/ en Fri, 25 Apr 2025 20:16:35 -0500 Wed, 22 Jan 25 15:51:18 -0600 /news/headline/2025-01-22-baxter-increases-allocations-two-iv-solutions-100 <p>Baxter <a href="/lettercomment/2025-01-21-update-product-allocations-us-iv-products-hurricane-impact-baxters-north-cove-nc-facility" target="_blank">notified customers</a> on Jan. 22 that allocations for two sodium chloride IV solutions have been increased to 100%. According to Baxter, the products will have a one- to two-week lag time while they progress through the full distribution network after implementing changes. AHA members have notified the association of two- to three-week lag times in some cases following previous allocation updates.</p> Wed, 22 Jan 2025 15:51:18 -0600 Suppliers /news/headline/2024-12-20-8-10-baxter-manufacturing-lines-restarted <p>After incurring damage from Hurricane Helene on Sept. 27, <a href="https://www.baxter.com/baxter-newsroom/hurricane-helene-updates">Baxter reports</a> that as of Dec. 19, nearly all of its manufacturing lines in its North Cove, N.C., facility have been restarted. The producer of IV and peritoneal dialysis solutions says that the lines represent 85% of the site’s total pre-hurricane capacity.  </p><p>Baxter officials say they expect production across the plant to rise to pre-hurricane levels early in the first quarter of 2025. “Note that it will take some time for product to flow through the distribution channels,” according to the Baxter website. </p> Fri, 20 Dec 2024 13:59:56 -0600 Suppliers /news/headline/2024-12-10-baxter-restores-additional-iv-solutions-production-lines <p>Baxter has resumed production on all of its 3-liter irrigation and peritoneal dialysis solutions manufacturing lines, the company <a href="https://www.baxter.com/baxter-newsroom/hurricane-helene-updates">announced</a> Dec. 5. The company noted that despite production resuming for those lines, more time is needed to restore output to levels reached prior to Hurricane Helene. Baxter expects all manufacturing lines to resume operation by the end of the month.</p> Tue, 10 Dec 2024 15:09:03 -0600 Suppliers /news/headline/2024-12-04-fda-says-empty-iv-bag-shortage-expected-last-through-march <p>The Food and Drug Administration Dec. 4 <a href="https://www.fda.gov/medical-devices/medical-device-supply-chain-and-shortages/medical-device-shortages-list">announced</a> empty IV bags have been added to its Medical Device Shortages List, and that the shortage is estimated to last through March. Bags of all sizes are in shortage due to increased demand, FDA said.</p> Wed, 04 Dec 2024 16:03:21 -0600 Suppliers /news/headline/2024-12-02-baxter-announces-increased-allocations-certain-iv-products <p>Baxter Nov. 26 <a href="https://www.baxter.com/baxter-newsroom/hurricane-helene-updates" download="file" target="_blank">announced</a> new allocation levels for multiple IV product groups and advised customers of a one- to two-week lead time for products to flow through its supply and distribution network. Allocation and fulfillment levels may vary based on product availability at the time of the order. In a letter shared with customers, Baxter highlighted increased allocations for 0.9% sodium chloride product groups. Its 1000 ml group will increase from 60% to 80%, its 500 ml group from 60% to 90% and its 250 ml group from 60% to 90%. The company said it expects to share details later this month on the next phase of increased allocations and expects to reach 100% allocation across several IV product codes by the end of the month.</p> Mon, 02 Dec 2024 16:34:05 -0600 Suppliers /news/headline/2024-10-31-group-says-medical-radioisotope-supply-return-normal-week-nov-11 <p>Supplies of Mo-99/Tc-99M, which are medical radioisotopes used in procedures to diagnose and detect diseases including heart disease and cancer, are anticipated to return to normal the week of Nov. 11, according to <a href="https://snmmi.org/common/Uploaded%20files/Advocacy/HFR%20DELAYED%20RESTART%2030%20OCT.pdf">Nuclear Medicine Europe</a>. The association Oct. 18 <a href="https://sponsors.aha.org/rs/710-ZLL-651/images/NMEU%20Communication%20Oct%2014%202024%20-%20HFR%20outage.pdf">warned</a> of a shortage due to a delayed start of an isotope reactor and said Tuesday that various regions of the world have since experienced shortages from 50-100%.</p> Thu, 31 Oct 2024 15:40:28 -0500 Suppliers /news/headline/2024-10-31-baxter-restarts-busiest-iv-solutions-manufacturing-line <p>Baxter <a href="https://www.baxter.com/baxter-newsroom/hurricane-helene-updates">announced</a> Oct. 31 that it has restarted its North Cove, N.C. facility's highest-throughput IV solutions manufacturing line, which normally accounts for nearly 25% of the site's total production and approximately 50% of its one-liter IV solutions — the most commonly used size by hospitals and clinics. The earliest new products could begin shipment is late November, Baxter said. The company is continuing to assess and repair equipment at the facility and is working with the Food and Drug Administration to resume operation in phases. Baxter said it does not have a timeline on when production at the facility will be restored to pre-Hurricane Helene levels. </p> Thu, 31 Oct 2024 15:11:26 -0500 Suppliers /news/headline/2024-10-29-aha-bulletin-details-fda-authorization-extending-use-date-baxter-products-due-iv-solutions-shortage <p>The AHA Oct. 28 issued a Special Bulletin to members informing them of the <a href="https://www.fda.gov/drugs/updates-2024-hurricane-season/hurricane-helene-baxters-manufacturing-recovery-north-carolina">Food and Drug Administration's authorization</a> extending the use date for certain Baxter products amid the ongoing IV solutions shortage. The authorization allows providers to use products up to 24 months after the manufacture date. See the <a href="/2024-10-28-baxter-announces-expiration-dating-extensions-certain-products-related-iv-solutions-disruption">AHA Special Bulletin</a> for more information.</p> Tue, 29 Oct 2024 16:15:10 -0500 Suppliers /news/headline/2024-10-15-cdc-issues-health-advisory-disruptions-pd-and-iv-solutions-due-baxter-plant-closure <p>The Centers for Disease Control and Prevention has issued a <a href="https://emergency.cdc.gov/han/2024/han00518.asp">health advisory</a> on the supply disruption of peritoneal dialysis and intravenous solutions due to the Baxter plant closure in North Carolina following Hurricane Helene. The advisory summarizes recommendations from the Food and Drug Administration; the Administration for Strategic Preparedness and Response Technical Resources, Assistance Center, and Information Exchange; the American Society of Health-System Pharmacists; the American Society of Nephrology; and the American Society of Pediatric Nephrology, among others, about addressing supply disruptions to PD and IV solutions.  <br><br>Baxter Oct. 9 <a href="/news/headline/2024-10-09-baxter-increase-allocations-iv-solution-supplies-hospitals-effective-oct-9">announced</a> it was increasing the current U.S. allocation levels of its highest-demand IV fluids for direct customers from 40% to 60%, and for distributors from 10% to 60%. For the latest on the IV solutions situation, including additional resources that hospitals and health systems can use for conservation efforts, visit <a href="/updates-iv-fluid-supplies-after-helene-forces-closure-baxter-manufacturing-plant">AHA's webpage</a>.</p> Tue, 15 Oct 2024 15:02:10 -0500 Suppliers /news/headline/2024-10-09-baxter-increase-allocations-iv-solution-supplies-hospitals-effective-oct-9 <p>Baxter <a href="https://www.baxter.com/baxter-newsroom/hurricane-helene-updates">announced</a> that it is increasing the current U.S. allocation levels of its highest-demand IV fluids for direct customers from 40% to 60%, and for distributors from 10% to 60%, effective Oct. 9. Baxter also said it is increasing high concentration dextrose and sterile water for injection allocations and expects to be in a position to make additional increases for certain product codes by early November. Baxter expects to be at 90% to 100% allocations by the end of the year. In addition, due to the vulnerable patient population they serve, allocations for IV solutions and nutrition products for designated children’s hospitals were increased to 100%, Baxter said.  <br>  <br>Baxter also said it is actively delivering supplies to current peritoneal dialysis 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,” Baxter said. “In addition, we are closely monitoring stock levels and working with partners and professional bodies to optimize utilization of PD supplies.”   <br>  <br>In a <a href="https://www.hhs.gov/about/news/2024/10/09/letter-health-care-leaders-stakeholders-impacts-hurricane-helene-secretary-becerra.html">letter</a> to health care leaders and stakeholders, Department of Health and Human Services Secretary Xavier Becerra said the department is coordinating a government-wide response to address the supply chain. The letter said the Food and Drug Administration “will continue working with Baxter to identify both potential products already in their system and alternative manufacturing sites, including for potential temporary imports.” <br> <br>“Baxter’s announcement is welcome news for patients and health care providers,” AHA President and CEO Rick Pollack said in a statement. “We appreciate the Administration’s collaboration with us on this and their responses to date to ensure the needs of hospitals and patients are met. While we know the recovery from this historic storm will take time, we are grateful for the ongoing commitment to mitigate these supply chain disruptions and ensure access to care for patients.”  <br> <br>For the latest on the IV solutions situation, including resources that hospitals and health systems can use for conservation efforts, visit <a href="/updates-iv-fluid-supplies-after-helene-forces-closure-baxter-manufacturing-plant">AHA's webpage</a>.</p> Wed, 09 Oct 2024 14:34:23 -0500 Suppliers