B. Braun Medical, Inc.

Baxter announced this week that it has restarted the highest-throughput IV solutions manufacturing line at its North Cove plant in Marion, North Carolina. Before Hurricane Helene’s devastating remnants hit western North Carolina in late September with heavy rain and flooding, the line represented roughly a quarter of the site’s total production and about half of the site’s production of 1-liter IV solutions that hospitals and clinics most commonly use. Since the North Cove plant went offline, hospitals across the country have faced disruption in the supply of some sterile intravenous fluids used in everything from intravenous dialysis care to some surgeries. The 1.4 million-ft² facility employs 2,500 people and is the largest manufacturer of intravenous and peritoneal dialysis products in the U.S., according to Baxter. Baxter says its goal remains to return to 90% to 100% allocation of certain IV solution product codes for U.S. customers by the end of the year. The company also recently announced: The first temporary bridge at the North Cove site has already transported more than 885 truckloads of finished products off-site and to customers. Baxter has started to expand support for new peritoneal dialysis patients on a limited basis, with a the goal of returning to pre-Helene levels for new patient starts by the end of 2024. The Baxter International Foundation has donated roughly $4 million to support employees and communities impacted by Hurricane Helene. Other medtech companies including B. Braun Medical and Fresenius Medical Care have also responded to the shortage. In a statement, U.S. Health and Human Services Secretary Xavier Becerra described Baxter’s progress at North Cove as encouraging. “The output from the restarted line, which will be closely monitored to help ensure the quality and safety of released product, will supplement product that is being imported from abroad in accordance with temporary grants of regulatory flexibility from FDA,” Becerra said. “While important steps remain to ensure the safety of this production, this latest development moves us another step closer to ensuring partners and patients have access to the quality supplies they need. I look forward to continued progress in the coming weeks.” Related: An even larger medtech supply chain shock looms beyond the pandemic

Company worked with federal government to protect finished products in Florida and ramps up production at three manufacturing sites BETHLEHEM, Pa., Oct. 18, 2024 /PRNewswire/ -- B. Braun Medical Inc. (B. Braun), a leader in smart infusion therapy and pain management, provided an update today on the company's efforts to secure supplies of critical IV fluids in response to Hurricane Milton and damage caused by Hurricane Helene to a large IV fluids manufacturing plant in North Carolina. B. Braun's IV solutions manufacturing plant and distribution center in Daytona Beach, Florida were not seriously impacted by Hurricane Milton and resumed operations as planned on October 11. To safeguard the supply of finished products from the distribution center, B. Braun worked closely with the Administration for Strategic Preparedness and Response (ASPR) to leverage their resources to move 60 truckloads containing 70,000 cases of IV solutions to a secure facility north of Florida. The entire operation was completed on Tuesday, October 8. Now that the storm has passed, the product is being returned to B. Braun's distribution site in Daytona Beach. Steps being taken by B. Braun to increase the supply of IV fluids and medical devices needed for patient care include: Ramping up production at B. Braun's IV fluids manufacturing facilities in Irvine, CA and Daytona Beach, FL. In the coming weeks, production levels at those facilities are expected to increase by 20 percent. Increasing production of tubing, valves, connectors and other devices needed for infusion therapy at B. Braun's manufacturing plant in Allentown, PA. The increase will boost the annual number of IV sets B. Braun delivers to healthcare providers by more than 30 million. In addition, B. Braun is encouraging all healthcare providers across the country to conserve IV fluids using the newly updated ASHP suggestions for managing IV fluid shortages and is working with federal government officials to identify and authorize the use of IV fluids from B. Braun facilities outside the U.S. "I want to thank the officials at ASPR and other federal agencies who have been working with us day and night to address this situation and also all of our employees who are demonstrating their commitment to patient care by their tireless efforts to increase the supply of these vital products," said Rob Albert, Chief Executive Officer, B. Braun of America. "Events like these are why B. Braun invested well over $1 billion in the last five years to increase our capacity to supply these critical healthcare products from facilities on both coasts. We will continue to do everything we can, working closely with government agencies, industry partners and other stakeholders, to help ensure that providers and patients get the infusion therapy products they need," Albert concluded. About B. Braun B. Braun Medical Inc. (B. Braun) is a leader in smart infusion therapy and safe and effective pharmacy products, patient and provider safety, and sustainable health solutions. Our purpose is to help providers constantly improve patient satisfaction and outcomes. With products and services created to help healthcare professionals focus on what matters most—their patients—we're uniquely positioned to help health systems succeed now and in the future. B. Braun is headquartered in Bethlehem, Pennsylvania and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®. The company employs 8,500 people at over 30 locations across North America. Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, explore our website. SOURCE B. Braun Medical Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Two major hurricanes in the eastern U.S. in recent weeks have had medtech companies, including Baxter, B. Braun Medical and Fresenius Medical Care, scrambling to prevent an IV bags shortage. According to media reports, hospitals across the country are facing disruption in the supply of some sterile intravenous fluids used in everything from intravenous dialysis care to some surgeries. The problems started late last month after Hurricane Helene flooded Baxter’s largest manufacturing facility — its North Cove plant in Marion, North Carolina. The 1.4-million-square-foot facility employs 2,500 people and is the largest manufacturer of intravenous and peritoneal dialysis products in the United States, according to the company. Since the disaster, Baxter has scaled production across its global locations, working with the FDA on temporarily importing products to boost available inventory. Thanks to the efforts, Baxter announced on Oct. 9 that it was increasing U.S. allocation levels of its highest demand IV fluids for direct customers to 60% from 40%, and for distributors to 60% from 10%. Baxter says its goal is to restore customers to 100% allocation levels as soon as possible. The plan is to return North Cove production in phases and return to 90% to 100% allocation of certain IV solution product codes by the end of 2024. “We will spare no resource — human or financial — to restart operations and help ensure patients and providers have the products they need,” said CEO Joe Almeida. Meanwhile, other medtech companies have sought to respond to the shortage. But B. Braun Medical faced its own challenge this week as Hurricane Milton approached Florida, with the New York Times describing a scene of B. Braun workers loading trucks at the company’s Daytona Beach plant and driving the medical bags north to what the company hoped would be safer locations. The Daytona Beach IV solutions manufacturing site and distribution center had been a key part of B. Braun’s efforts to address the supply shortages caused by Baxter’s North Cove outage. After Milton had passed through Florida, B. Braun Medical reported that the hurricane had not seriously impacted Daytona Beach facility. In partnership with the Administration for Strategic Preparedness and Response, the company is boosting production of critical IV fluids at its plant in Irvine, California — with plans to resume work in Daytona Beach today. Fresenius Medical Care, a major provider of products and services for individuals with renal diseases, is also responding as it ramps up production of peritoneal dialysis products (PD) and IV fluids to boost supply. In the short term, this includes maximizing the use of existing production capacity at international sites, according to a news release that the company posted yesterday. In an Oct. 9 letter to health providers, U.S. Health and Human Services Department Secretay Xavier Becerra said the federal government is actively working with both public and private health providers to address the IV supplies shortage: ” FDA will continue working with Baxter to identify both potential products already in their system and alternative manufacturing sites, including for potential temporary imports. As alternatives are identified, FDA is expediting assessments of those options. FDA will also expedite consideration of any shelf-life extension requests manufacturers submit for short-dated product. FDA will continue to work with Baxter as they bring their plant back online and with other suppliers to increase supply.” This isn’t the first time that hurricanes have had a significant impact on medical device companies. In September 2017, Hurricane Maria took Medtronic’s four manufacturing plants in Puerto Rico offline for nearly two weeks; the cost for Medtronic was $60 million. With climate change causing ever more extreme weather events, medical device manufacturing companies and corporations, in general, are increasingly seeking to innovate their supply chains to make them more resilient to the challenges.