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Supply Chain Disruption Resource Center

 

Last Updated: 11-16-04 10:10 am ET

ISSUE OPEN

The following Emergent Supply Chain Disruption Resource Center is being provided to you by the Association of Healthcare Value Analysis Professionals (AHVAP). We are proud to partner with our colleagues at the following professional associations on this important work:

  • Association of Perioperative Registered Nurses (AORN)

  • Association for Vascular Access (AVA)

 

 

Baxter Intravenous Fluids Supply Chain Disruption Due to Hurricane Helene

As many of you are aware, the Baxter North Cove manufacturing facility located in Marion, North Carolina was recently directly impacted by the devastating impacts of Hurricane Helene and is currently offline. The facility is currently closed due to the impacts of the hurricane and Baxter is working aggressively to preserve as much product as safely possible in collaboration with the Food and Drug Administration. Due to road closures in the area, physical access to the facility has also been extremely difficult.

In light of the recent closure of Baxter's North Carolina manufacturing site due to Hurricane Helene, healthcare providers could face a significant reduction in the availability of intravenous (IV) fluids. As this shortage continues to impact healthcare facilities nationwide, it is critical that providers take immediate and strategic steps to preserve the limited supply of IV fluids, ensuring that they remain available for patients with the most urgent clinical need.

To effectively manage the reduced supply, healthcare providers should adopt the following strategies to optimize the use of intravenous fluids, in collaboration with your system’s anesthesiology, perioperative, vascular access, infection prevention, and pharmacy departments:

  1. Prioritize IV Fluids for Critical Care Patients: Providers should carefully assess each patient's clinical need for IV fluids, prioritizing their use for critically ill patients, those undergoing surgeries, or those with conditions where IV administration is necessary for life-saving hydration, medication delivery, or electrolyte balance.
  2. Encourage Oral Hydration When Clinically Appropriate: For patients who are able to tolerate oral intake, healthcare providers should prioritize oral hydration over intravenous fluids whenever clinically appropriate. This includes encouraging the use of oral rehydration solutions, electrolyte replacement drinks, and regular fluids to meet hydration needs. Providers should exercise their best clinical judgment and follow evidence-based guidelines for patient care treatment.
  3. Review and Adjust Clinical Protocols: Facilities should review their clinical protocols to identify opportunities for reducing IV fluid usage when possible, particularly in routine cases where oral hydration or alternative routes of administration may be sufficient. Consider adjustments in post-operative care, where oral hydration might be introduced earlier in recovery for eligible patients.
  4. Minimize Waste Through Precise Dosing and Administration: Healthcare providers should take steps to reduce wastage of IV fluids by ensuring precise dosing and administration. This includes accurately calculating fluid requirements, limiting the use of IV fluids to the exact volume needed, and preventing over-administration or unnecessary continuation of IV therapies.
  5. Use Alternative Routes of Medication Administration: When possible, healthcare providers should consider alternative routes of administration for medications that are typically delivered intravenously. Oral, subcutaneous, or intramuscular administration of medications can help conserve IV fluids for patients who cannot tolerate these alternatives.
  6. Educate Staff on Conservation Efforts: All clinical staff should be educated on the importance of conserving IV fluids during this shortage. Regular communication should emphasize the necessity of critical thinking in assessing the need for IV fluids and implementing strategies for conserving supplies without compromising patient care.

By adopting these strategies, healthcare providers can help preserve the remaining supply of intravenous fluids, ensuring that this vital resource is available for patients who most critically need it. Preserving the integrity of care while managing limited resources will be key to navigating the challenges posed by the recent disruption in the supply chain. We thank all healthcare professionals for their diligence and adaptability in maintaining patient safety and care quality during this period.

Thank you for your continued dedication and adaptability in these challenging times. Together, we can safeguard the delivery of essential care in the face of uncertainty. AHVAP has added this information to the emergency resource page for this issue, which is available to all healthcare professionals here.

As new information becomes available, AHVAP will post it on this dedicated resource center for all AHVAP, AVA, and AORN members, as well as the general healthcare community. We encourage perioperative and healthcare value analysis teams to collaborate on this potential threat to healthcare supply chain to ensure continuity of care for your patients.

Additionally, healthcare facilities should regularly monitor the Baxter webpage where updated information is being provided. 

The following tool is provided by our Industry Partners at the nonprofit, ECRI. Please note that this tool is not reviewed or endorsed by AHVAP, and AHVAP appreciates our partners at ECRI making this tool available to all healthcare professionals to assist with mitigating risks associated with this supply chain disruption.

There is a functional equivalent report included in efforts to assist our colleagues and partners in navigating shortages associated with the Baxter facility shutdown, which identifies the top three alternatives from other manufacturers to the IV and irrigation solutions impacted: DOWNLOAD ECRI RESOURCE HERE

The Food and Drug Administration (FDA) is an additional resource on known drug shortages as well. The current FDA list of drug shortages can be accessed here

Latest Industry Updates:

Baxter Hurricane Helene Update 11-14-24

Baxter Resources for Products Authorized for Temporary Importation

Baxter Hurricane Helene Update 11-7-24

Baxter Hurricane Helene Update 10-31-24

Baxter Side by Side Comparison: 0.9% Sodium Chloride

AORN Town Hall - Managing IV Fluid Shortages in Perioperative Care: Strategies to Reduce Patient Risk (Added 10/29/24)

Baxter Customer Letter: Temporary Importation of Injection Solutions from Shanghai (1.1)

Baxter Customer Letter: Temporary importation of 0.9% Sodium Chloride Injection from Shanghai, China, labeled in Chinese, to address drug shortages

Baxter Updated Customer Letter: Expiration Dating Extensions to 24 Months – Hurricane Impact on Baxter’s North Cove, NC Manufacturing Facility 

Baxter Hurricane Helene Update 10-24-24

Society of Critical Care Medicine Strategies for IV Fluid Conservation

Baxter Hurricane Helene Update 10-21-24

FDA Extension of the Expiration Date for 10% LMD in 0.9% Sodium Chloride Injection (Dextran 40 in Sodium Chloride Injection, USP) Lot 5859955 through April 1, 2025 and 10% LMD in 5% Dextrose Injection (Dextran 40 in Dextrose Injection, USP) Lot 6040410 through September 1, 2025

Fact Sheet: HHS Continues Taking Action to Increase Access and Supply of IV Fluids Following Hurricane Helene 10-18-24

Infusion Nurses Society Guidance to Address IV Solution Shortages as a Result of Hurricane Helene

Baxter Hurricane Helene Update 10-17-24

CDC Health Alert Network Health Advisory 10-15-24

ECRI Supply Chain Report including Intravenous AND Irrigation Fluids 10-15-24

FDA Update 10-14-24 Baxter Update

AHVAP Intravenous Fluids Supply Chain Disruption Webinar Recording 10-14-24

FDA Temporary Policies for Compounding Certain Parenteral Drug Products Guidance for Industry

B. Braun Medical Statement on Hurricane Milton Impact 10-10-24

Baxter Hurricane Helene Updates 10-9-24

Baxter Customer Letter 9-20-24 Regarding Conservation Strategies

 

Additional Clinical Resources:

AHVAP Mitigating Risks Associated with Supply Chain Disruptions of Intravenous Fluids Due to Disaster

CDC Safe Injection Practices

Association of Perioperative Registered Nurses Guidelines for Perioperative Practice

2024 Parenteral Nutrition Product Shortage Recommendations: Intravenous Dextrose

ASPEN BUD Recommendations for PN Formulation While Following FDA’s Temporary Guidance for Parenteral Drug Products

Parenteral Nutrition Product Shortages

Association for Vascular Access

ASHP Guidelines on Managing Drug Product Shortages

Baxter Customer Letter 9-20-24 Regarding Conservation Strategies

ASHP Small- and Large-Volume Fluid Shortages – Suggestions for Management and Conservation

National Home Infusion Association Guidance for Addressing Product Shortages during Disruptions in Manufacturing 

ATS Clinical Recommendations: 10 Steps for Hospitals Facing Intravenous Fluid Shortages

Society of Critical Care Medicine-Optimizing Fluid Stewardship in the ICU

Society of Critical Care Medicine-Finding Fluid Stewardship in the ICU

Society of Critical Care Medicine-Supply Chain Management During Outbreaks and Disasters 

Society of Critical Care Medicine-Mitigation for Medication Shortages

End Drug Shortages Alliance Webinar on Fluid Conservation

Navigating Hospital Drug Shortages: Bringing the Team Together

Multidisciplinary Management of Drug Shortages and Associated Ethical Dilemmas 

Importance of Effectively Communicating Drug Shortages

Society of Critical Care Medicine IV Solutions Disruption Center

FDA Emergency Guidance for Compounding Certain Parenteral Drug Products

Interim Guidance on PD Solution Conservation During Supply Shortage

CDC Preventing Unsafe Injection Practices

American Society of Nephrology Interim Strategies for Conservation of Peritoneal Dialysis (PD) Solution

Administration for Strategic Preparedness and Response, the Technical Resources, Assistance Center, and Information Exchange (TRACIE)

Food and Drug Administration

 

Additional Supply Chain Disruptions

Baxter Flexiport Blood Pressure Cuffs (Added 10-25-24, Updated 11-2-24)

ISSUE CLOSED

Summary of the Situation:

Baxter is experiencing a temporary constraint on raw material availability for our blood pressure cuff production out of our manufacturing plant in Mexico. U.S. imports of raw materials into Mexico are temporarily halted, pending release from the Mexican government authorities, which has led to a pause in production at our plant. 

They have provided all requested information to the authorities, and we understand the release to be imminent, but the exact timeline remains unclear. As soon as they receive the pending authorization, raw material staged in the region will be made immediately available and we will resume 24/7 production. 

This unplanned downtime will result in extended lead times, necessitating thoughtful conservation of supply, and implementation of a cleaning protocol to reuse BP cuffs as necessary. 

Baxter is working expeditiously to bring BP Cuff supply back online as fast as possible. 

In order to bridge the temporary gap in supply, they encourage you to implement a cleaning protocol on your BP cuffs per the cleaning instructions provided in the Instructions for Use. This is outlined below: 

FlexiPort Soft and Vinyl Disposable cuffs 

The term "disposable" in reference to Welch Allyn blood pressure cuffs is a model designator only and not meant to imply single patient use 

Cleaning instructions for the FlexiPort Soft and Vinyl Disposable Cuffs are available in the IFU: Click Here: FlexiPort Disposable IFU* 

FlexiPort Reusable Cuffs 

Cleaning instructions for the FlexiPort Reusable Cuffs are available in the IFU: Click Here: FlexiPort Reusable IFU* 

Baxter recommends only the use of cleaning agents that are defined in the Instructions for Use. Use of alternative cleaning agents has not been tested and therefore Baxter cannot recommend nor guarantee the performance and accuracy of the device with any cleaning agents other than those identified in the IFU. 

The following are the reusable SKUs provided by Baxter:

Baxter Resources:

Dear Customer Letter 11-1-24

Dear Customer Letter 10-23-24

Baxter Flexiport Blood Pressure Cuff DFU

 

Port Worker Strike Resource Center 

This Emergency Resource Center is being brought to you as part of our ongoing partnership with the Association of Perioperative Registered Nurses (AORN). AHVAP is making this special resource center available to all AORN members and healthcare value analysis professionals/leaders. 

This strike has been delayed until January 2025. Further updates will be posted here as they are available. 

The healthcare sector, which relies heavily on timely deliveries of surgical instruments, medical devices, personal protective equipment (PPE), and pharmaceuticals, could face severe shortages in the coming weeks. These disruptions will likely have direct consequences for our perioperative teams, increasing the risk of delayed surgeries, treatment interruptions, and shortages of critical supplies.

Anticipated Impacts: 

  1. Delays in Medical Product Deliveries: Many medical products and supplies are imported through major shipping ports, and the strike could severely delay the arrival of essential items such as surgical trays, sutures, and sterilization supplies. This could affect operating room schedules and patient safety.
  2. Shortages of Medications: Medications, especially those with limited domestic production or reliant on international sources, may face supply shortages. This could impact everything from anesthetics used in perioperative care to commonly prescribed medications.
  3. Increased Costs and Resource Allocation: Limited availability of supplies could drive up costs for the medical products that remain in circulation, forcing healthcare organizations to allocate additional resources to source alternatives or manage existing stock. Value analysis professionals will be called upon to evaluate alternative suppliers and products, balancing cost, quality, and availability. 

What We Can Do: 

In preparation for potential shortages, it is essential that we take proactive measures to mitigate the impact on patient care and organizational operations. We recommend the following immediate actions:

  • Inventory Review: Conduct a thorough review of your current inventory for critical perioperative supplies and medications. Identify potential shortages and prioritize procurement of essential items while maintaining flexibility for alternative products.
  • Collaboration with Suppliers: Work closely with your suppliers to stay informed about their inventory and shipment statuses. Open communication can help identify delays early and provide opportunities to seek alternative sourcing options before supplies run out.
  • Evaluating Alternatives: Engage your value analysis teams to evaluate and pre-approve substitute products or alternative vendors for high-risk items. Having these alternatives vetted ahead of time can prevent treatment disruptions and delays in perioperative care.
  • Resource Sharing and Partnerships: Collaborate with other healthcare organizations in your region to explore resource-sharing agreements that ensure critical supplies remain available to all facilities in times of shortage.

Looking Ahead

We recognize that the uncertainty surrounding the potential port worker strike can create anxiety for healthcare providers and administrators alike. However, by taking early, coordinated steps to prepare, we can mitigate the effects of supply chain disruptions and continue providing high-quality, timely care to our patients.

We encourage each of you to engage your teams in discussions around contingency planning and to communicate regularly with your supply chain and procurement departments as we monitor the situation closely.

Food and Drug Administration Resources: 

Drug Shortage List: ACCESS HERE

Medical Devices Shortage List: ACCESS HERE

 

Additional Suggested Resources for Clinical Practice:

AHVAP Position Statements: ACCESS HERE

AORN Guidelines for Perioperative Practice: ACCESS HERE

HealthcareReady Supply Ready: Leading Practices for Disaster-Related Supply Chain Resilience in Community Health Centers

Healthcare Ready Enhancing Community Health Center Supply Chain Preparedness and Resilience Collaborative Procurement Playbook

Healthcare Ready Worksheet 1: Quick EP Checklist

Healthcare Ready Worksheet 2: Collaborative Procurement

Healthcare Ready Critical Supplies Guide

Healthcare Ready Alert Hub