On-Demand Saline: Smart Tech, But Not a Miracle Cure

The Administration for Strategic Preparedness and Response (ASPR) has launched a pilot program to decentralize intravenous (IV) fluid production. In partnership with DEKA Research and Development Corp, the initiative centers on “Caspian,” an automated, sterile saline manufacturing system. Two pilot units are currently being deployed-one at Walter Reed National Military Medical Center in Bethesda, MD, and another undergoing FDA evaluation. Each unit can produce up to 500 IV bags per day, representing a meaningful step toward localized autonomy and national supply chain resilience.

While many questions remain, and not all details are yet publicly available, the concept reflects a broader commitment to strengthen domestic production and reimagine how lifesaving supplies are distributed.

Why Decentralization Makes Sense

• Reducing Single-Point Failures: The IV supply chain in the U.S. relies heavily on a small number of manufacturers. Localized production helps buffer against disruptions caused by pandemics, natural disasters, or supply chain bottlenecks.

• Faster Emergency Response: Onsite production allows hospitals to maintain operations during sudden surges, avoiding delays tied to transportation or international sourcing.

• Strategic Redundancy: Distributed production units offer essential backup capacity when centralized facilities are overwhelmed or inaccessible.

These benefits align with federal goals to reduce foreign dependence, bolster domestic manufacturing, and strengthen critical infrastructure.

Practical Realities and Cost Considerations

Despite its potential, widespread deployment of these manufacturing units comes with real-world challenges:

1. Upfront and Operational Costs

• Implementation requires significant investment in sterile equipment, clean room environments, staff training, and ongoing maintenance.

• Rural hospitals and small clinics may be unable to adopt this technology without dedicated subsidies or grants.

2. Capacity Constraints

• Each unit produces up to 500 IV bags per day. This may be insufficient for medium or large hospitals, which often require 500–1,000 bags daily—and significantly more during crises.

• Caspian units are best seen as supplementary assets, not full replacements for centralized suppliers.

3. Feasibility for Rural and Underserved Areas

• Although these units could enhance regional resilience, many rural facilities lack the infrastructure, funding, or workforce to implement them independently.

• Federal support, similar to rural broadband initiatives such as those outlined by USDA Rural Development, may be necessary to ensure equitable adoption.

4. Return on Investment (ROI)

• Local production may appear cost-inefficient during normal operations but proves invaluable during supply disruptions.

• Long-term savings come from avoided delays, improved surge capacity, and sustained continuity of care.

5. Legal, Regulatory, and Quality Control Considerations

• Sterile IV fluid production requires compliance with FDA Good Manufacturing Practices (GMP), including sterility protocols and batch-level documentation.

• Facilities will need FDA approval, trained quality assurance staff, and robust inspection systems.

• Legal risks—including liability for contamination, product recalls, and inconsistent oversight—must be factored into planning.

• State health departments may impose additional licensing or inspection requirements, complicating multi-state deployment.

A Strategic Middle Ground: Regional Production Hubs

Lessons from the Baxter Disruption

The need for diversified IV production became especially clear following the disruption at Baxter’s North Cove facility in North Carolina in 2024. The plant, which produced a significant share of the nation’s IV fluids, was damaged by Hurricane Helene, resulting in a nationwide shortage that affected nearly 90% of hospitals. Significant disruption was reported widespread disruptions across the healthcare system. Elective procedures were delayed, alternative rehydration solutions were used, and the Defense Production Act had to be invoked to accelerate recovery.

Despite federal intervention and restored operations by early 2025, ripple effects lingered for months- highlighting the fragility of our centralized production model.

This disruption underscores the value of decentralized- but regionally concentrated- IV fluid production. A single storm should not threaten the national supply chain of something as fundamental as sterile saline.

Why Regional Makes Sense

While point-of-care production is innovative, a regional approach may offer greater efficiency, oversight, and sustainability. Producing IV fluids regionally allows facilities to benefit from the economies of scale typically enjoyed by centralized manufacturers- without the geographic vulnerabilities of relying on a handful of national suppliers. By concentrating production in regional hubs, systems can:

• Reduce per-unit costs through higher output volumes.

• Pool staffing, training, and quality control resources.

• Establish shared logistics networks for storage and delivery.

• Build redundancies into multi-hospital systems without duplicating infrastructure at every site.

This model preserves the agility and local responsiveness of point-of-care systems while boosting economic and operational feasibility:

• Hub-and-Spoke Models: Regional medical centers equipped with Caspian units could supply nearby hospitals and clinics.

• Scalable Infrastructure: Larger systems may require multiple units or integration with existing procurement networks.

• Cross-Sector Collaboration: Effective governance will rely on strong partnerships among hospitals, public health agencies, and emergency planners.

Recommendations for Success

To ensure meaningful impact, policymakers and implementers should:

• Provide subsidies and incentives to support adoption, particularly in rural and under-resourced areas.

• Promote regional deployment models to extend production capacity beyond individual hospitals.

• Develop performance benchmarks and integrate real-time monitoring to track production and distribution.

• Clarify regulatory pathways to streamline approvals while ensuring safety and consistency.

Final Thoughts

ASPR’s Caspian initiative represents a promising step toward a more resilient and distributed medical supply system. While not a replacement for centralized manufacturing, it offers critical redundancy and flexibility to bolster national healthcare infrastructure.

There are still many unknowns- from cost models to regulatory frameworks, but this effort signals a refreshing shift toward smarter, more responsive supply chains. With thoughtful implementation, decentralized IV production can play a transformative role in emergency preparedness and health system resilience, especially for rural and under-resourced communities.