It before IV fluid products from Baxter International Inc.鈥檚 Marion plant make their way back into the marketplace.
The North Cove plant experienced significant flooding damage from Hurricane Helene on Sept. 27. It is Baxter鈥檚 largest manufacturing facility with more than 2,500 employees. Baxter continued to caution that 鈥渨e do not yet have a timeline for when we expect North Cove production to be fully restored to pre-hurricane levels.鈥
Meanwhile, all the employees have been accounted for as the manufacturer slowly recovers from Helene鈥檚 damage. Baxter said employees are returning to work at pre-hurricane staffing levels, 鈥渨orking alongside remediation contractors that have been engaged on a temporary basis for site recovery.鈥
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鈥淲e are encouraged to report that, barring any unanticipated developments, Baxter anticipates restarting the highest-throughput IV solutions manufacturing line within the next week.
鈥淚nitial batches will be manufactured concurrently with ongoing quality activities and would only be released in accordance with applicable regulatory requirements to ensure the quality and safety of the products.鈥
The Food and Drug Administration announced Oct. 9 it has authorized temporary importation from five Baxter manufacturing facilities in Canada, China (two sites), Ireland and the United Kingdom. Since then, sites in Mexico, Singapore, Spain and Thailand have been authorized along the same lines.
Additional shipments of product authorized for temporary importation arrived in the last week with levels of up to 100,000 products per flight.
The bridge on Pitts Station Road in Marion that leads from U.S. 221 to Baxter Healthcare was severely damaged by floodwaters during Hurricane Helene as seen on Oct. 2. A new route using culverts and rock is being built to cross the North Fork Catawba River.
Resumption schedule
Baxter said Oct. 14 it had started sourcing IV fluids and peritoneal dialysis solutions from its global network. Baxter is the largest U.S. manufacturer of these solutions.
Andrea Garcia, vice president of science, medicine and public health for American Medical Association, said the Baxter shipments from other plants are making a supply difference.
鈥淎ccording to US DHHS, hospitals have 50% more product available to them now compared to right after the hurricane,鈥 Garcia said.
Baxter said it will communicate distribution plans for this product with customers including direct communication to support any associated set-up and training needs.
鈥淭o date, we have been partnering with healthcare professionals to limit new PD patient starts in the U.S. to pediatric patients and communicated that other medically necessary patient exceptions may be considered,鈥 Baxter said.
鈥淲e expect to be in a position to accept new patients on a limited basis beginning in the next few weeks.鈥
Hospitals鈥 impact
Garcia described the .
Garcia said the North Cove closure 鈥渃aused massive supply disruptions. We know that hospitals and government agencies are now scrambling to cope with these shortages.鈥
The plant closure exasperated what the FDA also was saying was a shortage of supplies of several IV fluid products going back at least a couple of years. 鈥淭he closure of this North Cove facility has been particularly devastating and has had major repercussions for the supply chain,鈥 Garcia said.
鈥淲e know that according to the American Hospital Association, the site produces about 60%, or 1.5 million bags, of the IV fluid used by U.S. hospitals. And that鈥檚 really a staggering amount.鈥
Garcia said a survey of more than 220 health care providers conducted Oct. 7-8 by the health analytics consulting firm Premier found that more than 86% of U.S. health care providers were experiencing shortages of IV fluids. About 54% reporting supplies of 10 days or less of IV fluids in their inventories at that time. Garcia said the FDA also has declared national shortage of peritoneal dialysis solution, that it would 鈥渘ot be commercially available in adequate supply to meet national demand.鈥
Part of Pitts Station Road in Marion that leads from U.S. Highway 221 to Baxter Manufacturing was severely damaged by floodwaters during Hurricane Helene as seen on Oct. 2.
鈥淎s a result of these shortages, we know that nearly 17% of those respondents said that they鈥檝e already opted to postpone elective surgeries and other procedures, and 58% reported that they were considering taking those measures,鈥 Garcia said.
Garcia also expressed concerns about the current respiratory season potentially making the shortage situation worse as November arrives.
鈥淲e know hospitals are already likely to see higher demand. So any extended shortage of IV fluids can certainly put a further strain on hospital resources,鈥 Garcia said.
鈥淗ospitals are also turning to alternatives for hydration, like hydration tablets and Gatorade. And they鈥檙e prioritizing IV fluids for the most acute patients and the most vulnerable, like children.鈥
Novant Health Inc. said in a statement Monday that 鈥淏axter has been one of our trusted vendors for many years, and our thoughts are with their teams as they face this unimaginable disaster.鈥
鈥淟ike health systems across the nation, Novant Health has not received our full allocation of Baxter products, and our primary IV solution supplier is supplementing this shortfall.
鈥淥ur dedicated team is actively conserving IV fluid supplies and we do not anticipate any impacts to patient care,鈥 Novant said. 鈥淲e have no plans to delay or cancel elective procedures at this time.鈥
Cone Health said in a statement Monday that 鈥渟urgeries and procedures are continuing as normal at Cone Health.鈥 鈥淥ur medical staff and team members have taken significant steps to conserve limited IV fluids and adjust usage where possible. These efforts include patients drinking liquids when dehydrated as appropriate, using smaller IV fluid bags, and giving certain medications as a shot, rather than using continuous IV fluids.鈥
Cone said that 鈥淲hile there are still significant uncertainties regarding the supply, we remain committed to our conservation measures and confident that our efforts will minimize impact on patient care.鈥
Plant recovery
In terms of the plant, Baxter said 鈥渙ur progress in restoring the physical facilities has exceeded our expectations in many respects, with meaningful advances in our recovery efforts.鈥
鈥淒eep cleaning has been completed for production rooms within the facility.鈥
鈥淎ssessment and repair of equipment with phased testing is progressing across all production lines, which will, in coordination with FDA, support resumption of operations in phases.鈥
Utilities, including electric capability, water and wastewater treatment, have been fully restored. Boilers and backup systems are operational, as is its information technology infrastructure.
鈥淥utside engineers confirmed that the site is structurally sound,鈥 Baxter said. Baxter said a second temporary bridge is being installed with an expected debut in early November. It will enable additional truck and equipment traffic to enter and leave the site.
