88% Of Health Care Providers Short Of I.V. Fluids

Baxter's latest update on North Cove:

https://www.baxter.com/baxter-newsroom/hurricane-helene-updates

Hurricane Helene Updates
DEERFIELD, Ill. - 2024-10-09

Baxter’s North Cove manufacturing site was significantly impacted by the rain and storm surge from Hurricane Helene, which was unprecedented in Western North Carolina and resulted in water flooding the facility.

Supporting our employees in the impacted communities, bringing the North Cove facility back online and helping to ensure ongoing supply to patients are our top priorities.

Below is an update on supply continuity:

Allocations: As previously shared, Baxter is advancing multiple paths to help ensure we are appropriately managing inventory and minimizing disruption to patient care as we work to fully restore our North Cove manufacturing operations. This includes implementing allocations, which limit what a customer can order based on historical purchases and medical necessity as well as available and projected inventory. Allocations help limit stockpiling and increase the likelihood of equitable access to available products.

Based on Baxter’s efforts to increase manufacturing capacity at its other sites and our current assessment of anticipated timing of inbound products and air shipments, we are increasing the current U.S. allocation levels of our highest demand IV fluids for direct customers from 40% to 60%, and for distributors from 10% to 60%, effective Wednesday, Oct. 9. We are also increasing high concentration dextrose and sterile water for injection allocations and expect to be in a position to make additional increases for certain product codes by early November. Due to the vulnerable patient population they serve, allocations for IV solutions and nutrition products for designated children’s hospitals were increased to 100%.

We continue to actively deliver supplies to current peritoneal dialysis (PD) patients. The allocations for PD solutions remain as communicated, and we are working with our partners to conserve and identify alternate sources of supply across all PD product categories. In addition, we are closely monitoring stock levels and working with partners and professional bodies to optimize utilization of PD supplies.

Our goal continues to be to restore customers to 100% allocation levels as soon as possible. This would be achieved through a combination of importing product from other Baxter facilities and the resumption of operations and scale up of production at our North Cove facility.

Site Status: As shared in our Oct. 7 update, Baxter continues to scale production across its global locations and is working closely with FDA on temporary importation of products to increase available inventory. Based on 1) the current status of our remediation efforts, 2) our expectations regarding our ability to reallocate capacity from other Baxter facilities, and 3) initiation of temporary importation on certain products, our goal is to restart North Cove production in phases and return to 90% to 100% allocation of certain IV solution product codes by the end of 2024.

As our CEO, Joe Almeida, reiterated, “We will spare no resource — human or financial — to restart operations and help ensure patients and providers have the products they need.”

We are aware that there is a tremendous amount of misinformation circulating in the marketplace, and we are disheartened to see blatant speculation fueling patient and customer concerns. As always, prioritizing patient care is our goal, and it is our sincere hope that everyone works to uphold this standard.

We are appreciative of and grateful for the ongoing support and patience of our customers and partners as we work diligently to fulfill our Mission to Save and Sustain Lives for our employees, patients and communities.

https://www.upi.com/Health_News/2024/10/31/IV-solutions-shortage/6781730416400/

Biden invokes wartime powers to address IV fluids shortage
By Mike Heuer - 31 October 2024

Oct. 31 (UPI) -- A North Carolina facility is leading efforts to restore the nation's depleted supply of IV solutions after Hurricane Helene temporarily put it out of business.

The shortage of IV solutions has prompted President Joe Biden to invoke the Defense Production Act to rapidly rebuild a North Carolina manufacturing facility that was damaged by the hurricane.

The Baxter medical supplies manufacturing plant in North Cove, N.C., supplied about 60% of the nation's IV solutions but has been closed since Hurricane Helene made landfall on Sept. 26 and saturated much of the southeastern United States with excessive rainfall.

"In a matter of weeks, our team has advanced from the depths of Hurricane Helene's impact to restarting our highest-throughput manufacturing line," Baxter Chief Executive Officer Jose Almeida said Thursday in a prepared statement.

"This is a pivotal milestone, but more hard work remains as we work to return the plant to full production," he added.

Resuming production will help alleviate the shortage of IV solutions, but other measures are in place to help ensure a suitable supply.

"Baxter has now restarted manufacturing of some IV solutions," Health and Human Services Secretary Xavier Becerra said in a statement on Thursday. "The output from the restarted line ... will supplement product that is being imported from abroad."

Becerra said steps are being take to ensure the imported IV solutions are safe while ensuring access to the solutions for those who need them.

Steps also are being taken to conserve the IV solutions, so they are available when needed.

"Whether they have experienced a supply disruption or not, we encourage manufacturers, wholesalers, distributors and providers to continue to take measures to conserve these important products," Becerra said.

Biden and former President Donald Trump each invoked the wartime powers of the Defense Production Act to produce COVID-19 vaccines, test swabs and access ventilators during the pandemic.

Meanwhile, 97 people are still missing in the vicinity of the Baxter facility.

FDA does not expect I.V. fluid availability to improve until March:

https://legalinsurrection.com/2025/01/fda-says-iv-fluid-shortage-will-last-until-march-2025/

FDA Says IV Fluid Shortage Will Last until March 2025

The deficit in supplies was triggered by Hurricane Helene, which caused significant damage to Baxter International’s manufacturing facility in North Carolina.

By Leslie Eastman - January 1, 2025

As we enter the New Year, it is hard to believe that the nation is still reeling from the effects of Hurricane Helene.

It appears that the country is still dealing with a shortage of intravenous (IV) fluids in the US, and the ongoing situation remains a critical issue for hospitals and healthcare providers nationwide.

In late September, the historic storm caused significant damage to Baxter International’s manufacturing facility in North Carolina. The manufacturer was responsible for about 60% of the IV fluids used by American hospitals, equivalent to about 1.5 million bags.

The problem was so severe that the Biden administration invoked the wartime powers of the Defense Production Act to speed the rebuilding of a major American factory of intravenous fluids in mid-October.

While the factory remains offline, the Food and Drug Administration has greenlighted Baxter to import IV fluids from its other plants around the world. Officials say they are also backing plans to airlift more supplies into the U.S.

“It turns out, a huge part of my time has been taken up, including today, on very basic supply chain issues across every commodity that we regulate,” FDA Commissioner Robert Califf said earlier this month at a meeting of the agency’s science advisers.

Califf warned shortages were likely to worsen in the coming years, as many generic drugmakers are racing to cut costs amid growing threats to supply chains.

The FDA announced Friday that it had declared three more IV fluids in shortage, adding to an ongoing shortage of other IV supplies now worsened by the closed plant.

The importance of IV fluid use in medicine is hard to overstate. They are vital for maintaining proper hydration and restoring electrolyte balance in patients. This is particularly important in cases of severe dehydration.

IV fluids serve as an efficient vehicle for delivering medications directly into the bloodstream, which allows for rapid distribution of drugs throughout the body and enables quick therapeutic effects. The fluids also facilitate blood transfusions.

Now the Food and Drug Administration (FDA) has announced the shortage will last until March.

The FDA announced that IV fluid containers of all sizes have been added to its medical device shortages list, with the shortage expected to persist through March 2025.

The FDA cited an acute increase in demand as the primary factor behind the supply constraint. The shortage affects a wide range of IV containers, which are critical for the administration of fluids and medications in hospital settings.

The announcement comes as hospitals and medical facilities report growing concerns about their ability to meet patient needs due to limited availability of IV products and devices.

Hospitals, such as Onvida Health in rural Yuma, Arizona, monitor their supplies and rationing as needed.

Michael Tracy, an orthopedic surgeon at the hospital said it’s been challenging especially during these winter months.

“Our population tends to double when the winter visitors arrive. So when we shifted from the summer to the winter months we had a much higher population which unfortunately means many more patients in the hospital needing those same fluids,” said Tracy.

Although they’ve been able to get back to doing some elective surgeries, he said it’s all based on their daily supply.

“It does tend to change day to day which products are available and which products are limited. We have to keep a very close eye on our shipments,” Tracy said. “We’ve had to become really good stewards of the limited amount of IV fluids that are available to us.”

He said the hospital has been busy with a bigger population in Yuma during the winter months.

Tracy said emergency visits have not been disrupted, and they’ve been able to meet the needs of patients who need IV fluids the most.