventory and minimizing disruption to patient care.”
“That means that after review and consideration of available inventory and the medical necessity of the impacted products, a specific limit on what a customer can order has been implemented. This allocation helps limit stockpiling and increases the likelihood of equitable access to available products.”
The restrictions have been applied to saline, dextrose, and peritoneal dialysis solution products. Baxter is also working with the U.S. Food and Drug Association (FDA) to leverage the firm’s global manufacturing network to mitigate supply issues.
The Florida Hospital Association said in an Oct. 5 X post that hospitals in the state were facing a supply disruption in securing intravenous and peritoneal dialysis solutions due to the closure of the North Cove facility.
The group was working with state and federal partners to “implement mitigation strategies to avoid disruptions in patient care.”
The California Hospital Association advised the state’s hospitals to take stock of their existing inventory of IV solutions and to alert their county’s Medical and Health Operational Area Coordinator (MHOAC) about any shortages.
“We are at the beginning of a major healthcare crisis among acute hospital care, cancer care, surgical centers, and dialysis centers,” nephrologist Saugar Maripuri said in an Oct. 4 X post. “Don’t be surprised if your elective surgical case gets canceled.”
He said the saline shortage situation is posing a “serious threat for dialysis centers.”
Remedying Site Damage, FDA Action
Approximately 500 workers are currently on the North Cove site as part of remediation efforts.“Bridges to our site were damaged in the storm. One access point requires re-establishing the County-maintained bridge. This will allow us to both transport remediation equipment to the site and get some finished goods that were stored in trailers,” Baxter said. “Our team has worked diligently to establish a temporary bridge to support limited transfers.”
The government is planning to install a permanent bridge in the coming weeks, the firm stated.
The FDA said it was working with Baxter, as well as officials from the U.S. Department of Health and Human Services and other agencies, to confirm how many products were released recently for distribution and are available to wholesalers.
The agency is also assessing what resources and assistance it can provide to deal with the supply situation. “This could include reviewing potential temporary imports or expediting reviews of the cleaned and restored manufacturing lines,” it said.
“As of October 1, 2024, FDA has not declared any new shortages related to products produced at the North Cove facility,” the agency said. FDA claimed it will work with alternative suppliers if required to manage shortages in critical products.
Jose E. Almeida, president and chief executive officer at Baxter, said the company will spare “no resource—human or financial” in its attempt to resume production. The North Cove facility employs 2,500 workers.
This isn’t the first time that Baxter has faced a supply disruption due to a natural disaster. Back in September 2017, Hurricane Maria hit Puerto Rico, affecting the company’s operations on the island.
While the firm resumed manufacturing in a limited manner within a week of the storm’s passing, it wasn’t until early 2018 that the plant was able to manufacture at pre-hurricane levels.
