Resources for IV Fluid Mitigation

Jan. 27

CHA held a call with children's hospitals on Tuesday, Jan. 27, to discuss Baxter International's phased approach to bring the "Divine 9+2" products back online. These include several products that are important to pediatrics and are slated to be back in production after mid-February.

During the meeting, a member hospital provided an update on its conservation strategies and workflows. Another resource call is planned for Feb. 7.

Action items from the call:

• CHA offered to provide supporting information to the Baxter Medical Affairs team so pediatric codes can be prioritized.
• Baxter will follow up with CHA after working with its internal medical affairs team. 

Jan. 13

CHA held an IV fluids resource call on Monday, Jan. 13, with Baxter International and children’s hospitals. On the call, Baxter International provided an update on the supply status, and two children's hospitals provided effective mitigation strategies for ACD-A and Heparin (see below).

Baxter updates:

• Baxter announced updates to product allocations for U.S. IV products.
• Baxter expects to be producing at pre-hurricane levels across the plant early in the first quarter of 2025.
• Nine of the site’s 10 manufacturing lines have restarted, representing more than 85% of the site’s total pre-hurricane capacity.
• The final manufacturing line, which primarily produces specialty IV fluids, is estimated to restart by the end of January.
• The production recovery plan has grouped products into waves, prioritizing production and allocation increases for core IV fluids and those deemed most critical to patient care and then based on customer usage and availability of substitute products.
• There will be another allocation update the week of January 20.

Action items from the call:

• CHA offered to provide supporting information to the Baxter Medical Affairs team so pediatric codes can be prioritized.
• Baxter will follow up with CHA after working with its internal medical affairs team.
• CHA will send Baxter a list of key products to prioritize and seek a timeline for the estimated return of supply.
• Hospitals willing to share mitigation strategies on future calls should reach out to Terri.
• Hospitals should inform their wholesalers of significant anticipated changes in demand for a product.

On Dec. 20, the Department of Health and Human Services distributed information about initiatives that are underway to ensure hospitals continue to have needed IV fluid products.

The Administration for Strategic Preparedness and Response (ASPR) has been collaborating with the U.S. Food and Drug Administration (FDA), Department of Homeland Security’s Customs and Border Protection (CBP), and aviation partners to rapidly bolster domestic supply through the temporary importation of certain international product manufactured by Baxter for which FDA and CBP have granted regulatory flexibility. In addition to certain Baxter product, the FDA provided regulatory discretion for the temporary import of certain product from Sichuan Kelun Pharma5ceutical Co., Ltd., in China and HK Inno.N Corporation in South Korea.

As of Dec. 17, more than 12 million units of product from international facilities have been expedited into the U.S. from China, Spain, Canada, South Korea, and the UK, with the assistance of the U.S. Government and aviation partners mentioned above.

For more information about Hurricane Helene recovery efforts and available products, please visit the FDA’s website. For product-specific questions, visit Baxter’s Hurricane Helene website.

• ACD-A shortage
• Heparin 10 units/ml prefilled syringe shortage

• Daily morning leadership huddle. All elective cases may possibly be canceled if we can’t safely proceed and have resources for urgent/emergent cases.
• All procedures should be evaluated based on this algorithm, even those scheduled for current day. If the procedure is to be rescheduled, work with clinic scheduler to coordinate with the OR schedulers. The clinic is responsible for contacting patients to cancel/reschedule.
• For patients who are admitted after surgery, fluids used in surgery will be continued for the patient going to the floor/ICU and not changed per typical practice. (LR, NS, etc., will have a maintenance rate instead of changing to D5 NS +KC, etc.)
• Anesthesia – reduce NPO with 1hr status to allow for oral hydration.
• Any surgery patient who is less than 2hrs doesn’t get an IV. They wake up quickly and start drinking.
• Our ED has moved to irrigating wounds with tap water as it is supported by the literature. I suspect this will be adopted permanently.
• We are working with pharmacy to prepare IV syringes, dividing 1000ml bags for smaller procedures.
• Implement ERAS procedures to reduce the amount of fluids that will be needed during procedure.
• Utilize 0.9% saline flushes instead of small volume IV piggy backs to flush IV lines.
• Pharmacy is compounding smaller bags of normal saline and lactated ringers. These should be utilized for short term fluid needs, including medication riders, and surgical cases shorter than 30 minutes.
• We are preserving the 250cc--1000cc bags for bigger cases and utilizing mainly IV flushes and/or 100cc NS bags for our smaller ambulatory cases.
• A 24-hour hard stop will be entered on maintenance IV fluids for patients outside of critical care floors. Providers will be prompted to take action to continue the fluid past that time.
• Pharmacists are approved to convert IV medications to an equivalent oral therapy once a patient is tolerating 25% of goal enteral feeds. This will fall under the pharmacist's scope of practice and does not require a call to the provider.
• We are constantly refining our algorithm to schedule cases. We have rescheduled roughly 49 cases so far and are evaluating time-sensitive cases as needed.

• Hurricane Helene: Baxter's Manufacturing Recovery in North Carolina
• CDC Health Alert Network (HAN) Health Advisory
• CHA Letter to HHS on Hurricane Helene Baxter Impact
• FDA Guidance: Temporary Policies for Compounding Certain Parenteral Drug Products
• CDC Guidance: Disruptions in Availability of Peritoneal Dialysis and Intravenous Solutions From Baxter International Facility in North Carolina
• Fact Sheet: HHS Continues Taking Action to Increase Access and Supply of IV Fluids Following Hurricane Helene

• NEW: On-Demand Webinar: The Solution to IV Fluid Management: Best Practices for Fluid Stewardship
• 2024 Fluid Conservation Guidelines
• Combined Conservation Actions From Service Lines
• Recommendations from AABB’s Clinical Transfusion Medicine Committee on Sterile Saline Shortage
• Infusion Nurses Society Response to IC Shortage
• Vizient: Product Disruption Brief
• Vizient: IV Fluid Checklist and Conservation Strategies
• ASHP: Updated Drug Shortage List to Include Fluid Bags
• Injection Solutions Packaged in VIAFLO Plastic Container
• ASPEN: 2024 Parenteral Nutrition Product Shortage Recommendations: Intravenous Dextrose
• ASPEN: 2024 Parenteral Nutrition Product Shortage Recommendations: Sterile Water for Injection
• ASPEN: PN Shortage Management Recommendations